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Suicide after leaving the UK armed forces--a cohort study.

Background: Few studies have examined suicide risk in individuals once they have left the military. We aimed to investigate the rate, timing, and risk factors for suicide in all those who had left the UK Armed Forces (1996-2005). Methods and findings: We carried out a cohort study of ex-Armed Forces personnel by linking national databases of discharged personnel and suicide deaths (which included deaths receiving either a suicide or undetermined verdict). Comparisons were made with both general and serving populations. During the study period 233,803 individuals left the Armed Forces and 224 died by suicide. Although the overall rate of suicide was not greater than that in the general population, the risk of suicide in men aged 24 y and younger who had left the Armed Forces was approximately two to three times higher than the risk for the same age groups in the general and serving populations (age-specific rate ratios ranging from 170 to 290). The risk of suicide for men aged 30-49 y was lower than that in the general population. The risk was persistent but may have been at its highest in the first 2 y following discharge. The risk of suicide was greatest in males, those who had served in the Army, those with a short length of service, and those of lower rank. The rate of contact with specialist mental health was lowest in the age groups at greatest risk of suicide (14% for those aged under 20 y, 20% for those aged 20-24 y). Conclusions: Young men who leave the UK Armed Forces were at increased risk of suicide. This may reflect preservice vulnerabilities rather than factors related to service experiences or discharge. Preventive strategies might include practical and psychological preparation for discharge and encouraging appropriate help-seeking behaviour once individuals have left the services.

PLoS medicine · cohort or longitudinal · 63 citationsread the source →

Psychological therapies for women who experience intimate partner violence.

Background: Intimate partner violence (IPV) against women is prevalent and strongly associated with mental health problems. Women experiencing IPV attend health services frequently for mental health problems. The World Health Organization recommends that women who have experienced IPV and have a mental health diagnosis should receive evidence-based mental health treatments. However, it is not known if psychological therapies work for women in the context of IPV and whether they cause harm. Objectives: To assess the effectiveness of psychological therapies for women who experience IPV on the primary outcomes of depression, self-efficacy and an indicator of harm (dropouts) at six- to 12-months' follow-up, and on secondary outcomes of other mental health symptoms, anxiety, quality of life, re-exposure to IPV, safety planning and behaviours, use of healthcare and IPV services, and social support. Search methods: We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR), CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, and three other databases, to the end of October 2019. We also searched international trials registries to identify unpublished or ongoing trials and handsearched selected journals, reference lists of included trials and grey literature. Selection criteria: We included randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs and cross-over trials of psychological therapies with women aged 16 years and older who self-reported recent or lifetime experience of IPV. We included trials if women also experienced co-existing mental health diagnoses or substance abuse issues, or both. Psychological therapies included a wide range of interventions that targeted cognition, motivation and behaviour compared with usual care, no treatment, delayed or minimal interventions. We classified psychological therapies according to Cochrane Common Mental Disorders's psychological therapies list. Data collection and analysis: Two review authors extracted data and undertook 'Risk of Bias' assessment. Treatment effects were compared between experimental and comparator interventions at short-term (up to six months post-baseline), medium-term (six to under 12 months, primary outcome time point), and long-term follow-up (12 months and above). We used standardised mean difference (SMD) for continuous and odds ratio (OR) for dichotomous outcomes, and used random-effects meta-analysis, due to high heterogeneity across trials. Main results: We included 33 psychological trials involving 5517 women randomly assigned to experimental (2798 women, 51%) and comparator interventions (2719 women, 49%). Psychological therapies included 11 integrative therapies, nine humanistic therapies, six cognitive behavioural therapy, four third-wave cognitive behavioural therapies and three other psychologically-orientated interventions. There were no trials classified as psychodynamic therapies. Most trials were from high-income countries (19 in USA, three in Iran, two each in Australia and Greece, and one trial each in China, India, Kenya, Nigeria, Pakistan, Spain and UK), among women recruited from healthcare, community, shelter or refuge settings, or a combination of any or all of these. Psychological therapies were mostly delivered face-to-face (28 trials), but varied by length of treatment (two to 50 sessions) and staff delivering therapies (social workers, nurses, psychologists, community health workers, family doctors, researchers). The average sample size was 82 women (14 to 479), aged 37 years on average, and 66% were unemployed. Half of the women were married or living with a partner and just over half of the participants had experienced IPV in the last 12 months (17 trials), 6% in the past two years (two trials) and 42% during their lifetime (14 trials). Whilst 20 trials (61%) described reliable low-risk random-sampling strategies, only 12 trials (36%) described reliable procedures to conceal the allocation of participant status. While 19 trials measured women's depression, only four trials measured depression as a continuous outcome at medium-term follow-up. These showed a probable beneficial effect of psychological therapies in reducing depression (SMD -0.24, 95% CI -0.47 to -0.01; four trials, 600 women; moderate-certainty evidence). However, for self-efficacy, there may be no evidence of a difference between groups (SMD -0.12, 95% CI -0.33 to 0.09; one trial with medium-term follow-up data, 346 women; low-certainty evidence). Further, there may be no difference between the number of women who dropped out from the experimental or comparator intervention groups, an indicator of no harm (OR 1.04, 95% CI 0.75 to 1.44; five trials with medium-term follow-up data, 840 women; low-certainty evidence). Although no trials reported adverse events from psychological therapies or participation in the trial, only one trial measured harm outcomes using a validated scale. For secondary outcomes, trials measured anxiety only at short-term follow-up, showing that psychological therapies may reduce anxiety symptoms (SMD -0.96, 95% CI -1.29 to -0.63; four trials, 158 women; low-certainty evidence). However, within medium-term follow-up, low-certainty evidence revealed that there may be no evidence between groups for the outcomes safety planning (SMD 0.04, 95% CI -0.18 to 0.25; one trial, 337 women), post-traumatic stress disorder (SMD -0.24, 95% CI -0.54 to 0.06; four trials, 484 women) or re-exposure to any form of IPV (SMD 0.03, 95% CI -0.14 to 0.2; two trials, 547 women). Authors' conclusions: There is evidence that for women who experience IPV, psychological therapies probably reduce depression and may reduce anxiety. However, we are uncertain whether psychological therapies improve other outcomes (self-efficacy, post-traumatic stress disorder, re-exposure to IPV, safety planning) and there are limited data on harm. Thus, while psychological therapies probably improve emotional health, it is unclear if women's ongoing needs for safety, support and holistic healing from complex trauma are addressed by this approach. There is a need for more interventions focused on trauma approaches and more rigorous trials (with consistent outcomes at similar follow-up time points), as we were unable to synthesise much of the research.

