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Dialectical behaviour therapy for adolescents: a comparison of 16-week and 24-week programmes delivered in a public community setting.

Background: Dialectical behaviour therapy for adolescents (DBT-A) is an intervention with a growing evidence base for treating adolescents with emotional and behavioural dysregulation. Previous studies have reported on varying lengths of treatment, however, and optimal treatment duration has not yet been identified. While the treatment developers initially proposed a 16-week programme, they have more recently recommended an extension to 24 weeks. This study compares outcomes for adolescents and parent/guardians who participated in 16- and 24-week DBT-A programmes in a community setting. Methods: Eighty-four adolescents and 100 parent/guardians participated in 16-week DBT-A, while 68 adolescents and 67 parent/guardians participated in the 24-week programme. Outcome measures for adolescents included the presence and frequency of self-harm, suicidal ideation and depression; and for parents were burden, grief and parental stress. Outcomes were assessed at pre- and postintervention. Linear mixed-effects models were used to estimate the treatment duration effect (24-week vs. 16-week) utilising all available data at pre- and postintervention. Results: Data analyses showed a reduction in the presence and frequency of self-harm at postintervention for adolescents in both programmes. Both adolescent and parent participants in the 16- and 24-week programmes also showed changes indicating significant improvement on all self-report outcome measures (p < .05). A treatment duration effect was identified with adolescents in the 24-week programme reporting greater gains on measures of suicidal ideation and depression (p < .05). However, drop-out rates were higher for the 24-week programme. Conclusions: The findings of the current study indicate that 24-week DBT-A may have additional benefits in comparison to 16-week DBT-A in terms of further reductions in suicidal ideation and depression. Given the nature of this study, it was not possible to explore a potential time effect, however, so these results should be interpreted with caution. Further research will assist in determining an optimal programme duration of DBT-A.

Child and adolescent mental health · 10 citationsread the source →

Targeting and managing behavioral symptoms in individuals with dementia: a randomized trial of a nonpharmacological intervention.

Objectives: To test the effects of an intervention that helps families manage distressing behaviors in family members with dementia. Design: Two-group randomized trial. Setting: In home. Participants: Two hundred seventy-two caregivers and people with dementia. Intervention: Up to 11 home and telephone contacts over 16 weeks by health professionals who identified potential triggers of patient behaviors, including communication and environmental factors and patient undiagnosed medical conditions (by obtaining blood and urine samples) and trained caregivers in strategies to modify triggers and reduce their upset. Between 16 and 24 weeks, three telephone contacts reinforced strategy use. Measurements: Primary outcomes were frequency of targeted problem behavior and caregiver upset with and confidence managing it at 16 weeks. Secondary outcomes were caregiver well-being and management skills at 16 and 24 weeks and caregiver perceived benefits. Prevalence of medical conditions for intervention patients were also examined. Results: At 16 weeks, 67.5% of intervention caregivers reported improvement in targeted problem behavior, compared with 45.8% of caregivers in a no-treatment control group (P=.002), and reduced upset with (P=.03) and enhanced confidence managing (P=.01) the behavior. Additionally, intervention caregivers reported less upset with all problem behaviors (P=.001), less negative communication (P=.02), less burden (P=.05), and better well-being (P=.001) than controls. Fewer intervention caregivers had depressive symptoms (53.0%) than control group caregivers (67.8%, P=.02). Similar caregiver outcomes occurred at 24 weeks. Intervention caregivers perceived more study benefits (P<.05), including ability to keep family members home, than controls. Blood and urine samples of intervention patients with dementia showed that 40 (34.1%) had undiagnosed illnesses requiring physician follow-up. Conclusion: Targeting behaviors upsetting to caregivers and modifying potential triggers improves symptomatology in people with dementia and caregiver well-being and skills.

Journal of the American Geriatrics Society · randomised controlled trial · 166 citationsread the source →

Pharmacotherapy for anxiety and comorbid alcohol use disorders.

Background: Anxiety disorders are a potentially disabling group of disorders that frequently co-occur with alcohol use disorders. Comorbid anxiety and alcohol use disorders are associated with poorer outcomes, and are difficult to treat with standard psychosocial interventions. In addition, improved understanding of the biological basis of the conditions has contributed to a growing interest in the use of medications for the treatment of people with both diagnoses. Objectives: To assess the effects of pharmacotherapy for treating anxiety in people with comorbid alcohol use disorders, specifically: to provide an estimate of the overall effects of medication in improving treatment response and reducing symptom severity in the treatment of anxiety disorders in people with comorbid alcohol use disorders; to determine whether specific medications are more effective and tolerable than other medications in the treatment of particular anxiety disorders; and to identify which factors (clinical, methodological) predict response to pharmacotherapy for anxiety disorders. Search methods: Review authors searched the specialized registers of The Cochrane Collaboration Depression, Anxiety and Neurosis Review Group (CCDANCTR, to January 2014) and the Cochrane Drugs and Alcohol Group (CDAG, to March 2013) for eligible trials. These registers contain reports of relevant randomized controlled trials (RCT) from: the Cochrane Central Register of Controlled Trials (CENTRAL, all years), MEDLINE (1950 to date), EMBASE (1974 to date) and PsycINFO (1967 to date). Review authors ran complementary searches on EMBASE, PubMed, PsycINFO and the Alcohol and Alcohol Problems Science Database (ETOH) (to August 2013). We located unpublished trials through the National Institutes of Health (NIH) RePORTER service and the World Health Organization (WHO) International Clinical Trials Registry Platform (to August 2013). We screened reference lists of retrieved articles for additional studies. Selection criteria: All true RCTs of pharmacotherapy for treating anxiety disorders with comorbid alcohol use disorders. Trials assessing drugs administered for the treatment of drinking behaviour, such as naltrexone, disulfiram and acomprosate were not eligible for inclusion in this systematic review. Data collection and analysis: A systematic review is a standardised evaluation of all research studies that address a particular clinical issue. Two review authors independently assessed RCTs for inclusion in the review, collated trial data and assessed trial quality. We contacted investigators to obtain missing data. We calculated categorical and continuous treatment effect estimates and their 95% confidence intervals (CI) for treatment using a random-effects model with effect-size variability expressed using Chi(2) and I(2) heterogeneity statistics. Main results: We included five placebo-controlled pharmacotherapy RCTs (with 290 participants) in the review. Most of the trials provided little information on how randomization was performed or on whether both participants and study personnel were blinded to the intervention. Two of the three trials reporting superiority of medication compared with placebo on anxiety symptom outcomes were industry funded. We regarded one trial as being at high risk of bias due to selective reporting. Study participants had Diagnostic and Statistical Manual (DSM) III- and DSM IV-diagnosed alcohol use disorders and post-traumatic stress disorder (two studies), social anxiety disorder (SAD; two studies) or generalized anxiety disorder (GAD; one study). Four trials assessed the efficacy of the selective serotonin re-uptake inhibitors (SSRIs: sertraline, paroxetine); one RCT investigated the efficacy of buspirone, a 5-hydroxytryptamine (5-HT) partial agonist. Treatment duration lasted between eight and 24 weeks. Overall, 70% of participants included in the review were male. There was very low quality evidence for an effect of paroxetine on global clinical response to treatment, as assessed by the Clinical Global Impressions - Improvement scale (CGI-I). Global clinical response was observed in more than twice as many participants with paroxetine than with placebo (57.7% with paroxetine versus 25.8% with placebo; risk ratio (RR) 2.23, 95% CI 1.13 to 4.41; 2 trials, 57 participants). However, there was substantial uncertainty regarding the size of the effect of paroxetine due to the small number of studies providing data on clinically diverse patient samples. The second primary outcome measure was reduction of anxiety symptom severity. Although study investigators reported that buspirone (one trial) was superior to placebo in reducing the severity of anxiety symptoms over 12 weeks, no evidence of efficacy was observed for paroxetine (mean difference (MD) -14.70, 95% CI -33.00 to 3.60, 2 trials, 44 participants) and sertraline (one trial). Paroxetine appeared to be equally effective in reducing the severity of post-traumatic stress disorder (PTSD) symptoms as the tricyclic antidepressant desipramine in one RCT. The maximal reduction in anxiety disorder symptom severity was achieved after six weeks with paroxetine (two RCTs) and 12 weeks with buspirone (one RCT), with maintenance of medication efficacy extending to 16 with paroxetine and 24 weeks with buspirone. There was no evidence of an effect for any of the medications tested on abstinence from alcohol use or depression symptoms. There was very low quality evidence that paroxetine was well tolerated, based on drop-out due to treatment-emergent adverse effects. Nevertheless, levels of treatment discontinuation were high, with 43.1% of the participants in the studies withdrawing from medication treatment. Certain adverse effects, such as sexual problems, were commonly reported after treatment with paroxetine and sertraline. Authors' conclusions: The evidence-base for the effectiveness of medication in treating anxiety disorders and comorbid alcohol use disorders is currently inconclusive. There was a small amount of evidence for the efficacy of medication, but this was limited and of very low quality. The majority of the data for the efficacy and tolerability of medication were for SSRIs; there were insufficient data to establish differences in treatment efficacy between medication classes or patient subgroups. There was a small amount of very low quality evidence that medication was well tolerated. There was no evidence that alcohol use was responsive to medication. Large, rigorously conducted RCTs would help supplement the small evidence-base for the efficacy and tolerability of pharmacotherapy for anxiety and comorbid alcohol use disorders. Further research on patient subgroups who may benefit from pharmacological treatment, as well as novel pharmacological interventions, is warranted.

The Cochrane database of systematic reviews · meta-analysis · 54 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 →

Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation.

Background: Nicotine replacement therapy (NRT) aims to replace nicotine from cigarettes to ease the transition from cigarette smoking to abstinence. It works by reducing the intensity of craving and withdrawal symptoms. Although there is clear evidence that NRT used after smoking cessation is effective, it is unclear whether higher doses, longer durations of treatment, or using NRT before cessation add to its effectiveness. Objectives: To determine the effectiveness and safety of different forms, deliveries, doses, durations and schedules of NRT, for achieving long-term smoking cessation, compared to one another. Search methods: We searched the Cochrane Tobacco Addiction Group trials register, and trial registries for papers mentioning NRT in the title, abstract or keywords. Date of most recent search: April 2018. Selection criteria: Randomized trials in people motivated to quit, comparing one type of NRT use with another. We excluded trials that did not assess cessation as an outcome, with follow-up less than six months, and with additional intervention components not matched between arms. Trials comparing NRT to control, and trials comparing NRT to other pharmacotherapies, are covered elsewhere. Data collection and analysis: We followed standard Cochrane methods. Smoking abstinence was measured after at least six months, using the most rigorous definition available. We extracted data on cardiac adverse events (AEs), serious adverse events (SAEs), and study withdrawals due to treatment. We calculated the risk ratio (RR) and the 95% confidence interval (CI) for each outcome for each study, where possible. We grouped eligible studies according to the type of comparison. We carried out meta-analyses where appropriate, using a Mantel-Haenszel fixed-effect model. Main results: We identified 63 trials with 41,509 participants. Most recruited adults either from the community or from healthcare clinics. People enrolled in the studies typically smoked at least 15 cigarettes a day. We judged 24 of the 63 studies to be at high risk of bias, but restricting the analysis only to those studies at low or unclear risk of bias did not significantly alter results, apart from in the case of the preloading comparison. There is high-certainty evidence that combination NRT (fast-acting form + patch) results in higher long-term quit rates than single form (RR 1.25, 95% CI 1.15 to 1.36, 14 studies, 11,356 participants; I2 = 4%). Moderate-certainty evidence, limited by imprecision, indicates that 42/44 mg are as effective as 21/22 mg (24-hour) patches (RR 1.09, 95% CI 0.93 to 1.29, 5 studies, 1655 participants; I2 = 38%), and that 21 mg are more effective than 14 mg (24-hour) patches (RR 1.48, 95% CI 1.06 to 2.08, 1 study, 537 participants). Moderate-certainty evidence (again limited by imprecision) also suggests a benefit of 25 mg over 15 mg (16-hour) patches, but the lower limit of the CI encompassed no difference (RR 1.19, 95% CI 1.00 to 1.41, 3 studies, 3446 participants; I2 = 0%). Five studies comparing 4 mg gum to 2 mg gum found a benefit of the higher dose (RR 1.43, 95% CI 1.12 to 1.83, 5 studies, 856 participants; I2 = 63%); however, results of a subgroup analysis suggest that only smokers who are highly dependent may benefit. Nine studies tested the effect of using NRT prior to quit day (preloading) in comparison to using it from quit day onward; there was moderate-certainty evidence, limited by risk of bias, of a favourable effect of preloading on abstinence (RR 1.25, 95% CI 1.08 to 1.44, 9 studies, 4395 participants; I2 = 0%). High-certainty evidence from eight studies suggests that using either a form of fast-acting NRT or a nicotine patch results in similar long-term quit rates (RR 0.90, 95% CI 0.77 to 1.05, 8 studies, 3319 participants; I2 = 0%). We found no evidence of an effect of duration of nicotine patch use (low-certainty evidence); 16-hour versus 24-hour daily patch use; duration of combination NRT use (low- and very low-certainty evidence); tapering of patch dose versus abrupt patch cessation; fast-acting NRT type (very low-certainty evidence); duration of nicotine gum use; ad lib versus fixed dosing of fast-acting NRT; free versus purchased NRT; length of provision of free NRT; ceasing versus continuing patch use on lapse; and participant- versus clinician-selected NRT. However, in most cases these findings are based on very low- or low-certainty evidence, and are the findings from single studies.AEs, SAEs and withdrawals due to treatment were all measured variably and infrequently across studies, resulting in low- or very low-certainty evidence for all comparisons. Most comparisons found no evidence of an effect on cardiac AEs, SAEs or withdrawals. Rates of these were low overall. Significantly more withdrawals due to treatment were reported in participants using nasal spray in comparison to patch in one trial (RR 3.47, 95% CI 1.15 to 10.46, 922 participants; very low certainty) and in participants using 42/44 mg patches in comparison to 21/22 mg patches across two trials (RR 4.99, 95% CI 1.60 to 15.50, 2 studies, 544 participants; I2 = 0%; low certainty). Authors' conclusions: There is high-certainty evidence that using combination NRT versus single-form NRT, and 4 mg versus 2 mg nicotine gum, can increase the chances of successfully stopping smoking. For patch dose comparisons, evidence was of moderate certainty, due to imprecision. Twenty-one mg patches resulted in higher quit rates than 14 mg (24-hour) patches, and using 25 mg patches resulted in higher quit rates than using 15 mg (16-hour) patches, although in the latter case the CI included one. There was no clear evidence of superiority for 42/44 mg over 21/22 mg (24-hour) patches. Using a fast-acting form of NRT, such as gum or lozenge, resulted in similar quit rates to nicotine patches. There is moderate-certainty evidence that using NRT prior to quitting may improve quit rates versus using it from quit date only; however, further research is needed to ensure the robustness of this finding. Evidence for the comparative safety and tolerability of different types of NRT use is of low and very low certainty. New studies should ensure that AEs, SAEs and withdrawals due to treatment are both measured and reported.

The Cochrane database of systematic reviews · systematic review · 126 citationsread the source →

Prevalence of Health Misinformation on Social Media: Systematic Review.

Background: Although at present there is broad agreement among researchers, health professionals, and policy makers on the need to control and combat health misinformation, the magnitude of this problem is still unknown. Consequently, it is fundamental to discover both the most prevalent health topics and the social media platforms from which these topics are initially framed and subsequently disseminated. Objective: This systematic review aimed to identify the main health misinformation topics and their prevalence on different social media platforms, focusing on methodological quality and the diverse solutions that are being implemented to address this public health concern. Methods: We searched PubMed, MEDLINE, Scopus, and Web of Science for articles published in English before March 2019, with a focus on the study of health misinformation in social media. We defined health misinformation as a health-related claim that is based on anecdotal evidence, false, or misleading owing to the lack of existing scientific knowledge. We included (1) articles that focused on health misinformation in social media, including those in which the authors discussed the consequences or purposes of health misinformation and (2) studies that described empirical findings regarding the measurement of health misinformation on these platforms. Results: A total of 69 studies were identified as eligible, and they covered a wide range of health topics and social media platforms. The topics were articulated around the following six principal categories: vaccines (32%), drugs or smoking (22%), noncommunicable diseases (19%), pandemics (10%), eating disorders (9%), and medical treatments (7%). Studies were mainly based on the following five methodological approaches: social network analysis (28%), evaluating content (26%), evaluating quality (24%), content/text analysis (16%), and sentiment analysis (6%). Health misinformation was most prevalent in studies related to smoking products and drugs such as opioids and marijuana. Posts with misinformation reached 87% in some studies. Health misinformation about vaccines was also very common (43%), with the human papilloma virus vaccine being the most affected. Health misinformation related to diets or pro-eating disorder arguments were moderate in comparison to the aforementioned topics (36%). Studies focused on diseases (ie, noncommunicable diseases and pandemics) also reported moderate misinformation rates (40%), especially in the case of cancer. Finally, the lowest levels of health misinformation were related to medical treatments (30%). Conclusions: The prevalence of health misinformation was the highest on Twitter and on issues related to smoking products and drugs. However, misinformation on major public health issues, such as vaccines and diseases, was also high. Our study offers a comprehensive characterization of the dominant health misinformation topics and a comprehensive description of their prevalence on different social media platforms, which can guide future studies and help in the development of evidence-based digital policy action plans.

Journal of medical Internet research · systematic review · 808 citationsread the source →

Systematic Review of Electronic Cigarette Use (Vaping) and Mental Health Comorbidity Among Adolescents and Young Adults.

Introduction: The prevalence of electronic cigarette (EC) use has risen dramatically among adolescents and young adults (AYA, ages 12-26) over the past decade. Despite extensive established relationships between combustible cigarette use and mental health problems, the mental health comorbidities of EC use remain unclear. Aims and methods: To provide a systematic review of existing literature on mental health comorbidities of EC use among AYA. Database searches using search terms related to EC, AYA, and mental health identified 1168 unique articles, 87 of which prompted full-text screening. Multiple authors extracted data, applied the Effective Public Health Practice Project Quality Assessment Tool to evaluate the evidence, and synthesized findings. Results: Forty articles met eligibility criteria (n = 24 predominantly adolescent and 16 predominantly young adult). Analyses yielded three main categories of focus: internalizing disorders (including depression, anxiety, suicidality, eating disorders, post-traumatic stress disorder), externalizing disorders (attention-deficit/hyperactivity disorder and conduct disorder), and transdiagnostic concepts (impulsivity and perceived stress). Significant methodological limitations were noted. Conclusions: Youth EC use is associated with greater mental health problems (compared with nonuse) across several domains, particularly among adolescents. Because many existing studies are cross-sectional, directionality remains uncertain. Well-designed longitudinal studies to investigate long-term mental health sequelae of EC use remain needed. Implications: Forty recent studies demonstrate a variety of mental health comorbidities with AYA EC use, particularly among adolescents. Mental health comorbidities of EC use generally parallel those of combustible cigarette use, with a few exceptions. Future EC prevention and treatment strategies may be enhanced by addressing mental health.

