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Two-Year Clinical Results of Lateral Collagen Meniscus Implant: A Multicenter Study.

Purpose: To present the 2-year results of the use of the lateral Collagen Meniscus Implant (CMI) for the treatment of irreparable lateral meniscal lesions or partial lateral meniscal defects, to investigate the potential predictors of clinical results, and to monitor device safety. Methods: Forty-three patients with a mean age of 30.1 ± 12.0 years were clinically evaluated 24 months after treatment of partial lateral meniscal defects with the CMI (Ivy Sports Medicine, Gräfelfing, Germany). We used the Lysholm score, the Tegner Activity Scale, a visual analog scale for pain (during strenuous activity, during routine activity, and at rest), a functional questionnaire, and a satisfaction questionnaire for the evaluation. All demographic and surgical parameters were used for multiple regression analysis to find outcome predictors. Serious adverse events and reoperations were monitored. Results: All clinical scores significantly improved from preoperatively to final evaluation at 24.2 ± 1.9 months' follow-up. The Lysholm score improved significantly from 64.3 ± 18.4 preoperatively to 93.2 ± 7.2 at final follow-up (P = .0001). Functional improvement was detected from 6 months after surgery, whereas strenuous activities and knee swelling reached optimal results after 12 months. The highest pain ratings experienced during strenuous activity, during routine activity, and at rest significantly improved from 59 ± 29, 29 ± 25, and 20 ± 25, respectively, preoperatively to 14 ± 18, 3 ± 5, and 2 ± 6, respectively, at 2 years' follow-up (P = .0001). At final follow-up, 58% of patients reported activity levels similar to their preinjury values whereas 95% of patients reported that they were satisfied with the procedure. A higher body mass index, the presence of concomitant procedures, and a chronic injury pattern seemed to negatively affect the final outcomes. Serious adverse events with a known or unknown relation to the scaffold, such as pain, swelling, and scaffold resorption, were reported in 6% of patients, leading to CMI explantation, debridement, or synovectomy. Conclusions: The lateral CMI scaffold could be considered a potentially effective and safe procedure to treat both irreparable lateral meniscal tears and post-meniscectomy syndrome in appropriately selected patients. Chronic injury, high body mass index, and concomitant procedures have been shown to negatively affect the short-term results; however, the results appeared to slowly improve through the 24-month follow-up period. Thus patience is needed when evaluating the expectations for and results of the described procedure. Level of evidence: Level IV, therapeutic case series.

Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association · randomised controlled trial · 28 citationsread the source →

Treatment efficacy and effectiveness in adults with major depressive disorder and childhood trauma history: a systematic review and meta-analysis.

Background: Childhood trauma is a common and potent risk factor for developing major depressive disorder in adulthood, associated with earlier onset, more chronic or recurrent symptoms, and greater probability of having comorbidities. Some studies indicate that evidence-based pharmacotherapies and psychotherapies for adult depression might be less efficacious in patients with a history of childhood trauma than patients without childhood trauma, but findings are inconsistent. Therefore, we examined whether individuals with major depressive disorder, including chronic forms of depression, and a reported history of childhood trauma, had more severe depressive symptoms before treatment, had more unfavourable treatment outcomes following active treatments, and were less likely to benefit from active treatments relative to a control condition, compared with individuals with depression without childhood trauma. Methods: We did a comprehensive meta-analysis (PROSPERO CRD42020220139). Study selection combined the search of bibliographical databases (PubMed, PsycINFO, and Embase) from Nov 21, 2013, to March 16, 2020, and full-text randomised clinical trials (RCTs) identified from several sources (1966 up to 2016-19) to identify articles in English. RCTs and open trials comparing the efficacy or effectiveness of evidence-based pharmacotherapy, psychotherapy, or combination intervention for adult patients with depressive disorders and the presence or absence of childhood trauma were included. Two independent researchers extracted study characteristics. Group data for effect-size calculations were requested from study authors. The primary outcome was depression severity change from baseline to the end of the acute treatment phase, expressed as standardised effect size (Hedges' g). Meta-analyses were done using random-effects models. Findings: From 10 505 publications, 54 trials met the inclusion criteria, of which 29 (20 RCTs and nine open trials) contributed data of a maximum of 6830 participants (age range 18-85 years, male and female individuals and specific ethnicity data unavailable). More than half (4268 [62%] of 6830) of patients with major depressive disorder reported a history of childhood trauma. Despite having more severe depression at baseline (g=0·202, 95% CI 0·145 to 0·258, I2=0%), patients with childhood trauma benefitted from active treatment similarly to patients without childhood trauma history (treatment effect difference between groups g=0·016, -0·094 to 0·125, I2=44·3%), with no significant difference in active treatment effects (vs control condition) between individuals with and without childhood trauma (childhood trauma g=0·605, 0·294 to 0·916, I2=58·0%; no childhood trauma g=0·178, -0·195 to 0·552, I2=67·5%; between-group difference p=0·051), and similar dropout rates (risk ratio 1·063, 0·945 to 1·195, I2=0%). Findings did not significantly differ by childhood trauma type, study design, depression diagnosis, assessment method of childhood trauma, study quality, year, or treatment type or length, but differed by country (North American studies showed larger treatment effects for patients with childhood trauma; false discovery rate corrected p=0·0080). Most studies had a moderate to high risk of bias (21 [72%] of 29), but the sensitivity analysis in low-bias studies yielded similar findings to when all studies were included. Interpretation: Contrary to previous studies, we found evidence that the symptoms of patients with major depressive disorder and childhood trauma significantly improve after pharmacological and psychotherapeutic treatments, notwithstanding their higher severity of depressive symptoms. Evidence-based psychotherapy and pharmacotherapy should be offered to patients with major depressive disorder regardless of childhood trauma status. Funding: None.

The lancet. Psychiatry · meta-analysis · 65 citationsread the source →

Cannabinoids for the treatment of mental disorders and symptoms of mental disorders: a systematic review and meta-analysis.

Background: Medicinal cannabinoids, including medicinal cannabis and pharmaceutical cannabinoids and their synthetic derivatives, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), have been suggested to have a therapeutic role in certain mental disorders. We analysed the available evidence to ascertain the effectiveness and safety of all types of medicinal cannabinoids in treating symptoms of various mental disorders. Methods: For this systematic review and meta-analysis we searched MEDLINE, Embase, PsycINFO, the Cochrane Central Register of Controlled Clinical Trials, and the Cochrane Database of Systematic Reviews for studies published between Jan 1, 1980, and April 30, 2018. We also searched for unpublished or ongoing studies on ClinicalTrials.gov, the EU Clinical Trials Register, and the Australian and New Zealand Clinical Trials Registry. We considered all studies examining any type and formulation of a medicinal cannabinoid in adults (≥18 years) for treating depression, anxiety, attention-deficit hyperactivity disorder (ADHD), Tourette syndrome, post-traumatic stress disorder, or psychosis, either as the primary condition or secondary to other medical conditions. We placed no restrictions on language, publication status, or study type (ie, both experimental and observational study designs were included). Primary outcomes were remission from and changes in symptoms of these mental disorders. The safety of medicinal cannabinoids for these mental disorders was also examined. Evidence from randomised controlled trials was synthesised as odds ratios (ORs) for disorder remission, adverse events, and withdrawals and as standardised mean differences (SMDs) for change in symptoms, via random-effects meta-analyses. The quality of the evidence was assessed with the Cochrane risk of bias tool and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. This study is registered with PROSPERO (CRD42017059372, CRD42017059373, CRD42017059376, CRD42017064996, and CRD42018102977). Findings: 83 eligible studies (40 randomised controlled trials, n=3067) were included: 42 for depression (23 randomised controlled trials; n=2551), 31 for anxiety (17 randomised controlled trials; n=605), eight for Tourette syndrome (two randomised controlled trials; n=36), three for ADHD (one randomised controlled trial; n=30), 12 for post-traumatic stress disorder (one randomised controlled trial; n=10), and 11 for psychosis (six randomised controlled trials; n=281). Pharmaceutical THC (with or without CBD) improved anxiety symptoms among individuals with other medical conditions (primarily chronic non-cancer pain and multiple sclerosis; SMD -0·25 [95% CI -0·49 to -0·01]; seven studies; n=252), although the evidence GRADE was very low. Pharmaceutical THC (with or without CBD) worsened negative symptoms of psychosis in a single study (SMD 0·36 [95% CI 0·10 to 0·62]; n=24). Pharmaceutical THC (with or without CBD) did not significantly affect any other primary outcomes for the mental disorders examined but did increase the number of people who had adverse events (OR 1·99 [95% CI 1·20 to 3·29]; ten studies; n=1495) and withdrawals due to adverse events (2·78 [1·59 to 4·86]; 11 studies; n=1621) compared with placebo across all mental disorders examined. Few randomised controlled trials examined the role of pharmaceutical CBD or medicinal cannabis. Interpretation: There is scarce evidence to suggest that cannabinoids improve depressive disorders and symptoms, anxiety disorders, attention-deficit hyperactivity disorder, Tourette syndrome, post-traumatic stress disorder, or psychosis. There is very low quality evidence that pharmaceutical THC (with or without CBD) leads to a small improvement in symptoms of anxiety among individuals with other medical conditions. There remains insufficient evidence to provide guidance on the use of cannabinoids for treating mental disorders within a regulatory framework. Further high-quality studies directly examining the effect of cannabinoids on treating mental disorders are needed. Funding: Therapeutic Goods Administration, Australia; Commonwealth Department of Health, Australia; Australian National Health and Medical Research Council; and US National Institutes of Health.

The lancet. Psychiatry · meta-analysis · 309 citationsread the source →

Rapid Systematic Review: The Impact of Social Isolation and Loneliness on the Mental Health of Children and Adolescents in the Context of COVID-19.

Objective: Disease containment of COVID-19 has necessitated widespread social isolation. We aimed to establish what is known about how loneliness and disease containment measures impact on the mental health in children and adolescents. Method: For this rapid review, we searched MEDLINE, PsycInfo, and Web of Science for articles published between January 1, 1946, and March 29, 2020. Of the articles, 20% were double screened using predefined criteria, and 20% of data was double extracted for quality assurance. Results: A total of 83 articles (80 studies) met inclusion criteria. Of these, 63 studies reported on the impact of social isolation and loneliness on the mental health of previously healthy children and adolescents (n = 51,576; mean age 15.3 years). In all, 61 studies were observational, 18 were longitudinal, and 43 were cross-sectional studies assessing self-reported loneliness in healthy children and adolescents. One of these studies was a retrospective investigation after a pandemic. Two studies evaluated interventions. Studies had a high risk of bias, although longitudinal studies were of better methodological quality. Social isolation and loneliness increased the risk of depression, and possibly anxiety at the time at which loneliness was measured and between 0.25 and 9 years later. Duration of loneliness was more strongly correlated with mental health symptoms than intensity of loneliness. Conclusion: Children and adolescents are probably more likely to experience high rates of depression and most likely anxiety during and after enforced isolation ends. This may increase as enforced isolation continues. Clinical services should offer preventive support and early intervention where possible and be prepared for an increase in mental health problems.

Journal of the American Academy of Child and Adolescent Psychiatry · systematic review · 1492 citationsread the source →

Hope, optimism, self-efficacy, and posttraumatic stress disorder: A meta-analytic review of the protective effects of positive expectancies.

Objective: The present meta-analysis consolidated research examining how positive expectancies (e.g., hope, self-efficacy, and optimism) may protect against the development of posttraumatic stress disorder (PTSD). Method: Articles were identified by searching PILOTS, PsycINFO, PubMed, and ProQuest Dissertations and Theses databases. Results: Aggregated results from 154 studies indicated that positive expectancies were associated with lower levels of PTSD symptoms. This relationship was stronger for coping-specific self-efficacy (k = 38, r = -.49; -.54 to -.43) and hope (k = 20, r = -.34; -.39 to -.28) compared with general self-efficacy (k = 45, r = -.25; -.30 to -.20) and optimism (k = 59, r = -.29; -.33 to -.25) when examining cross-sectional studies, and results were consistent in prospective studies. Age and gender did not moderate the cross-sectional relationships. Conclusions: These findings indicate that positive expectancies predict post-trauma resilience. Future research should identify moderators and examine positive expectancies as mechanisms of change in therapy.

Journal of clinical psychology · meta-analysis · 116 citationsread the source →

Gender differences in behavioural changes induced by latent toxoplasmosis.

There is growing evidence that the protozoan Toxoplasma gondii modifies behaviour of its intermediate hosts, including humans, where it globally infects about 20-60% of the population. Although it is considered asymptomatic in its latent stage, it was previously found to have remarkable and gender different effects on the personality factors A (warmth), G (rule consciousness), L (vigilance, mistrust) and Q3 (self-control, self-image) from Cattell's 16PF Questionnaire. We performed a double blind experiment testing 72 and 142 uninfected men and women, respectively, and 20 and 29 infected men and women, respectively, in order to verify these gender differences using behavioural experiments. Our composite behavioural variables Self-Control and Clothes Tidiness (analogue to the 16PF factors G--conscientiousness and Q3--self-control) showed a significant effect of the toxoplasmosis-gender interaction with infected men scoring significantly lower than uninfected men and a trend in the opposite direction in women. The effect of the toxoplasmosis-gender interaction on our composite behavioural variable Relationships (analogue to factor A--warmth) approached significance; infected men scored significantly lower than uninfected men whereas there was no difference in women. In the composite behavioural variable Mistrust (analogue to factor L), the pattern was affected by environment (rural versus urban). Possible interpretations of the gender differences are discussed.

International journal for parasitology · randomised controlled trial · 81 citationsread the source →

A randomized effectiveness trial of cognitive-behavioral therapy and medication for primary care panic disorder.

Background: Panic disorder is a prevalent, often disabling condition among patients in the primary care setting. Although numerous studies have assessed the effectiveness of treatments for depression in primary care, few such studies have been conducted for panic disorder. Objective: To implement and test the effectiveness of a combined pharmacotherapy and cognitive-behavioral intervention for panic disorder tailored to the primary care setting. Design: Randomized, controlled study comparing intervention to treatment as usual. Setting: Six primary care clinics associated with 3 university medical schools, serving an ethnically and socioeconomically diverse patient population. Participants: Two hundred thirty-two primary care patients meeting DSM-IV criteria for panic disorder. Comorbid mental and physical disorders were permitted, provided these did not contraindicate the treatment to be provided and were not acutely life threatening. Intervention: Patients were randomized to receive either treatment as usual or an intervention consisting of a combination of up to 6 sessions (across 12 weeks) of cognitive-behavioral therapy (CBT) modified for the primary care setting, with up to 6 follow-up telephone contacts during the next 9 months, and algorithm-based pharmacotherapy provided by the primary care physician with guidance from a psychiatrist. Behavioral health specialists, the majority inexperienced in CBT for panic disorder, were trained to deliver the CBT and coordinated overall care, including pharmacotherapy. Main outcomes measures: Proportion of subjects remitted (no panic attacks in the past month, minimal anticipatory anxiety, and agoraphobia subscale score <10 on Fear Questionnaire) and responding (Anxiety Sensitivity Index score <20) and change over time in World Health Organization Disability Scale and short form 12 scores. Results: The combined cognitive-behavioral and pharmacotherapeutic intervention resulted in sustained and gradually increasing improvement relative to treatment as usual, with significantly higher rates at all points of both the proportion of subjects remitted (3 months, 20% vs 12%; 12 months, 29% vs 16%) and responding (3 months, 46% vs 27%; 12 months, 63% vs 38%) and significantly greater improvements in World Health Organization Disability Scale (all points) and short form 12 mental health functioning (3 and 6 months) scores. These effects were obtained in spite of similar rates of delivery of guideline-concordant pharmacotherapy to the 2 groups. Conclusion: Delivery of evidence-based CBT and medication using the collaborative care model and a CBT-naive, midlevel behavioral health specialist is feasible and significantly more effective than usual care for primary care panic disorder.

Archives of general psychiatry · randomised controlled trial · 150 citationsread the source →

Anti-vascular endothelial growth factor for diabetic macular oedema.

Background: Diabetic macular oedema (DMO) is a common complication of diabetic retinopathy. Although grid or focal laser photocoagulation has been shown to reduce the risk of visual loss in DMO, or clinically significant macular oedema (CSMO), vision is rarely improved. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) modalities is used to try to improve vision in people with DMO. Objectives: To investigate the effects in preserving and improving vision and acceptability, including the safety, compliance with therapy and quality of life, of antiangiogenic therapy with anti-VEGF modalities for the treatment of DMO. Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 3), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to April 2014), EMBASE (January 1980 to April 2014), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to April 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 28 April 2014. Selection criteria: We included randomised controlled trials (RCTs) comparing any antiangiogenic drugs with an anti-VEGF mechanism of action versus another treatment, sham treatment or no treatment in people with DMO. Data collection and analysis: We used standard methodological procedures expected by The Cochrane Collaboration. The risk ratios (RR) for visual loss and visual gain of three or more lines of logMAR visual acuity were estimated at one year of follow-up (plus or minus six months) after treatment initiation. Main results: Eighteen studies provided data on four comparisons of interest in this review. Participants in the trials had central DMO and moderate vision loss. Compared with grid laser photocoagulation, people treated with antiangiogenic therapy were more likely to gain 3 or more lines of vision at one year (RR 3.6, 95% confidence interval (CI) 2.7 to 4.8, 10 studies, 1333 cases, high quality evidence) and less likely to lose 3 or more lines of vision (RR 0.11, 95% CI 0.05 to 0.24, 7 studies, 1086 cases, high quality evidence). In meta-analyses, no significant subgroup difference was demonstrated between bevacizumab, ranibizumab and aflibercept for the two primary outcomes, but there was little power to detect a difference. The quality of the evidence was judged to be high, because the effect was large, precisely measured and did not vary across studies, although some studies were at high or unclear risk of bias for one or more domains. Regarding absolute benefit, we estimated that 8 out of 100 participants with DMO may gain 3 or more lines of visual acuity using photocoagulation whereas 28 would do so with antiangiogenic therapy, meaning that 100 participants need to be treated with antiangiogenic therapy to allow 20 more people (95% CI 13 to 29) to markedly improve their vision after one year. People treated with anti-VEGF on average had 1.6 lines better vision (95% CI 1.4 to 1.8) after one year compared to laser photocoagulation (9 studies, 1292 cases, high quality evidence). To achieve this result, seven to nine injections were delivered in the first year and three or four in the second, in larger studies adopting either as needed regimens with monthly monitoring or fixed regimens. In other analyses antiangiogenic therapy was more effective than sham (3 studies on 497 analysed participants, high quality evidence) and ranibizumab associated with laser was more effective than laser alone (4 studies on 919 participants, high quality evidence).Ocular severe adverse events, such as endophthalmitis, were rare in the included studies. Meta-analyses conducted for all antiangiogenic drugs compared with either sham or photocoagulation did not show a significant difference regarding serious systemic adverse events (15 studies, 441 events in 2985 participants, RR 0.98, 95% CI 0.83 to 1.17), arterial thromboembolic events (14 studies, 129 events in 3034 participants, RR 0.89, 95% CI 0.63 to 1.25) and overall mortality (63 events in 3562 participants, RR 0.88, 95% CI 0.52 to 1.47). We judged the quality of the evidence on adverse effects as moderate due to partial reporting of safety data and the exclusion of participants with previous cardiovascular events in some studies. Authors' conclusions: There is high quality evidence that antiangiogenic drugs provide a benefit compared to current therapeutic options for DMO, that is grid laser photocoagulation, in clinical trial populations at one or two years. Future research should investigate differences between drugs, effectiveness under real-world monitoring and treatment conditions, and safety in high-risk populations, particularly regarding cardiovascular risk.

The Cochrane database of systematic reviews · meta-analysis · 99 citationsread the source →

Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery.

Background: Abdominal surgery represents a physiologic stress and is associated with a period of recovery during which functional capacity is often diminished. "Prehabilitation" is a program to increase functional capacity in anticipation of an upcoming stressor. We reported recently the results of a randomized trial comparing 2 prehabilitation programs before colorectal surgery (stationary cycling plus weight training versus a recommendation to increase walking coupled with breathing exercises); however, adherence to the programs was low. The objectives of this study were to estimate: (1) the extent to which physical function could be improved with either prehabilitation program and identify variables associated with response; and (2) the impact of change in preoperative function on postoperative recovery. Methods: This study involved a reanalysis of data arising from a randomized trial. The primary outcome measure was functional walking capacity measured by the Six-Minute Walk Test; secondary outcomes were anxiety, depression, health-related quality of life, and complications (Clavien classification). Multiple linear regression was used to estimate the extent to which key variables predicted change in functional walking capacity over the prehabilitation and follow-up periods. Results: We included 95 people who completed the prehabilitation phase (median, 38 days; interquartile range, 22-60), and 75 who were also evaluated postoperatively (mean, 9 weeks). During prehabilitation, 33% improved their physical function, 38% stayed within 20 m of their baseline score, and 29% deteriorated. Among those who improved, mental health, vitality, self-perceived health, and peak exercise capacity also increased significantly. Women were less likely to improve; low baseline walking capacity, anxiety, and the belief that fitness aids recovery were associated with improvements during prehabilitation. In the postoperative phase, the patients who had improved during prehabilitation were also more likely to have recovered to their baseline walking capacity than those with no change or deterioration (77% vs 59% and 32%; P = .0007). Patients who deteriorated were at greater risk of complications requiring reoperation and/or intensive care management. Significant predictors of poorer recovery included deterioration during prehabilitation, age >75 years, high anxiety, complications requiring intervention, and timing of follow-up assessment. Conclusion: In a group of patients undergoing scheduled colorectal surgery, meaningful changes in functional capacity can be achieved over several weeks of prehabilitation. Patients and those who care for them, especially those with poor physical capacity, should consider a prehabilitation regimen to enhance functional exercise capacity before colectomy.

Surgery · randomised controlled trial · 298 citationsread the source →

Do urban environments increase the risk of anxiety, depression and psychosis? An epidemiological study.