The Cochrane database of systematic reviews · meta-analysis · 78 citationsread the source →

Age at onset of mental disorders worldwide: large-scale meta-analysis of 192 epidemiological studies.

Promotion of good mental health, prevention, and early intervention before/at the onset of mental disorders improve outcomes. However, the range and peak ages at onset for mental disorders are not fully established. To provide robust, global epidemiological estimates of age at onset for mental disorders, we conducted a PRISMA/MOOSE-compliant systematic review with meta-analysis of birth cohort/cross-sectional/cohort studies, representative of the general population, reporting age at onset for any ICD/DSM-mental disorders, identified in PubMed/Web of Science (up to 16/05/2020) (PROSPERO:CRD42019143015). Co-primary outcomes were the proportion of individuals with onset of mental disorders before age 14, 18, 25, and peak age at onset, for any mental disorder and across International Classification of Diseases 11 diagnostic blocks. Median age at onset of specific disorders was additionally investigated. Across 192 studies (n = 708,561) included, the proportion of individuals with onset of any mental disorders before the ages of 14, 18, 25 were 34.6%, 48.4%, 62.5%, and peak age was 14.5 years (k = 14, median = 18, interquartile range (IQR) = 11-34). For diagnostic blocks, the proportion of individuals with onset of disorder before the age of 14, 18, 25 and peak age were as follows: neurodevelopmental disorders: 61.5%, 83.2%, 95.8%, 5.5 years (k = 21, median=12, IQR = 7-16), anxiety/fear-related disorders: 38.1%, 51.8%, 73.3%, 5.5 years (k = 73, median = 17, IQR = 9-25), obsessive-compulsive/related disorders: 24.6%, 45.1%, 64.0%, 14.5 years (k = 20, median = 19, IQR = 14-29), feeding/eating disorders/problems: 15.8%, 48.1%, 82.4%, 15.5 years (k = 11, median = 18, IQR = 15-23), conditions specifically associated with stress disorders: 16.9%, 27.6%, 43.1%, 15.5 years (k = 16, median = 30, IQR = 17-48), substance use disorders/addictive behaviours: 2.9%, 15.2%, 48.8%, 19.5 years (k = 58, median = 25, IQR = 20-41), schizophrenia-spectrum disorders/primary psychotic states: 3%, 12.3%, 47.8%, 20.5 years (k = 36, median = 25, IQR = 20-34), personality disorders/related traits: 1.9%, 9.6%, 47.7%, 20.5 years (k = 6, median = 25, IQR = 20-33), and mood disorders: 2.5%, 11.5%, 34.5%, 20.5 years (k = 79, median = 31, IQR = 21-46). No significant difference emerged by sex, or definition of age of onset. Median age at onset for specific mental disorders mapped on a time continuum, from phobias/separation anxiety/autism spectrum disorder/attention deficit hyperactivity disorder/social anxiety (8-13 years) to anorexia nervosa/bulimia nervosa/obsessive-compulsive/binge eating/cannabis use disorders (17-22 years), followed by schizophrenia, personality, panic and alcohol use disorders (25-27 years), and finally post-traumatic/depressive/generalized anxiety/bipolar/acute and transient psychotic disorders (30-35 years), with overlap among groups and no significant clustering. These results inform the timing of good mental health promotion/preventive/early intervention, updating the current mental health system structured around a child/adult service schism at age 18.