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · systematic review · 166 citationsread the source →

Telephone-Based Cognitive Behavioral Therapy for Insomnia in Perimenopausal and Postmenopausal Women With Vasomotor Symptoms: A MsFLASH Randomized Clinical Trial.

Importance: Effective, practical, nonpharmacologic therapies are needed to treat menopause-related insomnia symptoms in primary and women's specialty care settings. Objective: To evaluate the efficacy of telephone-based cognitive behavioral therapy for insomnia (CBT-I) vs menopause education control (MEC). Design, setting, and participants: A single-site, randomized clinical trial was conducted from September 1, 2013, to August 31, 2015, in western Washington State among 106 perimenopausal or postmenopausal women aged 40 to 65 years with moderate insomnia symptoms (Insomnia Severity Index [ISI] score, ≥12) and 2 or more daily hot flashes. Blinded assessments were conducted at baseline, 8, and 24 weeks postrandomization. An intent-to-treat analysis was conducted. Interventions: Six CBT-I or MEC telephone sessions in 8 weeks. Participants submitted weekly electronic sleep diaries and received group-specific written educational materials. The CBT-I sessions included sleep restriction, stimulus control, sleep hygiene education, cognitive restructuring, and behavioral homework; MEC sessions provided information about menopause and women's health. Main outcomes and measures: Primary outcome was scores on the ISI (score range, 0-28; scores ≥15 indicate moderate to severe insomnia). Secondary outcome was scores on the Pittsburgh Sleep Quality Index (score range, 0-21; higher scores indicate worse sleep quality). Additional outcomes included sleep and hot flash diary variables and hot flash interference. Results: At 8 weeks, ISI scores had decreased 9.9 points among 53 women receiving CBT-I (mean [SD] age, 55.0 [3.5] years) and 4.7 points among 53 women receiving MEC (age, 54.7 [4.7] years), a mean between-group difference of 5.2 points (95% CI, -6.1 to -3.3; P < .001). Pittsburgh Sleep Quality Index scores decreased 4.0 points in women receiving CBT-I and 1.4 points in women receiving MEC, a mean between-group difference of 2.7 points (95% CI, -3.9 to -1.5; P < .001). Significant group differences were sustained at 24 weeks. At 8 and 24 weeks, 33 of 47 women (70%) and 37 of 44 (84%) in the CBT-I group, respectively, had ISI scores in the no-insomnia range compared with 10 of 41 (24%) and 16 of 37 (43%) in the MEC group, respectively. The CBT-I group also had greater improvements in diary-reported sleep latency, wake time, and sleep efficiency. There were no between-group differences in frequency of daily hot flashes, but hot flash interference was significantly decreased at 8 weeks for the CBT-I group (-15.7; 95% CI, -20.4 to -11.0) compared with the MEC group (-7.1; 95% CI, -14.6 to 0.4) (P = .03), differences that were maintained at 24 weeks for the CBT-I group (-22.8; 95% CI, -28.6 to -16.9) and MEC group (-11.6; 95% CI, -19.4 to -3.8) (P = .003). Conclusions and relevance: Telephone-based CBT-I improved sleep in perimenopausal and postmenopausal women with insomnia and hot flashes. Results support further development and testing of centralized CBT-I programs for treating menopausal insomnia. Trial registration: clinicaltrials.gov Identifier: NCT01936441.

JAMA internal medicine · randomised controlled trial · 114 citationsread the source →

Dialectical behavior therapy for high suicide risk in individuals with borderline personality disorder: a randomized clinical trial and component analysis.

Importance: Dialectical behavior therapy (DBT) is an empirically supported treatment for suicidal individuals. However, DBT consists of multiple components, including individual therapy, skills training, telephone coaching, and a therapist consultation team, and little is known about which components are needed to achieve positive outcomes. Objective: To evaluate the importance of the skills training component of DBT by comparing skills training plus case management (DBT-S), DBT individual therapy plus activities group (DBT-I), and standard DBT which includes skills training and individual therapy. Design, setting, and participants: We performed a single-blind randomized clinical trial from April 24, 2004, through January 26, 2010, involving 1 year of treatment and 1 year of follow-up. Participants included 99 women (mean age, 30.3 years; 69 [71%] white) with borderline personality disorder who had at least 2 suicide attempts and/or nonsuicidal self-injury (NSSI) acts in the last 5 years, an NSSI act or suicide attempt in the 8 weeks before screening, and a suicide attempt in the past year. We used an adaptive randomization procedure to assign participants to each condition. Treatment was delivered from June 3, 2004, through September 29, 2008, in a university-affiliated clinic and community settings by therapists or case managers. Outcomes were evaluated quarterly by blinded assessors. We hypothesized that standard DBT would outperform DBT-S and DBT-I. Interventions: The study compared standard DBT, DBT-S, and DBT-I. Treatment dose was controlled across conditions, and all treatment providers used the DBT suicide risk assessment and management protocol. Main outcomes and measures: Frequency and severity of suicide attempts and NSSI episodes. Results: All treatment conditions resulted in similar improvements in the frequency and severity of suicide attempts, suicide ideation, use of crisis services due to suicidality, and reasons for living. Compared with the DBT-I group, interventions that included skills training resulted in greater improvements in the frequency of NSSI acts (F1,85 = 59.1 [P < .001] for standard DBT and F1,85 = 56.3 [P < .001] for DBT-S) and depression (t399 = 1.8 [P = .03] for standard DBT and t399 = 2.9 [P = .004] for DBT-S) during the treatment year. In addition, anxiety significantly improved during the treatment year in standard DBT (t94 = -3.5 [P < .001]) and DBT-S (t94 = -2.6 [P = .01]), but not in DBT-I. Compared with the DBT-I group, the standard DBT group had lower dropout rates from treatment (8 patients [24%] vs 16 patients [48%] [P = .04]), and patients were less likely to use crisis services in follow-up (ED visits, 1 [3%] vs 3 [13%] [P = .02]; psychiatric hospitalizations, 1 [3%] vs 3 [13%] [P = .03]). Conclusions and relevance: A variety of DBT interventions with therapists trained in the DBT suicide risk assessment and management protocol are effective for reducing suicide attempts and NSSI episodes. Interventions that include DBT skills training are more effective than DBT without skills training, and standard DBT may be superior in some areas. Trial registration: clinicaltrials.gov Identifier: NCT00183651.

JAMA psychiatry · randomised controlled trial · 325 citationsread the source →

The feasibility of low-intensity psychological therapy for depression co-occurring with autism in adults: The Autism Depression Trial (ADEPT) - a pilot randomised controlled trial.

Low-intensity cognitive behaviour therapy including behavioural activation is an evidence-based treatment for depression, a condition frequently co-occurring with autism. The feasibility of adapting low-intensity cognitive behaviour therapy for depression to meet the needs of autistic adults via a randomised controlled trial was investigated. The adapted intervention (guided self-help) comprised materials for nine individual sessions with a low-intensity psychological therapist. Autistic adults (n = 70) with depression (Patient Health Questionnaire-9 score ⩾10) recruited from National Health Service adult autism services and research cohorts were randomly allocated to guided self-help or treatment as usual. Outcomes at 10-, 16- and 24-weeks post-randomisation were blind to treatment group. Rates of retention in the study differed by treatment group with more participants attending follow-up in the guided self-help group than treatment as usual. The adapted intervention was well-received, 86% (n = 30/35) of participants attended the pre-defined 'dose' of five sessions of treatment and 71% (25/35) attended all treatment sessions. The findings of this pilot randomised controlled trial indicate that low-intensity cognitive behaviour therapy informed by behavioural activation can be successfully adapted to meet the needs of autistic people. Evaluation of the effectiveness of this intervention in a full scale randomised controlled trial is now warranted.

Autism : the international journal of research and practice · randomised controlled trial · 29 citationsread the source →

Inactivated poliovirus vaccine given alone or in a sequential schedule with bivalent oral poliovirus vaccine in Chilean infants: a randomised, controlled, open-label, phase 4, non-inferiority study.

Background: Bivalent oral poliovirus vaccine (bOPV; types 1 and 3) is expected to replace trivalent OPV (tOPV) globally by April, 2016, preceded by the introduction of at least one dose of inactivated poliovirus vaccine (IPV) in routine immunisation programmes to eliminate vaccine-associated or vaccine-derived poliomyelitis from serotype 2 poliovirus. Because data are needed on sequential IPV-bOPV schedules, we assessed the immunogenicity of two different IPV-bOPV schedules compared with an all-IPV schedule in infants. Methods: We did a randomised, controlled, open-label, non-inferiority trial with healthy, full-term (>2·5 kg birthweight) infants aged 8 weeks (± 7 days) at six well-child clinics in Santiago, Chile. We used supplied lists to randomly assign infants (1:1:1) to receive three polio vaccinations (IPV by injection or bOPV as oral drops) at age 8, 16, and 24 weeks in one of three sequential schedules: IPV-bOPV-bOPV, IPV-IPV-bOPV, or IPV-IPV-IPV. We did the randomisation with blocks of 12 stratified by study site. All analyses were done in a masked manner. Co-primary outcomes were non-inferiority of the bOPV-containing schedules compared with the all-IPV schedule for seroconversion (within a 10% margin) and antibody titres (within two-thirds log2 titres) to poliovirus serotypes 1 and 3 at age 28 weeks, analysed in the per-protocol population. Secondary outcomes were seroconversion and titres to serotype 2 and faecal shedding for 4 weeks after a monovalent OPV type 2 challenge at age 28 weeks. Safety analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01841671, and is closed to new participants. Findings: Between April 25 and August 1, 2013, we assigned 570 infants to treatment: 190 to IPV-bOPV-bOPV, 192 to IPV-IPV-bOPV, and 188 to IPV-IPV-IPV. 564 (99%) were vaccinated and included in the intention-to-treat cohort, and 537 (94%) in the per-protocol analyses. In the IPV-bOPV-bOPV, IPV-IPV-bOPV, and IPV-IPV-IPV groups, respectively, the proportions of children with seroconversion to type 1 poliovirus were 166 (98·8%) of 168, 95% CI 95·8-99·7; 178 (100%), 97·9-100·0; and 175 (100%), 97·9-100·0. Proportions with seroconvsion to type 3 poliovirus were 163 (98·2%) of 166, 94·8-99·4; 177 (100%), 97·9-100·0, and 172 (98·9%) of 174, 95·9-99·7. Non-inferiority was thus shown for the bOPV-containing schedules compared with the all-IPV schedule, with no significant differences between groups. In the IPV-bOPV-bOPV, IPV-IPV-bOPV, and IPV-IPV-IPV groups, respectively, the proportions of children with seroprotective antibody titres to type 1 poliovirus were 168 (98·8%) of 170, 95% CI 95·8-99·7; 181 (100%), 97·9-100·0; and 177 (100%), 97·9-100·0. Proportions to type 3 poliovirus were 166 (98·2%) of 169, 94·9-99·4; 180 (100%), 97·9-100·0; and 174 (98·9%) of 176, 96·0-99·7. Non-inferiority comparisons could not be done for this outcome because median titres for the groups receiving OPV were greater than the assay's upper limit of detection (log2 titres >10·5). The proportions of children seroconverting to type 2 poliovirus in the IPV-bOPV-bOPV, IPV-IPV-bOPV, and IPV-IPV-IPV groups, respectively, were 130 (77·4%) of 168, 95% CI 70·5-83·0; 169 (96·0%) of 176, 92·0-98·0; and 175 (100%), 97·8-100. IPV-bOPV schedules resulted in almost a 0·3 log reduction of type 2 faecal shedding compared with the IPV-only schedule. No participants died during the trial; 81 serious adverse events were reported, of which one was thought to be possibly vaccine-related (intestinal intussusception). Interpretation: Seroconversion rates against polioviruses types 1 and 3 were non-inferior in sequential schedules containing IPV and bOPV, compared with an all-IPV schedule, and proportions of infants with protective antibodies were high after all three schedules. One or two doses of bOPV after IPV boosted intestinal immunity for poliovirus type 2, suggesting possible cross protection. Additionally, there was evidence of humoral priming for type 2 from one dose of IPV. Our findings could give policy makers flexibility when choosing a vaccination schedule, especially when trying to eliminate vaccine-associated and vaccine-derived poliomyelitis. Funding: Bill & Melinda Gates Foundation.

The Lancet. Infectious diseases · randomised controlled trial · 60 citationsread the source →

Digital cognitive behavioural therapy for insomnia versus digital sleep education control in an Australian community-based sample: a randomised controlled trial.

Background: Insomnia is a prevalent condition in Australia that increases the risk of depression and anxiety symptoms. Cognitive behaviour therapy for insomnia (CBT-i) is the recommended 'first line' treatment but is accessed by a minority of people with insomnia. Aims: To improve CBT-i access in Australia, we aimed to develop and test a self-guided interactive digital CBT-i program. Methods: An online randomised controlled trial was conducted from August 2022 to August 2023 to investigate the effect of digital CBT-i, versus digital sleep education control, on symptoms of insomnia (ISI), depression (PHQ-9), anxiety (GAD-7), fatigue, sleepiness and maladaptive beliefs about sleep at 8-week follow-up. The control group accessed the intervention after the 8-week follow-up. Questionnaires were additionally administered at 16 and 24 weeks. Intent-to-treat mixed models and complete-case chi-squared analyses were used. Results: Participants included 62 adults with insomnia symptoms (age M (SD) = 52.5 (16.3), 82% female, ISI = 18.6 (2.9)). There were no between-group differences in baseline characteristics or missing 8-week data (14.5%). After adjusting for baseline scores, CBT-i was associated with lower insomnia (Diffadj (95% CI) = 7.32 (5.0-9.6), P < 0.001, d = 1.64), depression (3.36 (1.3-5.4), p = 0.002, d = 0.84), fatigue (5.2 (2.5-7.9), P < 0.001, d = 1.00) and maladaptive beliefs about sleep (11.0 (4.1-18.0), P = 0.002, d = 0.82), but not anxiety symptoms at 8 weeks (1.84 (-0.1 to 3.8), p = 0.060, d = 0.50). Compared to control, CBT-i was associated with greater rates of insomnia remission (ISI <8; 0.0%, vs 40.0%, P < 0.001) and response at 8 weeks (ISI reduction ≥6; 7.1% vs 72.0%, P < 0.001). Improvements in insomnia and depression were maintained at 24 weeks in the CBT-i group. Conclusions: This interactive digital CBT-i program resulted in large and sustained improvements in symptoms of insomnia, depression, fatigue and maladaptive beliefs about sleep in Australian adults with insomnia symptoms. Implementation programs are required to increase digital CBT-i access and uptake.

Internal medicine journal · randomised controlled trial · 7 citationsread the source →

Computerized Cognitive Training for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors: A Randomized Controlled Trial.

Purpose: Children receiving CNS-directed therapy for cancer are at risk for cognitive problems, with few available empirically supported interventions. Cognitive problems indicate neurodevelopmental disruption that may be modifiable with intervention. This study evaluated short-term efficacy of a computerized cognitive training program and neural correlates of cognitive change. Patient and methods: A total of 68 survivors of childhood acute lymphoblastic leukemia (ALL) or brain tumor (BT) with identified cognitive deficits were randomly assigned to computerized cognitive intervention (male, n = 18; female, n = 16; ALL, n = 23; BT, n = 11; mean age ± standard deviation, 12.21 ± 2.47 years) or waitlist (male, n = 18; female, n = 16; ALL, n = 24; BT, n = 10; median age ± standard deviation, 11.82 ± 2.42 years). Intervention participants were asked to complete 25 training sessions at home with weekly, telephone-based coaching. Cognitive assessments and functional magnetic resonance imaging scans (intervention group) were completed pre- and postintervention, with immediate change in spatial span backward as the primary outcome. Results: Survivors completing the intervention (n = 30; 88%) demonstrated greater improvement than controls on measures of working memory (mean ± SEM; eg, Wechsler Intelligence Scale for Children [fourth edition; WISC-IV] spatial span backward, 3.13 ± 0.58 v 0.75 ± 0.43; P = .002; effect size [ES], 0.84), attention (eg, WISC-IV spatial span forward, 3.30 ± 0.71 v 1.25 ± 0.39; P = .01; ES, 0.65), and processing speed (eg, Conners' Continuous Performance Test hit reaction time, -2.10 ± 1.47 v 2.54 ± 1.25; P = .02; ES, .61) and showed greater reductions in reported executive dysfunction (eg, Conners' Parent Rating Scale III, -6.73 ± 1.51 v 0.41 ± 1.53; P = .002; ES, 0.84). Functional magnetic resonance imaging revealed significant pre- to post-training reduction in activation of left lateral prefrontal and bilateral medial frontal areas. Conclusion: Study findings show computerized cognitive training is feasible and efficacious for childhood cancer survivors, with evidence for training-related neuroplasticity.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · randomised controlled trial · 119 citationsread the source →

Psychotherapy for depression in older veterans via telemedicine: a randomised, open-label, non-inferiority trial.

Background: Many older adults with major depression, particularly veterans, do not have access to evidence-based psychotherapy. Telemedicine could increase access to best-practice care for older adults facing barriers of mobility, stigma, and geographical isolation. We aimed to establish non-inferiority of behavioural activation therapy for major depression delivered via telemedicine to same-room care in largely male, older adult veterans. Methods: In this randomised, controlled, open-label, non-inferiority trial, we recruited veterans (aged ≥58 years) meeting DSM-IV criteria for major depressive disorder from the Ralph H Johnson Veterans Affairs Medical Center and four associated community outpatient-based clinics in the USA. We excluded actively psychotic or demented people, those with both suicidal ideation and clear intent, and those with substance dependence. The study coordinator randomly assigned participants (1:1; block size 2-6; stratified by race; computer-generated randomisation sequence by RGK) to eight sessions of behavioural activation for depression either via telemedicine or in the same room. The primary outcome was treatment response according to the Geriatric Depression Scale (GDS) and Beck Depression Inventory (BDI; defined as a 50% reduction in symptoms from baseline at 12 months), and Structured Clinical Interview for DSM-IV, clinician version (defined as no longer being diagnosed with major depressive disorder at 12 months follow-up), in the per-protocol population (those who completed at least four treatment sessions and for whom all outcome measurements were done). Those assessing outcomes were masked. The non-inferiority margin was 15%. This trial is registered with ClinicalTrials.gov, number NCT00324701. Findings: Between April 1, 2007, and July 31, 2011, we screened 780 patients, and the study coordinator randomly assigned participants to either telemedicine (120 [50%]) or same-room treatment (121 [50%]). We included 100 (83%) patients in the per-protocol analysis in the telemedicine group and 104 (86%) in the same-room group. Treatment response according to GDS did not differ significantly between the telemedicine (22 [22·45%, 90% CI 15·52-29·38] patients) and same-room (21 [20·39%, 90% CI 13·86-26·92]) groups, with an absolute difference of 2·06% (90% CI -7·46 to 11·58). Response according to BDI also did not differ significantly (telemedicine 19 [24·05%, 90% CI 16·14-31·96] patients; same room 19 [23·17%, 90% CI 15·51-30·83]), with an absolute difference of 0·88% (90% CI -10·13 to 11·89). Response on the Structured Clinical Interview for DSM-IV, clinician version, also did not differ significantly (39 [43·33%, 90% CI 34·74-51·93] patients in the telemedicine group and 46 [48·42%, 90% CI 39·99-56·85] in the same-room group), with a difference of -5·09% (-17·13 to 6·95; p=0·487). Results from the intention-to-treat population were similar. MEM analyses showed that no significant differences existed between treatment trajectories over time for BDI and GDS. The criteria for non-inferiority were met. We did not note any adverse events. Interpretation: Telemedicine-delivered psychotherapy for older adults with major depression is not inferior to same-room treatment. This finding shows that evidence-based psychotherapy can be delivered, without modification, via home-based telemedicine, and that this method can be used to overcome barriers to care associated with distance from and difficulty with attendance at in-person sessions in older adults. Funding: US Department of Veterans Affairs.