Background: The present study aimed to investigate whether there is an association between type of living environment (urban versus rural) and anxiety, depression and psychosis in the Scottish population. Methods: Data were obtained from the Scottish Neighbourhood Statistics database on Scottish Index of Multiple Deprivation and urban-rural classifications for 6505 data zones across Scotland. Multiple regression was used to test the association between prescriptions for psychotropic medication for anxiety, depression and psychosis, and type of living environment according to urban-rural classification, controlling for a range of socio-economic factors. Results: Urban-rural classification significantly predicted poorer mental health both before (β=-.29) and after (β=-.20) controlling for a large number of socio-economic variables, with more urban areas having higher rates of prescription for psychotropic medication for anxiety, depression and psychosis. Limitations: The current study focussed on macro-level variables and did not include individual level data. As such, the study did not include data on individual diagnoses, but instead used drug prescriptions for anxiety, depression and psychosis as a proxy for level of affective disorders within data zones. Conclusion: More urban living environments in Scotland are associated with higher rates of prescription for psychotropic medication for anxiety, depression and psychosis.

Journal of affective disorders · cohort or longitudinal · 72 citationsread the source →

Significant Risk of Graft-versus-Host Disease with Exposure to Checkpoint Inhibitors before and after Allogeneic Transplantation.

Investigators are using checkpoint inhibitors (CPIs) to treat aggressive hematologic malignancies in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) and in some patients with relapsed disease after allo-HSCT. CTLA-4 inhibitors and PD-1 inhibitors are 2 main types of CPIs, which work through activation of the immune system. On one hand, CPIs can achieve graft-versus-tumor effect, and on the other hand, there is a risk of graft-versus-host disease (GVHD). After a comprehensive literature review, we included data (n = 283) from 24 studies (11 original manuscripts and 13 case reports or case series) and evaluated the results to assess the safety and efficacy of CPI use in conjunction with allo-HSCT. Among the 283 patients, 107 received CPI before allo-HSCT, and 176 received CPI after allo-HSCT. The most common indication for CPI use was for Hodgkin lymphoma. The CPIs used in various studies included ipilimumab, nivolumab, and pembrolizumab. Among the patients exposed to CPI before allo-HSCT, 56% developed acute GVHD and 29% developed chronic GVHD. Investigators reported 20 deaths, 60% of which were GVHD-related. The overall mortality risk with GVHD is 11%. In this group, investigators noted an objective response rate (ORR) in 68% of patients, with complete remission (CR) in 47%, partial remission (PR) in 21%, and stable disease in 11%. Among the patients who received a CPI after allo-HSCT for disease relapse, 14% developed acute GVHD and 9% developed chronic GVHD. Investigators reported 40 deaths, 28% of which were GVHD-related. The mortality risk with GVHD is approximately 7%. Investigators reported ORR in 54% of patients, with CR in 33%, PR in 21%, and disease stabilization in 5%. After careful evaluation of collective data, we found that CPI use both before and after allo-HSCT can be highly effective, but exposure can lead to a significantly increased risk of GVHD-related morbidity and mortality in this patient population. Despite limited availability of data, there is need for extreme caution while making decisions regarding the use of CPIs. Detailed discussions and prospective well-designed clinical trials are needed to explore this issue further.

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · review · 134 citationsread the source →

Adverse childhood experiences and related outcomes among adults experiencing homelessness: a systematic review and meta-analysis.

Background: Adverse childhood experiences (ACEs) are strong risk factors for homelessness and poor health and functioning. We aimed to evaluate the lifetime prevalence of ACEs and their associations with health-related and functioning-related outcomes among homeless adults. Methods: In this systematic review and meta-analysis, we searched from database inception to Nov 11, 2020, for original and peer-reviewed studies in English that documented lifetime prevalence of ACEs or associations between ACEs and health-related or functioning-related outcomes. We selected studies if they included a definable group of homeless adults and measured at least four ACE categories. We calculated pooled estimates of lifetime prevalence of one or more ACEs and four or more ACEs with random-effects models. We used the leave-one-out method in sensitivity analyses and studied meta-regressions to explore potential moderators of ACE prevalence. We also did a narrative summary of associations between ACEs and health-related and functioning-related outcomes, as there were too few studies on each outcome for quantitative meta-analysis. This study is registered with PROSPERO, CRD42020218741. Findings: We identified 2129 studies through systematic search, of which 29 studies (16 942 individuals) were included in the systematic review, 20 studies (10 034 individuals) were included in the meta-analysis for one or more ACEs, and 15 studies (5693 individuals) were included in the meta-analysis for four or more ACEs. Studies included samples of adults experiencing homelessness in the USA, Canada, and the UK; participants in the included studies were predominantly male (65·2%) and mean ages ranged between 18·3 and 58·1 years, but many studies did not report race, ethnicity, and sexual and gender minority data. Lifetime prevalence of one or more ACEs among homeless adults was 89·8% (95% CI 83·7-93·7) and the lifetime prevalence of four or more ACEs was 53·9% (45·9-61·7). Considerable heterogeneity was identified in both meta-analyses (I2>95%). Of the potential moderators analysed, the ACE measurement tool significantly moderated the estimated lifetime prevalence of one or more ACEs and four or more ACEs, and age also significantly moderated the estimated lifetime prevalence of four or more ACEs. In the narrative synthesis, ACEs were consistently positively associated with high suicidality (two studies), suicide attempt (three studies), major depressive disorder (two studies), substance misuse (two studies), and adult victimisation (two studies). Interpretation: The lifetime prevalence of ACEs is substantially higher among homeless adults than among the general population, and ACE exposure might be associated with prevalence of mental illness, substance misuse, and victimisation. Policy efforts and evidence-based interventions are urgently needed to prevent ACEs and address associated poor outcomes among this population. Funding: Rhodes Trust and Canadian Institutes of Health Research.

The Lancet. Public health · meta-analysis · 70 citationsread the source →

Substance use and abuse in first-episode psychosis: prevalence before and after early intervention.

Unlabelled: Despite the high prevalence of substance abuse among first-episode psychosis (FEP) populations, few studies examine whether early intervention (EI) improves substance abuse. Objective: To examine the prevalence and pattern of substance use and abuse among an FEP sample over 12 months. Methods: All the participants were diagnosed with a first episode of a schizophrenia spectrum disorder. The participants were followed prospectively. The prevalence rates of substance use and abuse from this sample were compared before and after 12 months of EI services and were compared with rates observed in a sample from the general population. Results: A total of 200 participants (80.0% males; mean age 24 years) entered the study: 183 participants completed all the assessments at baseline, 131 participants completed all the assessments at 12 months. At baseline, the findings showed similar prevalence rates between the FEP sample and the general sample for lifetime cannabis use (60% vs 55%, respectively) and hazardous alcohol use (26% vs 21%) but significantly different prevalence rates for lifetime hallucinogen (29% vs 15%; P < .001) and cocaine use (20% vs 14%; P < .001). At 12 months, the prevalence rates for drug abuse (P < .01), hazardous alcohol use (P < .01), and concurrent drug abuse and hazardous alcohol use (P < .05) were significantly lower than at baseline. Conclusion: Substance use and abuse decreased significantly after 12 months of EI services; EI services may be able to detect and to reduce substance use among FEP patients before it becomes a more serious disorder.

Schizophrenia bulletin · cohort or longitudinal · 74 citationsread the source →

Associations Between Health Screening Rates and Visits to Their Primary Care Provider in Young Adults Transitioning From Pediatrics to Adult Medicine.

Introduction: This study examines associations between a young adult's visit to a designated primary care physician (PCP) in the 18 months after transitioning from pediatrics and their completion of preventive healthcare screenings. The period from 18 to 25 years is marked by transition and continued brain development, making it an ideal period for impactful intervention on healthy behaviors and outcomes. Methods: Completion of screening for alcohol use, mental health issues, exercise habits, and tobacco use was measured in members upon turning 18 during 2020-2021. These members had transitioned from pediatrics to adult medicine at an integrated healthcare system at Kaiser Permanente Northern California. Associations of sex, race and ethnicity, need of interpreter, insurance type, neighborhood deprivation, pediatric PCP visit, and chronic conditions were compared for members with or without a visit with their new PCP during the 18 months of transition. Results: A multivariate model showed that young adults with a visit to their PCP had increased likelihood of completion of screening: 21% for alcohol use, 12% for mental health issues, 18% for exercise, and 16% for tobacco use. Several characteristics were associated with a reduced likelihood of a visit with a PCP: 15% reduced likelihood for residence in more deprived neighborhoods (incidence rate ratio=0.85, 95% CI=0.82, 0.88); between a 6% and 3% reduced likelihood for individuals who were Asian, Black or Hispanic (incidence rate ratio=0.96, 95% CI=0.93, 0.99), (incidence rate ratio=0.94, 95% CI=0.90, 0.98), (incidence rate ratio=0.97, 95% CI=0.94, 0.99) respectively; 55% reduced likelihood for those requiring an interpreter (incidence rate ratio=0.45, 95% CI=0.37, 0.53); and 16% reduced likelihood for males (incidence rate ratio=0.84, 95% CI=0.82, 0.86). Individuals who had a visit to their pediatric PCP, and individuals with chronic conditions, were 20% and 29% more likely, respectively, to have had a visit with their adult PCP (incidence rate ratio=1.20, 95% CI=1.18, 1.23) and (incidence rate ratio=1.29, 95% CI=1.27, 1.32). Conclusion: Promotion of PCP visits and outreach to individuals with a reduced likelihood of visiting their PCP during this transition could provide opportunities for preventive health interventions among young adults.

AJPM focusread the source →

Effect of habits, traditions, and beliefs on seizure diagnosis and provide first aid in Taif city, KSA.

Aim: To determine the effect of habits, traditions, and beliefs on seizure diagnosis and provide first aid in Taif city, KSA. Methods: A cross-sectional study was conducted on 297 participants from Taif, KSA. An Arabic self-administrated electronic questionnaire was used that included different parts to collect the information from participants; characters, previous history of seizures, habits, beliefs and traditions about the seizures and first aid. Results: Most of the participants had an average level of knowledge by 20.88, 47.14 and 31.99% of the participants had a poor, average and good level of knowledge about seizures and epilepsy. 70.0% of our participants knew that seizure is a symptom associated with many diseases; 40.7% knew that hypoglycemia can cause a seizure, while 37 and 32.3% did not know seizure treatment and whether Hijama and Cupping therapy were enough to treat seizure; 26.9 and 35.4% of the participants responded by neither putting something hard on the patient's mouth nor opening the patient's mouth by force to protect him from swallowing his tongue, respectively. Only 17.2% agreed on not calling the ambulance for all seizure cases. Participants aged between 20 and 29 and single had a significant higher percent of good knowledge with no significant association between gender, income and educational level and the participant's level of knowledge. Conclusion: There is a lack of knowledge and misconceptions about aspects related to seizures among the studied participants. It is recommended to raise awareness and correct false misconceptions about providing first aid to seizure patients.

Journal of family medicine and primary care · 2 citationsread the source →

Effect of Package of Interventions on the Use and Quality of Postpartum Family Planning Services at Yekatit 12 Hospital Medical College (Y12HMC), Addis Ababa, Ethiopia.

Background: Postpartum Family Planning (PPFP), which aims to prevent high risk unintended and closely spaced pregnancies during the first year following childbirth, is one of the highest impact interventions to avoid increased risk of premature birth, low birth weight, fetal and neonatal death, and adverse maternal health outcomes. This study aimed to assess the combined effect of a package of interventions on the use and quality of PPFP services at Y12HMC, Addis Ababa Ethiopia. Method: Cross-sectional study design was conducted to evaluate the effect of the package of chosen interventions: creating a private counseling space near the postpartum ward and providing training for health care providers on the WHO decision tool kit and Long Acting Contraceptive Methods (LACM). Interviews were conducted with 470 women (235 before and 235 after the intervention). Frequency tables and graphs were used to describe the study variables and statistical significance between pre and post intervention indicators was declared at P value <.05. Results: From 470 participants, 421 respondents participated which makes response rate of 90%. The majority of the participants were in the age category 20 to 29 years, married/lived together, completed at least primary education and had more than one child both at baseline and post intervention. The proportion of women who chose PPFP increased from 55.8% at baseline to 69% after the intervention. The most preferred contraceptive method was implant. The overall service satisfaction level of the study participants was 95.4% post intervention, significantly higher than at baseline (78%, P < .05). Providers indicated that clients are satisfied with the service and that the institutional structure is appropriate for delivering integrated services following the intervention. Conclusion: This study demonstrated that quality improvement interventions like creating a private counseling space and providing training using WHO decision tool kit can achieve significant improvement on satisfaction of clients and PPFP uptake.

Health services insights · 5 citationsread the source →

Iron deficiency without anemia is associated with anger and fatigue in young Japanese women.

Iron deficiency without anemia (IDNA), the most prevalent nutritional deficiency worldwide, affects young women of reproductive age. This study aimed to elucidate the relationship between IDNA and mental and somatic symptoms including anger and fatigue using the Japanese version of the Cornell Medical Index Health Questionnaire (CMI-J). Data regarding demographic characteristics, anthropometry, hematological, and biochemical indices of the iron status, frequencies of selected food intakes assessed by self-administered food frequency questionnaires (FFQs), frequencies of nonspecific symptoms, and grades of neurotic tendencies assessed by CMI-J were collected from 76 young women aged 18-22 years living in the metropolitan area of Tokyo, Japan. The subjects were classified as having IDNA (hemoglobin (Hb)≥12 g/dL and serum ferritin<20 ng/mL; n=29), having iron deficiency anemia (IDA) (Hb<12 g/dL and serum ferritin<20 ng/mL; n=10), or having a normal iron status (Hb≥12 g/dL and serum ferritin≥20 ng/mL; n=36). One subject was excluded from the analyses because of Hb<12 g/dL and serum ferritin≥20 ng/mL. Fisher's protected least significant difference and the Dwass-Steel-Chritchlow-Fligner multiple comparison tests were used to compare the data of the three groups. P values<0.05 were considered significant. Sections M-R (mental complaints) were significantly higher in the IDNA subjects than in the normal subjects. No significant difference in CMI scores was found between the normal and IDA subjects. Sections I (fatigability), Q (anger), and R (tension) were significantly higher in the IDNA subjects than in the normal subjects, regardless of no significant differences between the normal and IDA subjects in those sections. Young women with IDNA demonstrated a significantly higher proportion of neurotic tendencies (grades II-IV). The intake frequency score of canned or bottled green tea fortified with vitamin C was significantly higher in the IDNA subjects than the IDA subjects. The findings suggest that IDNA may be a risk factor for anger, fatigue, and tension in women of childbearing age.

Biological trace element research · 31 citationsread the source →

Effect of a Workplace Wellness Program on Employee Health and Economic Outcomes: A Randomized Clinical Trial.

Importance: Employers have increasingly invested in workplace wellness programs to improve employee health and decrease health care costs. However, there is little experimental evidence on the effects of these programs. Objective: To evaluate a multicomponent workplace wellness program resembling programs offered by US employers. Design, setting, and participants: This clustered randomized trial was implemented at 160 worksites from January 2015 through June 2016. Administrative claims and employment data were gathered continuously through June 30, 2016; data from surveys and biometrics were collected from July 1, 2016, through August 31, 2016. Interventions: There were 20 randomly selected treatment worksites (4037 employees) and 140 randomly selected control worksites (28 937 employees, including 20 primary control worksites [4106 employees]). Control worksites received no wellness programming. The program comprised 8 modules focused on nutrition, physical activity, stress reduction, and related topics implemented by registered dietitians at the treatment worksites. Main outcomes and measures: Four outcome domains were assessed. Self-reported health and behaviors via surveys (29 outcomes) and clinical measures of health via screenings (10 outcomes) were compared among 20 intervention and 20 primary control sites; health care spending and utilization (38 outcomes) and employment outcomes (3 outcomes) from administrative data were compared among 20 intervention and 140 control sites. Results: Among 32 974 employees (mean [SD] age, 38.6 [15.2] years; 15 272 [45.9%] women), the mean participation rate in surveys and screenings at intervention sites was 36.2% to 44.6% (n = 4037 employees) and at primary control sites was 34.4% to 43.0% (n = 4106 employees) (mean of 1.3 program modules completed). After 18 months, the rates for 2 self-reported outcomes were higher in the intervention group than in the control group: for engaging in regular exercise (69.8% vs 61.9%; adjusted difference, 8.3 percentage points [95% CI, 3.9-12.8]; adjusted P = .03) and for actively managing weight (69.2% vs 54.7%; adjusted difference, 13.6 percentage points [95% CI, 7.1-20.2]; adjusted P = .02). The program had no significant effects on other prespecified outcomes: 27 self-reported health outcomes and behaviors (including self-reported health, sleep quality, and food choices), 10 clinical markers of health (including cholesterol, blood pressure, and body mass index), 38 medical and pharmaceutical spending and utilization measures, and 3 employment outcomes (absenteeism, job tenure, and job performance). Conclusions and relevance: Among employees of a large US warehouse retail company, a workplace wellness program resulted in significantly greater rates of some positive self-reported health behaviors among those exposed compared with employees who were not exposed, but there were no significant differences in clinical measures of health, health care spending and utilization, and employment outcomes after 18 months. Although limited by incomplete data on some outcomes, these findings may temper expectations about the financial return on investment that wellness programs can deliver in the short term. Trial registration: ClinicalTrials.gov Identifier: NCT03167658.

JAMA · randomised controlled trial · 170 citationsread the source →

Non-clinical interventions for reducing unnecessary caesarean section.

Background: Caesarean section rates are increasing globally. The factors contributing to this increase are complex, and identifying interventions to address them is challenging. Non-clinical interventions are applied independently of a clinical encounter between a health provider and a patient. Such interventions may target women, health professionals or organisations. They address the determinants of caesarean births and could have a role in reducing unnecessary caesarean sections. This review was first published in 2011. This review update will inform a new WHO guideline, and the scope of the update was informed by WHO's Guideline Development Group for this guideline. Objectives: To evaluate the effectiveness and safety of non-clinical interventions intended to reduce unnecessary caesarean section. Search methods: We searched CENTRAL, MEDLINE, Embase, CINAHL and two trials registers in March 2018. We also searched websites of relevant organisations and reference lists of related reviews. Selection criteria: Randomised trials, non-randomised trials, controlled before-after studies, interrupted time series studies and repeated measures studies were eligible for inclusion. The primary outcome measures were: caesarean section, spontaneous vaginal birth and instrumental birth. Data collection and analysis: We followed standard methodological procedures recommended by Cochrane. We narratively described results of individual studies (drawing summarised evidence from single studies assessing distinct interventions). Main results: We included 29 studies in this review (19 randomised trials, 1 controlled before-after study and 9 interrupted time series studies). Most of the studies (20 studies) were conducted in high-income countries and none took place in low-income countries. The studies enrolled a mixed population of pregnant women, including nulliparous women, multiparous women, women with a fear of childbirth, women with high levels of anxiety and women having undergone a previous caesarean section. Overall, we found low-, moderate- or high-certainty evidence that the following interventions have a beneficial effect on at least one primary outcome measure and no moderate- or high-certainty evidence of adverse effects. Interventions targeted at women or familiesChildbirth training workshops for mothers alone may reduce caesarean section (risk ratio (RR) 0.55, 95% confidence interval (CI) 0.33 to 0.89) and may increase spontaneous vaginal birth (RR 2.25, 95% CI 1.16 to 4.36). Childbirth training workshops for couples may reduce caesarean section (RR 0.59, 95% CI 0.37 to 0.94) and may increase spontaneous vaginal birth (RR 2.13, 95% CI 1.09 to 4.16). We judged this one study with 60 participants to have low-certainty evidence for the outcomes above. Nurse-led applied relaxation training programmes (RR 0.22, 95% CI 0.11 to 0.43; 104 participants, low-certainty evidence) and psychosocial couple-based prevention programmes (RR 0.53, 95% CI 0.32 to 0.90; 147 participants, low-certainty evidence) may reduce caesarean section. Psychoeducation may increase spontaneous vaginal birth (RR 1.33, 95% CI 1.11 to 1.61; 371 participants, low-certainty evidence). The control group received routine maternity care in all studies. There were insufficient data on the effect of the four interventions on maternal and neonatal mortality or morbidity. Interventions targeted at healthcare professionalsImplementation of clinical practice guidelines combined with mandatory second opinion for caesarean section indication slightly reduces the risk of overall caesarean section (mean difference in rate change -1.9%, 95% CI -3.8 to -0.1; 149,223 participants). Implementation of clinical practice guidelines combined with audit and feedback also slightly reduces the risk of caesarean section (risk difference (RD) -1.8%, 95% CI -3.8 to -0.2; 105,351 participants). Physician education by local opinion leader (obstetrician-gynaecologist) reduced the risk of elective caesarean section to 53.7% from 66.8% (opinion leader education: 53.7%, 95% CI 46.5 to 61.0%; control: 66.8%, 95% CI 61.7 to 72.0%; 2496 participants). Healthcare professionals in the control groups received routine care in the studies. There was little or no difference in maternal and neonatal mortality or morbidity between study groups. We judged the certainty of evidence to be high. Interventions targeted at healthcare organisations or facilitiesCollaborative midwifery-labourist care (in which the obstetrician provides in-house labour and delivery coverage, 24 hours a day, without competing clinical duties), versus a private practice model of care, may reduce the primary caesarean section rate. In one interrupted time series study, the caesarean section rate decreased by 7% in the year after the intervention, and by 1.7% per year thereafter (1722 participants); the vaginal birth rate after caesarean section increased from 13.3% before to 22.4% after the intervention (684 participants). Maternal and neonatal mortality were not reported. We judged the certainty of evidence to be low. We studied the following interventions, and they either made little or no difference to caesarean section rates or had uncertain effects. Moderate-certainty evidence suggests little or no difference in caesarean section rates between usual care and: antenatal education programmes for physiologic childbirth; antenatal education on natural childbirth preparation with training in breathing and relaxation techniques; computer-based decision aids; individualised prenatal education and support programmes (versus written information in pamphlet).Low-certainty evidence suggests little or no difference in caesarean section rates between usual care and: psychoeducation; pelvic floor muscle training exercises with telephone follow-up (versus pelvic floor muscle training without telephone follow-up); intensive group therapy (cognitive behavioural therapy and childbirth psychotherapy); education of public health nurses on childbirth classes; role play (versus standard education using lectures); interactive decision aids (versus educational brochures); labourist model of obstetric care (versus traditional model of obstetric care).We are very uncertain as to the effect of other interventions identified on caesarean section rates as the certainty of the evidence is very low. Authors' conclusions: We evaluated a wide range of non-clinical interventions to reduce unnecessary caesarean section, mostly in high-income settings. Few interventions with moderate- or high-certainty evidence, mainly targeting healthcare professionals (implementation of guidelines combined with mandatory second opinion, implementation of guidelines combined with audit and feedback, physician education by local opinion leader) have been shown to safely reduce caesarean section rates. There are uncertainties in existing evidence related to very-low or low-certainty evidence, applicability of interventions and lack of studies, particularly around interventions targeted at women or families and healthcare organisations or facilities.