Molecular psychiatry · meta-analysis · 2420 citationsread the source →

Educational interventions to train healthcare professionals in end-of-life communication: a systematic review and meta-analysis.

Background: Practicing healthcare professionals and graduates exiting training programs are often ill-equipped to facilitate important discussions about end-of-life care with patients and their families. We conducted a systematic review to evaluate the effectiveness of educational interventions aimed at providing healthcare professionals with training in end-of-life communication skills, compared to usual curriculum. Methods: We searched MEDLINE, Embase, CINAHL, ERIC and the Cochrane Central Register of Controlled Trials from the date of inception to July 2014 for randomized control trials (RCT) and prospective observational studies of educational training interventions to train healthcare professionals in end-of-life communication skills. To be eligible, interventions had to provide communication skills training related to end-of-life decision making; other interventions (e.g. breaking bad news, providing palliation) were excluded. Our primary outcomes were self-efficacy, knowledge and end-of-life communication scores with standardized patient encounters. Sufficiently similar studies were pooled in a meta-analysis. The quality of evidence was assessed using GRADE. Results: Of 5727 candidate articles, 20 studies (6 RCTs, 14 Observational) were included in this review. Compared to usual teaching, educational interventions to train healthcare professionals in end-of-life communication skills were associated with greater self-efficacy (8 studies, standardized mean difference [SMD] 0.57;95% confidence interval [CI] 0.40-0.75; P < 0.001; very low quality evidence), more knowledge (4 studies, SMD 0.76;95% CI 0.40-1.12; p < 0.001; low quality evidence), and improvements in communication scores (8 studies, SMD 0.69; 95% CI 0.41-0.96; p < 0.001; very low quality evidence). There was insufficient evidence to determine whether these educational interventions affect patient-level outcomes. Conclusion: Very low to low quality evidence suggests that end-of-life communication training may improve healthcare professionals' self-efficacy, knowledge, and EoL communication scores compared to usual teaching. Further studies comparing two active educational interventions are recommended with a continued focus on contextually relevant high-level outcomes. Trial registration: PROSPERO CRD42014012913.

BMC medical education · meta-analysis · 103 citationsread the source →

Comparative efficacy and acceptability of antidepressants, psychotherapies, and their combination for acute treatment of children and adolescents with depressive disorder: a systematic review and network meta-analysis.