The lancet. Psychiatry · randomised controlled trial · 123 citationsread the source →

Young men's attitudes and behaviour in relation to mental health and technology: implications for the development of online mental health services.

Background: This mixed-methods study was designed to explore young Australian men's attitudes and behaviour in relation to mental health and technology use to inform the development of online mental health services for young men. Methods: National online survey of 486 males (aged 16 to 24) and 17 focus groups involving 118 males (aged 16 to 24). Results: Young men are heavy users of technology, particularly when it comes to entertainment and connecting with friends, but they are also using technology for finding information and support. The focus group data suggested that young men would be less likely to seek professional help for themselves, citing a preference for self-help and action-oriented strategies instead. Most survey participants reported that they have sought help for a problem online and were satisfied with the help they received. Focus group participants identified potential strategies for how technology could be used to overcome the barriers to help-seeking for young men. Conclusions: The key challenge for online mental health services is to design interventions specifically for young men that are action-based, focus on shifting behaviour and stigma, and are not simply about increasing mental health knowledge. Furthermore, such interventions should be user-driven, informed by young men's views and everyday technology practices, and leverage the influence of peers.

BMC psychiatry · 76 citationsread the source →

Stepped care treatment for depression and anxiety in primary care. a randomized controlled trial.

Background: Depressive and anxiety disorders are common in general practice but not always treated adequately. Introducing stepped care might improve this. In this randomized trial we examined the effectiveness of such a stepped care model. Methods: The study population consisted of primary care attendees aged 18-65 years with minor or major DSM-IV depressive and/or anxiety disorders, recruited through screening. We randomized 120 patients to either stepped care or care as usual. The stepped care program consisted of (1) watchful waiting, (2) guided self-help, (3) short face-to-face problem solving treatment and (4) pharmacotherapy and/or specialized mental health care. Patients were assessed at baseline and after 8, 16 and 24 weeks. Results: Symptoms of depression and anxiety decreased significantly over time for both groups. However, there was no statistically significant difference between the two groups (IDS: P = 0.35 and HADS: P = 0.64). The largest, but not significant, effect (d = -0.21) was found for anxiety on T3. In both groups approximately 48% of the patients were recovered from their DSM-IV diagnosis at the final 6 months assessment. Conclusions: In summary we could not demonstrate that stepped care for depression and anxiety in general practice was more effective than care as usual. Possible reasons are discussed. Trial registration: Current Controlled Trails: ISRCTN17831610.

Trials · randomised controlled trial · 46 citationsread the source →

Stepped care for depression and anxiety: from primary care to specialized mental health care: a randomised controlled trial testing the effectiveness of a stepped care program among primary care patients with mood or anxiety disorders.

Background: Mood and anxiety disorders are highly prevalent and have a large impact on the lives of the affected individuals. Therefore, optimal treatment of these disorders is highly important. In this study we will examine the effectiveness of a stepped care program for primary care patients with mood and anxiety disorders. A stepped care program is characterized by different treatment steps that are arranged in order of increasing intensity. Methods: This study is a randomised controlled trial with two conditions: stepped care and care as usual, whereby the latter forms the control group. The stepped care program consists of four evidence based interventions: (1) Watchful waiting, (2) Guided self-help, (3) Problem Solving Treatment and (4) Medication and/or specialized mental health care. The study population consists of primary care attendees aged 18-65 years. Screeners are sent to all patients of the participating general practitioners. Individuals with a Diagnostic and Statistical Manual of mental disorders (DSM) diagnosis of major depression, dysthymia, panic disorder (with or without agoraphobia), generalized anxiety disorder, or social phobia are included as well as individuals with minor depression and anxiety disorders. Primary focus is the reduction of depressive and anxiety symptoms. Both conditions are monitored at 8, 16 and 24 weeks. Discussion: This study evaluates the effectiveness of a stepped care program for patients with depressive and anxiety disorder. If effective, a stepped care program can form a worthwhile alternative for care as usual. Strengths and limitations of this study are discussed. Trial registration: Current Controlled Trails: ISRCTN17831610.

BMC health services research · randomised controlled trial · 26 citationsread the source →

Cognitive behavioural therapy and short-term psychoanalytical psychotherapy versus a brief psychosocial intervention in adolescents with unipolar major depressive disorder (IMPACT): a multicentre, pragmatic, observer-blind, randomised controlled superiority trial.

Background: Psychological treatments for adolescents with unipolar major depressive disorder are associated with diagnostic remission within 28 weeks in 65-70% of patients. We aimed to assess the medium-term effects and costs of psychological therapies on maintenance of reduced depression symptoms 12 months after treatment. Methods: We did this multicentre, pragmatic, observer-blind, randomised controlled superiority trial (IMPACT) at 15 National Health Service child and adolescent mental health service (CAMHS) clinics in three regions in England. Adolescent patients (aged 11-17 years) with a diagnosis of DSM IV major depressive disorder were randomly assigned (1:1:1), via a web-based randomisation service, to receive cognitive behavioural therapy (CBT) or short-term psychoanalytical therapy versus a reference brief psychological intervention. Randomisation was stochastically minimised by age, sex, self-reported depression sum score, and region. Patients and clinicians were aware of group allocation, but allocation was concealed from outcome assessors. Patients were followed up and reassessed at weeks 6, 12, 36, 52, and 86 post-randomisation. The primary outcome was self-reported depression symptoms at weeks 36, 52, and 86, as measured with the self-reported Mood and Feelings Questionnaire (MFQ). Because our aim was to compare the two psychological therapies with the brief psychosocial intervention, we first established whether CBT was inferior to short-term psychoanalytical psychotherapy for the same outcome. Primary analysis was by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN83033550. Findings: Between June 29, 2010, and Jan 17, 2013, we randomly assigned 470 patients to receive the brief psychosocial intervention (n=158), CBT (n=155), or short-term psychoanalytical therapy (n=157); 465 patients comprised the intention-to-treat population. 392 (84%) patients had available data for primary analysis by the end of follow-up. Treatment fidelity and differentiation were established between the three interventions. The median number of treatment sessions differed significantly between patients in the brief psychosocial intervention group (n=6 [IQR 4-11]), CBT group (n=9 [5-14]), and short-term psychoanalytical therapy group (n=11 [5-23]; p<0·0001), but there was no difference between groups in the average duration of treatment (27·5 [SD 21·5], 24·9 [17·7], 27·9 [16·8] weeks, respectively; Kruskal-Wallis p=0·238). Self-reported depression symptoms did not differ significantly between patients given CBT and those given short-term psychoanalytical therapy at weeks 36 (treatment effect 0·179, 95% CI -3·731 to 4·088; p=0·929), 52 (0·307, -3·161 to 3·774; p=0·862), or 86 (0·578, -2·948 to 4·104; p=0·748). These two psychological treatments had no superiority effect compared with brief psychosocial intervention at weeks 36 (treatment effect -3·234, 95% CI -6·611 to 0·143; p=0·061), 52 (-2·806, -5·790 to 0·177; p=0·065), or 86 (-1·898, -4·922 to 1·126; p=0·219). Physical adverse events (self-reported breathing problems, sleep disturbances, drowsiness or tiredness, nausea, sweating, and being restless or overactive) did not differ between the groups. Total costs of the trial interventions did not differ significantly between treatment groups. Interpretation: We found no evidence for the superiority of CBT or short-term psychoanalytical therapy compared with a brief psychosocial intervention in maintenance of reduced depression symptoms 12 months after treatment. Short-term psychoanalytical therapy was as effective as CBT and, together with brief psychosocial intervention, offers additional patient choice for psychological therapy, alongside CBT, for adolescents with moderate to severe depression who are attending routine specialist CAMHS clinics. Funding: National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, and the Department of Health.

The lancet. Psychiatry · randomised controlled trial · 149 citationsread the source →

Financial incentives for smoking cessation in pregnancy: randomised controlled trial.

Objective: To assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit. Design: Phase II therapeutic exploratory single centre, individually randomised controlled parallel group superiority trial. Setting: One large health board area with a materially deprived, inner city population in the west of Scotland, United Kingdom. Participants: 612 self reported pregnant smokers in NHS Greater Glasgow and Clyde who were English speaking, at least 16 years of age, less than 24 weeks pregnant, and had an exhaled carbon monoxide breath test result of 7 ppm or more. 306 women were randomised to incentives and 306 to control. Interventions: The control group received routine care, which was the offer of a face to face appointment to discuss smoking and cessation and, for those who attended and set a quit date, the offer of free nicotine replacement therapy for 10 weeks provided by pharmacy services, and four, weekly support phone calls. The intervention group received routine care plus the offer of up to £400 of shopping vouchers: £50 for attending a face to face appointment and setting a quit date; then another £50 if at four weeks' post-quit date exhaled carbon monoxide confirmed quitting; a further £100 was provided for continued validated abstinence of exhaled carbon monoxide after 12 weeks; a final £200 voucher was provided for validated abstinence of exhaled carbon monoxide at 34-38 weeks' gestation. Main outcome measure: The primary outcome was cotinine verified cessation at 34-38 weeks' gestation through saliva (<14.2 ng/mL) or urine (<44.7 ng/mL). Secondary outcomes included birth weight, engagement, and self reported quit at four weeks. Results: Recruitment was extended from 12 to 15 months to achieve the target sample size. Follow-up continued until September 2013. Of the 306 women randomised, three controls opted out soon after enrolment; these women did not want their data to be used, leaving 306 intervention and 303 control group participants in the intention to treat analysis. No harms of financial incentives were documented. Significantly more smokers in the incentives group than control group stopped smoking: 69 (22.5%) versus 26 (8.6%). The relative risk of not smoking at the end of pregnancy was 2.63 (95% confidence interval 1.73 to 4.01) P<0.001. The absolute risk difference was 14.0% (95% confidence interval 8.2% to 19.7%). The number needed to treat (where financial incentives need to be offered to achieve one extra quitter in late pregnancy) was 7.2 (95% confidence interval 5.1 to 12.2). The mean birth weight was 3140 g (SD 600 g) in the incentives group and 3120 (SD 590) g in the control group (P=0.67). Conclusion: This phase II randomised controlled trial provides substantial evidence for the efficacy of incentives for smoking cessation in pregnancy; as this was only a single centre trial, incentives should now be tested in different types of pregnancy cessation services and in different parts of the United Kingdom. Trial registration: Current Controlled Trials ISRCTN87508788.

BMJ (Clinical research ed.) · randomised controlled trial · 143 citationsread the source →

Perceived barriers to smoking cessation in selected vulnerable groups: a systematic review of the qualitative and quantitative literature.

Objectives: To identify barriers that are common and unique to six selected vulnerable groups: low socioeconomic status; Indigenous; mental illness and substance abuse; homeless; prisoners; and at-risk youth. Design: A systematic review was carried out to identify the perceived barriers to smoking cessation within six vulnerable groups. Data sources: MEDLINE, EMBASE, CINAHL and PsycInfo were searched using keywords and MeSH terms from each database's inception published prior to March 2014. Study selection: Studies that provided either qualitative or quantitative (ie, longitudinal, cross-sectional or cohort surveys) descriptions of self-reported perceived barriers to quitting smoking in one of the six aforementioned vulnerable groups were included. Data extraction: Two authors independently assessed studies for inclusion and extracted data. Results: 65 eligible papers were identified: 24 with low socioeconomic groups, 16 with Indigenous groups, 18 involving people with a mental illness, 3 with homeless groups, 2 involving prisoners and 1 involving at-risk youth. One study identified was carried out with participants who were homeless and addicted to alcohol and/or other drugs. Barriers common to all vulnerable groups included: smoking for stress management, lack of support from health and other service providers, and the high prevalence and acceptability of smoking in vulnerable communities. Unique barriers were identified for people with a mental illness (eg, maintenance of mental health), Indigenous groups (eg, cultural and historical norms), prisoners (eg, living conditions), people who are homeless (eg, competing priorities) and at-risk youth (eg, high accessibility of tobacco). Conclusions: Vulnerable groups experience common barriers to smoking cessation, in addition to barriers that are unique to specific vulnerable groups. Individual-level, community-level and social network-level interventions are priority areas for future smoking cessation interventions within vulnerable groups. Trial registration number: A protocol for this review has been registered with PROSPERO International Prospective Register of Systematic Reviews (Identifier: CRD42013005761).

BMJ open · systematic review · 316 citationsread the source →

Euthanasia and Assisted Suicide of Patients With Psychiatric Disorders in the Netherlands 2011 to 2014.

Importance: Euthanasia or assisted suicide (EAS) of psychiatric patients is increasing in some jurisdictions such as Belgium and the Netherlands. However, little is known about the practice, and it remains controversial. Objectives: To describe the characteristics of patients receiving EAS for psychiatric conditions and how the practice is regulated in the Netherlands. Design, setting, and participants: This investigation reviewed psychiatric EAS case summaries made available online by the Dutch regional euthanasia review committees as of June 1, 2015. Two senior psychiatrists used directed content analysis to review and code the reports. In total, 66 cases from 2011 to 2014 were reviewed. Main outcomes and measures: Clinical and social characteristics of patients, physician review process of the patients' requests, and the euthanasia review committees' assessments of the physicians' actions. Results: Of the 66 cases reviewed, 70% (n = 46) were women. In total, 32% (n = 21) were 70 years or older, 44% (n = 29) were 50 to 70 years old, and 24% (n = 16) were 30 to 50 years old. Most had chronic, severe conditions, with histories of attempted suicides and psychiatric hospitalizations. Most had personality disorders and were described as socially isolated or lonely. Depressive disorders were the primary psychiatric issue in 55% (n = 36) of cases. Other conditions represented were psychotic, posttraumatic stress or anxiety, somatoform, neurocognitive, and eating disorders, as well as prolonged grief and autism. Comorbidities with functional impairments were common. Forty-one percent (n = 27) of physicians performing EAS were psychiatrists. Twenty-seven percent (n = 18) of patients received the procedure from physicians new to them, 14 of whom were physicians from the End-of-Life Clinic, a mobile euthanasia clinic. Consultation with other physicians was extensive, but 11% (n = 7) of cases had no independent psychiatric input, and 24% (n = 16) of cases involved disagreement among consultants. The euthanasia review committees found that one case failed to meet legal due care criteria. Conclusions and relevance: Persons receiving EAS for psychiatric disorders in the Netherlands are mostly women and of diverse ages, with complex and chronic psychiatric, medical, and psychosocial histories. The granting of their EAS requests appears to involve considerable physician judgment, usually involving multiple physicians who do not always agree (sometimes without independent psychiatric input), but the euthanasia review committees generally defer to the judgments of the physicians performing the EAS.

JAMA psychiatry · 129 citationsread the source →

Pharmacokinetics of atazanavir/ritonavir once daily and lopinavir/ritonavir twice and once daily over 72 h following drug cessation.

Background: We investigated the pharmacokinetics of atazanavir/ritonavir once daily and lopinavir/ritonavir twice and once daily over 72 h following drug intake cessation. Methods: This was an open-label, three-session, pharmacokinetic trial. Healthy volunteers received atazanavir/ritonavir 300/100 mg once daily and lopinavir/ritonavir 400/100 mg twice daily and 800/200 mg once daily separately for 10 days. Pharmacokinetic profiles were assessed for each phase on day 10 over 72 h. Pharmacokinetic parameters were determined over 12 or 24 h and to the last measurable concentration by non-compartmental methods. Results: Sixteen participants completed the study. Geometric mean terminal elimination half-life to 72 h of atazanavir was 8.35 h and not different from the 0-24 h half-life (9.91 h). Terminal elimination halflife of lopinavir was 2.33 h (twice daily) and 2.44 h (once daily). These values were lower compared with the half-life over the respective dosing intervals (7.15 and 4.88 h for 0-12 and 0-24 h, respectively). No participant on atazanavir had concentrations below the minimum effective concentration (MEC) of 150 ng/ml at 24 h. In total, 44% of the participants on lopinavir once daily had concentrations below the MEC of 1,000 ng/ml at 24 h. At 16 h and 20 h, 13% and 63% of participants were below target for twice daily lopinavir, respectively. At 36 h, all participants on lopinavir and 31% on atazanavir were below target. Ritonavir area under the plasma concentration-time curve was 30% lower and 26% higher when dosed at 100 mg or 200 mg with lopinavir versus atazanavir. Conclusions: This study investigated the pharmacokinetic forgiveness of two boosted protease inhibitors. Whereas the decline in lopinavir concentrations occured rapidly as the boosting effect of ritonavir diminished, the rate of decline of atazanavir remained constant to 72 h.

Antiviral therapy · clinical trial · 27 citationsread the source →

Prevalence of depression in cancer patients: a meta-analysis of diagnostic interviews and self-report instruments.

Objective: We aimed to investigate the prevalence of depression in cancer patients assessed by diagnostic interviews and self-report instruments, and to study differences in prevalence between type of instrument, type of cancer and treatment phase. Methods: A literature search was conducted in four databases to select studies on the prevalence of depression among adult cancer patients during or after treatment. A total of 211 studies met the inclusion criteria. Pooled mean prevalence of depression was calculated using Comprehensive Meta-Analysis. Results: Hospital Anxiety and Depression Scale-depression subscale (HADS-D) ≥ 8, HADS-D ≥11, Center for Epidemiologic Studies ≥ 16, and (semi-)structured diagnostic interviews were used to define depression in 66, 53, 35 and 49 studies, respectively. Respective mean prevalence of depression was 17% (95% CI = 16-19%), 8% (95% CI = 7-9%), 24% (95% CI = 21-26%), and 13% (95% CI = 11-15%) (p < 0.001). Prevalence of depression ranged from 3% in patients with lung cancer to 31% in patients with cancer of the digestive tract, on the basis of diagnostic interviews. Prevalence of depression was highest during treatment 14% (95% CI = 11-17%), measured by diagnostic interviews, and 27% (95% CI = 25-30%), measured by self-report instruments. In the first year after diagnosis, prevalence of depression measured with diagnostic interviews and self-report instruments were 9% (95% CI = 7-11%) and 21% (95% CI = 19-24%), respectively, and they were 8% (95% CI = 5-12%) and 15% (95% CI = 13-17%) ≥ 1 year after diagnosis. Conclusions: Pooled mean prevalence of depression in cancer patients ranged from 8% to 24% and differed by the type of instrument, type of cancer and treatment phase. Future prospective studies should disentangle whether differences in prevalence of depression are caused by differences in the type of instrument, type of cancer or treatment phase. © 2013 The Authors. Psycho-Oncology published by John Wiley & Sons, Ltd.