The Cochrane database of systematic reviews · meta-analysis · 131 citationsread the source →

Efficacy, acceptability and safety of cognitive behavioural therapies in fibromyalgia syndrome - A systematic review and meta-analysis of randomized controlled trials.

This updated systematic review aimed at evaluating the efficacy, acceptability and safety of cognitive behavioural therapies (CBTs) in fibromyalgia syndrome (FMS). Clinicaltrials.gov, Cochrane Library, MEDLINE, PsycINFO and SCOPUS were searched from September 2013 to May 2017. Randomized controlled trials (RCTs) comparing CBTs with controls were analysed. Primary outcomes were ≥50% pain relief, ≥20% improvement of health-related quality of life (HRQoL), negative mood, fatigue, disability, acceptability and safety at end of therapy and at 6 months follow-up. Effects were summarized by a random effects model using risk differences (RD) or standardized mean differences (SMD) with 95% confidence intervals (CI). 29 RCTs with 2509 subjects were included. CBTs were superior to controls (waiting list, attention control, treatment as usual, other active non-pharmacological therapies) in pain relief of 50% or greater (RD 0.05 [95% CI 0.02-0.07] (high-quality evidence), improvement of HRQoL of 20% or greater (RD 0.13 [95% CI 0.00-0.26], (moderate quality evidence), and in reducing negative mood (SMD -0.43 [95% CI -0.62 to -0.24]) (high-quality evidence), disability (SMD -0.30 [95% CI -0.52 to -0.08]) (high-quality evidence) and fatigue (SMD - 0-27 [95% CI -0.50 to -0.03]) (high-quality evidence). There were no statistically significant differences between CBTs and controls in acceptability and safety (high-quality evidence). The update did not change the major findings of the previous review. CBTs provided a clinically relevant benefit over control interventions in reducing some key symptoms of FMS and disability at the end of treatment. Significance: This updated systematic review with meta-analysis on cognitive behavioural therapies (CBTs) including acceptance-based CBTs endorse the efficacy and tolerability of CBTs in reducing key symptoms and disability in FMS in the short- and long-term if compared to waiting list, treatment as usual, attention controls and active non-pharmacological therapies. CBTs did not differ in efficacy except superiority for coping with pain and tolerability from recommended drug therapy (pregabalin and/or duloxetine).

European journal of pain (London, England) · meta-analysis · 137 citationsread the source →

Psychological therapies for the management of chronic pain (excluding headache) in adults.

Background: Chronic non-cancer pain, a disabling and distressing condition, is common in adults. It is a global public health problem and economic burden on health and social care systems and on people with chronic pain. Psychological treatments aim to reduce pain, disability and distress. This review updates and extends its previous version, published in 2012. Objectives: To determine the clinical efficacy and safety of psychological interventions for chronic pain in adults (age > 18 years) compared with active controls, or waiting list/treatment as usual (TAU). Search methods: We identified randomised controlled trials (RCTs) of psychological therapies by searching CENTRAL, MEDLINE, Embase and PsycINFO to 16 April 2020. We also examined reference lists and trial registries, and searched for studies citing retrieved trials. Selection criteria: RCTs of psychological treatments compared with active control or TAU of face-to-face therapies for adults with chronic pain. We excluded studies of headache or malignant disease, and those with fewer than 20 participants in any arm at treatment end. Data collection and analysis: Two or more authors rated risk of bias, extracted data, and judged quality of evidence (GRADE). We compared cognitive behavioural therapy (CBT), behavioural therapy (BT), and acceptance and commitment therapy (ACT) with active control or TAU at treatment end, and at six month to 12 month follow-up. We did not analyse the few trials of other psychological treatments. We assessed treatment effectiveness for pain intensity, disability, and distress. We extracted data on adverse events (AEs) associated with treatment. Main results: We added 41 studies (6255 participants) to 34 of the previous review's 42 studies, and now have 75 studies in total (9401 participants at treatment end). Most participants had fibromyalgia, chronic low back pain, rheumatoid arthritis, or mixed chronic pain. Most risk of bias domains were at high or unclear risk of bias, with selective reporting and treatment expectations mostly at unclear risk of bias. AEs were inadequately recorded and/or reported across studies. CBT The largest evidence base was for CBT (59 studies). CBT versus active control showed very small benefit at treatment end for pain (standardised mean difference (SMD) -0.09, 95% confidence interval (CI) -0.17 to -0.01; 3235 participants; 23 studies; moderate-quality evidence), disability (SMD -0.12, 95% CI -0.20 to -0.04; 2543 participants; 19 studies; moderate-quality evidence), and distress (SMD -0.09, 95% CI -0.18 to -0.00; 3297 participants; 24 studies; moderate-quality evidence). We found small benefits for CBT over TAU at treatment end for pain (SMD -0.22, 95% CI -0.33 to -0.10; 2572 participants; 29 studies; moderate-quality evidence), disability (SMD -0.32, 95% CI -0.45 to -0.19; 2524 participants; 28 studies; low-quality evidence), and distress (SMD -0.34, 95% CI -0.44 to -0.24; 2559 participants; 27 studies; moderate-quality evidence). Effects were largely maintained at follow-up for CBT versus TAU, but not for CBT versus active control. Evidence quality for CBT outcomes ranged from moderate to low. We rated evidence for AEs as very low quality for both comparisons. BT We analysed eight studies (647 participants). We found no evidence of difference between BT and active control at treatment end (pain SMD -0.67, 95% CI -2.54 to 1.20, very low-quality evidence; disability SMD -0.65, 95% CI -1.85 to 0.54, very low-quality evidence; or distress SMD -0.73, 95% CI -1.47 to 0.01, very low-quality evidence). At follow-up, effects were similar. We found no evidence of difference between BT and TAU (pain SMD -0.08, 95% CI -0.33 to 0.17, low-quality evidence; disability SMD -0.02, 95% CI -0.24 to 0.19, moderate-quality evidence; distress SMD 0.22, 95% CI -0.10 to 0.54, low-quality evidence) at treatment end. At follow-up, we found one to three studies with no evidence of difference between BT and TAU. We rated evidence for all BT versus active control outcomes as very low quality; for BT versus TAU. Evidence quality ranged from moderate to very low. We rated evidence for AEs as very low quality for BT versus active control. No studies of BT versus TAU reported AEs. ACT We analysed five studies (443 participants). There was no evidence of difference between ACT and active control for pain (SMD -0.54, 95% CI -1.20 to 0.11, very low-quality evidence), disability (SMD -1.51, 95% CI -3.05 to 0.03, very low-quality evidence) or distress (SMD -0.61, 95% CI -1.30 to 0.07, very low-quality evidence) at treatment end. At follow-up, there was no evidence of effect for pain or distress (both very low-quality evidence), but two studies showed a large benefit for reducing disability (SMD -2.56, 95% CI -4.22 to -0.89, very low-quality evidence). Two studies compared ACT to TAU at treatment end. Results should be interpreted with caution. We found large benefits of ACT for pain (SMD -0.83, 95% CI -1.57 to -0.09, very low-quality evidence), but none for disability (SMD -1.39, 95% CI -3.20 to 0.41, very low-quality evidence), or distress (SMD -1.16, 95% CI -2.51 to 0.20, very low-quality evidence). Lack of data precluded analysis at follow-up. We rated evidence quality for AEs to be very low. We encourage caution when interpreting very low-quality evidence because the estimates are uncertain and could be easily overturned. Authors' conclusions: We found sufficient evidence across a large evidence base (59 studies, over 5000 participants) that CBT has small or very small beneficial effects for reducing pain, disability, and distress in chronic pain, but we found insufficient evidence to assess AEs. Quality of evidence for CBT was mostly moderate, except for disability, which we rated as low quality. Further trials may provide more precise estimates of treatment effects, but to inform improvements, research should explore sources of variation in treatment effects. Evidence from trials of BT and ACT was of moderate to very low quality, so we are very uncertain about benefits or lack of benefits of these treatments for adults with chronic pain; other treatments were not analysed. These conclusions are similar to our 2012 review, apart from the separate analysis of ACT.

The Cochrane database of systematic reviews · meta-analysis · 349 citationsread the source →

Cannabis-based medicines for chronic neuropathic pain in adults.

Background: This review is one of a series on drugs used to treat chronic neuropathic pain. Estimates of the population prevalence of chronic pain with neuropathic components range between 6% and 10%. Current pharmacological treatment options for neuropathic pain afford substantial benefit for only a few people, often with adverse effects that outweigh the benefits. There is a need to explore other treatment options, with different mechanisms of action for treatment of conditions with chronic neuropathic pain. Cannabis has been used for millennia to reduce pain. Herbal cannabis is currently strongly promoted by some patients and their advocates to treat any type of chronic pain. Objectives: To assess the efficacy, tolerability, and safety of cannabis-based medicines (herbal, plant-derived, synthetic) compared to placebo or conventional drugs for conditions with chronic neuropathic pain in adults. Search methods: In November 2017 we searched CENTRAL, MEDLINE, Embase, and two trials registries for published and ongoing trials, and examined the reference lists of reviewed articles. Selection criteria: We selected randomised, double-blind controlled trials of medical cannabis, plant-derived and synthetic cannabis-based medicines against placebo or any other active treatment of conditions with chronic neuropathic pain in adults, with a treatment duration of at least two weeks and at least 10 participants per treatment arm. Data collection and analysis: Three review authors independently extracted data of study characteristics and outcomes of efficacy, tolerability and safety, examined issues of study quality, and assessed risk of bias. We resolved discrepancies by discussion. For efficacy, we calculated the number needed to treat for an additional beneficial outcome (NNTB) for pain relief of 30% and 50% or greater, patient's global impression to be much or very much improved, dropout rates due to lack of efficacy, and the standardised mean differences for pain intensity, sleep problems, health-related quality of life (HRQoL), and psychological distress. For tolerability, we calculated number needed to treat for an additional harmful outcome (NNTH) for withdrawal due to adverse events and specific adverse events, nervous system disorders and psychiatric disorders. For safety, we calculated NNTH for serious adverse events. Meta-analysis was undertaken using a random-effects model. We assessed the quality of evidence using GRADE and created a 'Summary of findings' table. Main results: We included 16 studies with 1750 participants. The studies were 2 to 26 weeks long and compared an oromucosal spray with a plant-derived combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) (10 studies), a synthetic cannabinoid mimicking THC (nabilone) (two studies), inhaled herbal cannabis (two studies) and plant-derived THC (dronabinol) (two studies) against placebo (15 studies) and an analgesic (dihydrocodeine) (one study). We used the Cochrane 'Risk of bias' tool to assess study quality. We defined studies with zero to two unclear or high risks of bias judgements to be high-quality studies, with three to five unclear or high risks of bias to be moderate-quality studies, and with six to eight unclear or high risks of bias to be low-quality studies. Study quality was low in two studies, moderate in 12 studies and high in two studies. Nine studies were at high risk of bias for study size. We rated the quality of the evidence according to GRADE as very low to moderate. Primary outcomesCannabis-based medicines may increase the number of people achieving 50% or greater pain relief compared with placebo (21% versus 17%; risk difference (RD) 0.05 (95% confidence interval (CI) 0.00 to 0.09); NNTB 20 (95% CI 11 to 100); 1001 participants, eight studies, low-quality evidence). We rated the evidence for improvement in Patient Global Impression of Change (PGIC) with cannabis to be of very low quality (26% versus 21%;RD 0.09 (95% CI 0.01 to 0.17); NNTB 11 (95% CI 6 to 100); 1092 participants, six studies). More participants withdrew from the studies due to adverse events with cannabis-based medicines (10% of participants) than with placebo (5% of participants) (RD 0.04 (95% CI 0.02 to 0.07); NNTH 25 (95% CI 16 to 50); 1848 participants, 13 studies, moderate-quality evidence). We did not have enough evidence to determine if cannabis-based medicines increase the frequency of serious adverse events compared with placebo (RD 0.01 (95% CI -0.01 to 0.03); 1876 participants, 13 studies, low-quality evidence).Secondary outcomesCannabis-based medicines probably increase the number of people achieving pain relief of 30% or greater compared with placebo (39% versus 33%; RD 0.09 (95% CI 0.03 to 0.15); NNTB 11 (95% CI 7 to 33); 1586 participants, 10 studies, moderate quality evidence). Cannabis-based medicines may increase nervous system adverse events compared with placebo (61% versus 29%; RD 0.38 (95% CI 0.18 to 0.58); NNTH 3 (95% CI 2 to 6); 1304 participants, nine studies, low-quality evidence). Psychiatric disorders occurred in 17% of participants using cannabis-based medicines and in 5% using placebo (RD 0.10 (95% CI 0.06 to 0.15); NNTH 10 (95% CI 7 to 16); 1314 participants, nine studies, low-quality evidence).We found no information about long-term risks in the studies analysed. Subgroup analysesWe are uncertain whether herbal cannabis reduces mean pain intensity (very low-quality evidence). Herbal cannabis and placebo did not differ in tolerability (very low-quality evidence). Authors' conclusions: The potential benefits of cannabis-based medicine (herbal cannabis, plant-derived or synthetic THC, THC/CBD oromucosal spray) in chronic neuropathic pain might be outweighed by their potential harms. The quality of evidence for pain relief outcomes reflects the exclusion of participants with a history of substance abuse and other significant comorbidities from the studies, together with their small sample sizes.

The Cochrane database of systematic reviews · meta-analysis · 288 citationsread the source →

Parental correlates in child and adolescent physical activity: a meta-analysis.

Objective: Physical activity (PA) has a profound impact on health and development in children. Parental behaviors (i.e., modeling and support) represent an obvious important factor in child PA. The purpose of this paper was to provide a comprehensive meta-analysis that overcomes the limitations of prior narrative reviews and quantitative reviews with small samples. Methods: Ten major databases were used in the literature search. One-hundred and fifteen studies passed the eligibility criteria. Both fixed and random effects models with correction for sampling and measurement error were examined in the analysis. Moderator analyses investigating the effects of child's developmental age, study design, parental gender, measurement of child PA, and quality rating were performed. Results: Based on the random effects model, the results showed that parental modeling was weakly associated with child PA (summary r = .16, 95% CI .09-.24) and none of the proposed moderators were significant. Separate analyses examining the moderating effects of parental gender and boys' PA found that that father-son PA modeling (r = .29, 95% CI .21-.36) was significantly higher compared to mother-son PA (r = .19, 95% CI .14-.23; p < .05). However, parental gender did not moderate the relationship between parental modeling and girls' PA (p > .05). The random effects model indicated an overall moderate effect size for the parental support and child PA relationship (summary r = .38, 95% CI .30-.46). Here, the only significant moderating variable was the measurement of child PA (objective: r = .20, 95% CI .13-.26; reported: r = .46, 95% CI .37-.55; p < .01). Conclusions: Parental support and modeling relate to child PA, yet our results revealed a significant degree of heterogeneity among the studies that could not be explained well by our proposed moderators.

The international journal of behavioral nutrition and physical activity · meta-analysis · 282 citationsread the source →

Emerging Adulthood and College‐aged Youth: An Overlooked Age for Weight‐related Behavior Change

Obesity is a major public health concern, and effective population-wide intervention strategies aimed at reducing obesity are needed. Although a growing body of literature has explored modifiable determinants of excess weight gain in adults and, to a lesser extent, in children, other important ages have been understudied. Though once considered to be an age of optimal health and well-being, the transition from adolescence to young adulthood is gaining recognition as an important time for health promotion and disease prevention. Not only is the presence of obesity and unhealthy lifestyle characteristics at this life stage associated with increased chronic disease risk, but this also may be a critical time during which young people establish independence and adopt lasting health behavior patterns. The objectives of this article are to: (i) describe emerging adulthood as a developmentally unique life stage, (ii) highlight epidemiologic evidence documenting adverse changes in diet, physical activity, and weight during this stage, (iii) discuss the influence of food and beverage marketing targeting emerging adults, and (iv) illustrate the need for health promotion and intervention efforts that could target young adults through settings such as postsecondary institutions. Over the past 50 years, major population-level demographic shifts including increases in postsecondary education and delays in marriage and childbearing have occurred. These shifts have opened the door for a period of “emerging adulthood,” typically defined as 18–25 years of age (1). This period is marked by important transitions such as leaving home and increasing autonomy in decision-making; however at the same time, adult responsibilities such as financial independence and residential and employment stability are still in flux. This period of emerging adulthood may be an important, yet overlooked, age for establishing long-term health behavior patterns. Several factors differentiate emerging adulthood from other life stages and have specific relevance to the formation of health behavior patterns, including identity development and shifting interpersonal influences. One defining characteristic of this life stage is the development of a self identity. Emerging adulthood is a time for the exploration of new ideologies and behaviors which allow individuals to express their individuality. Given previous research showing that identity (e.g., incorporating healthy lifestyle characteristics in the concept of one's self) is an important indicator of lasting health behavior change, emerging adulthood may be a particularly important time for establishing and intervening on long-term health behavior patterns (2,3). In addition, other psychosocial attributes associated with beneficial health behaviors (e.g., self-efficacy) develop or become established during this period of emerging adulthood (4), providing support for the unique importance of this life stage in long-term behavioral patterning. Emerging adulthood may also be a time for changing support systems and shifting interpersonal influences. Although the influence of parents and family is well established in the literature on childhood and, to a lesser extent, adolescent diet and physical activity patterns, little research has examined these issues among young adults. Young adults spend more leisure time alone compared to other age group (except retirees ≥55 years) (5) and are often assumed to be more disconnected from their family. However, some research suggests that closer relationships with parents (6,7) and siblings (8) may evolve as youth transition into college and adulthood (9,10). As youth become more independent, family and social network influences begin to shift and may serve different roles, as compared to that which they served in childhood and adolescence. Much additional research is needed to understand the evolving social influences in the emerging adult years and the extent to which this may influence health behavior patterns. Given the overall paucity of research in this area, more work is needed to understand better how the unique characteristics of emerging adulthood may contribute to establishing long-term behavioral patterns and the possible vulnerability of this life stage to various influences. The transition from adolescence to adulthood and the determinants of eating and physical activity is understudied. However, national trend data suggest that this is a risky period for the development of obesity, as well as unhealthy diet and physical activity practices. Weight gain. Research from national surveys and longitudinal cohorts has identified the transition between adolescence and adulthood as a period of increased risk for excess weight gain. Nationally representative cross-sectional survey data from the Behavioral Risk Factor Surveillance System indicated that from 1991 to 1998, the greatest magnitude of increase in obesity prevalence was among 18–29-year olds (increasing from 7.1 to 12.1%) (11). The prevalence of obesity among young adults more than doubled in the past 30 years. The most recent National Health and Nutrition Examination Survey (NHANES) data indicate that the prevalence has continued to increase since 1999 (ref. 12). Currently, 28.5% of 20–39-year olds are obese and 57.1% are overweight or obese (12). Nationally representative longitudinal cohort data from the National Longitudinal Study of Adolescent Health (Add Health) (13), assessing 9,795 adolescents (baseline age: 13–20 years in 1996), found that the 5-year incidence of obesity was nearly 13% (follow-up age: 19–26 years in 2001), whereas only 1.6% shifted from being obese to nonobese. In comparison to NHANES (1971–1974), the Add Health cohort showed substantial secular changes in the BMI distribution over time, particularly among individuals aged 19–26 years (13). In addition, findings from the CARDIA (Coronary Artery Risk Development in Young Adults) (14,15) longitudinal cohort illustrate both 5- and 10-year increases in weight among individuals 18–30 years of age at baseline (1985). Five-year weight gain was greater for men aged 18–24 years compared to men aged 25–30 years (14). Furthermore, the largest 10-year weight gains were seen among those in their early- to mid-twenties, as compared to those in their thirties (15). Physical activity. Although longitudinal data are limited, there is evidence of dramatic changes in lifestyle characteristics during this period. Cohort data from Add Health indicate that although most adolescents fail to meet national guidelines for physical activity (33.6%), even fewer meet these guidelines as young adults (12.7%) (16). In addition, findings from Project EAT (Eating Among Teens), a 5-year longitudinal cohort study of Minnesota adolescents, confirm such adverse changes in activity patterns during the transition from high school to young adulthood (17). Findings showed longitudinal changes in moderate to vigorous physical activity, particularly among girls (decreasing from 5.1 to 3.5 h/week aged from 16 to 20 years), and leisure time computer use, particularly among boys (increasing from 10.4 to 14.2 h/week aged from 16 to 20 years). Overall, many changes in physical activity patterns began during the transition from junior to senior high school and continued during the transition from high school to post-high school. One notable exception is moderate to vigorous physical activity among boys, which only began to decline during the transition after high school. Furthermore, a recent analysis of the National Health Interview survey data (18) indicated that age-related declines in physical activity are particularly pronounced between 15 and 18 years of age and continue through age 21. Physical activity has been shown to decline even further with specific life events typically following emerging adulthood (such as moving into a live-in relationship, getting married, and becoming a parent), but generally do not appear to continue to decline with age after mid-adulthood (30–64 years) (18). Thus health-promotion efforts to increase activity during emerging adulthood may be particularly important. Dietary intake. Research also suggests that declines in overall-diet quality may accompany these unfavorable shifts in activity patterns during the transition to adulthood (19,20). For example, fast food consumption has been associated with weight gain over time, and findings from national survey data indicate that fast food restaurant use is highest in young adulthood: 52% of 20–39 years reported eating fast food on one or both days of the Continuing Survey of Food Intakes by Individuals (1994–1996, 1998) (21). These data also indicate that soft drink intake is highest among 19–39-year olds compared to other age groups (22). In addition, NHANES data illustrate that a majority of young adults (aged 20–29 years) consume <1 serving/day of fruit (males 63%, females 59%) and vegetables (including potatoes, males 19%, females 20%) (23). Unfortunately, however, the collapsing of ages 19–39 years does not allow for an examination of the emerging adult period. Longitudinal findings from Project EAT also indicate adverse changes in dietary intake. For example, total fruit and vegetable intake decreased significantly (by >½ serving/day) during the 5-year transition period after high school (24). Add Health data indicate that fast food consumption markedly increased and consumption of breakfast decreased across a 5-year transition between adolescence and adulthood (25). The Bogalusa Heart Study (19), a longitudinal study of a biracial cohort following children >15 years into young adulthood, also showed a substantial decline in diet quality as individuals progressed through this transition. Findings indicate that individuals consumed less fruits/fruit juice and milk (19) and more sweetened beverages, salty snacks, and beef as young adults (19–28 years) than as children. Several studies have reported that despite changes in diet quality, there is substantial tracking in dietary intake between adolescence and young adulthood, as well as into later adulthood (20,26,27). Weight status also shows a high degree of tracking over time (28). Thus setting a “trajectory” for beneficial health behavior patterns and dietary intake during this time may be an important step toward initiating lasting healthy behaviors. Furthermore, a growing number of individuals are now becoming obese during adolescence and are exposed to a wide array of precursors to poor-diet quality and inactivity before the emerging adult years. For example, secular trends suggest declining rates of family meals and home food preparation (29), potentially leaving young adults without the skills to prepare foods and plan healthful meals on their own. Thus, challenges lie in reversing the effects of adverse adolescent exposures during the emerging adult years and promoting healthful long-term behavior patterns in all segments of the population. Dietary intake is influenced by a variety of factors, including individual, interpersonal, institutional, and macro-system influences. Although many of these influences are thought to be shared by a wide range of age groups, food and beverage marketing may be a particularly potent macro-level influence for emerging adults. The food, beverage and restaurant industries are estimated to have spent >$11 billion on advertising in 2004 alone (30). Young adults aged 18–24 years are a highly desirable market, particularly among fast food and soft drink companies. Marketing campaigns geared toward young adults, particularly males, have brought increased sales to fast food restaurant chains in the past decade (31,32,33,34). These campaigns have been specifically designed to increase product recognition, sales and brand loyalty among this group and have been widely promoted in young adult media markets. A number of these successful campaigns have targeted issues such as fast food late night dining and value pricing (32,35). For example, in launching its late night “Fourthmeal” campaign (with “Fourthmeal” marketed as “the meal between dinner and breakfast”), Taco Bell cites industry research in its press release indicating that nearly 50% of males aged 18–29 years are eating out after 7 pm (32). Industry research also suggests that young males spend well above market averages in these visits, averaging over $7.00 (ref. 36). To our knowledge, similar peer-reviewed evidence in the scientific literature is not available to confirm these trends. A number of these successful industry-driven campaigns have received recognition from the marketing and advertising community, for example, receiving EFFIE Awards (prestigious annual advertising awards) for their work in effectively targeting young adults. Honored campaigns include: • Hardee's. In 2001, industry research found that among its target markets Hardee's was “the most avoided restaurant in the fast food category” (31). Launching a major initiative targeting frequent fast food consumers, the company conducted “a segmentation analysis … to create a landscape from which we selected a more meaningful target for Hardee's. We called this target ‘Young Hungry Guys.’ This group is defined as young burger eaters (men 16–34) who want a more adult-like place to eat the burgers they love. This group seeks out big burgers as their food of choice, has the most growth potential for Hardee's and represent the heaviest usage in the fast food category” (31). With this, the Thickburger was introduced (providing ∼850–1,400 calories/burger). As a result, the company grew from the lowest to the highest ranked leading quick-service restaurant among young male fast food consumers (31). • Burger King. In February 2004 after significantly declining sales, Burger King refocused its efforts on its heaviest users, identified as males aged 16–34 years (34). To do so, they introduced the large-sized Angus Steak Burger. Describing its creative strategy, the marketing team states that “since the beginning of time, men have been eating large amounts of meat cooked over fires. For thousands of years, society has been wired to associate this kind of indulgence with power, pleasure and status. The problem is our culture is on an anti-indulgence craze the likes of which we have never seen before. Our strategy was to give our target permission to indulge in a great tasting burger and not apologize for it. And nothing gives them permission better than the affordable, deeply satisfying fire-grilled Angus Steak Burger…” (34). After increasing its market share among young men, this single-menu item subsequently accounted for 10% of sales dollars for Burger King. • Jack in the Box. After from the of a Jack in the that its was to create with the of the fast food young men, ages These were the fast food most began a marketing campaign on to to this including the campaign a of a media targeting males 18–24 years, Jack in the sales more than doubled from over billion in drink have also emerging adults as an important market For example, has major marketing campaigns targeting men, with the and In to promoting and advertising their through soft drink have to the of beverage by new targeting this age such as and (e.g., Thus, in we have little in the of public health to health among young adults, food and beverage marketing particularly from the fast food and soft drink have been targeting this age group over the past decade to establish brand loyalty and a of aged years are postsecondary In the development of health-promotion such may be well for emerging adult behaviors. However, that this life stage has been an of particularly in of obesity evidence is available to specific behaviors of college we have the which is from is a of research behaviors among other of such as those or obesity and weight Obesity is a major health among from the Health National Health an of indicated that the prevalence of overweight was including of these individuals who are obese Among the there has been recognition of the weight gain associated with college however, little research has explored this and its Several studies have shown that college is by substantial weight gain. the of gain an of with the of overweight or obese as as by the of the In females who home to to college have been shown to be to as to gain or more above their weight compared to females who not home indicating an important influence of some in the college on Furthermore, previous research suggests that this weight gain is specifically to important changes in body increased decreased Although some weight college has been estimated that gain weight during their years research following across years of that this weight gain is over time, with females on gaining and males gaining from to senior Although some growth may be to continued gains in particularly among males, many college youth may be on a of weight gain. 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In to diet and activity, there are other risk factors that are in emerging adults which may be to data indicate that of college consumed at one during the past intake has been with decreased and increased dietary intake in Although research that is associated with a range of adverse dietary patterns, and unhealthy weight among college youth additional work is needed to understand better the by which these behaviors are little research is available to understand the of other use (e.g., which of college youth in the past on meal and weight gain. 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As adopt new health behavior patterns, often from home for the time, college life may the stage for establishing important behavioral patterns that chronic disease postsecondary are settings for diet and physical may share residential factors (e.g., have to (e.g., less than of college and are to a Although postsecondary an even of groups (e.g., groups of work to has the prevalence of behaviors on these and the of these Although some of the factors (e.g., may not be to both and settings shared eating on and and in the for the need in this area, have not to work with these to and and physical activity In obesity and healthy weight are to and To be such strategies be and to the of the target Although there is a paucity of epidemiologic research to understand the most potent modifiable determinants of excess weight gain during the emerging adult years, we are to use the little evidence that is available to important for research in this Given the of influence on health as by the widely important for epidemiologic and intervention research a range of from macro-level to In some from research in other settings (e.g., and may be highly in postsecondary institutions. 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Although research in other of health promotion suggests that emerging adults who are not postsecondary may represent particularly youth research to has examined health behaviors among this work in this is by the through we these Although and postsecondary may a to develop health-promotion strategies targeting large groups of there is a continued need to develop through which also be that we do not the research is also needed to the for health which may also for many individuals during the emerging adult years, particularly as begin to ideologies of autonomy are on with those of on responsibilities and to This growing of and may in that an important influence diet and physical behaviors. 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Obesity · 1316 citationsread the source →