Psycho-oncology · meta-analysis · 595 citationsread the source →

A systematic review of the associations between biodiversity and children's mental health and wellbeing.

There is a growing interest in how exposure to biodiversity influences mental health and wellbeing; however, few studies have focused on children. The aim of this review was to identify studies that used components of biodiversity and children's health outcomes to assess if there were any themes that could be used to inform urban design and understand the mechanisms behind associations. We used a PROSPERO registered protocol to identify eligible studies following pre-defined inclusion criteria. After searching five databases, 25 studies were included in the review. From these articles we extracted data on the biodiversity exposure and mental health and wellbeing outcomes. Five categories of biodiversity exposure were identified, including species diversity (n = 1; 4%), functional diversity (n = 6; 26%), ecological community (n = 9; 36%), green space metrics (n = 4; 16%), and high-level classifications (n = 6; 24%). Children's health and wellbeing were tabulated into seven categories: play (n = 10; 40%), wellbeing (n = 6; 24%), mental health and cognitive functioning (n = 5; 20%), attention deficit hyperactivity disorder (ADHD)-related behaviours (n = 4; 16%), preferences for nature (n = 3; 12%), academic achievement (n = 2; 8%), and restoration (n = 2; 8%). The high heterogeneity of biodiversity and health measures reduced our ability to identify relationships across studies and formally test for an exposure-dose response. Future research that uses standardised and transferable biodiversity measurements at multiple scales, has stronger reporting rigour, greater consideration of potential modifiers, and increased representation of studies from the Majority World are essential for building a stronger evidence base to deliver child-centred biodiverse landscapes.

Environmental research · systematic review · 2 citationsread the source →

Amygdala and hippocampus volumes in pediatric major depression.

Background: The purpose of this study was to measure amygdala and hippocampus volumes in pediatric major depressive disorder (MDD) and to address the question of neuroanatomical continuity with adult-onset depression. Methods: We studied 20 children and adolescents with MDD (17 female subjects) and 24 healthy comparison subjects (16 female subjects) using 1.5 Tesla magnetic resonance imaging. Group differences in left and right amygdala and hippocampus volumes were examined using repeated measures analyses of covariance, adjusting for age, gender, and whole brain volume. Results: Depressed children had significant reductions of left and right amygdala volumes compared with healthy subjects. Hippocampus volumes did not differ between the groups. No significant correlations were found between amygdala volumes and depressive symptom severity, age at onset, or illness duration. Conclusions: Smaller amygdalas are present early in the course of pediatric depression and may predispose to the development of this disorder or perhaps more generally of childhood mood disorders. Future research should examine the longitudinal course and functional correlates of amygdala volume abnormalities in childhood-onset depression, including their possible moderation by gender.

Biological psychiatry · cohort or longitudinal · 167 citationsread the source →

Health impacts of parental migration on left-behind children and adolescents: a systematic review and meta-analysis.

Background: Globally, a growing number of children and adolescents are left behind when parents migrate. We investigated the effect of parental migration on the health of left behind-children and adolescents in low-income and middle-income countries (LMICs). Methods: For this systematic review and meta-analysis we searched MEDLINE, Embase, CINAHL, the Cochrane Library, Web of Science, PsychINFO, Global Index Medicus, Scopus, and Popline from inception to April 27, 2017, without language restrictions, for observational studies investigating the effects of parental migration on nutrition, mental health, unintentional injuries, infectious disease, substance use, unprotected sex, early pregnancy, and abuse in left-behind children (aged 0-19 years) in LMICs. We excluded studies in which less than 50% of participants were aged 0-19 years, the mean or median age of participants was more than 19 years, fewer than 50% of parents had migrated for more than 6 months, or the mean or median duration of migration was less than 6 months. We screened studies using systematic review software and extracted summary estimates from published reports independently. The main outcomes were risk and prevalence of health outcomes, including nutrition (stunting, wasting, underweight, overweight and obesity, low birthweight, and anaemia), mental health (depressive disorder, anxiety disorder, conduct disorders, self-harm, and suicide), unintentional injuries, substance use, abuse, and infectious disease. We calculated pooled risk ratios (RRs) and standardised mean differences (SMDs) using random-effects models. This study is registered with PROSPERO, number CRD42017064871. Findings: Our search identified 10 284 records, of which 111 studies were included for analysis, including a total of 264 967 children (n=106 167 left-behind children and adolescents; n=158 800 children and adolescents of non-migrant parents). 91 studies were done in China and focused on effects of internal labour migration. Compared with children of non-migrants, left-behind children had increased risk of depression and higher depression scores (RR 1·52 [95% CI 1·27-1·82]; SMD 0·16 [0·10-0·21]), anxiety (RR 1·85 [1·36-2·53]; SMD 0·18 [0·11-0·26]), suicidal ideation (RR 1·70 [1·28-2·26]), conduct disorder (SMD 0·16 [0·04-0·28]), substance use (RR 1·24 [1·00-1·52]), wasting (RR 1·13 [1·02-1·24]) and stunting (RR 1·12 [1·00-1·26]). No differences were identified between left-behind children and children of non-migrants for other nutrition outcomes, unintentional injury, abuse, or diarrhoea. No studies reported outcomes for other infectious diseases, self-harm, unprotected sex, or early pregnancy. Study quality varied across the included studies, with 43% of studies at high or unclear risk of bias across five or more domains. Interpretation: Parental migration is detrimental to the health of left-behind children and adolescents, with no evidence of any benefit. Policy makers and health-care professionals need to take action to improve the health of these young people. Funding: Wellcome Trust.

Lancet (London, England) · meta-analysis · 330 citationsread the source →

Alliance in couple and family therapy.

Couple and family therapy (CFT) is challenging because multiple interacting working alliances develop simultaneously and are heavily influenced by preexisting family dynamics. An original meta-analysis of 24 published CFT alliance-retention/outcome studies (k = 17 family and 7 couple studies; N = 1,416 clients) showed a weighted aggregate r = .26, z = 8.13 (p < .005); 95% CI = .33, .20. This small-to-medium effect size is almost identical to that reported for individual adult psychotherapy (Horvath, Del Re, Flückiger, & Symonds, this issue, pp. 9-16). Analysis of the 17 family studies (n = 1,081 clients) showed a similar average weighted effect size (r = .24; z = 6.55, p < .005; 95% CI = .30, .16), whereas the analysis of the 7 couple therapy studies (n = 335 clients) indicated r = .37; z = 6.16, p < .005; 95% CI = .48, .25. Tests of the null hypothesis of homogeneity suggested unexplained variability in the alliance-outcome association in both treatment formats. In this article we also summarize the most widely used alliance measures used in CFT research, provide an extended clinical example, and describe patient contributions to the developing alliance. Although few moderator or mediator studies have been conducted, the literature points to three important alliance-related phenomena in CFT: the frequency of "split" or "unbalanced" alliances, the importance of ensuring safety, and the need to foster a strong within-family sense of purpose about the purpose, goals, and value of conjoint treatment. We conclude with a series of therapeutic practices predicated on the research evidence.

Psychotherapy (Chicago, Ill.) · meta-analysis · 52 citationsread the source →

Comparison of paediatric emergency department visits for attempted suicide, self-harm, and suicidal ideation before and during the COVID-19 pandemic: a systematic review and meta-analysis.

Background: There is a lack of consensus about the effect of the COVID-19 pandemic on the mental health of children and adolescents. We aimed to compare rates of paediatric emergency department visits for attempted suicide, self-harm, and suicidal ideation during the pandemic with those before the pandemic. Methods: For this systematic review and meta-analysis, we searched MEDLINE, Embase, and PsycINFO for studies published between Jan 1, 2020, and Dec 19, 2022. Studies published in English with data on paediatric (ie, those aged <19 years) emergency department visits before and during the COVID-19 pandemic were included. Case studies and qualitative analyses were excluded. Changes in attempted suicide, self-harm, suicidal ideation, and other mental-illness indicators (eg, anxiety, depression, and psychosis) were expressed as ratios of the rates of emergency department visits during the pandemic compared with those before the pandemic, and we analysed these with a random-effects meta-analysis. This study was registered with PROSPERO, CRD42022341897. Findings: 10 360 non-duplicate records were retrieved, which yielded 42 relevant studies (with 130 sample-estimates) representing 11·1 million emergency department visits for all indications of children and adolescents across 18 countries. The mean age of the samples of children and adolescents across studies was 11·7 years (SD 3·1, range 5·5-16·3), and there were on average 57·6% girls and 43·4% boys as a proportion of emergency department visits for any health reasons (ie, physical and mental). Only one study had data related to race or ethnicity. There was good evidence of an increase in emergency department visits for attempted suicide during the pandemic (rate ratio 1·22, 90% CI 1·08-1·37), modest evidence of an increase in emergency department visits for suicidal ideation (1·08, 0·93-1·25), and good evidence for only a slight change in self-harm (0·96, 0·89-1·04). Rates of emergency department visits for other mental-illness indications showed very good evidence of a decline (0·81, 0·74-0·89), and paediatric visits for all health indications showed strong evidence of a reduction (0·68, 0·62-0·75). When rates for attempted suicide and suicidal ideation were combined as a single measure, there was good evidence of an increase in emergency department visits among girls (1·39, 1·04-1·88) and only modest evidence of an increase among boys (1·06, 0·92-1·24). Self-harm among older children (mean age 16·3 years, range 13·0-16·3) showed good evidence of an increase (1·18, 1·00-1·39), but among younger children (mean age 9·0 years, range 5·5-12·0) there was modest evidence of a decrease (0·85, 0·70-1·05). Interpretation: The integration of mental health support within community health and the education system-including promotion, prevention, early intervention, and treatment-is urgently needed to increase the reach of mental health support that can mitigate child and adolescent mental distress. In future pandemics, increased resourcing in some emergency department settings would help to address their expected increase in visits for acute mental distress among children and adolescents. Funding: None.

The lancet. Psychiatry · meta-analysis · 164 citationsread the source →

Risk and resilience in preterm children at age 6.

Children born preterm are at risk for experiencing significant deleterious developmental outcomes throughout their childhood and adolescence. However, individual variation and resilience are hallmarks of the preterm population. The present study examined pathways to resilience across multiple domains (e.g., social activities, peer relations, attention-deficit/hyperactivity disorder symptomology, externalizing and internalizing behavior, and sleep quality) as children born preterm reached school age. The study also examined early child and family predictors of resilience. Using a prospective longitudinal design, 173 infants born preterm and without significant neurological complications were assessed at five time points: neonatal intensive care unit discharge, 9 months, 16 months, 24 months, and 6 years. Three pathways of adaptation emerged at 6 years: children who were resilient, those who remained at-risk, and children who exhibited significant difficulties. Resilient children were less likely to have experienced negative parenting at 9 and 16 months, more likely to delay gratification at 24 months, and more likely to experience neonatal health complications than nonresilient children.

Development and psychopathology · 41 citationsread the source →

Autologous Mesenchymal Stem Cells Improve Motor Recovery in Subacute Ischemic Stroke: a Randomized Clinical Trial.

While preclinical stroke studies have shown that mesenchymal stem cells (MSCs) promote recovery, few randomized controlled trials (RCT) have assessed cell therapy in humans. In this RCT, we assessed the safety, feasibility, and efficacy of intravenous autologous bone marrow-derived MSCs in subacute stroke. ISIS-HERMES was a single-center, open-label RCT, with a 2-year follow-up. We enrolled patients aged 18-70 years less than 2 weeks following moderate-severe ischemic carotid stroke. Patients were randomized 2:1 to receive intravenous MSCs or not. Primary outcomes assessed feasibility and safety. Secondary outcomes assessed global and motor recovery. Passive wrist movement functional MRI (fMRI) activity in primary motor cortex (MI) was employed as a motor recovery biomarker. We compared "treated" and "control" groups using as-treated analyses. Of 31 enrolled patients, 16 patients received MSCs. Treatment feasibility was 80%, and there were 10 and 16 adverse events in treated patients, and 12 and 24 in controls at 6-month and 2-year follow-up, respectively. Using mixed modeling analyses, we observed no treatment effects on the Barthel Index, NIHSS, and modified-Rankin scores, but significant improvements in motor-NIHSS (p = 0.004), motor-Fugl-Meyer scores (p = 0.028), and task-related fMRI activity in MI-4a (p = 0.031) and MI-4p (p = 0.002). Intravenous autologous MSC treatment following stroke was safe and feasible. Motor performance and task-related MI activity results suggest that MSCs improve motor recovery through sensorimotor neuroplasticity. ClinicalTrials.gov Identifier NCT00875654.

Translational stroke research · randomised controlled trial · 145 citationsread the source →

Botulinum toxin type A in the treatment of lower limb spasticity in children with cerebral palsy.

Background: Cerebral palsy (CP) is the most common cause of physical disabilities in children in high-income countries. Spasticity is the most common motor disturbance in CP. Botulinum toxin type A (BoNT-A) is considered the first-line treatment for focal spasticity in people with CP. Objectives: To evaluate the effectiveness and safety of BoNT-A compared to other treatments used in the management of lower limb spasticity in children with CP. Search methods: We searched CENTRAL, PubMed, four other databases, and two trial registers in October 2018. We also searched the reference lists of relevant studies and reviews and contacted experts in the field. We did not apply any date or language restrictions. Selection criteria: Randomised controlled trials of children with CP, aged between birth and 19 years, treated with BoNT-A injections in the lower limb muscles compared to other interventions. The primary outcomes were gait analysis and function. The secondary outcomes were joint range of motion, quality of life, satisfaction, spasticity, and adverse events. Data collection and analysis: Two review authors independently selected studies, extracted data, assessed risk of bias, and rated the quality of the evidence using GRADE. A third review author arbitrated in case of disagreements. We conducted meta-analyses of available data whenever possible, analysing dichotomous data with risk ratios (RR), and continuous data with mean differences (MD) or standardised mean differences (SMD), with 95% confidence intervals (CI). We considered a 5% significance level for all analyses. Whenever possible, we analysed outcomes at the time points at which they were assessed: short term (2 to 8 weeks); medium term (12 to 16 weeks); and long term (> 24 weeks). Main results: We included 31 randomised controlled trials assessing 1508 participants. Most studies included ambulatory patients with more than one motor type of CP, and with a mean age of between three and seven years. There was a slight predominance of males. Studies compared BoNT-A in the lower limb muscles to usual care or physiotherapy (14 studies), placebo or sham (12 studies), serial casting (4 studies), or orthoses (1 study).We rated studies as at high or unclear risk of bias mainly due to random sequence generation, allocation concealment, blinding of participants and personnel, and blinding of outcome assessment. BoNT-A versus usual care or physiotherapyBoNT-A might improve overall gait scores at medium-term follow-up (MD 2.80, 95% CI 1.55 to 4.05; 1 study, 40 children; very low-quality evidence) and is moderately effective at improving function at short-term (SMD 0.59, 95% CI 0.23 to 0.95; 2 studies, 123 children) and medium-term (SMD 1.04, 95% CI 0.16 to 1.91; 4 studies, 191 children) follow-up (all very low-quality evidence).BoNT-A improves ankle range of motion, satisfaction, and ankle plantarflexors spasticity at one or more time points (very low-quality evidence).The proportion of adverse events in the BoNT-A group was 0.37 (95% CI 0.08 to 0.66; I2 = 95%; very low-quality evidence). No adverse events were reported in the control group. BoNT-A versus placebo or shamBoNT-A improves overall gait scores at short-term (RR 1.66, 95% CI 1.16 to 2.37, P = 0.006; 4 studies, 261 assessments) and medium-term (RR 1.90, 95% CI 1.32 to 2.74, P < 0.001; 3 studies, 248 assessments) follow-up, and may improve peak ankle dorsiflexion in stance (MD 15.90 degrees, 95% CI 4.87 to 26.93, P = 0.005; 1 study, 19 children) and in swing (MD 10.20 degrees, 95% CI 4.01 to 16.39, P = 0.001; 1 study, 19 children) at short-term follow-up (all moderate-quality evidence).BoNT-A is not more effective than placebo or sham at improving function at short-term (SMD 0.24, 95% CI -0.35 to 0.83, P = 0.42; 4 studies, 305 children) or long-term (SMD -0.07, 95% CI -0.48 to 0.35, P = 0.76; 2 studies, 91 children) follow-up, but has a small positive effect at medium-term follow-up (SMD 0.28, 95% CI 0.06 to 0.49, P = 0.01; 5 studies, 327 children) (all moderate-quality evidence).BoNT-A improves passive ankle range of motion, satisfaction, and ankle plantarflexors spasticity at one or more time points (moderate-quality evidence).There was no difference between groups in the rate of adverse events at short-term follow-up (RR 1.29, 95% CI 0.87 to 1.93, P = 0.21; 12 studies, 918 children; moderate-quality evidence).BoNT-A versus serial castingThere was no difference between groups for overall gait scores at short-term (MD 0.00, 95% CI -1.66 to 1.66); medium-term (MD 0.65, 95% CI -1.21 to 2.51); or long-term (MD 0.46, 95% CI -1.33 to 2.25) follow-up in one study with 18 children (moderate-quality evidence).BoNT-A improved instrumented gait analysis only in terms of ankle dorsiflexion at initial contact (MD 6.59 degrees, 95% CI 1.39 to 11.78, P = 0.01; 2 studies, 47 children). There was no difference between groups for peak ankle dorsiflexion in stance and swing, and gait speed at any time point (moderate- and low-quality evidence).BoNT-A is not more effective than serial casting at improving function, ankle range of motion, and spasticity at any time point (moderate- and low-quality evidence).BoNT-A is not associated with a higher risk of adverse events than serial casting (RR 0.59, 95% CI 0.03 to 11.03; 3 studies, 64 children; low-quality evidence).BoNT-A versus orthosesThere was no difference between groups for function at medium-term follow-up (MD 11.14, 95% CI -0.05 to 22.33; 1 study, 43 children), but BoNT-A is more effective than orthoses at improving hip range of motion and hip adductors spasticity (all very low-quality evidence). Authors' conclusions: The quality of the evidence was low or very low for most of the outcomes analysed. We found limited evidence that BoNT-A is more effective than placebo or a non-placebo control at improving gait, joint range of motion, satisfaction, and lower limb spasticity in children with CP, whereas the results for function were contradictory. The rate of adverse events with BoNT-A is similar to placebo. BoNT-A is not more effective than ankle serial casting to treat ankle contractures for any of the assessed outcomes, but is more effective than orthotics at improving range of motion and spasticity.

The Cochrane database of systematic reviews · review · 38 citationsread the source →

Diet quality indices and their associations with health-related outcomes in children and adolescents: an updated systematic review.