Psychosocial service use and unmet need among recently diagnosed adolescent and young adult cancer patients.

Background: Adolescents and young adults (AYAs) with cancer demonstrate biomedical risks and psychosocial issues distinct from those of children or older adults. In this study, the authors examined and compared the extent to which AYAs treated in pediatric or adult oncology settings reported use of, and unmet need for, psychosocial support services. Methods: Within 4 months of initial cancer diagnosis, 215 AYAs ages 14 to 39 years (99 from pediatric care settings and 116 from adult care settings; 75% response rate) were assessed for reporting use of information resources, emotional support services, and practical support services. Statistical analyses derived odds ratios and 95% confidence intervals for service use and unmet needs after controlling for race, employment/school status, sex, relationship status, severity of cancer, treatment, and treatment-related side effects. Results: AYAs ages 20 to 29 years were significantly less likely than teens and older patients ages 30 to 39 years to report using professional mental health services and were significantly more likely to report an unmet need with regard to cancer information, infertility information, and diet/nutrition information. Compared with teens who were treated in pediatric facilities, AYAs who were treated in adult facilities were more likely to report an unmet need for age-appropriate Internet sites, professional mental health services, camp/retreats programs, transportation assistance, and complementary and alternative health services. Conclusions: Substantial proportions of AYAs are not getting their psychosocial care needs met. Bolstering psychosocial support staff and patient referral to community-based social service agencies and reputable Internet resources may enhance care and improve quality of life for AYAs.

Cancer · 184 citationsread the source →

Usage of social media and smartphone application in assessment of physical and psychological well-being of individuals in times of a major air pollution crisis.

Background: Crisis situations bring about many challenges to researchers, public institutions, and governments in collecting data and conducting research in affected individuals. Recent developments in Web-based and smartphone technologies have offered government and nongovernment organizations a new system to disseminate and acquire information. However, research into this area is still lacking. The current study focuses largely on how new social networking websites and, in particular, smartphone technologies could have helped in the acquisition of crucial research data from the general population during the recent 2013 Southeast Asian Haze. This crisis lasted only for 1 week, and is unlike other crisis where there are large-scale consequential after-effects. Objective: To determine whether respondents will make use of Internet, social media, and smartphone technologies to provide feedback regarding their physical and psychological wellbeing during a crisis, and if so, will these new mechanisms be as effective as conventional, technological, Internet-based website technologies. Methods: A Web-based database and a smartphone application were developed. Participants were recruited by snowball sampling. The participants were recruited either via a self-sponsored Facebook post featuring a direct link to the questionnaire on physical and psychological wellbeing and also a smartphone Web-based application; or via dissemination of the questionnaire link by emails, directed to the same group of participants. Information pertaining to physical and psychological wellbeing was collated. Results: A total of 298 respondents took part in the survey. Most of them were between the ages of 20 to 29 years and had a university education. More individuals preferred the option of accessing and providing feedback to a survey on physical and psychological wellbeing via direct access to a Web-based questionnaire. Statistical analysis showed that demographic variables like age, gender, and educational levels did not influence the mechanism of access. In addition, the participants reported a mean number of 4.03 physical symptoms (SD 2.6). The total Impact of Event Scale-Revised (IES-R) score was 18.47 (SD 11.69), which indicated that the study population did experience psychological stress but not post-traumatic stress disorder. The perceived dangerous Pollutant Standards Index (PSI) level and the number of physical symptoms were associated with higher IES-R Score (P<.05). Conclusions: This is one of the first few studies demonstrating the use of Internet in data collection during an air-pollution crisis. Our results demonstrated that the newer technological modalities have the potential to acquire data, similar to that of conventional technologies. Demographic variables did not influence the mechanism of usage. In addition, our findings also suggested that there are acute physical and psychological impacts on the population from an air-pollution crisis.

JMIR mHealth and uHealth · 47 citationsread the source →

Decreasing nonmarital births and strengthening marriage to reduce poverty.

Since the 1970s, the share of U.S. children growing up in single-parent families has doubled, a trend that has disproportionately affected disadvantaged families. Paul Amato and Rebecca Maynard argue that reversing that trend would reduce poverty in the short-term and, perhaps more important, improve children's growth and development over the long term, thus reducing the likelihood that they would be poor when they grew up. The authors propose school and community programs to help prevent nonmarital births. They also propose to lower divorce rates by offering more educational programs to couples before and during marriage. Amato and Maynard recommend that all school systems offer health and sex education whose primary message is that parenthood is highly problematic for unmarried youth. They also recommend educating young people about methods to prevent unintended pregnancies. Ideally, the federal government would provide tested curriculum models that emphasize both abstinence and use of contraception. All youth should understand that unintended pregnancies are preventable and have enormous costs for the mother, the father, the child, and society. Strengthening marriage, argue the authors, is also potentially an effective strategy for fighting poverty. Researchers consistently find that premarital education improves marital quality and lowers the risk of divorce. About 40 percent of couples about to marry now participate in premarital education. Amato and Maynard recommend doubling that figure to 80 percent and making similar programs available for married couples. Increasing the number of couples receiving services could mean roughly 72,000 fewer divorces each year, or around 65,000 fewer children entering a single-parent family every year because of marital dissolution. After seven or eight years, half a million fewer children would have entered single-parent families through divorce. Efforts to decrease the share of children in single-parent households, say the authors, would almost certainly be cost effective in the long run and could reduce child poverty by 20 to 29 percent.

The Future of children · 12 citationsread the source →

Training Community Health Advisors in African American Churches: Do Training Outcomes Predict Performance?

Programs that utilize Community Health Advisors (CHAs) to promote cancer screening are effective in community settings. However, predictors of CHA performance are not well understood. From 2016 to 2018, we partnered with 9 African American churches in South Los Angeles and trained 49 CHAs to promote cancer screening in an effort to build capacity for health promotion in a low-resource community. This paper examines CHA characteristics and training outcomes in African American faith-based settings and explores the relationship of these variables to successful recruitment of participants by CHAs. Pre- and post-tests showed statistically significant increases in knowledge of colorectal cancer screening guidelines (4 items) and human subjects protection rules (5 items) and CHAs' perceived self-efficacy to perform specific tasks for the study (13 items, Cronbach's alpha > 0.90). There were no significant differences between active CHAs who recruited at least 10 participants (N = 29) and inactive/less active CHAs (N = 20) with respect to demographic characteristics and training outcomes. We report challenges and facilitators to recruitment from CHA debriefings at 12 months follow-up. Based on our findings, we make recommendations for future studies to move this field forward.

Journal of cancer education : the official journal of the American Association for Cancer Education · 6 citationsread the source →

Burnout and psychological distress amongst Australian healthcare workers during the COVID-19 pandemic.

Objective: To examine psychological distress in healthcare workers (HCWs) during the COVID-19 pandemic in April-May 2020. Methods: A cross-sectional survey examining demographic, employment and mental health characteristics of HCWs in a large metropolitan hospital in Australia. Results: HCWs showed significant symptoms of moderate-severe level depression (21%), anxiety (20%) and posttraumatic stress disorder (PTSD; 29%), associated with burnout, prior psychiatric history, profession and resilience. Conclusion: Despite low levels of COVID contact, moderate to high levels of psychological distress were reported. Continued monitoring and support for HCWs' mental well-being is warranted as the COVID-19 pandemic develops.

Australasian psychiatry : bulletin of Royal Australian and New Zealand College of Psychiatrists · 148 citationsread the source →

Natural language processing for mental health interventions: a systematic review and research framework.

Neuropsychiatric disorders pose a high societal cost, but their treatment is hindered by lack of objective outcomes and fidelity metrics. AI technologies and specifically Natural Language Processing (NLP) have emerged as tools to study mental health interventions (MHI) at the level of their constituent conversations. However, NLP's potential to address clinical and research challenges remains unclear. We therefore conducted a pre-registered systematic review of NLP-MHI studies using PRISMA guidelines (osf.io/s52jh) to evaluate their models, clinical applications, and to identify biases and gaps. Candidate studies (n = 19,756), including peer-reviewed AI conference manuscripts, were collected up to January 2023 through PubMed, PsycINFO, Scopus, Google Scholar, and ArXiv. A total of 102 articles were included to investigate their computational characteristics (NLP algorithms, audio features, machine learning pipelines, outcome metrics), clinical characteristics (clinical ground truths, study samples, clinical focus), and limitations. Results indicate a rapid growth of NLP MHI studies since 2019, characterized by increased sample sizes and use of large language models. Digital health platforms were the largest providers of MHI data. Ground truth for supervised learning models was based on clinician ratings (n = 31), patient self-report (n = 29) and annotations by raters (n = 26). Text-based features contributed more to model accuracy than audio markers. Patients' clinical presentation (n = 34), response to intervention (n = 11), intervention monitoring (n = 20), providers' characteristics (n = 12), relational dynamics (n = 14), and data preparation (n = 4) were commonly investigated clinical categories. Limitations of reviewed studies included lack of linguistic diversity, limited reproducibility, and population bias. A research framework is developed and validated (NLPxMHI) to assist computational and clinical researchers in addressing the remaining gaps in applying NLP to MHI, with the goal of improving clinical utility, data access, and fairness.

Translational psychiatry · systematic review · 80 citationsread the source →

Maternal plasma levels of oxytocin during breastfeeding-A systematic review.

Introduction: Oxytocin is a key hormone in breastfeeding. No recent review on plasma levels of oxytocin in response to breastfeeding is available. Materials and methods: Systematic literature searches on breastfeeding induced oxytocin levels were conducted 2017 and 2019 in PubMed, Scopus, CINAHL, and PsycINFO. Data on oxytocin linked effects and effects of medical interventions were included if available. Results: We found 29 articles that met the inclusion criteria. All studies had an exploratory design and included 601 women. Data were extracted from the articles and summarised in tables. Breastfeeding induced an immediate and short lasting (20 minutes) release of oxytocin. The release was pulsatile early postpartum (5 pulses/10 minutes) and coalesced into a more protracted rise as lactation proceeded. Oxytocin levels were higher in multiparous versus primiparous women. The number of oxytocin pulses during early breastfeeding was associated with greater milk yield and longer duration of lactation and was reduced by stress. Breastfeeding-induced oxytocin release was associated with elevated prolactin levels; lowered ACTH and cortisol (stress hormones) and somatostatin (a gastrointestinal hormone) levels; enhanced sociability; and reduced anxiety, suggesting that oxytocin induces physiological and psychological adaptations in the mother. Mechanical breast pumping, but not bottle-feeding was associated with oxytocin and prolactin release and decreased stress levels. Emergency caesarean section reduced oxytocin and prolactin release in response to breastfeeding and also maternal mental adaptations. Epidural analgesia reduced prolactin and mental adaptation, whereas infusions of synthetic oxytocin increased prolactin and mental adaptation. Oxytocin infusion also restored negative effects induced by caesarean section and epidural analgesia. Conclusions: Oxytocin is released in response to breastfeeding to cause milk ejection, and to induce physiological changes to promote milk production and psychological adaptations to facilitate motherhood. Stress and medical interventions during birth may influence these effects and thereby adversely affect the initiation of breastfeeding.

PloS one · systematic review · 144 citationsread the source →

Workplace interventions to improve well-being and reduce burnout for nurses, physicians and allied healthcare professionals: a systematic review.

There is a growing need for interventions to improve well-being in healthcare workers, particularly since the onset of COVID-19. Objectives: To synthesise evidence since 2015 on the impact of interventions designed to address well-being and burnout in physicians, nurses and allied healthcare professionals. Design: Systematic literature review. Data sources: Medline, Embase, Emcare, CINAHL, PsycInfo and Google Scholar were searched in May-October 2022. Eligibility criteria for selecting studies: Studies that primarily investigated burnout and/or well-being and reported quantifiable preintervention and postintervention outcomes using validated well-being measures were included. Data extraction and synthesis: Full-text articles in English were independently screened and quality assessed by two researchers using the Medical Education Research Study Quality Instrument. Results were synthesised and presented in both quantitative and narrative formats. Meta-analysis was not possible due to variations in study designs and outcomes. Results: A total of 1663 articles were screened for eligibility, with 33 meeting inclusion criterium. Thirty studies used individually focused interventions, while three were organisationally focused. Thirty-one studies used secondary level interventions (managed stress in individuals) and two were primary level (eliminated stress causes). Mindfulness-based practices were adopted in 20 studies; the remainder used meditation, yoga and acupuncture. Other interventions promoted a positive mindset (gratitude journaling, choirs, coaching) while organisational interventions centred on workload reduction, job crafting and peer networks. Effective outcomes were reported in 29 studies, with significant improvements in well-being, work engagement, quality of life and resilience, and reductions in burnout, perceived stress, anxiety and depression. Conclusion: The review found that interventions benefitted healthcare workers by increasing well-being, engagement and resilience, and reducing burnout. It is noted that the outcomes of numerous studies were impacted by design limitations that is, no control/waitlist control, and/or no post intervention follow-up. Suggestions are made for future research.

BMJ open · systematic review · 197 citationsread the source →

Acculturation and biological stress markers: A systematic review.

Background: The association of acculturation with health among immigrant populations is believed to be mediated, in part, by acculturation-related stress and stress biology. Objectives: To review and qualitatively synthesize empirical findings on the relationship of acculturation with stress-related inflammatory and endocrine biomarkers and composite allostatic load (AL) scores. Methods: A literature search was performed in the PubMed and PsycInfo databases. Article titles, abstracts or full-texts were screened and checked for match with the search criteria. Studies were eligible if they empirically tested the relationship between acculturation and inflammatory/endocrine stress biomarkers or composite AL scores, and were published in the English language. Results: Among the 41 articles identified as relevant and included in this review, the majority were published after 2010, included adult Hispanic U.S.-based populations, used cross-sectional study designs, operationalized acculturation as a unidimensional construct, and varied considerably in the selection of covariates in the analyses. Acculturation was significantly associated with stress biomarkers in 29 studies, but the direction of effects varied across studies. Specifically, acculturation, operationalized as a higher orientation towards the host culture, was associated with inflammatory biomarkers in 10 of 14 studies, with endocrine stress biomarkers in 12 of 20 studies, and with composite AL scores in 7 of 8 studies. Overall, language-based proxy measures of acculturation were related to higher levels of stress-related inflammatory and endocrine biomarkers and to lower levels of AL scores, whereas nativity-, generation status- and length of stay-based proxy measures of acculturation were related to higher levels of inflammatory biomarkers and AL score. Discussion: The majority of studies reported associations between measures of acculturation and stress biomarkers, however the directions of effects varied across studies. We suggest this heterogeneity may, in part, be a function of limitations imposed by cross-sectional research designs and unidimensional measures of acculturation measures, and we highlight the need for longitudinal studies and use of multidimensional measures of acculturation to better uncover the biobehavioral mechanisms and pathways linking acculturation with health outcomes.

Psychoneuroendocrinology · systematic review · 26 citationsread the source →

Denosumab, raloxifene, romosozumab and teriparatide to prevent osteoporotic fragility fractures: a systematic review and economic evaluation.

Background: Fragility fractures are fractures that result from mechanical forces that would not ordinarily result in fracture. Objectives: The objectives were to evaluate the clinical effectiveness, safety and cost-effectiveness of non-bisphosphonates {denosumab [Prolia®; Amgen Inc., Thousand Oaks, CA, USA], raloxifene [Evista®; Daiichi Sankyo Company, Ltd, Tokyo, Japan], romosozumab [Evenity®; Union Chimique Belge (UCB) S.A. (Brussels, Belgium) and Amgen Inc.] and teriparatide [Forsteo®; Eli Lilly and Company, Indianapolis, IN, USA]}, compared with each other, bisphosphonates or no treatment, for the prevention of fragility fracture. Data sources: For the clinical effectiveness review, nine electronic databases (including MEDLINE, EMBASE and the World Health Organization International Clinical Trials Registry Platform) were searched up to July 2018. Review methods: A systematic review and network meta-analysis of fracture and femoral neck bone mineral density were conducted. A review of published economic analyses was undertaken and a model previously used to evaluate bisphosphonates was adapted. Discrete event simulation was used to estimate lifetime costs and quality-adjusted life-years for a simulated cohort of patients with heterogeneous characteristics. This was done for each non-bisphosphonate treatment, a strategy of no treatment, and the five bisphosphonate treatments previously evaluated. The model was populated with effectiveness evidence from the systematic review and network meta-analysis. All other parameters were estimated from published sources. An NHS and Personal Social Services perspective was taken, and costs and benefits were discounted at 3.5% per annum. Fracture risk was estimated from patient characteristics using the QFracture® (QFracture-2012 open source revision 38, Clinrisk Ltd, Leeds, UK) and FRAX® (web version 3.9, University of Sheffield, Sheffield, UK) tools. The relationship between fracture risk and incremental net monetary benefit was estimated using non-parametric regression. A probabilistic sensitivity analysis and scenario analyses were used to assess uncertainty. Results: Fifty-two randomised controlled trials of non-bisphosphonates were included in the clinical effectiveness systematic review and an additional 51 randomised controlled trials of bisphosphonates were included in the network meta-analysis. All treatments had beneficial effects compared with placebo for vertebral, non-vertebral and hip fractures, with hazard ratios varying from 0.23 to 0.94, depending on treatment and fracture type. The effects on vertebral fractures and the percentage change in bone mineral density were statistically significant for all treatments. The rate of serious adverse events varied across trials (0-33%), with most between-group differences not being statistically significant for comparisons with placebo/no active treatment, non-bisphosphonates or bisphosphonates. The incremental cost-effectiveness ratios were > £20,000 per quality-adjusted life-year for all non-bisphosphonate interventions compared with no treatment across the range of QFracture and FRAX scores expected in the population eligible for fracture risk assessment. The incremental cost-effectiveness ratio for denosumab may fall below £30,000 per quality-adjusted life-year at very high levels of risk or for high-risk patients with specific characteristics. Raloxifene was dominated by no treatment (resulted in fewer quality-adjusted life-years) in most risk categories. Limitations: The incremental cost-effectiveness ratios are uncertain for very high-risk patients. Conclusions: Non-bisphosphonates are effective in preventing fragility fractures, but the incremental cost-effectiveness ratios are generally greater than the commonly applied threshold of £20,000-30,000 per quality-adjusted life-year. Study registration: This study is registered as PROSPERO CRD42018107651. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 29. See the NIHR Journals Library website for further project information.

Health technology assessment (Winchester, England) · systematic review · 54 citationsread the source →

Long-term mental health of war-refugees: a systematic literature review.

Background: There are several million war-refugees worldwide, majority of whom stay in the recipient countries for years. However, little is known about their long-term mental health. This review aimed to assess prevalence of mental disorders and to identify their correlates among long-settled war-refugees. Methods: We conducted a systematic review of studies that assessed current prevalence and/or factors associated with depression and anxiety disorders in adult war-refugees 5 years or longer after displacement. We searched Medline, Embase, CINAHL, PsycINFO, and PILOTS from their inception to October 2014, searched reference lists, and contacted experts. Because of a high heterogeneity between studies, overall estimates of mental disorders were not discussed. Instead, prevalence rates were reviewed narratively and possible sources of heterogeneity between studies were investigated both by subgroup analysis and narratively. A descriptive analysis examined pre-migration and post-migration factors associated with mental disorders in this population. Results: The review identified 29 studies on long-term mental health with a total of 16,010 war-affected refugees. There was significant between-study heterogeneity in prevalence rates of depression (range 2.3-80%), PTSD (4.4-86%), and unspecified anxiety disorder (20.3-88%), although prevalence estimates were typically in the range of 20% and above. Both clinical and methodological factors contributed substantially to the observed heterogeneity. Studies of higher methodological quality generally reported lower prevalence rates. Prevalence rates were also related to both which country the refugees came from and in which country they resettled. Refugees from former Yugoslavia and Cambodia tended to report the highest rates of mental disorders, as well as refugees residing in the USA. Descriptive synthesis suggested that greater exposure to pre-migration traumatic experiences and post-migration stress were the most consistent factors associated with all three disorders, whilst a poor post-migration socio-economic status was particularly associated with depression. Conclusions: There is a need for more methodologically consistent and rigorous research on the mental health of long-settled war refugees. Existing evidence suggests that mental disorders tend to be highly prevalent in war refugees many years after resettlement. This increased risk may not only be a consequence of exposure to wartime trauma but may also be influenced by post-migration socio-economic factors.

BMC international health and human rights · systematic review · 561 citationsread the source →

Exercise interventions and patient beliefs for people with hip, knee or hip and knee osteoarthritis: a mixed methods review.

Background: Chronic peripheral joint pain due to osteoarthritis (OA) is extremely prevalent and a major cause of physical dysfunction and psychosocial distress. Exercise is recommended to reduce joint pain and improve physical function, but the effect of exercise on psychosocial function (health beliefs, depression, anxiety and quality of life) in this population is unknown. Objectives: To improve our understanding of the complex inter-relationship between pain, psychosocial effects, physical function and exercise. Search methods: Review authors searched 23 clinical, public health, psychology and social care databases and 25 other relevant resources including trials registers up to March 2016. We checked reference lists of included studies for relevant studies. We contacted key experts about unpublished studies. Selection criteria: To be included in the quantitative synthesis, studies had to be randomised controlled trials of land- or water-based exercise programmes compared with a control group consisting of no treatment or non-exercise intervention (such as medication, patient education) that measured either pain or function and at least one psychosocial outcome (self-efficacy, depression, anxiety, quality of life). Participants had to be aged 45 years or older, with a clinical diagnosis of OA (as defined by the study) or self-reported chronic hip or knee (or both) pain (defined as more than six months' duration).To be included in the qualitative synthesis, studies had to have reported people's opinions and experiences of exercise-based programmes (e.g. their views, understanding, experiences and beliefs about the utility of exercise in the management of chronic pain/OA). Data collection and analysis: We used standard methodology recommended by Cochrane for the quantitative analysis. For the qualitative analysis, we extracted verbatim quotes from study participants and synthesised studies of patients' views using framework synthesis. We then conducted an integrative review, synthesising the quantitative and qualitative data together. Main results: Twenty-one trials (2372 participants) met the inclusion criteria for quantitative synthesis. There were large variations in the exercise programme's content, mode of delivery, frequency and duration, participant's symptoms, duration of symptoms, outcomes measured, methodological quality and reporting. Comparator groups were varied and included normal care; education; and attention controls such as home visits, sham gel and wait list controls. Risk of bias was high in one and unclear risk in five studies regarding the randomisation process, high for 11 studies regarding allocation concealment, high for all 21 studies regarding blinding, and high for three studies and unclear for five studies regarding attrition. Studies did not provide information on adverse effects. There was moderate quality evidence that exercise reduced pain by an absolute percent reduction of 6% (95% confidence interval (CI) -9% to -4%, (9 studies, 1058 participants), equivalent to reducing (improving) pain by 1.25 points from 6.5 to 5.3 on a 0 to 20 scale and moderate quality evidence that exercise improved physical function by an absolute percent of 5.6% (95% CI -7.6% to 2.0%; standardised mean difference (SMD) -0.27, 95% CI -0.37 to -0.17, equivalent to reducing (improving) WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) function on a 0 to 100 scale from 49.9 to 44.3) (13 studies, 1599 participants)). Self-efficacy was increased by an absolute percent of 1.66% (95% CI 1.08% to 2.20%), although evidence was low quality (SMD 0.46, 95% CI 0.34 to 0.58, equivalent to improving the ExBeliefs score on a 17 to 85 scale from 64.3 to 65.4), with small benefits for depression from moderate quality evidence indicating an absolute percent reduction of 2.4% (95% CI -0.47% to 0.5%) (SMD -0.16, 95% CI -0.29 to -0.02, equivalent to improving depression measured using HADS (Hospital Anxiety and Depression Scale) on a 0 to 21 scale from 3.5 to 3.0) but no clinically or statistically significant effect on anxiety (SMD -0.11, 95% CI -0.26 to 0.05, 2% absolute improvement, 95% CI -5% to 1% equivalent to improving HADS anxiety on a 0 to 21 scale from 5.8 to 5.4; moderate quality evidence). Five studies measured the effect of exercise on health-related quality of life using the 36-item Short Form (SF-36) with statistically significant benefits for social function, increasing it by an absolute percent of 7.9% (95% CI 4.1% to 11.6%), equivalent to increasing SF-36 social function on a 0 to 100 scale from 73.6 to 81.5, although the evidence was low quality. Evidence was downgraded due to heterogeneity of measures, limitations with blinding and lack of detail regarding interventions. For 20/21 studies, there was a high risk of bias with blinding as participants self-reported and were not blinded to their participation in an exercise intervention. Twelve studies (with 6 to 29 participants) met inclusion criteria for qualitative synthesis. Their methodological rigour and quality was generally good. From the patients' perspectives, ways to improve the delivery of exercise interventions included: provide better information and advice about the safety and value of exercise; provide exercise tailored to individual's preferences, abilities and needs; challenge inappropriate health beliefs and provide better support. An integrative review, which compared the findings from quantitative trials with low risk of bias and the implications derived from the high-quality studies in the qualitative synthesis, confirmed the importance of these implications. Authors' conclusions: Chronic hip and knee pain affects all domains of people's lives. People's beliefs about chronic pain shape their attitudes and behaviours about how to manage their pain. People are confused about the cause of their pain, and bewildered by its variability and randomness. Without adequate information and advice from healthcare professionals, people do not know what they should and should not do, and, as a consequence, avoid activity for fear of causing harm. Participation in exercise programmes may slightly improve physical function, depression and pain. It may slightly improve self-efficacy and social function, although there is probably little or no difference in anxiety. Providing reassurance and clear advice about the value of exercise in controlling symptoms, and opportunities to participate in exercise programmes that people regard as enjoyable and relevant, may encourage greater exercise participation, which brings a range of health benefits to a large population of people.

The Cochrane database of systematic reviews · systematic review · 193 citationsread the source →

Additional behavioural support as an adjunct to pharmacotherapy for smoking cessation.

Background: Pharmacotherapies for smoking cessation increase the likelihood of achieving abstinence in a quit attempt. It is plausible that providing support, or, if support is offered, offering more intensive support or support including particular components may increase abstinence further. Objectives: To evaluate the effect of adding or increasing the intensity of behavioural support for people using smoking cessation medications, and to assess whether there are different effects depending on the type of pharmacotherapy, or the amount of support in each condition. We also looked at studies which directly compare behavioural interventions matched for contact time, where pharmacotherapy is provided to both groups (e.g. tests of different components or approaches to behavioural support as an adjunct to pharmacotherapy). Search methods: We searched the Cochrane Tobacco Addiction Group Specialised Register, clinicaltrials.gov, and the ICTRP in June 2018 for records with any mention of pharmacotherapy, including any type of nicotine replacement therapy (NRT), bupropion, nortriptyline or varenicline, that evaluated the addition of personal support or compared two or more intensities of behavioural support. Selection criteria: Randomised or quasi-randomised controlled trials in which all participants received pharmacotherapy for smoking cessation and conditions differed by the amount or type of behavioural support. The intervention condition had to involve person-to-person contact (defined as face-to-face or telephone). The control condition could receive less intensive personal contact, a different type of personal contact, written information, or no behavioural support at all. We excluded trials recruiting only pregnant women and trials which did not set out to assess smoking cessation at six months or longer. Data collection and analysis: For this update, screening and data extraction followed standard Cochrane methods. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically-validated rates, if available. We calculated the risk ratio (RR) and 95% confidence interval (CI) for each study. Where appropriate, we performed meta-analysis using a random-effects model. Main results: Eighty-three studies, 36 of which were new to this update, met the inclusion criteria, representing 29,536 participants. Overall, we judged 16 studies to be at low risk of bias and 21 studies to be at high risk of bias. All other studies were judged to be at unclear risk of bias. Results were not sensitive to the exclusion of studies at high risk of bias. We pooled all studies comparing more versus less support in the main analysis. Findings demonstrated a benefit of behavioural support in addition to pharmacotherapy. When all studies of additional behavioural therapy were pooled, there was evidence of a statistically significant benefit from additional support (RR 1.15, 95% CI 1.08 to 1.22, I² = 8%, 65 studies, n = 23,331) for abstinence at longest follow-up, and this effect was not different when we compared subgroups by type of pharmacotherapy or intensity of contact. This effect was similar in the subgroup of eight studies in which the control group received no behavioural support (RR 1.20, 95% CI 1.02 to 1.43, I² = 20%, n = 4,018). Seventeen studies compared interventions matched for contact time but that differed in terms of the behavioural components or approaches employed. Of the 15 comparisons, all had small numbers of participants and events. Only one detected a statistically significant effect, favouring a health education approach (which the authors described as standard counselling containing information and advice) over motivational interviewing approach (RR 0.56, 95% CI 0.33 to 0.94, n = 378). Authors' conclusions: There is high-certainty evidence that providing behavioural support in person or via telephone for people using pharmacotherapy to stop smoking increases quit rates. Increasing the amount of behavioural support is likely to increase the chance of success by about 10% to 20%, based on a pooled estimate from 65 trials. Subgroup analysis suggests that the incremental benefit from more support is similar over a range of levels of baseline support. More research is needed to assess the effectiveness of specific components that comprise behavioural support.

The Cochrane database of systematic reviews · systematic review · 110 citationsread the source →

Music interventions for improving psychological and physical outcomes in people with cancer.

Background: This is an update of the review published on the Cochrane Library in 2016, Issue 8. Having cancer may result in extensive emotional, physical and social suffering. Music interventions have been used to alleviate symptoms and treatment side effects in people with cancer. This review includes music interventions defined as music therapy offered by trained music therapists, as well as music medicine, which was defined as listening to pre-recorded music offered by medical staff. Objectives: To assess and compare the effects of music therapy and music medicine interventions for psychological and physical outcomes in people with cancer. Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 3) in the Cochrane Library, MEDLINE via Ovid, Embase via Ovid, CINAHL, PsycINFO, LILACS, Science Citation Index, CancerLit, CAIRSS, Proquest Digital Dissertations, ClinicalTrials.gov, Current Controlled Trials, the RILM Abstracts of Music Literature, http://www.wfmt.info/Musictherapyworld/ and the National Research Register. We searched all databases, except for the last two, from their inception to April 2020; the other two are no longer functional, so we searched them until their termination date. We handsearched music therapy journals, reviewed reference lists and contacted experts. There was no language restriction. Selection criteria: We included all randomized and quasi-randomized controlled trials of music interventions for improving psychological and physical outcomes in adults and pediatric patients with cancer. We excluded patients undergoing biopsy and aspiration for diagnostic purposes. Data collection and analysis: Two review authors independently extracted the data and assessed the risk of bias. Where possible, we presented results in meta-analyses using mean differences and standardized mean differences. We used post-test scores. In cases of significant baseline difference, we used change scores. We conducted separate meta-analyses for studies with adult participants and those with pediatric participants. Primary outcomes of interest included psychological outcomes and physical symptoms and secondary outcomes included physiological responses, physical functioning, anesthetic and analgesic intake, length of hospitalization, social and spiritual support, communication, and quality of life (QoL) . We used GRADE to assess the certainty of the evidence. Main results: We identified 29 new trials for inclusion in this update. In total, the evidence of this review rests on 81 trials with a total of 5576 participants. Of the 81 trials, 74 trials included adult (N = 5306) and seven trials included pediatric (N = 270) oncology patients. We categorized 38 trials as music therapy trials and 43 as music medicine trials. The interventions were compared to standard care. Psychological outcomes The results suggest that music interventions may have a large anxiety-reducing effect in adults with cancer, with a reported average anxiety reduction of 7.73 units (17 studies, 1381 participants; 95% confidence interval (CI) -10.02 to -5.44; very low-certainty evidence) on the Spielberger State Anxiety Inventory scale (range 20 to 80; lower values reflect lower anxiety). Results also suggested a moderately strong, positive impact of music interventions on depression in adults (12 studies, 1021 participants; standardized mean difference (SMD): -0.41, 95% CI -0.67 to -0.15; very low-certainty evidence). We found no support for an effect of music interventions on mood (SMD 0.47, 95% CI -0.02 to 0.97; 5 studies, 236 participants; very low-certainty evidence). Music interventions may increase hope in adults with cancer, with a reported average increase of 3.19 units (95% CI 0.12 to 6.25) on the Herth Hope Index (range 12 to 48; higher scores reflect greater hope), but this finding was based on only two studies (N = 53 participants; very low-certainty evidence). Physical outcomes We found a moderate pain-reducing effect of music interventions (SMD -0.67, 95% CI -1.07 to -0.26; 12 studies, 632 adult participants; very low-certainty evidence). In addition, music interventions had a small treatment effect on fatigue (SMD -0.28, 95% CI -0.46 to -0.10; 10 studies, 498 adult participants; low-certainty evidence). The results suggest a large effect of music interventions on adult participants' QoL, but the results were highly inconsistent across studies, and the pooled effect size was accompanied by a large confidence interval (SMD 0.88, 95% CI -0.31 to 2.08; 7 studies, 573 participants; evidence is very uncertain). Removal of studies that used improper randomization methods resulted in a moderate effect size that was less heterogeneous (SMD 0.47, 95% CI 0.06 to 0.88, P = 0.02, I2 = 56%). A small number of trials included pediatric oncology participants. The findings suggest that music interventions may reduce anxiety but this finding was based on only two studies (SMD -0.94, 95% CI -1.9 to 0.03; very low-certainty evidence). Due to the small number of studies, we could not draw conclusions regarding the effects of music interventions on mood, depression, QoL, fatigue or pain in pediatric participants with cancer. The majority of studies included in this review update presented a high risk of bias, and therefore the overall certainty of the evidence is low. For several outcomes (i.e. anxiety, depression, pain, fatigue, and QoL) the beneficial treatment effects were consistent across studies for music therapy interventions delivered by music therapists. In contrast, music medicine interventions resulted in inconsistent treatment effects across studies for these outcomes. Authors' conclusions: This systematic review indicates that music interventions compared to standard care may have beneficial effects on anxiety, depression, hope, pain, and fatigue in adults with cancer. The results of two trials suggest that music interventions may have a beneficial effect on anxiety in children with cancer. Too few trials with pediatric participants were included to draw conclusions about the treatment benefits of music for other outcomes. For several outcomes, music therapy interventions delivered by a trained music therapist led to consistent results across studies and this was not the case for music medicine interventions. Moreover, evidence of effect was found for music therapy interventions for QoL and fatigue but not for music medicine interventions. Most trials were at high risk of bias and low or very low certainty of evidence; therefore, these results need to be interpreted with caution.

The Cochrane database of systematic reviews · systematic review · 144 citationsread the source →

Cognitive rehabilitation for people with mild to moderate dementia.

Background: Cognitive impairments affect functional ability in people with dementia. Cognitive rehabilitation (CR) is a personalised, solution-focused approach that aims to enable people with mild-to-moderate dementia to manage everyday activities and maintain as much independence as possible. Objectives: To evaluate the effects of CR on everyday functioning and other outcomes for people with mild-to-moderate dementia, and on outcomes for care partners. To identify and explore factors that may be associated with the efficacy of CR. Search methods: We searched the Cochrane Dementia and Cognitive Improvement Group Specialised Register, which contains records from MEDLINE, EMBASE, CINAHL, PsycINFO, LILACS, and other clinical trial databases, and grey literature sources. The most recent search was completed on 19 October 2022. Selection criteria: We included randomised controlled trials (RCTs) comparing CR with control conditions and reporting relevant outcomes for the person with dementia and/or the care partner. Data collection and analysis: We extracted relevant data from published manuscripts and contacted trial authors if necessary. Within each of the comparisons, we pooled data for each outcome of interest and conducted inverse-variance, random-effects meta-analyses. We evaluated the certainty of the evidence using GRADEpro GDT. Main results: We identified six eligible RCTs published in English between 2010 and 2022, which together included 1702 participants. The mean age of participants ranged from 76 to 80 and the proportion of male participants was between 29.4% and 79.3%. Most participants, in the studies where the type of dementia was reported, had a diagnosis of Alzheimer's disease (AD; n = 1002, 58.9% of the whole sample, 81.2% of the participants for whom the specific diagnosis was reported). Risk of bias in the individual studies was relatively low. The exception was a high risk of bias in relation to blinding of participants and practitioners, which is not usually feasible with psychosocial interventions.  Our primary outcome of everyday functioning was operationalised in the included studies as goal attainment in relation to activities targeted in the intervention. For our main comparison of CR with usual care, we pooled data for goal attainment evaluated from three perspectives (self-rating of performance, informant rating of performance, and self-rating of satisfaction with performance) at end of treatment and at medium-term follow-up (3 to 12 months). We could also pool data at these time points for 20 and 19 secondary outcomes respectively. The review findings were strongly driven by one large, high-quality RCT.  We found high-certainty evidence of large positive effects of CR on all three primary outcome perspectives at the end of treatment: participant self-ratings of goal attainment (standardised mean difference (SMD) 1.46, 95% confidence interval (CI) 1.26 to 1.66; I2 = 0%; 3 RCTs, 501 participants), informant ratings of goal attainment (SMD 1.61, 95% CI 1.01 to 2.21; I2 = 41%; 3 RCTs, 476 participants), and self-ratings of satisfaction with goal attainment (SMD 1.31, 95% CI 1.09 to 1.54; I2 = 5%; 3 RCTs, 501 participants), relative to an inactive control condition. At medium-term follow-up, we found high-certainty evidence showing a large positive effect of CR on all three primary outcome perspectives: participant self-ratings of goal attainment (SMD 1.46, 95% CI 1.25 to 1.68; I2 = 0%; 2 RCTs, 432 participants), informant ratings of goal attainment (SMD 1.25, 95% CI 0.78 to 1.72; I2 = 29%; 3 RCTs, 446 participants), and self-ratings of satisfaction with goal attainment (SMD 1.19, 95% CI 0.73 to 1.66; I2 = 28%; 2 RCTs, 432 participants), relative to an inactive control condition. For participants at the end of treatment we found high-certainty evidence showing a small positive effect of CR on self-efficacy (2 RCTs, 456 participants) and immediate recall (2 RCTs, 459 participants). For participants at medium-term follow-up we found moderate-certainty evidence showing a small positive effect of CR on auditory selective attention (2 RCTs, 386 participants), and a small negative effect on general functional ability (3 RCTs, 673 participants), and we found low-certainty evidence showing a small positive effect on sustained attention (2 RCTs, 413 participants), and a small negative effect on memory (2 RCTs, 51 participants) and anxiety (3 RCTs, 455 participants).  We found moderate- and low-certainty evidence indicating that at the end of treatment CR had negligible effects on participant anxiety, quality of life, sustained attention, memory, delayed recall, and general functional ability, and at medium-term follow-up on participant self-efficacy, depression, quality of life, immediate recall, and verbal fluency. For care partners at the end of treatment we found low-certainty evidence showing a small positive effect on environmental aspects of quality of life (3 RCTs, 465 care partners), and small negative effects of CR on level of depression (2 RCTs, 32 care partners) and on psychological wellbeing (2 RCTs, 388 care partners).  For care partners at medium-term follow-up we found high-certainty evidence showing a small positive effect of CR on social aspects of quality of life (3 RCTs, 436 care partners) and moderate-certainty evidence showing a small positive effect on psychological aspects of quality of life (3 RCTs, 437 care partners). We found moderate- and low-certainty evidence at the end of treatment that CR had negligible effects on care partners' physical health, psychological and social aspects of quality of life, and stress, and at medium-term follow-up for the physical health aspect of care partners' quality of life and psychological wellbeing. Authors' conclusions: CR is helpful in enabling people with mild or moderate dementia to improve their ability to manage the everyday activities targeted in the intervention. Confidence in these findings could be strengthened if more high-quality studies contributed to the observed effects. The available evidence suggests that CR can form a valuable part of a clinical toolkit to assist people with dementia in overcoming some of the everyday barriers imposed by cognitive and functional difficulties. Future research, including process evaluation studies, could help identify avenues to maximise CR effects and achieve wider impacts on functional ability and wellbeing.