Background: To describe a-priori diet quality indices used in children and adolescents, appraise the validity and reliability of these indices, and synthesise evidence on the relationship between diet quality and physical and mental health, and growth-related outcomes. Methods: Five electronic databases were searched until January 2019. An a-priori diet quality index was included if it applied a scoring structure to rate child or adolescent (aged 0-18-years) dietary intakes relative to dietary or nutrient guidelines. Diagnostic accuracy studies and prospective cohort studies reporting health outcomes were appraised using the Academy of Nutrition and Dietetics Quality Criteria Checklist. Results: From 15,577 records screened, 128 unique paediatric diet quality indices were identified from 33 countries. Half of the indices' scores rated both food and nutrient intakes (n = 65 indices). Some indices were age specific: infant (< 24-months; n = 8 indices), child (2-12-years; n = 16), adolescent (13-18 years; n = 8), and child/adolescent (n = 14). Thirty-seven indices evaluated for validity and/or reliability. Eleven of the 15 indices which investigated associations with prospective health outcomes reported significant results, such as improved IQ, quality of life, blood pressure, body composition, and prevalence of metabolic syndrome. Conclusions: Research utilising diet quality indices in paediatric populations is rapidly expanding internationally. However, few indices have been evaluated for validity, reliability, or association with health outcomes. Further research is needed to determine the validity, reliability, and association with health of frequently utilised diet quality indices to ensure data generated by an index is useful, applicable, and relevant. Registration: PROSPERO number: CRD42018107630 .

Nutrition journal · systematic review · 103 citationsread the source →

Third Annual Report From the ISHLT Mechanically Assisted Circulatory Support Registry: A comparison of centrifugal and axial continuous-flow left ventricular assist devices.

Background: The IMACS Registry compiles and analyzes worldwide data from patients undergoing implantation of durable left ventricular assist devices. Methods: Data encompassing 16,286 LVAD recipients from 4 collectives and 24 individual hospitals was collected and analyzed. In this 3rd annual report we compare and contrast outcomes, adverse events and risks factors between axial flow and centrifugal flow device recipients. Results: Significant differences were found in the baseline characteristics of axial vs centrifugal flow LVAD recipients. Survival was similar between pump types. INTERMACS profile 1-3 constitute 85% of implants. A survival gap persists in destination therapy compared to bridge patients. RVAD need and delay impact survival dramatically. Centrifugal flow outperforms axial flow recipients in regards to GI bleeding and freedom from hemocompatibility related adverse events. No significant difference in the actuarial freedom from all strokes or either stroke subtype (hemorrhagic or ischemic) was seen among the two types of pumps. New end points to guide decision making are proposed. Conclusions: We demonstrate a transition from axial to centrifugal flow with four-year survival that approximates 60%. A high frequency of adverse events remains an impediment to the wider adoption of these technologies. In the future, composite study endpoints examining life quality and adverse events beyond survival may help in shared decision making prior to MCS implant, and may provide the requisite data to support extension of MCS therapy into the lesser ill heart failure population.

The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · cohort or longitudinal · 122 citationsread the source →

Emotional intelligence in medicine: a systematic review through the context of the ACGME competencies.

Objectives: Emotional intelligence (EI) involves the perception, processing, regulation and management of emotions. This article aims to systematically review the evidence for EI in medicine through the context of the Accreditation Council for Graduate Medical Education (ACGME) competencies. Methods: MEDLINE, EMBASE, PsycINFO, the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials were searched for English-language articles published between January 1980 and March 2009. The grey literature was also searched and experts in the field contacted for additional studies. Two independent reviewers selected articles which reported empirical research studies about clinicians or medical students. Conceptual articles and opinion pieces and commentaries were excluded. Information about the measure used to assess EI, the study parameter or domain, and the educational or clinical outcome (with specific relation to the ACGME competencies) was extracted. Results: The literature search identified 485 citations. An abstract review led to the retrieval of 24 articles for full-text assessment, of which 16 articles were included in the final review. Eleven studies focused on postgraduates, four on undergraduates and one on medical school applicants. Six out of seven studies found women to have higher EI than men. Higher EI was reported to positively contribute to the doctor-patient relationship (three studies), increased empathy (five studies), teamwork and communication skills (six studies), and stress management, organisational commitment and leadership (three studies). Conclusions: Measures of EI correlate with many of the competencies that modern medical curricula seek to deliver. Further research is required to determine whether training can improve EI and thus augment educational and clinical outcomes.

Medical education · systematic review · 199 citationsread the source →

A Dating Violence Prevention Program for Middle School Youth: A Cluster Randomized Trial.

Objectives: We conducted a cluster randomized controlled trial to test the a priori hypothesis that students attending an intervention middle school would be less likely to report physical adolescent relationship abuse (ARA) 1 year later compared with students attending a control school. Secondary objectives were to determine if the intervention reduced substance misuse, bullying, and fighting. Methods: Twenty-four Texas public middle schools were matched by the size of student enrollment, number of economically disadvantaged students, and race and ethnicity of the student body and randomly assigned to the intervention (n = 12; 1237 participants) or the control (n = 12; 1531participants) group. The intervention, Fourth R, is a classroom-based curriculum delivered by existing teachers and consists of 21 lessons on injury prevention, substance use, and growth and development. Results: Participants (50% female) self-reported ethnicity as Hispanic or Latinx (35%), Black or African American (24%), Asian American (17%), White (8%), and multiethnicity or other (16%). Among those who have dated, students in the intervention schools were less likely to report perpetrating physical ARA (intervention = 14.9% versus control = 18.3%) relative to students in the control schools (adjusted odds ratio, 0.66; 95% confidence interval, 0.43-1.00; P = .05). In the overall sample, no significant differences emerged between control and intervention groups with respect to substance misuse, fighting, and bullying. Conclusions: The middle school version of Fourth R is effective in reducing physical ARA perpetration over at least 1 year. The intervention did not have an effect on bullying perpetration, physical fighting with peers, and substance misuse. Long-term assessment, especially follow-up that covers the transition to high school, is needed to examine the program benefit on key outcomes.

Pediatrics · randomised controlled trial · 19 citationsread the source →

Association Between Breastfeeding and Postpartum Multiple Sclerosis Relapses: A Systematic Review and Meta-analysis.

Importance: Multiple sclerosis (MS) relapses may be increased in the postpartum period, and whether breastfeeding is associated with reduction in the risk of postpartum relapses remains controversial. Objective: To perform a systematic review and meta-analysis to evaluate whether breastfeeding is associated with reduction in postpartum MS relapses compared with not breastfeeding. Data sources: PubMed and Embase were searched for studies assessing the association between breastfeeding and MS disease activity published between January 1, 1980, and July 11, 2018, as well as reference lists of selected articles. Study selection: All study designs assessing the association between breastfeeding and postpartum relapses in MS relative to a comparator group were included. Data extraction and synthesis: Study eligibility assessment and extraction of study characteristics, methods, and outcomes, were performed independently by 2 reviewers following PRISMA guidelines. Risk of bias was evaluated by 2 independent reviewers with the ROBINS-I tool for nonrandomized, interventional studies. Findings from studies with data available for the number of women with postpartum relapses in the breastfeeding and nonbreastfeeding groups were combined with a random-effects model. Main outcomes and measures: Postpartum MS relapse. Results: The search identified 462 unique citations, and 24 (2974 women) satisfied eligibility criteria and were included, of which 16 were included in the quantitative meta-analysis. The pooled summary odds ratio for the association of breastfeeding with postpartum relapses was 0.63 (95% CI, 0.45-0.88; P = .006) compared with a reference of nonbreastfeeding. Pooled adjusted hazard ratio across 4 studies that reported this finding was 0.57 (95% CI, 0.38-0.85; P = .006). There was moderate heterogeneity (I2 = 48%), which was explained by variable prepregnancy relapse rate, postpartum follow-up duration, and the publication year. A stronger association was seen in studies of exclusive rather than nonexclusive breastfeeding, although both demonstrated an association. Studies were rated at moderate and serious risk of bias, with concern for residual confounding, although sensitivity analysis including only moderate quality studies was consistent with a protective outcome of breastfeeding. Conclusions and relevance: These findings suggest that breastfeeding is protective against postpartum relapses in MS, although high-quality prospective studies to date are limited and well-designed observational studies that aim to emulate a randomized trial would be of benefit.

JAMA neurology · meta-analysis · 69 citationsread the source →

Anxiety, Depression and Post Traumatic Stress Disorder after critical illness: a UK-wide prospective cohort study.

Background: Survivors of intensive care are known to be at increased risk of developing longer-term psychopathology issues. We present a large UK multicentre study assessing the anxiety, depression and post-traumatic stress disorder (PTSD) caseness in the first year following discharge from an intensive care unit (ICU). Methods: Design: prospective multicentre follow-up study of survivors of ICU in the UK. Setting: patients from 26 ICUs in the UK. Inclusion criteria: patients who had received at least 24 h of level 3 ICU care and were 16 years of age or older. Interventions: postal follow up: Hospital Anxiety and Depression Score (HADS) and the Post-Traumatic Stress Disorder (PTSD) Check List-Civilian (PCL-C) at 3 and 12 months following discharge from ICU. Main outcome measure: caseness of anxiety, depression and PTSD, 2-year survival. Results: In total, 21,633 patients admitted to ICU were included in the study. Postal questionnaires were sent to 13,155 survivors; of these 38% (4943/13155) responded and 55% (2731/4943) of respondents passed thresholds for one or more condition at 3 or 12 months following discharge. Caseness prevalence was 46%, 40% and 22% for anxiety, depression and PTSD respectively; 18% (870/4943 patients) met the caseness threshold for all three psychological conditions. Patients with symptoms of depression were 47% more likely to die during the first 2 years after discharge from ICU than those without (HR 1.47, CI 1.19-1.80). Conclusions: Over half of those who respond to postal questionnaire following treatment on ICU in the UK reported significant symptoms of anxiety, depression or PTSD. When symptoms of one psychological disorder are present, there is a 65% chance they will co-occur with symptoms of one of the other two disorders. Depression following critical illness is associated with an increased mortality risk in the first 2 years following discharge from ICU. Trial registration: ISRCTN Registry, ISRCTN69112866 . Registered on 2 May 2006.

Critical care (London, England) · cohort or longitudinal · 340 citationsread the source →

Anorexia nervosa: 30-year outcome.

Background: Little is known about the long-term outcome of anorexia nervosa. Aims: To study the 30-year outcome of adolescent-onset anorexia nervosa. Method: All 4291 individuals born in 1970 and attending eighth grade in 1985 in Gothenburg, Sweden were screened for anorexia nervosa. A total of 24 individuals (age cohort for anorexia nervosa) were pooled with 27 individuals with anorexia nervosa (identified through community screening) who were born in 1969 and 1971-1974. The 51 individuals with anorexia nervosa and 51 school- and gender-matched controls were followed prospectively and examined at mean ages of 16, 21, 24, 32 and 44. Psychiatric disorders, health-related quality of life and general outcome were assessed. Results: At the 30-year follow-up 96% of participants agreed to participate. There was no mortality. Of the participants, 19% had an eating disorder diagnosis (6% anorexia nervosa, 2% binge-eating disorder, 11% other specified feeding or eating disorder); 38% had other psychiatric diagnoses; and 64% had full eating disorder symptom recovery, i.e. free of all eating disorder criteria for 6 consecutive months. During the elapsed 30 years, participants had an eating disorder for 10 years, on average, and 23% did not receive psychiatric treatment. Good outcome was predicted by later age at onset among individuals with adolescent-onset anorexia nervosa and premorbid perfectionism. Conclusions: This long-term follow-up study reflects the course of adolescent-onset anorexia nervosa and has shown a favourable outcome regarding mortality and full symptom recovery. However, one in five had a chronic eating disorder.

The British journal of psychiatry : the journal of mental science · 129 citationsread the source →

Chinese college students' mental health during the first three months of the COVID-19 pandemic: the protective role of family functioning.

Background: Various psychological theories suggest that a supportive family environment protects the mental health of young adults during stressful life events. However, evidence is limited regarding the protective role of family support during a major public health crisis. Objective: To examine the role of family functioning on mental health among Chinese college students during first stage of the COVID-19 pandemic. Methods: Between January-March 2020, 1,555 college students (44% female, on average 19 years old) from five Chinese universities participated. Participants rated their family functioning on the Family APGAR Index and their mental health on the Psychological Questionnaires for Emergent Events of Public Health, measuring depression, neurasthenia, fear, obsessive-anxiety and hypochondriasis. Results: Better family functioning was associated with having fewer psychological symptoms. In addition, we identified three mental health profiles related to the severity across the psychological symptoms: Low-level, medium-level and high-level symptom clusters. Latent profile analysis showed that as family function improved, students were, respectively, 16 to 24% more likely to be in the low-level symptom group, compared to being in the medium symptom group or the high-level symptom group. Conclusion: These results support the notion that family support may act as a psychological buffer for young adults during a large-scale public health crisis like the COVID-19 pandemic.

Frontiers in public health · 8 citationsread the source →

Cognitive decline in older adults in the UK during and after the COVID-19 pandemic: a longitudinal analysis of PROTECT study data.

Background: Although the long-term health effects of COVID-19 are increasingly recognised, the societal restrictions during the COVID-19 pandemic hold the potential for considerable detriment to cognitive and mental health, particularly because major dementia risk factors-such as those related to exercise and dietary habits-were affected during this period. We used longitudinal data from the PROTECT study to evaluate the effect of the pandemic on cognition in older adults in the UK. Methods: For this longitudinal analysis, we used computerised neuropsychology data from individuals aged 50 years and older participating in the PROTECT study in the UK. Data were collected from the same participants before the COVID-19 pandemic (March 1, 2019-Feb 29, 2020) and during its first (March 1, 2020-Feb 28, 2021) and second (March 1, 2021-Feb 28, 2022) years. We compared cognition across the three time periods using a linear mixed-effects model. Subgroup analyses were conducted in people with mild cognitive impairment and in people who reported a history of COVID-19, and an exploratory regression analysis identified factors associated with changes in cognitive trajectory. Findings: Pre-pandemic data were included for 3142 participants, of whom 1696 (54·0%) were women and 1446 (46·0%) were men, with a mean age of 67·5 years (SD 9·6, range 50-96). Significant worsening of executive function and working memory was observed in the first year of the pandemic across the whole cohort (effect size 0·15 [95% CI 0·12-0·17] for executive function and 0·51 [0·49-0·53] for working memory), in people with mild cognitive impairment (0·13 [0·07-0·20] and 0·40 [0·36-0·47]), and in people with a history of COVID-19 (0·24 [0·16-0·31] and 0·46 [0·39-0·53]). Worsening of working memory was sustained across the whole cohort in the second year of the pandemic (0·47; 0·44-0·49). Regression analysis indicated that cognitive decline was significantly associated with reduced exercise (p=0·0049; executive function) and increased alcohol use (p=0·049; working memory) across the whole cohort, as well as depression (p=0·011; working memory) in those with a history of COVID-19 and loneliness (p=0·0038; working memory) in those with mild cognitive impairment. In the second year of the pandemic, reduced exercise continued to affect executive function across the whole cohort, and associations were sustained between worsening working memory and increased alcohol use (p=0·0040), loneliness (p=0·042), and depression (p=0·014) in those with mild cognitive impairment, and reduced exercise (p=0·0029), loneliness (p=0·031) and depression (p=0·036) in those with a history of COVID-19. Interpretation: The COVID-19 pandemic resulted in a significant worsening of cognition in older adults, associated with changes in known dementia risk factors. The sustained decline in cognition highlights the need for public health interventions to mitigate the risk of dementia-particularly in people with mild cognitive impairment, in whom conversion to dementia within 5 years is a substantial risk. Long-term intervention for people with a history of COVID-19 should be considered to support cognitive health. Funding: National Institute for Health and Care Research.

The lancet. Healthy longevity · 43 citationsread the source →

Childhood environmental risk and youth bedtime procrastination: A path model with life history strategy and sense of control as mediators.

Background: Bedtime procrastination is a serious threat to youths' sleep quality and physical and mental health. It is affected by various psychological and physiological factors, but few studies focused on the impact and internal mechanism of childhood experience on bedtime procrastination in adulthood from the evolutionary and developmental perspective. Objective: This study aims to explore the distal factors of bedtime procrastination among young people, that is, the association between childhood environmental risk (harshness and unpredictability) and bedtime procrastination, as well as the mediating roles of life history (LH) strategy and sense of control. Participants and setting: By convenience sampling, 453 Chinese college students aged 16 to 24 (55.2 % males, Mage = 21.21 years) completed questionnaires regarding demographics, childhood environmental harshness (from neighborhood, school, and family), and unpredictability (parental divorce, household moves, and parental employment changes), LH strategy, sense of control, and bedtime procrastination. Methods: Structural equation modeling was used to test the hypothesis model. Results: The results showed that childhood environmental harshness and unpredictability were both positively associated with bedtime procrastination. Sense of control had a partial mediating role between harshness and bedtime procrastination (B = 0.02, 95%CI = [0.004, 0.042]), and between unpredictability and bedtime procrastination (B = 0.01, 95%CI = [0.002, 0.031]), respectively. LH strategy and sense of control had a serial mediating role between harshness and bedtime procrastination (B = 0.04, 95%CI = [0.010, 0.074]), and between unpredictability and bedtime procrastination (B = 0.01, 95%CI = [0.003, 0.029]), respectively. Conclusions: The findings suggest that childhood environmental harshness and unpredictability are potential predictors of youths' bedtime procrastination. Young people can reduce bedtime procrastination problems by slowing LH strategies and improving their sense of control.

Child abuse & neglect · 4 citationsread the source →

Parental Autonomy Support and Pathological Internet Use among Chinese Undergraduate Students: Gratitude Moderated the Mediating Effect of Filial Piety.

Applying an integrated theoretical model consisting of the socioecological theory, the self-determination theory, and the broaden-and-build theory, the present study tested a moderated mediation model of parental autonomy support, filial piety, and gratitude to study how these factors are jointly related to pathological Internet use (PIU) in Chinese undergraduate students. A total of 1054 Chinese undergraduate students (M age = 20.35, SD = 1.00, 34.7% females) aged between 16 and 24 years participated in this study. They were instructed to complete self-reported questionnaires on parental autonomy support, filial piety, gratitude, and PIU. The results showed that parental autonomy support was negatively associated with PIU, and filial piety partially mediated this relation. Specifically, parental autonomy support was positively related to filial piety, which, in turn, was negatively associated with PIU. In addition, gratitude moderated the first path of the indirect relation and the direct relation of this mediation effect. To be specific, undergraduate students with higher gratitude showed high filial piety and low PIU, in the context of low parental autonomy support, than those with lower gratitude. Taken together, the current study contributes to extant research by highlighting the vital role of parental autonomy support in mitigating undergraduate students' PIU and illustrating how filial piety explains the underlying mechanism of this association. This study also provides novel insights into intervention or prevention programs by demonstrating that gratitude alleviates the adverse effect of low parental autonomy support on students' PIU.

International journal of environmental research and public health · 9 citationsread the source →

Facilitating factors and barriers in help-seeking behaviour in adolescents and young adults with depressive symptoms: A qualitative study.