The Cochrane database of systematic reviews · systematic review · 51 citationsread the source →

Traditional healers in the treatment of common mental disorders in South Africa.

There are few population-level insights into the use of traditional healers and other forms of alternative care for the treatment of common mental disorders in sub-Saharan Africa. We examined the extent to which alternative practitioners are consulted, and predictors of traditional healer visits. A national survey was conducted with 3651 adult South Africans between 2002 and 2004, using the World Health Organization Composite International Diagnostic Interview (CIDI) to generate DSM-IV diagnoses for common mood, anxiety, and substance use disorders. A minority of participants with a lifetime DSM-IV diagnosis obtained treatment from Western (29%) or alternative (20%) practitioners. Traditional healers were consulted by 9% of the respondents and 11% consulted a religious or spiritual advisor. Use of traditional healers in the full sample was predicted by older age, black race, unemployment, lower education, and having an anxiety or a substance use disorder. Alternative practitioners, including traditional healers and religious advisors, appear to play a notable role in the delivery of mental health care in South Africa.

The Journal of nervous and mental disease · 97 citationsread the source →

The Effect of Heart Rate Variability Biofeedback Training on Mental Health of Pregnant and Non-Pregnant Women: A Randomized Controlled Trial.

In this study, we examined the efficacy of heart rate variability (HRV)-biofeedback on stress and stress-related mental health problems in women. Furthermore, we examined whether the efficacy differed between pregnant and non-pregnant women. Fifty women (20 pregnant, 30 non-pregnant; mean age 31.6, SD = 5.9) were randomized into an intervention (n = 29) or a waitlist condition (n = 21). All participants completed questionnaires on stress, anxiety, depressive symptoms, sleep, and psychological well-being on three occasions with 6-week intervals. Women in the intervention condition received HRV-biofeedback training between assessment 1 and 2, and women in the waitlist condition received the intervention between assessment 2 and 3. The intervention consisted of a 5-week HRV-biofeedback training program with weekly 60⁻90 min. sessions and daily exercises at home. Results indicated a statistically significant beneficial effect of HRV-biofeedback on psychological well-being for all women, and an additional statistically significant beneficial effect on anxiety complaints for pregnant women. No significant effect was found for the other stress-related complaints. These findings support the use of HRV-biofeedback as a stress-reducing technique among women reporting stress and related complaints in clinical practice to improve their well-being. Furthermore, it supports the use of this technique for reducing anxiety during pregnancy.

International journal of environmental research and public health · randomised controlled trial · 23 citationsread the source →

Alcohol misuse and relationship breakdown: findings from a longitudinal birth cohort.

Background: This study examined the associations between measures of alcohol abuse/dependence (AAD) and relationship dissolution from ages 19 to 30 in a New Zealand birth cohort. Methods: The outcome measure was self-reported breakdown of a marital/cohabiting relationship during each year from age 20-21 to age 29-30. The study also used contemporaneous and one-year lagged measures of AAD symptoms; and time-dynamic covariate factors including life stress, other substance use, mental health status, peer and partner substance use and offending, unemployment, exposure to intimate partner violence, and prior relationship breakdown. Data were analysed using conditional fixed effects regression modelling augmented by time-dynamic covariate factors to control for confounding. Results: Those with three or more AAD symptoms had unadjusted odds of relationship breakdown that were 2.17-2.23 times higher than those with no symptoms, but these associations did not differ by gender. Adjustment of the associations for both unobserved fixed effects and time-dynamic covariate factors reduced the magnitude of the associations, with those with three or more AAD symptoms having rates of relationship breakdown that were 1.57-1.66 times higher than those with no symptoms. Conclusions: The results suggest a causal association between alcohol misuse and relationship breakdown, with estimates suggesting that alcohol use disorder accounted for 4.5-4.6% of marital/cohabiting relationship dissolution in the cohort.

Drug and alcohol dependence · 21 citationsread the source →

Web-Based Psychotherapy for Posttraumatic Stress Disorder in War-Traumatized Arab Patients: Randomized Controlled Trial

BACKGROUND: In recent years, armed conflicts in the Middle East have resulted in high rates of exposure to traumatic events. Despite the increasing demand of mental health care provision, ongoing violence limits conventional approaches of mental health care provision. Internet-based interventions for posttraumatic stress disorder (PTSD) have proved feasible and effective in Western countries, but their applicability and efficacy in war and conflict regions remains unknown. OBJECTIVE: This study investigated the efficacy of a cognitive behavioral Internet-based intervention for war-traumatized Arab patients, with focus on Iraq. METHODS: A total of 159 individuals with PTSD participated in a parallel group randomized trial. Participants were randomly allocated by a computer-generated sequence to a treatment group (n=79) or a waiting list control group (n=80). The treatment group received 2 weekly 45-minute cognitive behavioral interventions via Internet over a 5-week period (10 sessions in total). The primary outcome was recovery from posttraumatic stress symptoms. RESULTS: Posttraumatic stress symptoms were significantly reduced from baseline to posttreatment (intention-to-treat analysis) in the treatment group relative to the control group (F1,157=44.29, P<.001, d=0.92). Treatment effects were sustained at 3-month follow-up. Completer analysis indicated that 29 of 47 patients (62%) in the treatment group had recovered from posttraumatic stress symptoms at posttreatment (reliable change and Posttraumatic Stress Diagnostic Scale score <20) versus 1 patient (2%) in the control group (OR 74.19, 95% CI 9.93-585.8, P<.001) indicating that the chance of recovering was 74.19 times higher in the treatment than in the control group. CONCLUSIONS: The results indicate, even in unstable and insecure settings with ongoing exposure to human rights violations through war and dictatorships, people with posttraumatic stress symptoms benefit from a cognitive behavioral treatment provided entirely through the Internet. This method of delivery could improve patients' access to humanitarian aid in the form of e-mental health services. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry, ACTRN12611001019998; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=347505 (Archived by WebCite at http://www.webcitation.org/6Wto4HCdH).

Journal of Medical Internet Research · randomised controlled trial · 194 citationsread the source →

Rare disease diagnosis: A review of web search, social media and large-scale data-mining approaches.

Physicians and the general public are increasingly using web-based tools to find answers to medical questions. The field of rare diseases is especially challenging and important as shown by the long delay and many mistakes associated with diagnoses. In this paper we review recent initiatives on the use of web search, social media and data mining in data repositories for medical diagnosis. We compare the retrieval accuracy on 56 rare disease cases with known diagnosis for the web search tools google.com, pubmed.gov, omim.org and our own search tool findzebra.com. We give a detailed description of IBM's Watson system and make a rough comparison between findzebra.com and Watson on subsets of the Doctor's dilemma dataset. The recall@10 and recall@20 (fraction of cases where the correct result appears in top 10 and top 20) for the 56 cases are found to be be 29%, 16%, 27% and 59% and 32%, 18%, 34% and 64%, respectively. Thus, FindZebra has a significantly (p < 0.01) higher recall than the other 3 search engines. When tested under the same conditions, Watson and FindZebra showed similar recall@10 accuracy. However, the tests were performed on different subsets of Doctors dilemma questions. Advances in technology and access to high quality data have opened new possibilities for aiding the diagnostic process. Specialized search engines, data mining tools and social media are some of the areas that hold promise.

Rare diseases (Austin, Tex.) · review · 49 citationsread the source →

Investigating the subjective and objective efficacy of a cognitive behavioural therapy for insomnia (CBT-I)-based smartphone app on sleep: A randomised controlled trial.

Due to insufficient treatment options for insomnia, effective solutions are urgently needed. We evaluated the effects of a CBT-I-based app combining sleep training with subjective and objective sleep monitoring on (i) sleep and (ii) subjective-objective sleep discrepancies (SOSD). Fifty-seven volunteers (20-76 years; MAge = 45.67 ± 16.38; 39 female) suffering from sleep problems were randomly assigned to an experimental group (EG, n = 28) or a waitlist control group (CG, n = 29). During the 6-week app phase, the EG used the CBT-I-based programme and a heart rate sensor for daily sleep monitoring and -feedback, while the CG used sleep monitoring only. Sleep was measured (i) subjectively via questionnaires (Insomnia Severity Index, ISI; Pittsburgh Sleep Quality Index, PSQI), (ii) objectively via ambulatory polysomnography (PSG), and (iii) continuously via heart-rate sensor and sleep diaries. Data revealed interactions for ISI (p = 0.003, ƞ2 part = 0.11) and PSQI (p = 0.050, ƞ2 part = 0.05), indicating training-specific improvements in EG, yet not in CG. While PSG-derived outcomes appear to be less training-specific, a tendential reduction in wake after sleep onset (WASO) was found in EG (p = 0.061, d = 0.55). Regarding changes in SOSD, the results indicate improvements during the app phase (EG) for sleep efficiency, sleep onset latency, and WASO (p ≤ 0.022, d ≥ 0.46); for total sleep time both groups showed a SOSD reduction. The findings indicate beneficial effects of a novel smartphone app on sleep and SOSD. More scientific evaluation of such digital programmes is needed to ultimately help in reducing the gap in non-pharmacological insomnia treatment.

Journal of sleep research · randomised controlled trial · 12 citationsread the source →

Effect of Varenicline Combined With Medical Management on Alcohol Use Disorder With Comorbid Cigarette Smoking: A Randomized Clinical Trial.

Importance: Individuals with alcohol use disorder have high rates of cigarette smoking. Varenicline tartrate, an approved treatment for smoking cessation, may reduce both drinking and smoking. Objectives: To test the efficacy of varenicline with medical management for patients with alcohol use disorder and comorbid smoking seeking alcohol treatment, and to evaluate the secondary effects on smoking abstinence. Design, setting, and participants: This phase 2, randomized, double-blind, parallel group, placebo-controlled trial was conducted at 2 outpatient clinics from September 19, 2012, to August 31, 2015. Eligible participants met alcohol-dependence criteria and reported heavy drinking (≥5 drinks for men and ≥4 drinks for women) 2 or more times per week and smoking 2 or more times per week; 131 participants were randomized to either varenicline or placebo stratified by sex and site. All analyses were of the intention-to-treat type. Data analysis was conducted from February 5, 2016, to September 29, 2017. Interventions: Varenicline tartrate, 1 mg twice daily, and matching placebo pills for 16 weeks. Medical management emphasized medication adherence for 4 weeks followed by support for changing drinking. Main outcomes and measures: Percentage of heavy drinking days (PHDD) weeks 9 to 16, no heavy drinking days (NHDD) weeks 9 to 16, and prolonged smoking abstinence weeks 13 to 16. Results: Of 131 participants, 39 (29.8%) were women and 92 (70.2%) were men, the mean (SD) age was 42.7 (11.7) years, and the race/ethnicity self-identified by most respondents was black (69 [52.7%]). Sixty-four participants were randomized to receive varenicline, and 67 to receive placebo. Mean change in PHDD between varenicline and placebo across sex and site was not significantly different. However, a significant treatment by sex by time interaction for PHDD (F1,106 = 4.66; P = .03) revealed that varenicline compared with placebo resulted in a larger decrease in log-transformed PHDD in men (least square [LS] mean difference in change from baseline, 0.54; 95% CI, -0.09 to 1.18; P = .09; Cohen d = 0.45) but a smaller decrease in women (LS mean difference, -0.69; 95% CI, -1.63 to 0.25; P = .15; Cohen d = -0.53). Thirteen of 45 men (29%) had NHDD taking varenicline compared with 3 of 47 men (6%) taking placebo (Cohen h = 0.64; 95% CI, 0.22-1.03), whereas 1 of 19 women (5%) had NHDD compared with 5 of 20 women (25%) taking placebo (Cohen h = -0.60; 95% CI, -1.21 to 0.04). Taking varenicline, 8 of 64 participants (13%) achieved prolonged smoking abstinence; no one (0 of 67) quit smoking taking placebo (P = .003; Cohen h = 0.72; 95% CI, 0.38-1.07). Conclusions and relevance: Varenicline with medical management resulted in decreased heavy drinking among men and increased smoking abstinence in the overall sample. Varenicline could be considered to promote improvements in men with these dual behavioral health risks. Trial registration: clinicaltrials.gov Identifier: NCT01553136.

JAMA psychiatry · randomised controlled trial · 77 citationsread the source →

Effects of the Learning Together intervention on bullying and aggression in English secondary schools (INCLUSIVE): a cluster randomised controlled trial.

Background: Bullying, aggression, and violence among children and young people are some of the most consequential public mental health problems. We tested the Learning Together intervention, which involved students in efforts to modify their school environment using restorative practice and by developing social and emotional skills. Methods: We did a cluster randomised trial, with economic and process evaluations, of the Learning Together intervention compared with standard practice (controls) over 3 years in secondary schools in south-east England. Learning Together consisted of staff training in restorative practice; convening and facilitating a school action group; and a student social and emotional skills curriculum. Primary outcomes were self-reported experience of bullying victimisation (Gatehouse Bullying Scale; GBS) and perpetration of aggression (Edinburgh Study of Youth Transitions and Crime (ESYTC) school misbehaviour subscale) measured at 36 months. We analysed data using intention-to-treat longitudinal mixed-effects models. This trial was registered with the ISRCTN registry (10751359). Findings: We included 40 schools (20 in each group); no schools withdrew. 6667 (93·6%) of 7121 students participated at baseline and 5960 (83·3%) of 7154 at 36 months. Mean GBS bullying score at 36 months was 0·34 (SE 0·02) in the control group versus 0·29 (SE 0·02) in the intervention group, with a significant adjusted mean difference (-0·03, 95% CI -0·06 to -0·001; adjusted effect size -0·08). Mean ESYTC score at 36 months was 4·33 (SE 0·20) in the control group versus 4·04 (0·21) in the intervention group, with no evidence of a difference between groups (adjusted difference -0·13, 95% CI -0·43 to 0·18; adjusted effect size -0·03). Costs were an additional £58 per pupil in intervention schools than in control schools. Interpretation: Learning Together had small but significant effects on bullying, which could be important for public health, but no effect on aggression. Interventions to promote student health by modifying the whole-school environment are likely to be one of the most feasible and efficient ways of addressing closely related risk and health outcomes in children and young people. Funding: National Institute for Health Research, Educational Endowment Foundation.

Lancet (London, England) · randomised controlled trial · 121 citationsread the source →

Targeted smoking cessation for dual users of combustible and electronic cigarettes: a randomised controlled trial.

Background: Although many smokers use electronic cigarettes (e-cigarettes) to quit smoking, most continue to smoke while vaping. This dual use might delay cessation and increase toxicant exposure. We aimed to test the efficacy of a self-help intervention designed to help dual users to quit smoking. Methods: In this three-arm randomised controlled trial we recruited individuals in the USA using Facebook and multimedia advertisements. Included participants were 18 years or older, smoked at least weekly in the preceding year, and vaped at least weekly in the preceding month. We used computer generated randomisation with balanced-permuted blocks (block size 10, with 2-4-4 ratio) to allocate participants to assessment only (ASSESS group), generic smoking cessation self-help booklets (GENERIC group), or booklets targeting dual users (eTARGET group). Individuals in the generic or targeted intervention groups received monthly cessation materials for 18 months, with assessments every 3 months for 24 months. The main outcome was self-reported 7-day point-prevalence smoking abstinence at each assessment point. All randomly allocated participants were included in primary analyses using generalised estimating equations for each of 20 datasets created by multiple imputation. Analysis of the χ2s produced an F test. The trial is registered with ClinicalTrials.gov, NCT02416011, and is now closed. Findings: Between July 12, 2016, and June 30, 2017, we randomly assigned 2896 dual users (575 to assessment, 1154 to generic intervention, and 1167 to targeted self-help). 7-day point-prevalence smoking abstinence increased from 14% at 3 months to 42% at 24 months (F7,541·7=67·1, p<0·0001) in the overall sample. Targeted self-help resulted in higher smoking abstinence than did assessment alone throughout the treatment period (F1,973·8=10·20, p=0·0014 [α=0·017]). The generic intervention group had abstinence rates between those of the assessment and targeted groups, but did not significantly differ from either when adjusted for multiple comparisons (GENERIC vs eTARGET F1,1102·5=1·79, p=0·18 [α=0·05]; GENERIC vs ASSESS F1,676·7=4·29, p=0·039 [α=0·025]). Differences between study groups attenuated after the interventions ended. Interpretation: A targeted self-help intervention with high potential for dissemination could be efficacious in promoting smoking cessation among dual users of combustible cigarettes and e-cigarettes. Funding: National Institute on Drug Abuse, National Cancer Institute.

The Lancet. Public health · randomised controlled trial · 45 citationsread the source →

A Novel Brief Therapy for Patients Who Attempt Suicide: A 24-months Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP).

Background: Attempted suicide is the main risk factor for suicide and repeated suicide attempts. However, the evidence for follow-up treatments reducing suicidal behavior in these patients is limited. The objective of the present study was to evaluate the efficacy of the Attempted Suicide Short Intervention Program (ASSIP) in reducing suicidal behavior. ASSIP is a novel brief therapy based on a patient-centered model of suicidal behavior, with an emphasis on early therapeutic alliance. Methods and findings: Patients who had recently attempted suicide were randomly allocated to treatment as usual (n = 60) or treatment as usual plus ASSIP (n = 60). ASSIP participants received three therapy sessions followed by regular contact through personalized letters over 24 months. Participants considered to be at high risk of suicide were included, 63% were diagnosed with an affective disorder, and 50% had a history of prior suicide attempts. Clinical exclusion criteria were habitual self-harm, serious cognitive impairment, and psychotic disorder. Study participants completed a set of psychosocial and clinical questionnaires every 6 months over a 24-month follow-up period. The study represents a real-world clinical setting at an outpatient clinic of a university hospital of psychiatry. The primary outcome measure was repeat suicide attempts during the 24-month follow-up period. Secondary outcome measures were suicidal ideation, depression, and health-care utilization. Furthermore, effects of prior suicide attempts, depression at baseline, diagnosis, and therapeutic alliance on outcome were investigated. During the 24-month follow-up period, five repeat suicide attempts were recorded in the ASSIP group and 41 attempts in the control group. The rates of participants reattempting suicide at least once were 8.3% (n = 5) and 26.7% (n = 16). ASSIP was associated with an approximately 80% reduced risk of participants making at least one repeat suicide attempt (Wald χ21 = 13.1, 95% CI 12.4-13.7, p < 0.001). ASSIP participants spent 72% fewer days in the hospital during follow-up (ASSIP: 29 d; control group: 105 d; W = 94.5, p = 0.038). Higher scores of patient-rated therapeutic alliance in the ASSIP group were associated with a lower rate of repeat suicide attempts. Prior suicide attempts, depression, and a diagnosis of personality disorder at baseline did not significantly affect outcome. Participants with a diagnosis of borderline personality disorder (n = 20) had more previous suicide attempts and a higher number of reattempts. Key study limitations were missing data and dropout rates. Although both were generally low, they increased during follow-up. At 24 months, the group difference in dropout rate was significant: ASSIP, 7% (n = 4); control, 22% (n = 13). A further limitation is that we do not have detailed information of the co-active follow-up treatment apart from participant self-reports every 6 months on the setting and the duration of the co-active treatment. Conclusions: ASSIP, a manual-based brief therapy for patients who have recently attempted suicide, administered in addition to the usual clinical treatment, was efficacious in reducing suicidal behavior in a real-world clinical setting. ASSIP fulfills the need for an easy-to-administer low-cost intervention. Large pragmatic trials will be needed to conclusively establish the efficacy of ASSIP and replicate our findings in other clinical settings. Trial registration: ClinicalTrials.gov NCT02505373.

PLoS medicine · randomised controlled trial · 178 citationsread the source →

The effects of volunteering on loneliness among lonely older adults: the HEAL-HOA dual randomised controlled trial.

Background: Previous randomised controlled trials have largely relied on self-reported volunteer work to assess the effects of volunteering and have rarely provided structured volunteering activities during the intervention period. The present study aimed to investigate the effects of social volunteering work over 12 months on loneliness among older adults during the COVID-19 pandemic. Methods: A dual randomised controlled trial was done in Hong Kong to investigate the long-term effects of telephone-delivered psychosocial interventions by older Chinese volunteers who were screened as lonely, for older adult recipients who had low income, lived alone, felt lonely, and were digitally excluded. Participants were included if they were aged 50-70 years; had provided consent to be trained and serve as a volunteer for at least 2 h per week for 6 months; had at least 3 years of secondary school education; had no severe self-reported physical, mental, or cognitive health problems; were not working full or part-time; had engaged in formal volunteering fewer than four times within the past year; and were lonely (ie, had a score of at least 6 on the three-item UCLA Loneliness Scale). Participants were allocated into either the volunteering or control group (psychoeducation programme) using a random number method. The details of group allocation were concealed as the research assistant responsible for randomisation was different to the research assistants responsible for recruitment and assessments (who were masked to the condition). Following a 6-week training, the volunteers delivered a psychosocial intervention to older intervention recipients for 6 months. The primary outcome was loneliness measured with the 20-item UCLA Loneliness Scale and the De Jong Gierveld (DJG) Loneliness Scales at 6 months and 12 months. Assessments were performed before training (baseline; T1), at 6 months (T2), and at 12 months after training (T3). The intention-to-treat principle was used to compare the effects of volunteering between the two groups. The trial was registered in the Clinical Trials Registry of the University of Hong Kong Clinical Trials Centre (HKUCTR-2929). This trial has completed. Findings: Between May 3, 2021, and Oct 6, 2022, a total of 375 individuals were recruited to the trial, including 84 males (22%) and 291 females (78%). 185 were randomly assigned to the volunteering group (56 to deliver a mindfulness intervention, 65 to deliver a behavioural activation intervention, and 64 to deliver a befriending intervention) and 190 were assigned to the control group. 311 (83%) of 375 participants were 60 years or older (median 64 years [SD 4·86]). Participants in the volunteering group reported a significantly lower level of loneliness at T2 (dppc2 ranged from -0·41 to -0·70) compared with T1 than participants in the control condition. There was a significant decrease in loneliness measured using the UCLA Loneliness Scale at T2 in the volunteering group but such a decline was not shown in the control group (condition × time interaction, estimate 0·19 [95% CI 0·08 to 0·29], p=0·00058, dppc2=-0·41). Similarly, when measured with the DJG Loneliness Scale, there was a significantly greater decrease in loneliness in the volunteering group compared with the control group at T2, including a medium to large effect size on total DJG scores (estimate 1·34 [95% CI 0·83 to 1·84], p<0·0001, dppc2=-0·70) and a medium effect size on emotional (estimate 0·63 [0·35 to 0·90], p<0·0001, dppc2=-0·59) and social subscales (estimate 0·71 [95% CI 0·37 to 1·05], p<0·0001, dppc2=-0·58). Although most of the positive effects of volunteering were not sustained at T3, the volunteers who continued to volunteer for more than 2 h per week at T3 reported lower levels of loneliness than those who did not maintain volunteering. Interpretation: This randomised controlled trial demonstrates the beneficial effect of volunteering on reducing loneliness in older adults who feel lonely, and that this benefit can be maintained through continued participation in voluntary work. Future intervention programmes should strengthen older adults' commitment to volunteer. Funding: Research Grants Committee of the Hong Kong Special Administrative Region, China.

The lancet. Healthy longevity · randomised controlled trial · 16 citationsread the source →

An internet-based intervention with brief nurse support to manage obesity in primary care (POWeR+): a pragmatic, parallel-group, randomised controlled trial.

Background: The obesity epidemic has major public health consequences. Expert dietetic and behavioural counselling with intensive follow-up is effective, but resource requirements severely restrict widespread implementation in primary care, where most patients are managed. We aimed to estimate the effectiveness and cost-effectiveness of an internet-based behavioural intervention (POWeR+) combined with brief practice nurse support in primary care. Methods: We did this pragmatic, parallel-group, randomised controlled trial at 56 primary care practices in central and south England. Eligible adults aged 18 years or older with a BMI of 30 kg/m(2) or more (or ≥28 kg/m(2) with hypertension, hypercholesterolaemia, or diabetes) registered online with POWeR+-a 24 session, web-based, weight management intervention lasting 6 months. After registration, the website automatically randomly assigned patients (1:1:1), via computer-generated random numbers, to receive evidence-based dietetic advice to swap foods for similar, but healthier, choices and increase fruit and vegetable intake, in addition to 6 monthly nurse follow-up (control group); web-based intervention and face-to-face nurse support (POWeR+Face-to-face [POWeR+F]; up to seven nurse contacts over 6 months); or web-based intervention and remote nurse support (POWeR+Remote [POWeR+R]; up to five emails or brief phone calls over 6 months). Participants and investigators were masked to group allocation at the point of randomisation; masking of participants was not possible after randomisation. The primary outcome was weight loss averaged over 12 months. We did a secondary analysis of weight to measure maintenance of 5% weight loss at months 6 and 12. We modelled the cost-effectiveness of each intervention. We did analysis by intention to treat, with multiple imputation for missing data. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21244703. Findings: Between Jan 30, 2013, and March 20, 2014, 818 participants were randomly assigned to the control group (n=279), the POWeR+F group (n=269), or the POWeR+R group (n=270). Weight loss averaged over 12 months was recorded in 666 (81%) participants. The control group lost almost 3 kg over 12 months (crude mean weight: baseline 104·38 kg [SD 21·11; n=279], 6 months 101·91 kg [19·35; n=136], 12 months 101·74 kg [19·57; n=227]). The primary imputed analysis showed that compared with the control group, patients in the POWeR+F group achieved an additional weight reduction of 1·5 kg (95% CI 0·6-2·4; p=0·001) averaged over 12 months, and patients in the POWeR+R group achieved an additional 1·3 kg (0·34-2·2; p=0·007). 21% of patients in the control group had maintained a clinically important 5% weight reduction at month 12, compared with 29% of patients in the POWeR+F group (risk ratio 1·56, 0·96-2·51; p=0·070) and 32% of patients in the POWeR+R group (1·82, 1·31-2·74; p=0·004). The incremental overall cost to the health service per kg weight lost with the POWeR+ interventions versus the control strategy was £18 (95% CI -129 to 195) for POWeR+F and -£25 (-268 to 157) for POWeR+R; the probability of being cost-effective at a threshold of £100 per kg lost was 88% and 98%, respectively. No adverse events were reported. Interpretation: Weight loss can be maintained in some individuals by use of novel written material with occasional brief nurse follow-up. However, more people can maintain clinically important weight reductions with a web-based behavioural program and brief remote follow-up, with no increase in health service costs. Future research should assess the extent to which clinically important weight loss can be maintained beyond 1 year. Funding: Health Technology Assessment Programme of the National Institute for Health Research.

The lancet. Diabetes & endocrinology · randomised controlled trial · 85 citationsread the source →

Clinical trial: A Mediterranean diet is feasible and improves gastrointestinal and psychological symptoms in irritable bowel syndrome.

Background: Diet is fundamental to the care of irritable bowel syndrome (IBS). However, some approaches are not appropriate for individuals experiencing psychological symptoms. Aims: To assess feasibility of a Mediterranean diet in IBS and its impact on gastrointestinal and psychological symptoms. Methods: We recruited adults with Rome IV IBS and mild or moderate anxiety and/or depressive symptoms to an unblinded 6-week randomised controlled trial. Patients were randomised to Mediterranean diet counselling or habitual diet. We collected gastrointestinal and psychological symptom data, dietary data and stool samples for metagenomic sequencing. Results: We randomised 59 individuals (29 Mediterranean diet, 30 control); 48 completed the study. The Mediterranean Diet Adherence Screener score was higher in the Mediterranean diet group than controls at week 6 (7.5 [95% CI: 6.9-8.0] vs. 5.7 [5.2-6.3], p < 0.001), and there was a greater score increase than controls (2.1 [95% CI: 1.3-2.9] vs. 0.5 [95% CI: 0.1-1.0], p = 0.004), demonstrating Mediterranean diet feasibility. There was a greater proportion of gastrointestinal symptom responders in the Mediterranean diet group than controls (24/29, 83% vs. 11/30, 37%, p < 0.001) and depression responders (15/29, 52% vs. 6/30 20%, p = 0.015). There was no difference in FODMAP intake at week 6 (p = 0.51). Gastrointestinal adverse events were similar (p = 0.588). There were no differences in change in microbiome parameters between groups. Conclusions: A Mediterranean diet is feasible in IBS and leads to improvement in gastrointestinal and psychological symptoms. Although this study was unblinded, these findings together with the broader benefits of the Mediterranean diet, provide strong impetus for future research in IBS. Australia New Zealand Clinical Trials Registry: ACTRN12620001362987.

Alimentary pharmacology & therapeutics · randomised controlled trial · 44 citationsread the source →

3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial.

Background: Post-traumatic stress disorder (PTSD) is prevalent in military personnel and first responders, many of whom do not respond to currently available treatments. This study aimed to assess the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treating chronic PTSD in this population. Methods: We did a randomised, double-blind, dose-response, phase 2 trial at an outpatient psychiatric clinic in the USA. We included service personnel who were 18 years or older, with chronic PTSD duration of 6 months or more, and who had a Clinician-Administered PTSD Scale (CAPS-IV) total score of 50 or greater. Using a web-based randomisation system, we randomly assigned participants (1:1:2) to three different dose groups of MDMA plus psychotherapy: 30 mg (active control), 75 mg, or 125 mg. We masked investigators, independent outcome raters, and participants until after the primary endpoint. MDMA was administered orally in two 8-h sessions with concomitant manualised psychotherapy. The primary outcome was mean change in CAPS-IV total score from baseline to 1 month after the second experimental session. Participants in the 30 mg and 75 mg groups subsequently underwent three 100-125 mg MDMA-assisted psychotherapy sessions in an open-label crossover, and all participants were assessed 12 months after the last MDMA session. Safety was monitored through adverse events, spontaneously reported expected reactions, vital signs, and suicidal ideation and behaviour. This study is registered with ClinicalTrials.gov, number NCT01211405. Findings: Between Nov 10, 2010, and Jan 29, 2015, 26 veterans and first responders met eligibility criteria and were randomly assigned to receive 30 mg (n=7), 75 mg (n=7), or 125 mg (n=12) of MDMA plus psychotherapy. At the primary endpoint, the 75 mg and 125 mg groups had significantly greater decreases in PTSD symptom severity (mean change CAPS-IV total scores of -58·3 [SD 9·8] and -44·3 [28·7]; p=0·001) than the 30 mg group (-11·4 [12·7]). Compared with the 30 mg group, Cohen's d effect sizes were large: 2·8 (95% CI 1·19-4·39) for the 75 mg group and 1·1 (0·04-2·08) for the 125 mg group. In the open-label crossover with full-dose MDMA (100-125 mg), PTSD symptom severity significantly decreased in the group that had previously received 30 mg (p=0·01), whereas no further significant decreases were observed in the group that previously achieved a large response after 75 mg doses in the blinded segment (p=0·81). PTSD symptoms were significantly reduced at the 12-month follow-up compared with baseline after all groups had full-dose MDMA (mean CAPS-IV total score of 38·8 [SD 28·1] vs 87·1 [16·1]; p<0·0001). 85 adverse events were reported by 20 participants. Of these adverse events, four (5%) were serious: three were deemed unrelated and one possibly related to study drug treatment. Interpretation: Active doses (75 mg and 125 mg) of MDMA with adjunctive psychotherapy in a controlled setting were effective and well tolerated in reducing PTSD symptoms in veterans and first responders. Funding: Multidisciplinary Association for Psychedelic Studies.

The lancet. Psychiatry · randomised controlled trial · 258 citationsread the source →

Cognitive behavioural therapy for adults with dissociative seizures (CODES): a pragmatic, multicentre, randomised controlled trial.

Background: Dissociative seizures are paroxysmal events resembling epilepsy or syncope with characteristic features that allow them to be distinguished from other medical conditions. We aimed to compare the effectiveness of cognitive behavioural therapy (CBT) plus standardised medical care with standardised medical care alone for the reduction of dissociative seizure frequency. Methods: In this pragmatic, parallel-arm, multicentre randomised controlled trial, we initially recruited participants at 27 neurology or epilepsy services in England, Scotland, and Wales. Adults (≥18 years) who had dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous 12 months were subsequently randomly assigned (1:1) from 17 liaison or neuropsychiatry services following psychiatric assessment, to receive standardised medical care or CBT plus standardised medical care, using a web-based system. Randomisation was stratified by neuropsychiatry or liaison psychiatry recruitment site. The trial manager, chief investigator, all treating clinicians, and patients were aware of treatment allocation, but outcome data collectors and trial statisticians were unaware of treatment allocation. Patients were followed up 6 months and 12 months after randomisation. The primary outcome was monthly dissociative seizure frequency (ie, frequency in the previous 4 weeks) assessed at 12 months. Secondary outcomes assessed at 12 months were: seizure severity (intensity) and bothersomeness; longest period of seizure freedom in the previous 6 months; complete seizure freedom in the previous 3 months; a greater than 50% reduction in seizure frequency relative to baseline; changes in dissociative seizures (rated by others); health-related quality of life; psychosocial functioning; psychiatric symptoms, psychological distress, and somatic symptom burden; and clinical impression of improvement and satisfaction. p values and statistical significance for outcomes were reported without correction for multiple comparisons as per our protocol. Primary and secondary outcomes were assessed in the intention-to-treat population with multiple imputation for missing observations. This trial is registered with the International Standard Randomised Controlled Trial registry, ISRCTN05681227, and ClinicalTrials.gov, NCT02325544. Findings: Between Jan 16, 2015, and May 31, 2017, we randomly assigned 368 patients to receive CBT plus standardised medical care (n=186) or standardised medical care alone (n=182); of whom 313 had primary outcome data at 12 months (156 [84%] of 186 patients in the CBT plus standardised medical care group and 157 [86%] of 182 patients in the standardised medical care group). At 12 months, no significant difference in monthly dissociative seizure frequency was identified between the groups (median 4 seizures [IQR 0-20] in the CBT plus standardised medical care group vs 7 seizures [1-35] in the standardised medical care group; estimated incidence rate ratio [IRR] 0·78 [95% CI 0·56-1·09]; p=0·144). Dissociative seizures were rated as less bothersome in the CBT plus standardised medical care group than the standardised medical care group (estimated mean difference -0·53 [95% CI -0·97 to -0·08]; p=0·020). The CBT plus standardised medical care group had a longer period of dissociative seizure freedom in the previous 6 months (estimated IRR 1·64 [95% CI 1·22 to 2·20]; p=0·001), reported better health-related quality of life on the EuroQoL-5 Dimensions-5 Level Health Today visual analogue scale (estimated mean difference 6·16 [95% CI 1·48 to 10·84]; p=0·010), less impairment in psychosocial functioning on the Work and Social Adjustment Scale (estimated mean difference -4·12 [95% CI -6·35 to -1·89]; p<0·001), less overall psychological distress than the standardised medical care group on the Clinical Outcomes in Routine Evaluation-10 scale (estimated mean difference -1·65 [95% CI -2·96 to -0·35]; p=0·013), and fewer somatic symptoms on the modified Patient Health Questionnaire-15 scale (estimated mean difference -1·67 [95% CI -2·90 to -0·44]; p=0·008). Clinical improvement at 12 months was greater in the CBT plus standardised medical care group than the standardised medical care alone group as reported by patients (estimated mean difference 0·66 [95% CI 0·26 to 1·04]; p=0·001) and by clinicians (estimated mean difference 0·47 [95% CI 0·21 to 0·73]; p<0·001), and the CBT plus standardised medical care group had greater satisfaction with treatment than did the standardised medical care group (estimated mean difference 0·90 [95% CI 0·48 to 1·31]; p<0·001). No significant differences in patient-reported seizure severity (estimated mean difference -0·11 [95% CI -0·50 to 0·29]; p=0·593) or seizure freedom in the last 3 months of the study (estimated odds ratio [OR] 1·77 [95% CI 0·93 to 3·37]; p=0·083) were identified between the groups. Furthermore, no significant differences were identified in the proportion of patients who had a more than 50% reduction in dissociative seizure frequency compared with baseline (OR 1·27 [95% CI 0·80 to 2·02]; p=0·313). Additionally, the 12-item Short Form survey-version 2 scores (estimated mean difference for the Physical Component Summary score 1·78 [95% CI -0·37 to 3·92]; p=0·105; estimated mean difference for the Mental Component Summary score 2·22 [95% CI -0·30 to 4·75]; p=0·084), the Generalised Anxiety Disorder-7 scale score (estimated mean difference -1·09 [95% CI -2·27 to 0·09]; p=0·069), and the Patient Health Questionnaire-9 scale depression score (estimated mean difference -1·10 [95% CI -2·41 to 0·21]; p=0·099) did not differ significantly between groups. Changes in dissociative seizures (rated by others) could not be assessed due to insufficient data. During the 12-month period, the number of adverse events was similar between the groups: 57 (31%) of 186 participants in the CBT plus standardised medical care group reported 97 adverse events and 53 (29%) of 182 participants in the standardised medical care group reported 79 adverse events. Interpretation: CBT plus standardised medical care had no statistically significant advantage compared with standardised medical care alone for the reduction of monthly seizures. However, improvements were observed in a number of clinically relevant secondary outcomes following CBT plus standardised medical care when compared with standardised medical care alone. Thus, adults with dissociative seizures might benefit from the addition of dissociative seizure-specific CBT to specialist care from neurologists and psychiatrists. Future work is needed to identify patients who would benefit most from a dissociative seizure-specific CBT approach. Funding: National Institute for Health Research, Health Technology Assessment programme.

The lancet. Psychiatry · randomised controlled trial · 192 citationsread the source →

Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial.

Background: Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented. Methods: We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563). Findings: Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19-88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference -3·05, 95% CI -3·83 to -2·28; p<0·0001; Cohen's d -0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention. Interpretation: Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder. Funding: The National Institute for Health and Care Research Health Technology Assessment Programme.

Lancet (London, England) · randomised controlled trial · 59 citationsread the source →

A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial.

Background: Attention-deficit hyperactivity disorder (ADHD) is a common paediatric neurodevelopmental disorder with substantial effect on families and society. Alternatives to traditional care, including novel digital therapeutics, have shown promise to remediate cognitive deficits associated with this disorder and may address barriers to standard therapies, such as pharmacological interventions and behavioural therapy. AKL-T01 is an investigational digital therapeutic designed to target attention and cognitive control delivered through a video game-like interface via at-home play for 25 min per day, 5 days per week for 4 weeks. This study aimed to assess whether AKL-T01 improved attentional performance in paediatric patients with ADHD. Methods: The Software Treatment for Actively Reducing Severity of ADHD (STARS-ADHD) was a randomised, double-blind, parallel-group, controlled trial of paediatric patients (aged 8-12 years, without disorder-related medications) with confirmed ADHD and Test of Variables of Attention (TOVA) Attention Performance Index (API) scores of -1·8 and below done by 20 research institutions in the USA. Patients were randomly assigned 1:1 to AKL-T01 or a digital control intervention. The primary outcome was mean change in TOVA API from pre-intervention to post-intervention. Safety, tolerability, and compliance were also assessed. Analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02674633 and is completed. Findings: Between July 15, 2016, and Nov 30, 2017, 857 patients were evaluated and 348 were randomly assigned to receive AKL-T01 or control. Among patients who received AKL-T01 (n=180 [52%]; mean [SD] age, 9·7 [1·3] years) or control (n=168 [48%]; mean [SD] age, 9·6 [1·3] years), the non-parametric estimate of the population median change from baseline TOVA API was 0·88 (95% CI 0·24-1·49; p=0·0060). The mean (SD) change from baseline on the TOVA API was 0·93 (3·15) in the AKL-T01 group and 0·03 (3·16) in the control group. There were no serious adverse events or discontinuations. Treatment-related adverse events were mild and included frustration (5 [3%] of 180) and headache (3 [2%] of 180). Patient compliance was a mean of 83 (83%) of 100 expected sessions played (SD, 29·2 sessions). Interpretation: Although future research is needed for this digital intervention, this study provides evidence that AKL-T01 might be used to improve objectively measured inattention in paediatric patients with ADHD, while presenting minimal adverse events. Funding: Sponsored by Akili Interactive Labs.

The Lancet. Digital health · randomised controlled trial · 215 citationsread the source →

Spirituality in pain medicine: A randomized experiment of pain perception, heart rate and religious spiritual well-being by using a single session meditation methodology.

The aim of this study is to investigate different effects on pain perception among randomly assigned volunteers practicing meditation compared to a relaxation condition. The study examines whether participants of the experimental conditions (meditation versus relaxation) differ in the change of pain perception and heart rate measurement and in religious and spiritual well-being after an intervention. Method: 147 volunteers (long-term practitioners and novices) were randomly assigned to the experimental conditions with a headphone guided 20-minute single session intervention. The change in their pre- and post-intervention pain perception was measured using Quantitative Sensory Testing and Cold Pressor Testing (CPTest), their stress-level was compared by monitoring heart rate, and their religious and spiritual well-being by using the Multidimensional Inventory for Religious/Spiritual Well-Being (MI-RSB48). Additionally, dimensions of the Brief Symptom Inventory (BSI) measured the psychological resilience of the participants; pain and stress experience, and the state of relaxation and spirituality experience were assessed. Five persons were excluded due to failure in measuring the heart rate and 29 participants had to be excluded because of high values on the BSI. Results: The meditation group showed an increase in their pain tolerance on the CPTest and a decrease in their pain intensity for heat after the experimental condition, in contrast to the relaxation group. Futhermore, the meditation group showed a higher level of religious spiritual well-being (MI-RSB48 Total score) as well as in the sub-dimensions General Religiosity, Forgiveness, and Connectedness after the experimental condition, compared to the relaxation group. Our data is consistent with the hypothesis that meditation increases pain tolerance and reduces pain intensity, however, further work is required to determine whether meditation contains similar implications for pain patients.

PloS one · randomised controlled trial · 18 citationsread the source →

Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: a randomised controlled, open-label, multicentre trial.