Objective: Despite the availability of mental health care, only a minority of depressed adolescents and young adults receive treatment. This study aimed to investigate facilitating factors and barriers in help-seeking behaviour of adolescents and young adults with depressive symptoms, using qualitative research methods. Methods: In-depth, semi-structured interviews with 32 participants with current or previous depressive symptoms aged 16 to 24 years using thematic content analysis. Findings: Our sample consisted mainly of adolescents who eventually found their way to professional help. Five main themes in help-seeking by adolescents and young adults were identified: (I) Individual functioning and well-being, (II) Health literacy, (III) Attitudinal aspects, (IV) Surroundings, and (V) Accessibility. Prompts to seek treatment were disease burden and poor academic performance. Health illiteracy negatively influenced treatment-seeking behaviour. Attitudinal aspects either hampered (shame, wanting to handle the problem oneself, negative attitudes towards treatment) or facilitated (positive attitudes towards treatment) help-seeking. Furthermore, adolescents' surroundings (school, family, and peers) appeared to play a critical role in the recognition of depressive symptoms and encouragement to seek help. Barriers regarding accessibility of mental health care were found, whereas direct and easy access to treatment greatly improved mental health care use. Conclusion: Facilitating factors can play a critical role in the help-seeking process of depressed adolescents and young adults, and may guide efforts to increase access to mental health care of this vulnerable age group. In particular, recognition and encouragement from school personnel and peers and easy access to care providers positively influenced help-seeking in our sample. Health illiteracy and attitudinal aspects appeared to be important barriers to seeking treatment and public/school campaigns aimed at reducing health illiteracy and stigma might be necessary to improve treatment-seeking and health care utilization in this age group.

PloS one · 44 citationsread the source →

Using a gender lens to understand eating behaviours of adolescent females living in low-income households in Bangladesh.

Adolescence is a critical period characterized by rapid physical, psychological, and social development and growth. In Bangladesh, high rates of undernutrition persist among adolescent females living in low-income households. Prevalence of adolescent marriage and pregnancy is extremely high, with almost half of Bangladeshi women giving birth by 18 years of age. Qualitative research was carried out from April to June 2017 to examine individual, social, and environmental factors influencing eating behaviours of female adolescents between 15 and 19 years of age living in low-income families in urban and rural settings in Bangladesh. Methods included freelisting exercises (33), key informant interviews (11), in-depth interviews (24), direct observations (16), and focus group discussions (12). Findings show that household food insecurity necessitates adjustments in meal food quality and frequency. Gender norms prescribe that females receive small meal portions and make sacrifices in food consumption so that male family members can eat more. Work and school schedules cause long breaks between meal consumption, restricting food intake of adolescent females for extended periods. Gender discrimination and its manifestations likely amplify susceptibility to psychological stresses in adolescent females. An inferior social position makes adolescent females living in food insecure households vulnerable to undernutrition, with factors affecting food deprivation increasing as they approach childbearing. Policies to increase age of marriage and reduce adolescent pregnancy must continue. Programmes must ensure that school-going adolescents eat adequately during the school day. Prolonging school education and strengthening the economic viability of women should alter cultural expectations regarding marriage age and normative female roles.

Maternal & child nutrition · 32 citationsread the source →

Randomised controlled trial of qigong in the treatment of mild essential hypertension.

Exercise and relaxation decrease blood pressure. Qigong is a traditional Chinese exercise consisting of breathing and gentle movements. We conducted a randomised controlled trial to study the effect of Guolin qigong on blood pressure. In all, 88 patients with mild essential hypertension were recruited from the community and randomised to Goulin qigong or conventional exercise for 16 weeks. The main outcome measurements were blood pressure, health status (SF-36 scores), Beck Anxiety and Depression Inventory scores. In the qigong group, blood pressure decreased significantly from 146.3+/-7.8/93.0+/-4.1 mmHg at baseline to 135.5+/-10.0/87.1+/-7.7 mmHg at week 16. In the exercise group, blood pressure also decreased significantly from 140.9+/-10.9/93.1+/-3.5 mmHg to 129.7+/-11.1/86.0+/-7.0 mmHg. Heart rate, weight, BMI, waist circumference, total cholesterol, renin and 24 h urinary albumin excretion significantly decreased in both groups after 16 weeks. General health, bodily pain, social functioning and depression also improved in both groups. No significant differences between qigong and conventional exercise were found. In conclusion, Guolin qigong and conventional exercise have similar effects on blood pressure in patients with mild hypertension. While no additional benefits were identified, it is nevertheless an alternative to conventional exercise in the nondrug treatment of hypertension.

Journal of human hypertension · randomised controlled trial · 72 citationsread the source →

Resilience under conditions of extreme stress: a multilevel perspective

From the perspective of developmental psychopathology, maladaptation and mental disorder are viewed as evolving from progressive liabilities in the organization of biological and psychological systems, resulting in the undermining of the individual's efforts to adapt effectively to stressful and adverse experiences 1,2. The dynamic interplay between risk and protective forces is conceived as influencing the developmental course through the impact it has on the quality of the organization of biological and psychological systems as the individual develops 3. Developmental psychopathologists stress that there is multifinality in developmental processes such that the manner in which persons respond to and interact with vulnerability and protective factors at each level of the ecology (i.e., culture, community, family, and their transactions) allows for diversity in developmental outcomes 4,5. Individuals may begin on the same major developmental trajectory, yet exhibit very different patterns of maladaptation or adaptation. The pathway to either psychopathology or resilience is influenced by a complex matrix of the individual's level of biological and psychological organization, current experiences, active choices, the social context, timing of the adverse event(s) and experiences, and the developmental history of the individual 5. Understanding the dynamic transactions between risk and protective factors plays a central role in building developmentally informed models of prevention. Through increasing the relative balance of protective processes over risk factors, the potential for righting the developmental course, attaining adaptive developmental pathways, and reducing the emergence of psychopathology may be achieved 4,6. Just as deviations from the average expectable environment potentiate some individuals toward the development of maladaptation, others demonstrate adaptation in the face of the same challenges 7,8,9. Thus, it is equally important to comprehend the mechanisms that promote adaptation among individuals experiencing significant adversity as it is to investigate the developmental trajectories toward maladaptation. Research conducted on biological, as well as psychological, protective factors is critically important for discovering mechanisms and processes that contribute to the development of either the recovery of function or resilient adaptation in the face of significant adversity 10,11,12. Resilience is conceived as a dynamic developmental process encompassing the attainment of positive adaptation within the context of significant adversity 8,13,14. There are two critical conditions that are implicit within this conceptualization of resilience: a) exposure to significant threat, severe adversity, or trauma; and b) the achievement of positive adaptation despite major assaults on the developmental process 8,14. For four decades, researchers interested in children who develop well in the context of significant adversity have endeavored to enhance understanding of the diverse pathways to psychopathology, to elucidate the processes that eventuate in normal development, and to inform preventive interventions and social policies that could improve the lives of vulnerable children and families 7,15,16,17,18. Investigations in the area of risk and resilience have led scientists to rethink their prior assumptions about the causes and course of psychopathology and have resulted in a reformulation of the deficit etiological models that characterized earlier viewpoints about the development of children who have experienced disadvantage and great adversity 9,19,20. Studies conducted on individuals at high risk for psychopathology and on persons with mental disorders frequently portrayed the developmental course as deterministic, inevitably resulting in maladaptive and pathological outcomes. Investigations focusing on genetic and biological predispositions to psychopathology, assaults on development associated with inadequate caregiving, and traumatic occurrences within the home — such as child maltreatment and domestic violence, exposure to community violence, chronic illness, and catastrophic life events — graphically convey the multiplicity of risks that can eventuate in disordered outcomes. As researchers discovered that not all high-risk children manifested the dire consequences that extant theories of psychopathology predicted, comprehending the processes through which children at risk did not develop psychopathology became viewed as important for informing theories on the development of maladaptation and pathology. Before investigations on resilience could be initiated, a significant and illustrious history of research detailing the precursors to, as well as the contemporary patterns of, stress resistance had to take place (e.g., 8,21). In many of these early studies, researchers had discovered evidence of adaptive behavior; however, the nomenclature for labeling these results as indicative of resilience had not yet emerged. The historical roots of resilience can be traced to early programs of research on individuals with schizophrenia and on persons exposed to parental mental illness, extreme stress and poverty, as well as on the functioning of individuals who experienced traumatic occurrences earlier in their lives 7,15,22,23. Early investigations of severely disordered schizophrenic patients were focused primarily on understanding maladaptive behavior, and the subset of patients who showed relatively adaptive patterns were considered atypical and afforded little attention. By the middle of the 20th century, researchers had discovered that people with schizophrenia with the least severe courses of illness were characterized by a premorbid history of a relative competence at work, good social relations, marriage and the capacity to fulfill responsibility (see 23). In a parallel fashion, studies of children of mothers with schizophrenia played a crucial role in the emergence of childhood resilience as a major theoretical and empirical topic 16,19,24. Additionally, Werner's longitudinal study 17,18, that systematically searched for protective forces that differentiated children with healthy adaptation profiles from those who were comparatively less well adjusted, was a groundbreaking investigation. Evidence that many of these children experiencing great adversity thrived despite their high-risk status led to increasing empirical efforts to understand individual variations in response to adversity. Early empirical efforts were primarily focused on the personal qualities of “resilient children”, such as autonomy or high self-esteem 25. As work in the area evolved, however, researchers increasingly acknowledged that resilience may often derive from factors external to the child 8. Subsequent research led to the delineation of these sets of factors implicated in the development of resilience: a) attributes of the children themselves; b) aspects of their families; and c) characteristics of their wider social environments 8,25. In recent decades, there has been a shift in the focus of empirical investigations; rather than searching for protective factors, researchers are increasingly striving to discover the mechanisms underlying resilient functioning 8. This focus on processes as opposed to identifying factors has enabled scientists to design prevention and intervention strategies that are developmentally sensitive for promoting resilience in persons experiencing significant adversity or trauma 26,27,28. Knowledge of the processes contributing to resilient functioning can enable prevention and intervention scientists to capitalize on periods of developmental change and transitions as unique opportunities for promoting positive adaptation during significant adversity or trauma 27,29. As S. Luthar asserted, “it is far more prudent to promote the development of resilient functioning early in the course of development rather than to implement treatments to repair disorders once they are already crystallized” 7. Randomized control trial (RCT) preventive interventions may be conceptualized as true experiments in altering the course of development 30, thereby presenting opportunities to test existing developmental theories as well as to provide insights into the etiology and course of positive adaptational outcomes in individuals experiencing significant adversity 8,31. As research on resilience has evolved and transformed over the years, it has become clear that the attainment of positive adaptation in the face of significant adversity involves a developmental progression; new vulnerabilities and challenges and/or strengths and opportunities often emerge with changing circumstances over the life course 8. Resilience is not something an individual “has” — it is a multiply determined developmental process that is not fixed or immutable. Hence, it is important to conduct longitudinal studies of the determinants of resilient functioning. In this regard, longitudinal studies on resilience should focus not only on assessing the stability of the construct over developmental time, but also on the ability of formerly resilient individuals to “bounce back” or to recover positive functioning experiencing periods and their prior resilient adaptation resilient adaptation may be achieved at in the life there is a for research on the achievement of positive outcomes at different in development, in and in life 8. the the empirical study of resilience focused on and of, and to, the and did not biological or studies were prior to the of for the and biological of and Evidence from earlier and investigations of resilience on a of attributes of child and environment that to be of adaptation and there were and in the early studies more contemporary investigations to the factors associated with resilient a) with and in the and b) c) positive of to be in the environment (i.e., and and and with and in and a to active and the capacity to and have all been associated with resilient functioning positive stressful occurrences in less and the ability to adverse experiences in a positive and to trauma have each been to resilience the relative of as to developmental on the of adaptive outcomes in the face of adversity was primarily to the of that about the and organization of the There was not about development and function to their role in the and of normal and mental in their to the development of resilient adaptation of is about the course, and consequences of resilient functioning in the face of adversity have been from investigations that focused on relatively of it is from the by developmental psychopathologists that toward a understanding of resilient adaptation the of research and strategies that for the of of within and of the In the a of scientists have researchers to and genetic into their investigations of the developmental pathways to resilient functioning in and have it more to conduct research on the development of resilience from a perspective In the of with many associated an to current and to the study of it is critically important to in that biological not function more the functioning of the of or more systems, through a developmental of influenced processes this increasing of the of many of processes in to the understanding of a such as it is resilience researchers to the of of and within systems and psychological are to in research on resilience and in level and all of the of on is different of as scientists more about of resilience researchers their work at each level to develop theories that are all function in they the risk of theories that be from has either been or is Just as is the in systems it is critical that there be an that all of about complex systems in the development of resilience conditions of child maltreatment a in severe stress that challenges and frequently development diverse of biological and psychological functioning The conditions associated with maltreatment a severe from the average expectable children are to in and development, social and children are to develop a of relatively vulnerability factors, at great risk for maladaptation and not all individuals who have been and to the extreme adversity in their of some individuals despite experiencing significant stress and trauma an to discover processes at of that are to be to in the face of adversity, yet less more stress exposure children develop and function despite experiencing a of for developmental theories of and for prevention and In a longitudinal of the pathways to resilience in to there were different pathways to resilient functioning in and children from and to there were between these in recovery of or in functioning over the of the study children than children on of resilient functioning (e.g., competence with with many of these or of each of the years, children a level of resilient functioning than did the Additionally, the of maladaptive functioning by children the course of this longitudinal study was these the impact that maltreatment experiences on functioning and to the of their In this also on the of resilient functioning in and of these that there was a of children than children in the resilient functioning a of than children competence thereby an of resilient the study that children the ability to some resilience in the of chronic and adversity. 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World Psychiatry · editorial or comment · 746 citationsread the source →

Does forgiving in a collectivistic culture affect only decisions to forgive and not emotions? REACH forgiveness collectivistic in Indonesia.

According to some theorising, in collectivistic societies, forgiveness is mainly enacted to maintain relationships, not engender emotional transformation. This present study was designed to explore whether forgiveness affects decisional and emotional forgiveness in Indonesia, a country categorised as collectivistic. The evidence-based REACH Forgiveness psychoeducational group intervention was adapted to collectivistic culture (REACH forgiveness collectivistic; REACH-FC), and its efficacy was assessed in a randomised controlled trial. Undergraduates in Indonesia (N = 97; 24 male; 73 female; ages 16-21) were randomly assigned within a 2 × 3(S) quasi-experimental repeated-measures design comparing immediate treatment (IT) and waiting list (WL) conditions [Condition (IT, WL) × Time ([S] 3 time points). Harmonious value, a personality variable assessing the strength of participants' desire for group harmony, was the covariate. The condition × time (S) interactions for both decisional and emotional forgiveness were significant, challenging some previous literature. Clearly, not all forms of collectivism have similar effects when individuals and communities deal with transgressions.

International journal of psychology : Journal international de psychologie · 5 citationsread the source →

Enduring effects of psychological treatments for anxiety disorders: meta-analysis of follow-up studies.

Background: It is a widespread opinion that after treatment with psychotherapy, patients with anxiety disorders maintain their gains beyond the active treatment period, whereas patients treated with medication soon experience a relapse after treatment termination. AimsWe aimed to provide evidence on whether enduring effects of psychotherapy differ from control groups. Method: We searched 93 randomised controlled studies with 152 study arms of psychological treatment (cognitive-behavioural therapy or other psychotherapies) for panic disorder, generalised anxiety disorder and social anxiety disorder that included follow-up assessments. In a meta-analysis, pre-post effect sizes for end-point and all follow-up periods were calculated and compared with control groups (medication: n = 16 study arms; pill and psychological placebo groups: n = 17 study arms). Results: Gains with psychotherapy were maintained for up to 24 months. For cognitive-behavioural therapy, we observed a significant improvement over time. However, patients in the medication group remained stable during the treatment-free period, with no significant difference when compared with psychotherapy. Patients in the placebo group did not deteriorate during follow-up, but showed significantly worse outcomes than patients in cognitive-behavioural therapy. Conclusions: Not only psychotherapy, but also medications and, to a lesser extent, placebo conditions have enduring effects. Long-lasting treatment effects observed in the follow-up period may be superimposed by effects of spontaneous remission or regression to the mean. Declaration of interestIn the past 12 months and in the near future, Dr Bandelow has been/will be on the speakers/advisory board for Hexal, Mundipharma, Lilly, Lundbeck, Pfizer and Servier. Dr Wedekind was on the speakers' board of AstraZeneca, Essex Pharma, Lundbeck and Servier. All other authors have nothing to declare.

The British journal of psychiatry : the journal of mental science · meta-analysis · 41 citationsread the source →

Effects of hypohydration and fluid balance in athletes' cognitive performance: a systematic review.

Background: The effects of progressive body fluid loss on athletic and cognitive performance are known to result from exposure to environmental heat stress, morphologic factors, and limited fluid replenishment. Athletes need to restore lost body water. However, athletes may fail to maintain euhydration during exercise. This systematic review investigated hypohydration and fluid balance effects on an athlete's cognitive function. Methods: The PubMed, Sports Discuss, and Ebsco databases were searched for studies reporting on hypohydration, fluid balance and heat on cognitive performance in sport. Multiple phrases including hydration, dehydration, fluid balance, mood, cognition, vigilance, decision making, and brain were explored. Participants in the studies did either receive fluid or did not receive fluid during exercise. Results: Twenty-four trials (n=493 participants) from 24 articles met the inclusion criteria. Significant hypohydration, >2% body mass loss was reported consistently in 16 publications. Five articles where hypohydration was associated with heat stress and limited fluid intake (3-5% body mass loss) impaired cognitive performance. Mood disturbance, fatigue, and ratings of perceived exertion constantly complemented hypohydration impairment on cognition. Conclusion: Findings show that hypohydration impairs cognitive performance and mood at higher levels of 3-5% body mass loss. However, sport-specific cognitive protocols of accessing hypohydration and fluid balance in individual and team sports remain equivocal.

African health sciences · systematic review · 15 citationsread the source →

Interventions to prevent obesity in children aged 5 to 11 years old.

Background: Prevention of obesity in children is an international public health priority given the prevalence of the condition (and its significant impact on health, development and well-being). Interventions that aim to prevent obesity involve behavioural change strategies that promote healthy eating or 'activity' levels (physical activity, sedentary behaviour and/or sleep) or both, and work by reducing energy intake and/or increasing energy expenditure, respectively. There is uncertainty over which approaches are more effective and numerous new studies have been published over the last five years, since the previous version of this Cochrane review. Objectives: To assess the effects of interventions that aim to prevent obesity in children by modifying dietary intake or 'activity' levels, or a combination of both, on changes in BMI, zBMI score and serious adverse events. Search methods: We used standard, extensive Cochrane search methods. The latest search date was February 2023. Selection criteria: Randomised controlled trials in children (mean age 5 years and above but less than 12 years), comparing diet or 'activity' interventions (or both) to prevent obesity with no intervention, usual care, or with another eligible intervention, in any setting. Studies had to measure outcomes at a minimum of 12 weeks post baseline. We excluded interventions designed primarily to improve sporting performance. Data collection and analysis: We used standard Cochrane methods. Our outcomes were body mass index (BMI), zBMI score and serious adverse events, assessed at short- (12 weeks to < 9 months from baseline), medium- (9 months to < 15 months) and long-term (≥ 15 months) follow-up. We used GRADE to assess the certainty of the evidence for each outcome. Main results: This review includes 172 studies (189,707 participants); 149 studies (160,267 participants) were included in meta-analyses. One hundred forty-six studies were based in high-income countries. The main setting for intervention delivery was schools (111 studies), followed by the community (15 studies), the home (eight studies) and a clinical setting (seven studies); one intervention was conducted by telehealth and 31 studies were conducted in more than one setting. Eighty-six interventions were implemented for less than nine months; the shortest was conducted over one visit and the longest over four years. Non-industry funding was declared by 132 studies; 24 studies were funded in part or wholly by industry. Dietary interventions versus control Dietary interventions, compared with control, may have little to no effect on BMI at short-term follow-up (mean difference (MD) 0, 95% confidence interval (CI) -0.10 to 0.10; 5 studies, 2107 participants; low-certainty evidence) and at medium-term follow-up (MD -0.01, 95% CI -0.15 to 0.12; 9 studies, 6815 participants; low-certainty evidence) or zBMI at long-term follow-up (MD -0.05, 95% CI -0.10 to 0.01; 7 studies, 5285 participants; low-certainty evidence). Dietary interventions, compared with control, probably have little to no effect on BMI at long-term follow-up (MD -0.17, 95% CI -0.48 to 0.13; 2 studies, 945 participants; moderate-certainty evidence) and zBMI at short- or medium-term follow-up (MD -0.06, 95% CI -0.13 to 0.01; 8 studies, 3695 participants; MD -0.04, 95% CI -0.10 to 0.02; 9 studies, 7048 participants; moderate-certainty evidence). Five studies (1913 participants; very low-certainty evidence) reported data on serious adverse events: one reported serious adverse events (e.g. allergy, behavioural problems and abdominal discomfort) that may have occurred as a result of the intervention; four reported no effect. Activity interventions versus control Activity interventions, compared with control, may have little to no effect on BMI and zBMI at short-term or long-term follow-up (BMI short-term: MD -0.02, 95% CI -0.17 to 0.13; 14 studies, 4069 participants; zBMI short-term: MD -0.02, 95% CI -0.07 to 0.02; 6 studies, 3580 participants; low-certainty evidence; BMI long-term: MD -0.07, 95% CI -0.24 to 0.10; 8 studies, 8302 participants; zBMI long-term: MD -0.02, 95% CI -0.09 to 0.04; 6 studies, 6940 participants; low-certainty evidence). Activity interventions likely result in a slight reduction of BMI and zBMI at medium-term follow-up (BMI: MD -0.11, 95% CI -0.18 to -0.05; 16 studies, 21,286 participants; zBMI: MD -0.05, 95% CI -0.09 to -0.02; 13 studies, 20,600 participants; moderate-certainty evidence). Eleven studies (21,278 participants; low-certainty evidence) reported data on serious adverse events; one study reported two minor ankle sprains and one study reported the incident rate of adverse events (e.g. musculoskeletal injuries) that may have occurred as a result of the intervention; nine studies reported no effect. Dietary and activity interventions versus control Dietary and activity interventions, compared with control, may result in a slight reduction in BMI and zBMI at short-term follow-up (BMI: MD -0.11, 95% CI -0.21 to -0.01; 27 studies, 16,066 participants; zBMI: MD -0.03, 95% CI -0.06 to 0.00; 26 studies, 12,784 participants; low-certainty evidence) and likely result in a reduction of BMI and zBMI at medium-term follow-up (BMI: MD -0.11, 95% CI -0.21 to 0.00; 21 studies, 17,547 participants; zBMI: MD -0.05, 95% CI -0.07 to -0.02; 24 studies, 20,998 participants; moderate-certainty evidence). Dietary and activity interventions compared with control may result in little to no difference in BMI and zBMI at long-term follow-up (BMI: MD 0.03, 95% CI -0.11 to 0.16; 16 studies, 22,098 participants; zBMI: MD -0.02, 95% CI -0.06 to 0.01; 22 studies, 23,594 participants; low-certainty evidence). Nineteen studies (27,882 participants; low-certainty evidence) reported data on serious adverse events: four studies reported occurrence of serious adverse events (e.g. injuries, low levels of extreme dieting behaviour); 15 studies reported no effect. Heterogeneity was apparent in the results for all outcomes at the three follow-up times, which could not be explained by the main setting of the interventions (school, home, school and home, other), country income status (high-income versus non-high-income), participants' socioeconomic status (low versus mixed) and duration of the intervention. Most studies excluded children with a mental or physical disability. Authors' conclusions: The body of evidence in this review demonstrates that a range of school-based 'activity' interventions, alone or in combination with dietary interventions, may have a modest beneficial effect on obesity in childhood at short- and medium-term, but not at long-term follow-up. Dietary interventions alone may result in little to no difference. Limited evidence of low quality was identified on the effect of dietary and/or activity interventions on severe adverse events and health inequalities; exploratory analyses of these data suggest no meaningful impact. We identified a dearth of evidence for home and community-based settings (e.g. delivered through local youth groups), for children living with disabilities and indicators of health inequities.

The Cochrane database of systematic reviews · meta-analysis · 40 citationsread the source →

Early additional food and fluids for healthy breastfed full-term infants.

Background: Health organisations recommend exclusive breastfeeding for six months. However, the addition of other fluids or foods before six months is common in many countries. Recently, research has suggested that introducing solid food at around four months of age while the baby continues to breastfeed is more protective against developing food allergies compared to exclusive breastfeeding for six months. Other studies have shown that the risks associated with non-exclusive breastfeeding are dependent on the type of additional food or fluid given. Given this background we felt it was important to update the previous version of this review to incorporate the latest findings from studies examining exclusive compared to non-exclusive breastfeeding. Objectives: To assess the benefits and harms of additional food or fluid for full-term healthy breastfeeding infants and to examine the timing and type of additional food or fluid. Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 March 2016) and reference lists of all relevant retrieved papers. Selection criteria: Randomised or quasi-randomised controlled trials in infants under six months of age comparing exclusive breastfeeding versus breastfeeding with any additional food or fluids. Data collection and analysis: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two review authors assessed the quality of the evidence using the GRADE approach. Main results: We included 11 trials (2542 randomised infants/mothers). Nine trials (2226 analysed) provided data on outcomes of interest to this review. The variation in outcome measures and time points made it difficult to pool results from trials. Data could only be combined in a meta-analysis for one primary (breastfeeding duration) and one secondary (weight change) outcome. None of the trials reported on physiological jaundice. Infant mortality was only reported in one trial. For the majority of older trials, the description of study methods was inadequate to assess the risk of bias. Most studies that we could assess showed a high risk of other biases and over half were at high risk of selection bias. Providing breastfeeding infants with artifical milk, compared to exclusive breastfeeding, did not affect rates of breastfeeding at hospital discharge (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.97 to 1.08; one trial, 100 infants; low-quality evidence). At three months, breastfeeding infants who were provided with artificial milk had higher rates of any breastfeeding compared to exclusively breastfeeding infants (RR 1.21, 95% CI 1.05 to 1.41; two trials, 137 infants; low-quality evidence). Infants who were given artifical milk in the first few days after birth before breastfeeding, had less "obvious or probable symptoms" of allergy compared to exclusively breastfeeding infants (RR 0.56, 95% CI 0.35 to 0.91; one trial, 207 infants; very low-quality evidence). No difference was found in maternal confidence when comparing non-exclusive breastfeeding infants who were provided with artificial milk with exclusive breastfeeding infants (mean difference (MD) 0.10, 95% CI -0.34 to 0.54; one study, 39 infants; low-quality evidence). Rates of breastfeeding were lower in the non-exclusive breastfeeding group compared to the exclusive breastfeeding group at four, eight, 12 (RR 0.68, 95% CI 0.53 to 0.87; one trial, 170 infants; low-quality evidence), 16 and 20 weeks. The addition of glucose water resulted in fewer episodes of hypoglycaemia (below 2.2 mmol/L) compared to the exclusive breastfeeding group, reported at 12 hours (RR 0.07, 95% CI 0.00 to 1.20; one trial, 170 infants; very low-quality evidence), but no significant difference at 24 hours (RR 1.57, 95% CI 0.27 to 9.17; one trial, 170 infants; very low-quality evidence). Weight loss was lower for infants who received additional glucose water (one trial, 170 infants) at six, 12, 24 and 48 hours of life (MD -32.50 g, 95% CI -52.09 to -12.91; low-quality evidence) compared to the exclusively breastfeeding infants but no difference between groups was observed at 72 hours of life (MD 3.00 g, 95% CI -20.83 to 26.83; very low-quality evidence). In another trial with the water and glucose water arms combined (one trial, 47 infants), we found no significant difference in weight loss between the additional fluid group and the exclusively breastfeeding group on either day three or day five (MD -1.03%, 95% CI -2.24 to 0.18; very low-quality evidence) and (MD -0.20%, 95% CI -0.86 to 0.46; very low-quality evidence).Infant mortality was reported in one trial with no deaths occurring in either group (1162 infants). The early introduction of potentially allergenic foods, compared to exclusively breastfeeding, did not reduce the risk of "food allergy" to one or more of these foods between one to three years of age (RR 0.80, 95% CI 0.51 to 1.25; 1162 children), visible eczema at 12 months stratified by visible eczema at enrolment (RR 0.86, 95% CI 0.51 to 1.44; 284 children), or food protein-induced enterocolitis syndrome reactions (RR 2.00, 95% CI 0.18 to 22.04; 1303 children) (all moderate-quality evidence). Breastfeeding infants receiving additional foods from four months showed no difference in infant weight gain (g) from 16 to 26 weeks compared to exclusive breastfeeding to six months (MD -39.48, 95% CI -128.43 to 49.48; two trials, 260 children; low-quality evidence) or weight z-scores (MD -0.01, 95% CI -0.15 to 0.13; one trial, 100 children; moderate-quality evidence). Authors' conclusions: We found no evidence of benefit to newborn infants on the duration of breastfeeding from the brief use of additional water or glucose water. The quality of the evidence on formula supplementation was insufficient to suggest a change in practice away from exclusive breastfeeding. For infants at four to six months, we found no evidence of benefit from additional foods nor any risks related to morbidity or weight change. The majority of studies showed high risk of other bias and most outcomes were based on low-quality evidence which meant that we were unable to fully assess the benefits or harms of supplementation or to determine the impact from timing and type of supplementation. We found no evidence to disagree with the current international recommendation that healthy infants exclusively breastfeed for the first six months.

The Cochrane database of systematic reviews · meta-analysis · 47 citationsread the source →

Reduction in saturated fat intake for cardiovascular disease.

Background: Reducing saturated fat reduces serum cholesterol, but effects on other intermediate outcomes may be less clear. Additionally, it is unclear whether the energy from saturated fats eliminated from the diet are more helpfully replaced by polyunsaturated fats, monounsaturated fats, carbohydrate or protein. Objectives: To assess the effect of reducing saturated fat intake and replacing it with carbohydrate (CHO), polyunsaturated (PUFA), monounsaturated fat (MUFA) and/or protein on mortality and cardiovascular morbidity, using all available randomised clinical trials. Search methods: We updated our searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid) and Embase (Ovid) on 15 October 2019, and searched Clinicaltrials.gov and WHO International Clinical Trials Registry Platform (ICTRP) on 17 October 2019. Selection criteria: Included trials fulfilled the following criteria: 1) randomised; 2) intention to reduce saturated fat intake OR intention to alter dietary fats and achieving a reduction in saturated fat; 3) compared with higher saturated fat intake or usual diet; 4) not multifactorial; 5) in adult humans with or without cardiovascular disease (but not acutely ill, pregnant or breastfeeding); 6) intervention duration at least 24 months; 7) mortality or cardiovascular morbidity data available. Data collection and analysis: Two review authors independently assessed inclusion, extracted study data and assessed risk of bias. We performed random-effects meta-analyses, meta-regression, subgrouping, sensitivity analyses, funnel plots and GRADE assessment. Main results: We included 15 randomised controlled trials (RCTs) (16 comparisons, 56,675 participants), that used a variety of interventions from providing all food to advice on reducing saturated fat. The included long-term trials suggested that reducing dietary saturated fat reduced the risk of combined cardiovascular events by 17% (risk ratio (RR) 0.83; 95% confidence interval (CI) 0.70 to 0.98, 12 trials, 53,758 participants of whom 8% had a cardiovascular event, I² = 67%, GRADE moderate-quality evidence). Meta-regression suggested that greater reductions in saturated fat (reflected in greater reductions in serum cholesterol) resulted in greater reductions in risk of CVD events, explaining most heterogeneity between trials. The number needed to treat for an additional beneficial outcome (NNTB) was 56 in primary prevention trials, so 56 people need to reduce their saturated fat intake for ~four years for one person to avoid experiencing a CVD event. In secondary prevention trials, the NNTB was 53. Subgrouping did not suggest significant differences between replacement of saturated fat calories with polyunsaturated fat or carbohydrate, and data on replacement with monounsaturated fat and protein was very limited. We found little or no effect of reducing saturated fat on all-cause mortality (RR 0.96; 95% CI 0.90 to 1.03; 11 trials, 55,858 participants) or cardiovascular mortality (RR 0.95; 95% CI 0.80 to 1.12, 10 trials, 53,421 participants), both with GRADE moderate-quality evidence. There was little or no effect of reducing saturated fats on non-fatal myocardial infarction (RR 0.97, 95% CI 0.87 to 1.07) or CHD mortality (RR 0.97, 95% CI 0.82 to 1.16, both low-quality evidence), but effects on total (fatal or non-fatal) myocardial infarction, stroke and CHD events (fatal or non-fatal) were all unclear as the evidence was of very low quality. There was little or no effect on cancer mortality, cancer diagnoses, diabetes diagnosis, HDL cholesterol, serum triglycerides or blood pressure, and small reductions in weight, serum total cholesterol, LDL cholesterol and BMI. There was no evidence of harmful effects of reducing saturated fat intakes. Authors' conclusions: The findings of this updated review suggest that reducing saturated fat intake for at least two years causes a potentially important reduction in combined cardiovascular events. Replacing the energy from saturated fat with polyunsaturated fat or carbohydrate appear to be useful strategies, while effects of replacement with monounsaturated fat are unclear. The reduction in combined cardiovascular events resulting from reducing saturated fat did not alter by study duration, sex or baseline level of cardiovascular risk, but greater reduction in saturated fat caused greater reductions in cardiovascular events.

The Cochrane database of systematic reviews · meta-analysis · 98 citationsread the source →

Prevalence of symptoms of anxiety and depression in patients with inflammatory bowel disease: a systematic review and meta-analysis.

Background: Inflammatory bowel disease (IBD) is a lifelong condition with no cure. Patients with IBD might experience symptoms of common mental disorders such as anxiety and depression because of bidirectional communication via the gut-brain axis and chronicity of symptoms, and because of impaired quality of life and reduced social functioning. However, uncertainties remain about the magnitude of this problem. We aimed to assess prevalence of symptoms of anxiety or depression in adult patients with IBD. Methods: In this systematic review and meta-analysis, we searched MEDLINE, Embase, Embase Classic, and PsycINFO for papers published from inception to Sept 30, 2020, reporting observational studies that recruited at least 100 adult patients with IBD and that reported prevalence of symptoms of anxiety or depression according to validated screening instruments. We excluded studies that only used a structured interview to assess for these symptoms and studies that did not provide extractable data. We extracted data from published study reports and calculated pooled prevalences of symptoms of anxiety and depression, odds ratios (OR), and 95% CIs. Findings: Of 5544 studies identified, 77 fulfilled the eligibility criteria, including 30 118 patients in total. Overall, pooled prevalence of anxiety symptoms was 32·1% (95% CI 28·3-36·0) in 58 studies (I2=96·9%) and pooled prevalence of depression symptoms was 25·2% (22·0-28·5) in 75 studies (I2=97·6%). In studies that reported prevalence of anxiety or depression in patients with Crohn's disease and ulcerative colitis within the same study population, patients with Crohn's disease had higher odds of anxiety symptoms (OR 1·2, 95% CI 1·1-1·4) and depression symptoms (1·2, 1·1-1·4) than patients with ulcerative colitis. Overall, women with IBD were more likely to have symptoms of anxiety than were men with IBD (pooled prevalence 33·8% [95% CI 26·5-41·5] for women vs 22·8% [18·7-27·2] for men; OR 1·7 [95% CI 1·2-2·3]). They were also more likely to have symptoms of depression than men were (pooled prevalence 21·2% [95% CI 15·4-27·6] for women vs 16·2% [12·6-20·3] for men; OR 1·3 [95% CI 1·0-1·8]). The prevalence of symptoms of anxiety (57·6% [95% CI 38·6-75·4]) or depression (38·9% [26·2-52·3]) was higher in patients with active IBD than in patients with inactive disease (38·1% [30·9-45·7] for anxiety symptoms and 24·2% [14·7-35·3] for depression symptoms; ORs 2·5 [95% CI 1·5-4·1] for anxiety and 3·1 [1·9-4·9] for depression). Interpretation: There is a high prevalence of symptoms of anxiety and depression in patients with IBD, with up to a third of patients affected by anxiety symptoms and a quarter affected by depression symptoms. Prevalence was also increased in patients with active disease: half of these patients met criteria for anxiety symptoms and a third met criteria for depression symptoms. Encouraging gastroenterologists to screen for and treat these disorders might improve outcomes for patients with IBD. Funding: None.

The lancet. Gastroenterology & hepatology · meta-analysis · 514 citationsread the source →

Global prevalence and risk factors for mental health problems in police personnel: a systematic review and meta-analysis.

Police face an increased risk of developing mental health problems, yet reliable estimates of their psychological difficulties remain unknown. This systematic review and meta-analysis estimate the pooled prevalence and risk factors for mental health problems among police personnel worldwide. Three independent reviewers searched 16 databases and screened 11 506 articles published between January 1980 and October 2019. Eligible studies involved at least 100 active police professionals and used validated instruments to ascertain specific mental health problems. Estimates were pooled using random-effects meta-analyses. In total, 60 cross-sectional and seven longitudinal studies, involving 272 463 police personnel from 24 countries met criteria for inclusion. The overall pooled point prevalence was 14.6% for depression (95% CI 10.9% to 18.6%), 14.2% for post-traumatic stress disorder (PTSD; 95% CI 10.3% to 18.7%), 9.6% for a generalised anxiety disorder (95% CI 6.7% to 12.9%), 8.5% for suicidal ideation (95% CI 6.1% to 11.2%), 5.0% for alcohol dependence (95% CI 3.5% to 6.7%) and 25.7% for hazardous drinking (95% CI 19.6% to 32.4%). The strongest risk factor for depression and suicidal ideation was higher occupational stress, and the strongest risk factors for PTSD were higher occupational stress and avoidant coping strategies. Higher levels of peer-support were associated with significantly lower PTSD symptoms. Our findings suggest that the prevalence of mental health problems among police exceeds twice that previously reported in mixed samples of first responders, and is associated with poor social support, occupational stress and maladaptive coping strategies. Without effective intervention, psychological difficulties will remain a substantial health concern among police.

Occupational and environmental medicine · meta-analysis · 101 citationsread the source →

Diet, physical activity and behavioural interventions for the treatment of overweight or obese children from the age of 6 to 11 years.