Background: Treatment of patients with ileocaecal Crohn's disease who have not responded to conventional therapy is commonly scaled up to biological agents, but surgery can also offer excellent short-term and long-term results. We compared laparoscopic ileocaecal resection with infliximab to assess how they affect health-related quality of life. Methods: In this randomised controlled, open-label trial, in 29 teaching hospitals and tertiary care centres in the Netherlands and the UK, adults with non-stricturing, ileocaecal Crohn's disease, in whom conventional therapy has failed were randomly allocated (1:1) by an internet randomisation module with biased-coin minimisation for participating centres and perianal fistula to receive laparoscopic ileocaecal resection or infliximab. Eligible patients were aged 18-80 years, had active Crohn's disease of the terminal ileum, and had not responded to at least 3 months of conventional therapy with glucocorticosteroids, thiopurines, or methotrexate. Patients with diseased terminal ileum longer than 40 cm or abdominal abscesses were excluded. The primary outcome was quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ) at 12 months. Secondary outcomes were general quality of life, measured by the Short Form-36 (SF-36) health survey and its physical and mental component subscales, days unable to participate in social life, days on sick leave, morbidity (additional procedures and hospital admissions), and body image and cosmesis. Analyses of the primary outcome were done in the intention-to-treat population, and safety analyses were done in the per-protocol population. This trial is registered at the Dutch Trial Registry (NTR1150). Findings: Between May 2, 2008, and October 14, 2015, 73 patients were allocated to have resection and 70 to receive infliximab. Corrected for baseline differences, the mean IBDQ score at 12 months was 178·1 (95% CI 171·1-185·0) in the resection group versus 172·0 (164·3-179·6) in the infliximab group (mean difference 6·1 points, 95% CI -4·2 to 16·4; p=0·25). At 12 months, the mean SF-36 total score was 112·1 (95% CI 108·0-116·2) in the resection group versus 106·5 (102·1-110·9) in the infliximab group (mean difference 5·6, 95% CI -0·4 to 11·6), the mean physical component score was 47·7 (45·7-49·7) versus 44·6 (42·5-46·8; mean difference 3·1, 4·2 to 6·0), and the mean mental component score was 49·5 (47·0-52·1) versus 46·1 (43·3-48·9; mean difference 3·5, -0·3 to 7·3). Mean numbers of days of sick leave were 3·4 days (SD 7·1) in the resection group versus 1·4 days (4·7) in the infliximab group (p<0·0001), days not able to take part in social life were 1·8 days (6·3) versus 1·1 days (4·5; p=0·20), days of scheduled hospital admission were 6·5 days (3·8) versus 6·8 days (3·2; p=0·84), and the number of patients who had unscheduled hospital admissions were 13 (18%) of 73 versus 15 (21%) of 70 (p=0·68). Body-image scale mean scores in the patients who had resection were 16·0 (95% CI 15·2-16·8) at baseline versus 17·8 (17·1-18·4) at 12 months, and cosmetic scale mean scores were 17·6 (16·6-18·6) versus 18·6 (17·6-19·6). Surgical intervention-related complications classified as IIIa or worse on the Clavien-Dindo scale occurred in four patients in the resection group. Treatment-related serious adverse events occurred in two patients in the infliximab group. During a median follow-up of 4 years (IQR 2-6), 26 (37%) of 70 patients in the infliximab group had resection, and 19 (26%) of 73 patients in the resection group received anti-TNF. Interpretation: Laparoscopic resection in patients with limited (diseased terminal ileum <40 cm), non-stricturing, ileocaecal Crohn's disease in whom conventional therapy has failed could be considered a reasonable alternative to infliximab therapy. Funding: Netherlands Organisation for Health Research and Development.

The lancet. Gastroenterology & hepatology · randomised controlled trial · 228 citationsread the source →

Decision aids for people facing health treatment or screening decisions.

Background: Decision aids are intended to help people participate in decisions that involve weighing the benefits and harms of treatment options often with scientific uncertainty. Objectives: To assess the effects of decision aids for people facing treatment or screening decisions. Search methods: For this update, we searched from 2009 to June 2012 in MEDLINE; CENTRAL; EMBASE; PsycINFO; and grey literature. Cumulatively, we have searched each database since its start date including CINAHL (to September 2008). Selection criteria: We included published randomized controlled trials of decision aids, which are interventions designed to support patients' decision making by making explicit the decision, providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies of participants making hypothetical decisions. Data collection and analysis: Two review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were:A) 'choice made' attributes;B) 'decision-making process' attributes. Secondary outcomes were behavioral, health, and health-system effects. We pooled results using mean differences (MD) and relative risks (RR), applying a random-effects model. Main results: This update includes 33 new studies for a total of 115 studies involving 34,444 participants. For risk of bias, selective outcome reporting and blinding of participants and personnel were mostly rated as unclear due to inadequate reporting. Based on 7 items, 8 of 115 studies had high risk of bias for 1 or 2 items each. Of 115 included studies, 88 (76.5%) used at least one of the IPDAS effectiveness criteria: A) 'choice made' attributes criteria: knowledge scores (76 studies); accurate risk perceptions (25 studies); and informed value-based choice (20 studies); and B) 'decision-making process' attributes criteria: feeling informed (34 studies) and feeling clear about values (29 studies).A) Criteria involving 'choice made' attributes:Compared to usual care, decision aids increased knowledge (MD 13.34 out of 100; 95% confidence interval (CI) 11.17 to 15.51; n = 42). When more detailed decision aids were compared to simple decision aids, the relative improvement in knowledge was significant (MD 5.52 out of 100; 95% CI 3.90 to 7.15; n = 19). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.82; 95% CI 1.52 to 2.16; n = 19). Exposure to a decision aid with explicit values clarification resulted in a higher proportion of patients choosing an option congruent with their values (RR 1.51; 95% CI 1.17 to 1.96; n = 13).B) Criteria involving 'decision-making process' attributes:Decision aids compared to usual care interventions resulted in:a) lower decisional conflict related to feeling uninformed (MD -7.26 of 100; 95% CI -9.73 to -4.78; n = 22) and feeling unclear about personal values (MD -6.09; 95% CI -8.50 to -3.67; n = 18);b) reduced proportions of people who were passive in decision making (RR 0.66; 95% CI 0.53 to 0.81; n = 14); andc) reduced proportions of people who remained undecided post-intervention (RR 0.59; 95% CI 0.47 to 0.72; n = 18).Decision aids appeared to have a positive effect on patient-practitioner communication in all nine studies that measured this outcome. For satisfaction with the decision (n = 20), decision-making process (n = 17), and/or preparation for decision making (n = 3), those exposed to a decision aid were either more satisfied, or there was no difference between the decision aid versus comparison interventions. No studies evaluated decision-making process attributes for helping patients to recognize that a decision needs to be made, or understanding that values affect the choice.C) Secondary outcomes Exposure to decision aids compared to usual care reduced the number of people of choosing major elective invasive surgery in favour of more conservative options (RR 0.79; 95% CI 0.68 to 0.93; n = 15). Exposure to decision aids compared to usual care reduced the number of people choosing to have prostate-specific antigen screening (RR 0.87; 95% CI 0.77 to 0.98; n = 9). When detailed compared to simple decision aids were used, fewer people chose menopausal hormone therapy (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable. The effect of decision aids on length of consultation varied from 8 minutes shorter to 23 minutes longer (median 2.55 minutes longer) with 2 studies indicating statistically-significantly longer, 1 study shorter, and 6 studies reporting no difference in consultation length. Groups of patients receiving decision aids do not appear to differ from comparison groups in terms of anxiety (n = 30), general health outcomes (n = 11), and condition-specific health outcomes (n = 11). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive. Authors' conclusions: There is high-quality evidence that decision aids compared to usual care improve people's knowledge regarding options, and reduce their decisional conflict related to feeling uninformed and unclear about their personal values. There is moderate-quality evidence that decision aids compared to usual care stimulate people to take a more active role in decision making, and improve accurate risk perceptions when probabilities are included in decision aids, compared to not being included. There is low-quality evidence that decision aids improve congruence between the chosen option and the patient's values. New for this updated review is further evidence indicating more informed, values-based choices, and improved patient-practitioner communication. There is a variable effect of decision aids on length of consultation. Consistent with findings from the previous review, decision aids have a variable effect on choices. They reduce the number of people choosing discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, cost-effectiveness, use with lower literacy populations, and level of detail needed in decision aids need further evaluation. Little is known about the degree of detail that decision aids need in order to have a positive effect on attributes of the choice made, or the decision-making process.

The Cochrane database of systematic reviews · meta-analysis · 891 citationsread the source →

Problematic Internet use: an overview

The “global village”, a metaphor used to describe how the Internet has shortened distances and facilitated the flow of information, has grown to over one billion users 1. Statistics from across the world highlight its reach and penetrance: 90% of South Korean households connect to high-speed, inexpensive broadband 2; Londoners spend an average of 45 days a year online, more than they spend watching TV 3; and the rate of increase in the number of Internet users in Africa and the Middle East exceeded 1,300% between 2000 and 2009 4. For the majority of Internet users, the World Wide Web represents a tremendous wellspring of opportunity that enhances well-being. For others, however, it can lead to a state that appears to meet the DSM definition of a mental disorder, described as a “clinically significant behavioral or psychological syndrome…that is associated with present distress… or with a significantly increased risk of suffering death, pain, disability, or an important loss of freedom” 5. Scientific understanding of that state has lagged behind media attention 6, in part because of inconsistency in defining the problem 7, disagreement about its very existence 8, and the variable research methodology used in studying it. Still, a body of data by scientists from the East and West (with the East increasingly leading the way) tells a cautionary tale about the Internet's potential to bring about psychological harm. In 1996, the psychologist K. Young became the first to publish a detailed case report of problematic Internet use 9. Her “patient zero” was a non-technologically oriented 43-year-old homemaker with a “content home life and no prior addiction or psychiatric history”, who, within three months of discovering chat rooms, was spending up to 60 hours per week online. She reported feeling excited in front of the computer, and depressed, anxious, and irritable when she would log off. She described having an addiction to the medium “like one would to alcohol”. Within one year of purchasing her home computer, she was ignoring household chores, had quit social activities she used to enjoy, and had become estranged from her two teenage daughters and her husband of 17 years. Based on this and other patients she interviewed, Young proposed the first set of diagnostic criteria for what she termed “Internet addiction”. She modeled them on the DSM-IV definition for substance dependence because of similarities she observed with the states of tolerance (needing more of the substance to achieve the same effect) and withdrawal (psychological and physical discomfort upon reducing or stopping the substance) 9. Others conceptualized problematic Internet use as a behavioral addiction not involving an intoxicant 10, and Young subsequently updated her definition, adapting the DSM-IV criteria for pathological gambling, an impulse control disorder often described as a behavioral addiction, into her Diagnostic Questionnaire 11 (Table 1). The questionnaire, which required at least five of the eight criteria be met for the Internet addiction diagnosis, has not received adequate psychometric testing. Shapira et al 12 proposed five years later a more inclusive diagnostic schema in the general style of the impulse control disorders. They argued that definitions based solely on substance dependence or pathological gambling were too narrow to capture the population of problematic Internet users and could lead to premature conclusions about the new disorder and the patients. They eschewed the “Internet addiction” label for lack of scientific proof for true addiction and favored the less controversial “problematic Internet use”, defining it as: a) maladaptive preoccupation with Internet use, experienced as irresistible use for periods of time longer than intended; b) significant distress or impairment resulting from the behavior; and c) the absence of other Axis I pathology that might explain the behavior, such as mania or hypomania. To date, only two studies have attempted to develop diagnostic criteria empirically by testing them against the diagnosis made on the basis of a systematic psychiatric interview. Ko et al 13 tested a set of criteria in 468 Taiwanese high school students. Starting with 13 candidate criteria, they eliminated those with low diagnostic accuracy, and determined that a cutoff of six out of the nine remaining criteria had the best diagnostic accuracy while maintaining high specificity (97.1%) and acceptable sensitivity (87.5%). The criterion for functional impairment was listed separately as criterion B and was required for the diagnosis (Table 2). In a second study, Ko et al 14 confirmed the diagnostic accuracy of their criteria in an older cohort of 216 Taiwanese college students. However, the relatively small size of both studies and the non-representative nature of the groups studied limit the applicability of the proposed criteria to the general population. Several assessment scales have been proposed to screen for, and help diagnose, problematic Internet use. As a group, these instruments show no consensus on the underlying dimensions that constitute the condition 6,15. In addition to Young's Diagnostic Questionnaire, two are in relatively common use in research and/or clinical settings: Young's Internet Addiction Test 16 and the Chen Internet Addiction Scale 17. Young's Internet Addiction Test 16 consists of 20 “how-often” questions, each rated on a scale of 1 to 5 (1=rarely; 2=occasionally; 3=frequently; 4=often; 5=always.) A score of 80 or above is consistent with problematic use (Table 3). The psychometric properties of the instrument were studied in 86 subjects 18. Six factors were extracted from the questionnaire: salience, excessive use, neglect of work, anticipation, lack of control, and neglect of social life. These factors showed good concurrent validity and internal consistency. Salience explained most of the variance and was also found to be the most reliable as indicated by its Cronbach's alpha. However, the selection bias introduced by online recruitment and the small size of the study limit its value. The Chen Internet Addiction Scale 17 is a self-report instrument composed of 26 items rated on a 4-point Likert scale (adapted in Table 4). It assesses five domains of Internet-related problems: compulsive use, withdrawal, tolerance, interpersonal and health consequences, and time management difficulties. Scores range from 26 to 104. In a study of 454 Taiwanese adolescents who completed the scale and received a structured diagnostic interview, a cutoff of 64 was shown to have high diagnostic accuracy and specificity (88% and 92.6%, respectively) 19. The internal reliability of the scale and subscales in the original study ranged from 0.79 to 0.93 17. Due to the lack of consensus on diagnostic criteria and the dearth of large epidemiological studies, the prevalence of problematic Internet use in the general population has not been established. Overall, prevalence surveys conducted in various countries fall into two main categories, online vs. offline studies, with the former typically yielding higher rates, most likely because of inherent selection bias 20. Only two epidemiological studies exploring the prevalence of problematic Internet use in the general population have been published. One was conducted in the US, the other in Norway 20,21. The US study used random-digit telephone dialing (cellular phone numbers were not included) to interview 2,513 adults taken from all 50 states in a manner proportional to the population in each state 20. More than half of the people reached agreed to be interviewed. Participants’ average age was 48, and 51% fell in the middle class socioeconomic stratum. 68.9% were regular Internet users. The authors’ diagnostic definition, based on published criteria and on similarities with impulse control disorders, substance dependence and obsessive-compulsive disorder, required: a) Internet use that interferes in personal relationships; b) preoccupation with the Internet when offline; c) unsuccessful attempts at quitting or cutting down; and d) staying online longer than intended. This definition yielded a point prevalence of 0.7%. Less stringent definitions yielded higher prevalence rates, and individual features consistent with problematic Internet use were endorsed by as many as 13.7% (respondents who found it hard to stay offline for days in a row). In the second study, Bakken et al 21 mailed Young's Diagnostic Questionnaire to 10,000 inhabitants of Norway, randomly selected from a database of the entire population. 3,399 completed questionnaires were returned (a somewhat lower response rate than the US study). Recipients of the mailed questionnaire also had the option of completing it online. Among respondents, 87% were Internet users. The prevalence of “addicted Internet use” (≥5 questions answered “yes”) was calculated to be 1%, whereas the prevalence of “at risk” Internet use (3–4 questions answered “yes”) was 5.2%. Multivariate analysis showed young age, male gender, higher educational achievement, and financial stress to be positively associated with “problematic Internet use” (defined by the authors to include both “Internet addicts” and “at risk” respondents). Prevalence rates among adolescents have been researched more extensively, perhaps because the so-called “digital natives” grew up incorporating the Internet in many aspects of life and as a result are perceived to be at higher risk. However, even when online-based surveys are excluded, the results can vary widely and are difficult to compare, due to differences in Internet access, recruitment methodology, the exact age bracket studied, and the definitions utilized. Considering only relatively large and offline studies, research from China 22, South Korea 23,24, Greece 25, Norway 26, and Iran 27 has yielded prevalence estimates ranging between 2% and 11%. Problematic Internet use has not been incorporated into large-scale epidemiological studies aimed at estimating the relative prevalence of mental disorders. Still, a review of published studies reveals that the presence of other psychiatric conditions in patients with problematic Internet use is the rule rather than the exception 6. The studies, however, were not designed or statistically powered to detect the nature of the association (cause, effect, or independent). In Bakken's general-population study 21, based on subjects’ self-report, 41.4% of Internet “addicts” reported feelings of depression in the 12-month period prior to the study, compared to 15.8% of non-problematic users. Sleep disturbances, anxious feelings, and alcohol and substance abuse were also more common (38.6% vs. 26.4%, 36.4% vs. 5%, and 13.6% vs. 1.1%, respectively). However, the questions used to assess co-occurring psychological impairment were not based on established criteria for mood, sleep, anxiety, or substance use disorders. Two US case series involved face-to-face interviews of adult patients with problematic Internet use. Black et al 28 assessed 21 subjects with the Diagnostic Interview Schedule and found the lifetime prevalence of mood disorders and major depression to be 33% and 15%, respectively. Further, 38% had a lifetime substance use disorder and 19% had a lifetime diagnosis of anxiety disorder. In a case series that included 20 patients, Shapira et al 29 found a very high (70%) lifetime prevalence for bipolar affective disorder, type I or II, compared with 15% for major depression. Fifty-five percent had a lifetime prevalence of substance abuse, and 45% met criteria for social anxiety disorder. Fifty percent of subjects had a lifetime diagnosis of an impulse control disorder. The authors highlight their observation that patients’ Internet-related symptoms were more impulsive and egosyntonic than compulsive and egodystonic, concluding that problematic Internet use resembles the DSM-IV definition of an impulse control disorder more closely than that of obsessive-compulsive disorder. Our clinical experience supports this conclusion. As a group, surveys conducted among high school and college students show similarly high comorbidity rates with mood and anxiety disorders, but a link between attention-deficit/hyperactivity disorder (ADHD) and problematic Internet use seems more obvious than among adults. One study in 752 South Korean elementary students found that 33% of those with ADHD also met criteria for problematic Internet use 30. Another study in 216 Taiwanese college students showed that 32% subjects with problematic Internet use also had ADHD compared to only 8% of regular Internet users 31. Whether Web-based activities appeal to the short attention span of ADHD sufferers or whether excessive Internet use may cause inattention remains to be elucidated. The clinical evaluation of the patient with problematic Internet use should include a careful assessment of the comorbid conditions frequently present. Those should then be treated according to established treatment guidelines. To the extent that the Internet-related problem may stem from another diagnosis (e.g., a patient with severe social anxiety who starts leading a “virtual” life at the expense of offline interactions), it might improve as the primary condition is addressed. Pharmacotherapeutic and psychotherapeutic interventions specific to problematic Internet use have not yet received adequate testing in large, rigorous studies. Pharmacotherapy often begins with selective serotonin reuptake inhibitors (SSRIs). However, while effective in treating obsessive-compulsive disorder, SSRIs have shown mixed results in impulse control disorders 32,33,34,35–36. In light of the greater similarity between problematic Internet use and impulse control disorders compared to obsessive-compulsive disorder 29, it is unclear whether SSRIs will ultimately prove beneficial, and no double-blind placebo-controlled studies have been published so far. One discontinuation study tested escitalopram, 20 mg/day, in 19 subjects with problematic Internet use 37. During the 10-week open-label phase, subjects showed significant decreases in weekly hours spent online (from a mean of 36.8 hours to 16.5 hours) and improvement in global functioning. At the end of the 10 weeks, subjects were blindly randomized to either continued escitalopram treatment or to placebo. Beyond that, they were followed for 9 weeks. No significant difference was seen between the two groups at the end of the second phase, as gains achieved at week 10 were maintained in both treatment groups. The authors speculate that nine weeks may have not been sufficient for the effect to be lost in the placebo group or for additional gains to be made in the escitalopram group, but do not rule out the possibility that the improvement seen in the open-label phase may have been a placebo response. One case study reported successful treatment with naltrexone 38, a drug that has shown benefit in other impulse control disorders 39,40. The patient was a 31 year old male with compulsive cybersexual behavior who had failed antidepressants, group and individual psychotherapy, Sexual Addicts Anonymous, and pastoral counseling. Naltrexone (150 mg/day), gradually added to a stable dose of sertraline which on its own had been ineffective in treating his problematic Internet use, helped induce a three-year remission. The authors hypothesize that, by blocking the capacity of endogenous opioids to trigger dopamine release in response to reward, naltrexone may block the reinforcing nature of compulsive Internet sexual activity. Another case study reported the successful use of an atypical antipsychotic, quetiapine, 200 mg/day, gradually added to citalopram, in a 23 year old subject with problematic Internet use 41. The improvement was maintained at four-month follow-up. More recently, a study tested methylphenidate in 62 children with ADHD who were Internet video game players 42. Participants’ average age was around 9. After 8 weeks of treatment (average dose 30.5 mg/day), Internet usage decreased significantly and correlated with reduction in ADHD symptoms. The authors cautiously suggest that methylphenidate might be beneficial as a treatment for problematic Internet use, especially when co-occurring with ADHD. Of the psychotherapy approaches used, cognitive behavioral therapy (CBT) has received the most empiric investigation. The largest study enrolled 114 adult subjects and employed CBT interventions including: keeping a daily log of Internet activity, teaching time management skills, and confronting cognitive distortions and rationalizations frequently used by patients to justify continued Internet usage, such as “just a few more minutes won't hurt” 43. Most subjects were able to control their symptoms by the eighth session, and improvement was sustained over a 6-month follow-up. For children and adolescents, family-based interventions that improve communication and teach family monitoring of Internet use can be helpful 44. However, the intensive (and typically very expensive) residential treatment options that have received much media attention have undergone little empiric investigation to warrant a strong recommendation 2,45. The same applies to online treatment websites that encourage the person with problematic Internet use to “click here if you are addicted to the Internet”. For a medium that has so radically changed the way we conduct our lives, the Internet's effects on our psychological health remain understudied. Simply stating that similar fears were raised when the radio, movies and early video games were introduced is not sufficient: the immersive and interactive qualities of the virtual world, and its sheer penetrance, make it potentially more serious. Also deserving of exploration are the more subtle psychological changes that occur in the virtual world, such as online disinhibition and increased risk-taking 46. Those changes are not necessarily evidence of “Internet addiction”, and may not be pathological, but, as important features of the new virtual psychology, should also be studied. As our field continues to debate whether their condition belongs in the next edition of the DSM 47, patients continue to present with symptoms born out of the digital age, and their symptoms are changing as the technology evolves from browsers, to “crackberries”, to “smart phones” that combine texting, talking, video games, and browsing in one device that to many is like a new appendage. Even the “problematic Internet use” designation now seems outdated, which is why some have wisely opted for “pathological use of electronic media”, instead 47. Technology, like media outlets, remains far ahead of scientific investigation. Given the dramatic changes that our society is undergoing as a result of the Internet revolution, it behooves us to try to bridge the gap.

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