Background: Child and adolescent overweight and obesity has increased globally, and can be associated with significant short- and long-term health consequences. This is an update of a Cochrane review published first in 2003, and updated previously in 2009. However, the update has now been split into six reviews addressing different childhood obesity treatments at different ages. Objectives: To assess the effects of diet, physical activity and behavioural interventions (behaviour-changing interventions) for the treatment of overweight or obese children aged 6 to 11 years. Search methods: We searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS as well as trial registers ClinicalTrials.gov and ICTRP Search Portal. We checked references of studies and systematic reviews. We did not apply any language restrictions. The date of the last search was July 2016 for all databases. Selection criteria: We selected randomised controlled trials (RCTs) of diet, physical activity, and behavioural interventions (behaviour-changing interventions) for treating overweight or obese children aged 6 to 11 years, with a minimum of six months' follow-up. We excluded interventions that specifically dealt with the treatment of eating disorders or type 2 diabetes, or included participants with a secondary or syndromic cause of obesity. Data collection and analysis: Two review authors independently screened references, extracted data, assessed risk of bias, and evaluated the quality of the evidence using the GRADE instrument. We contacted study authors for additional information. We carried out meta-analyses according to the statistical guidelines in the Cochrane Handbook for Systematic Reviews of Interventions. Main results: We included 70 RCTs with a total of 8461 participants randomised to either the intervention or control groups. The number of participants per trial ranged from 16 to 686. Fifty-five trials compared a behaviour-changing intervention with no treatment/usual care control and 15 evaluated the effectiveness of adding an additional component to a behaviour-changing intervention. Sixty-four trials were parallel RCTs, and four were cluster RCTs. Sixty-four trials were multicomponent, two were diet only and four were physical activity only interventions. Ten trials had more than two arms. The overall quality of the evidence was low or very low and 62 trials had a high risk of bias for at least one criterion. Total duration of trials ranged from six months to three years. The median age of participants was 10 years old and the median BMI z score was 2.2.Primary analyses demonstrated that behaviour-changing interventions compared to no treatment/usual care control at longest follow-up reduced BMI, BMI z score and weight. Mean difference (MD) in BMI was -0.53 kg/m2 (95% confidence interval (CI) -0.82 to -0.24); P < 0.00001; 24 trials; 2785 participants; low-quality evidence. MD in BMI z score was -0.06 units (95% CI -0.10 to -0.02); P = 0.001; 37 trials; 4019 participants; low-quality evidence and MD in weight was -1.45 kg (95% CI -1.88 to -1.02); P < 0.00001; 17 trials; 1774 participants; low-quality evidence. Thirty-one trials reported on serious adverse events, with 29 trials reporting zero occurrences RR 0.57 (95% CI 0.17 to 1.93); P = 0.37; 4/2105 participants in the behaviour-changing intervention groups compared with 7/1991 participants in the comparator groups). Few trials reported health-related quality of life or behaviour change outcomes, and none of the analyses demonstrated a substantial difference in these outcomes between intervention and control. In two trials reporting on minutes per day of TV viewing, a small reduction of 6.6 minutes per day (95% CI -12.88 to -0.31), P = 0.04; 2 trials; 55 participants) was found in favour of the intervention. No trials reported on all-cause mortality, morbidity or socioeconomic effects, and few trials reported on participant views; none of which could be meta-analysed. As the meta-analyses revealed substantial heterogeneity, we conducted subgroup analyses to examine the impact of type of comparator, type of intervention, risk of attrition bias, setting, duration of post-intervention follow-up period, parental involvement and baseline BMI z score. No subgroup effects were shown for any of the subgroups on any of the outcomes. Some data indicated that a reduction in BMI immediately post-intervention was no longer evident at follow-up at less than six months, which has to be investigated in further trials. Authors' conclusions: Multi-component behaviour-changing interventions that incorporate diet, physical activity and behaviour change may be beneficial in achieving small, short-term reductions in BMI, BMI z score and weight in children aged 6 to 11 years. The evidence suggests a very low occurrence of adverse events. The quality of the evidence was low or very low. The heterogeneity observed across all outcomes was not explained by subgrouping. Further research is required of behaviour-changing interventions in lower income countries and in children from different ethnic groups; also on the impact of behaviour-changing interventions on health-related quality of life and comorbidities. The sustainability of reduction in BMI/BMI z score and weight is a key consideration and there is a need for longer-term follow-up and further research on the most appropriate forms of post-intervention maintenance in order to ensure intervention benefits are sustained over the longer term.

The Cochrane database of systematic reviews · meta-analysis · 299 citationsread the source →

Death audits and reviews for reducing maternal, perinatal and child mortality.

Background: The United Nations' Sustainable Development Goals (SDGs) include reducing the global maternal mortality rate to less than 70 per 100,000 live births and ending preventable deaths of newborns and children under five years of age, in every country, by 2030. Maternal and perinatal death audit and review is widely recommended as an intervention to reduce maternal and perinatal mortality, and to improve quality of care, and could be key to attaining the SDGs. However, there is uncertainty over the most cost-effective way of auditing and reviewing deaths: community-based audit (verbal and social autopsy), facility-based audits (significant event analysis (SEA)) or a combination of both (confidential enquiry). Objectives: To assess the impact and cost-effectiveness of different types of death audits and reviews in reducing maternal, perinatal and child mortality. Search methods: We searched the following from inception to 16 January 2019: CENTRAL, Ovid MEDLINE, Embase OvidSP, and five other databases. We identified ongoing studies using ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform, and searched reference lists of included articles. Selection criteria: Cluster-randomised trials, cluster non-randomised trials, controlled before-and-after studies and interrupted time series studies of any form of death audit or review that involved reviewing individual cases of maternal, perinatal or child deaths, identifying avoidable factors, and making recommendations. To be included in the review, a study needed to report at least one of the following outcomes: perinatal mortality rate; stillbirth rate; neonatal mortality rate; mortality rate in children under five years of age or maternal mortality rate. Data collection and analysis: We used standard Cochrane Effective Practice and Organisation of Care (EPOC) group methodological procedures. Two review authors independently extracted data, assessed risk of bias and assessed the certainty of the evidence using GRADE. We planned to perform a meta-analysis using a random-effects model but included studies were not homogeneous enough to make pooling their results meaningful. Main results: We included two cluster-randomised trials. Both introduced death review and audit as part of a multicomponent intervention, and compared this to current care. The QUARITE study (QUAlity of care, RIsk management, and TEchnology) concerned maternal death reviews in hospitals in West Africa, which had very high maternal and perinatal mortality rates. In contrast, the OPERA trial studied perinatal morbidity/mortality conferences (MMCs) in maternity units in France, which already had very low perinatal mortality rates at baseline. The OPERA intervention in France started with an outreach visit to brief obstetricians, midwives and anaesthetists on the national guidelines on morbidity/mortality case management, and was followed by a series of perinatal MMCs. Half of the intervention units were randomised to receive additional support from a clinical psychologist during these meetings. The OPERA intervention may make little or no difference to overall perinatal mortality (low certainty evidence), however we are uncertain about the effect of the intervention on perinatal mortality related to suboptimal care (very low certainty evidence).The intervention probably reduces perinatal morbidity related to suboptimal care (unadjusted odds ratio (OR) 0.62, 95% confidence interval (CI) 0.40 to 0.95; 165,353 births; moderate-certainty evidence). The effect of the intervention on stillbirth rate, neonatal mortality, mortality rate in children under five years of age, maternal mortality or adverse effects was not reported. The QUARITE intervention in West Africa focused on training leaders of hospital obstetric teams using the ALARM (Advances in Labour And Risk Management) course, which included one day of training about conducting maternal death reviews. The leaders returned to their hospitals, established a multidisciplinary committee and started auditing maternal deaths, with the support of external facilitators. The intervention probably reduces inpatient maternal deaths (adjusted OR 0.85, 95% CI 0.73 to 0.98; 191,167 deliveries; moderate certainty evidence) and probably also reduces inpatient neonatal mortality within 24 hours following birth (adjusted OR 0.74, 95% CI 0.61 to 0.90; moderate certainty evidence). However, QUARITE probably makes little or no difference to the inpatient stillbirth rate (moderate certainty evidence) and may make little or no difference to the inpatient neonatal mortality rate after 24 hours, although the 95% confidence interval includes both benefit and harm (low certainty evidence). The QUARITE intervention probably increases the percent of women receiving high quality of care (OR 1.87, 95% CI 1.35 - 2.57, moderate-certainty evidence). The effect of the intervention on perinatal mortality, mortality rate in children under five years of age, or adverse effects was not reported. We did not find any studies that evaluated child death audit and review or community-based death reviews or costs. Authors' conclusions: A complex intervention including maternal death audit and review, as well as development of local leadership and training, probably reduces inpatient maternal mortality in low-income country district hospitals, and probably slightly improves quality of care. Perinatal death audit and review, as part of a complex intervention with training, probably improves quality of care, as measured by perinatal morbidity related to suboptimal care, in a high-income setting where mortality was already very low. The WHO recommends that maternal and perinatal death reviews should be conducted in all hospitals globally. However, conducting death reviews in isolation may not be sufficient to achieve the reductions in mortality observed in the QUARITE trial. This review suggests that maternal death audit and review may need to be implemented as part of an intervention package which also includes elements such as training of a leading doctor and midwife in each hospital, annual recertification, and quarterly outreach visits by external facilitators to provide supervision and mentorship. The same may also apply to perinatal and child death reviews. More operational research is needed on the most cost-effective ways of implementing maternal, perinatal and paediatric death reviews in low- and middle-income countries.

The Cochrane database of systematic reviews · meta-analysis · 65 citationsread the source →

Adverse events associated with medium- and long-term use of opioids for chronic non-cancer pain: an overview of Cochrane Reviews.

Background: Chronic pain is common and can be challenging to manage. Despite increased utilisation of opioids, the safety and efficacy of long-term use of these compounds for chronic non-cancer pain (CNCP) remains controversial. This overview of Cochrane Reviews complements the overview entitled 'High-dose opioids for chronic non-cancer pain: an overview of Cochrane Reviews'. Objectives: To provide an overview of the occurrence and nature of adverse events associated with any opioid agent (any dose, frequency, or route of administration) used on a medium- or long-term basis for the treatment of CNCP in adults. Methods: We searched the Cochrane Database of Systematic Reviews (the Cochrane Library) Issue 3, 2017 on 8 March 2017 to identify all Cochrane Reviews of studies of medium- or long-term opioid use (2 weeks or more) for CNCP in adults aged 18 and over. We assessed the quality of the reviews using the AMSTAR criteria (Assessing the Methodological Quality of Systematic Reviews) as adapted for Cochrane Overviews. We assessed the quality of the evidence for the outcomes using the GRADE framework. Main results: We included a total of 16 reviews in our overview, of which 14 presented unique quantitative data. These 14 Cochrane Reviews investigated 14 different opioid agents that were administered for time periods of two weeks or longer. The longest study was 13 months in duration, with most in the 6- to 16-week range. The quality of the included reviews was high using AMSTAR criteria, with 11 reviews meeting all 10 criteria, and 5 of the reviews meeting 9 out of 10, not scoring a point for either duplicate study selection and data extraction, or searching for articles irrespective of language and publication type. The quality of the evidence for the generic adverse event outcomes according to GRADE ranged from very low to moderate, with risk of bias and imprecision being identified for the following generic adverse event outcomes: any adverse event, any serious adverse event, and withdrawals due to adverse events. A GRADE assessment of the quality of the evidence for specific adverse events led to a downgrading to very low- to moderate-quality evidence due to risk of bias, indirectness, and imprecision. We calculated the equivalent milligrams of morphine per 24 hours for each opioid studied (buprenorphine, codeine, dextropropoxyphene, dihydrocodeine, fentanyl, hydromorphone, levorphanol, methadone, morphine, oxycodone, oxymorphone, tapentadol, tilidine, and tramadol). In the 14 Cochrane Reviews providing unique quantitative data, there were 61 studies with a total of 18,679 randomised participants; 12 of these studies had a cross-over design with two to four arms and a total of 796 participants. Based on the 14 selected Cochrane Reviews, there was a significantly increased risk of experiencing any adverse event with opioids compared to placebo (risk ratio (RR) 1.42, 95% confidence interval (CI) 1.22 to 1.66) as well as with opioids compared to a non-opioid active pharmacological comparator, with a similar risk ratio (RR 1.21, 95% CI 1.10 to 1.33). There was also a significantly increased risk of experiencing a serious adverse event with opioids compared to placebo (RR 2.75, 95% CI 2.06 to 3.67). Furthermore, we found significantly increased risk ratios with opioids compared to placebo for a number of specific adverse events: constipation, dizziness, drowsiness, fatigue, hot flushes, increased sweating, nausea, pruritus, and vomiting. There was no data on any of the following prespecified adverse events of interest in any of the included reviews in this overview of Cochrane Reviews: addiction, cognitive dysfunction, depressive symptoms or mood disturbances, hypogonadism or other endocrine dysfunction, respiratory depression, sexual dysfunction, and sleep apnoea or sleep-disordered breathing. We found no data for adverse events analysed by sex or ethnicity. Authors' conclusions: A number of adverse events, including serious adverse events, are associated with the medium- and long-term use of opioids for CNCP. The absolute event rate for any adverse event with opioids in trials using a placebo as comparison was 78%, with an absolute event rate of 7.5% for any serious adverse event. Based on the adverse events identified, clinically relevant benefit would need to be clearly demonstrated before long-term use could be considered in people with CNCP in clinical practice. A number of adverse events that we would have expected to occur with opioid use were not reported in the included Cochrane Reviews. Going forward, we recommend more rigorous identification and reporting of all adverse events in randomised controlled trials and systematic reviews on opioid therapy. The absence of data for many adverse events represents a serious limitation of the evidence on opioids. We also recommend extending study follow-up, as a latency of onset may exist for some adverse events.

The Cochrane database of systematic reviews · meta-analysis · 188 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 →

Psychosocial interventions following self-harm in adults: a systematic review and meta-analysis.

Background: Self-harm (intentional acts of non-fatal self-poisoning or self-injury) is common, particularly in young adults aged 15-35 years, often repeated, and strongly associated with suicide. Effective aftercare of individuals who self-harm is therefore important. We have undertaken a Cochrane systematic review and meta-analysis of the effectiveness of psychosocial interventions for self-harm in adults. Methods: We searched five electronic databases (CCDANCTR-Studies and References, CENTRAL, MEDLINE, Embase, and PsycINFO) between Jan 1, 1998, and April 29, 2015, for randomised controlled trials of psychosocial interventions for adults after a recent (within 6 months) episode of self-harm. Most interventions were assessed in single trials. We report results for interventions for which at least three randomised controlled trials comparing interventions with treatment as usual have been published and hence might contribute to clinical guidance. The primary outcome was repetition of self-harm at the conclusion of treatment and at 6, 12, and 24 months' follow-up analysed, when available, with the intention-to-treat method; if this was not possible, we analysed with all available case data. Findings: We identified 29 non-overlapping randomised controlled trials with three independent trials of the same intervention. Cognitive-behavioural-based psychotherapy (CBT; comprising cognitive-behavioural and problem-solving therapy) was associated with fewer participants repeating self-harm at 6 months' (odds ratio 0·54, 95% CI 0·34-0·85; 12 trials; n=1317) and at 12 months' follow-up (0·80, 0·65-0·98; ten trials; n=2232). There were also significant improvements in the secondary outcomes of depression, hopelessness, suicidal ideation, and problem solving. Patients receiving dialectical behaviour therapy (in three trials) were not less likely to repeat self-harm compared with those provided with treatment as usual at 6 months (odds ratio [OR] 0·59, 95% CI 0·16-2·15; n=267, three trials) or at 12 months (0·36, 0·05-2·47; n=172, two trials). However, the secondary endpoint of frequency of self-harm was associated with a significant reduction with use of dialectical behaviour therapy (mean difference -18·82, 95% CI -36·68 to -0·95). Four trials each of case management (OR 0·78, 95% CI 0·47-1·30; n=1608) and sending regular postcards (OR 0·87, 95% CI 0·62-1·23; n=3277) did not reduce repetition of self-harm. Interpretation: CBT seems to be effective in patients after self-harm. Dialectical behaviour therapy did not reduce the proportion of patients repeating self-harm but did reduce the frequency of self-harm. However, aside from CBT, there were few trials of other promising interventions, precluding firm conclusions as to their effectiveness. Funding: National Institute for Health Research.

The lancet. Psychiatry · meta-analysis · 141 citationsread the source →

Effect of psychological therapy on disease activity, psychological comorbidity, and quality of life in inflammatory bowel disease: a systematic review and meta-analysis.

Background: Inflammatory bowel disease is associated with psychological comorbidity and impaired quality of life. Psychological comorbidity could affect the natural history of inflammatory bowel disease. Psychological therapies might therefore have beneficial effects on disease activity, mood, and quality of life in patients with inflammatory bowel disease. We did a systematic review and meta-analysis examining these issues. Methods: In this systematic review and meta-analysis, we searched MEDLINE, Embase, Embase Classic, PsychINFO, and the Cochrane Central Register of Controlled Trials for articles published between 1947 and Sept 22, 2016. Randomised controlled trials (RCTs) recruiting patients with inflammatory bowel disease aged at least 16 years that compared psychological therapy with a control intervention or usual treatment were eligible. We pooled dichotomous data to obtain relative risks of induction of remission in active disease or prevention of relapse of quiescent disease, with 95% CIs. We pooled continuous data to estimate standardised mean differences in disease activity indices, anxiety, depression, perceived stress, and quality-of-life scores in patients dichotomised into those with clinically active or quiescent disease, with 95% CIs. We extracted data from published reports and contacted the original investigators of studies for which the required data were not available. We pooled all data using a random-effects model. Findings: The search identified 1824 studies, with 14 RCTs of 1196 patients eligible for inclusion. The relative risk of relapse of quiescent inflammatory bowel disease with psychological therapy versus control was 0·98 (95% CI 0·77-1·24; p=0·87; I2=50%; six trials; 518 patients). We observed a significant difference in depression scores (standardised mean difference -0·17 [-0·33 to -0·01]; p=0·04; I2=0%; seven trials; 605 patients) and quality of life (0·30 [0·07-0·52]; p=0·01; I2=42%; nine trials; 578 patients) with psychological therapy versus control at the end of therapy for patients with quiescent disease. However, these beneficial effects were lost at final point of follow-up (depression scores -0·11 [-0·27 to 0·05], p=0·17, I2=0%, eight trials, 593 patients; quality of life 0·15 [-0·05 to 0·34], p=0·14, I2=22%, ten trials, 577 patients). When we assessed the effect of individual physiological therapies on quality of life, only cognitive behavioural therapy had any significant beneficial effect (0·37 [0·02-0·72]). We noted no effect on disease activity indices or other psychological wellbeing scores when compared with control in patients with quiescent disease. Dichotomous data for induction of remission and continuous data for change in clinical disease activity indices, depression, anxiety, and perceived stress scores were only reported in one RCT of patients with active disease. Quality of life was assessed in two RCTs of patients with active disease, but was not significantly different between intervention and control groups (0·27 [-0·05 to 0·59]). Interpretation: Psychological therapies, and cognitive behavioural therapy in particular, might have small short-term beneficial effects on depression scores and quality of life in patients with inflammatory bowel disease. Further RCTs of these interventions in patients with coexistent psychological distress are required. Funding: None.

The lancet. Gastroenterology & hepatology · meta-analysis · 163 citationsread the source →