Background: Depressive disorders are common in children and adolescents. Antidepressants, psychotherapies, and their combination are often used in routine clinical practice; however, available evidence on the comparative efficacy and safety of these interventions is inconclusive. Therefore, we sought to compare and rank all available treatment interventions for the acute treatment of depressive disorders in children and adolescents. Methods: We did a systematic review and network meta-analysis. We searched PubMed, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, PsycINFO, ProQuest, CINAHL, LiLACS, international trial registries, and the websites of regulatory agencies for published and unpublished randomised controlled trials from database inception until Jan 1, 2019. We included placebo-controlled and head-to-head trials of 16 antidepressants, seven psychotherapies, and five combinations of antidepressant and psychotherapy that are used for the acute treatment of children and adolescents (≤18 years old and of both sexes) with depressive disorder diagnosed according to standard operationalised criteria. Trials recruiting participants with treatment-resistant depression, bipolar disorder, psychotic depression, treatment duration of less than 4 weeks, or an overall sample size of fewer than ten patients were excluded. We extracted data following a predefined hierarchy of outcome measures, and assessed risk of bias and certainty of evidence using validated methods. Primary outcomes were efficacy (change in depressive symptoms) and acceptability (treatment discontinuation due to any cause). We estimated summary standardised mean differences (SMDs) or odds ratios (ORs) with credible intervals (CrIs) using network meta-analysis with random effects. This study was registered with PROSPERO, number CRD42015020841. Findings: From 20 366 publications, we included 71 trials (9510 participants). Depressive disorders in most studies were moderate to severe. In terms of efficacy, fluoxetine plus cognitive behavioural therapy (CBT) was more effective than CBT alone (-0·78, 95% CrI -1·55 to -0·01) and psychodynamic therapy (-1·14, -2·20 to -0·08), but not more effective than fluoxetine alone (-0·22, -0·86 to 0·42). No pharmacotherapy alone was more effective than psychotherapy alone. Only fluoxetine plus CBT and fluoxetine were significantly more effective than pill placebo or psychological controls (SMDs ranged from -1·73 to -0·51); and only interpersonal therapy was more effective than all psychological controls (-1·37 to -0·66). Nortriptyline (SMDs ranged from 1·04 to 2·22) and waiting list (SMDs ranged from 0·67 to 2·08) were less effective than most active interventions. In terms of acceptability, nefazodone and fluoxetine were associated with fewer dropouts than sertraline, imipramine, and desipramine (ORs ranged from 0·17 to 0·50); imipramine was associated with more dropouts than pill placebo, desvenlafaxine, fluoxetine plus CBT, and vilazodone (2·51 to 5·06). Most of the results were rated as "low" to "very low" in terms of confidence of evidence according to Confidence In Network Meta-Analysis. Interpretation: Despite the scarcity of high-quality evidence, fluoxetine (alone or in combination with CBT) seems to be the best choice for the acute treatment of moderate-to-severe depressive disorder in children and adolescents. However, the effects of these interventions might vary between individuals, so patients, carers, and clinicians should carefully balance the risk-benefit profile of efficacy, acceptability, and suicide risk of all active interventions in young patients with depression on a case-by-case basis. Funding: National Key Research and Development Program of China.

The lancet. Psychiatry · systematic review · 248 citationsread the source →

A systematic review of the health-related quality of life and economic burdens of anorexia nervosa, bulimia nervosa, and binge eating disorder.

Purpose: To perform a systematic review of the health-related quality of life (HRQoL) and economic burdens of anorexia nervosa (AN), bulimia nervosa (BN), and binge eating disorder (BED). Methods: A systematic literature search of English-language studies was performed in Medline, Embase, PsycINFO, PsycARTICLES, Academic Search Complete, CINAHL Plus, Business Source Premier, and Cochrane Library. Cost data were converted to 2014 Euro. Results: Sixty-nine studies were included. Data on HRQoL were reported in 41 studies (18 for AN, 17 for BN, and 18 for BED), on healthcare utilization in 20 studies (14 for AN, 12 for BN, and 8 for BED), and on healthcare costs in 17 studies (9 for AN, 11 for BN, and only 2 for BED). Patients' HRQoL was significantly worse with AN, BN, and BED compared with healthy populations. AN, BN, and BED were associated with a high rate of hospitalization, outpatient care, and emergency department visits. However, patients rarely received specific treatment for their eating disorder. The annual healthcare costs for AN, BN, and BED were €2993 to €55,270, €888 to €18,823, and €1762 to €2902, respectively. Conclusions: AN, BN, and BED have a serious impact on patient's HRQoL and are also associated with increased healthcare utilization and healthcare costs. The burden of BED should be examined separately from that of BN. The limited evidence suggests that further research is warranted to better understand the differences in long-term HRQoL and economic burdens of AN, BN, and BED.

Eating and weight disorders : EWD · systematic review · 235 citationsread the source →

Parenting, mental health and economic pathways to prevention of violence against children in South Africa.

Background: Parenting programs based on social learning theory have increasing empirical evidence for reducing violence against children. Trials are primarily from high-income countries and with young children. Globally, we know little about how parenting programs work to reduce violence, with no known studies in low or middle-income countries (LMICs). This study examines mechanisms of change of a non-commercialized parenting program, Parenting for Lifelong Health for Teens, designed with the World Health Organization and UNICEF. A cluster randomized trial showed main effects on parenting and other secondary outcomes. We conducted secondary analysis of trial data to investigate five potential mediators of reduced violence against children: improved parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening. Methods: The trial was implemented in rural South Africa with 40 sites, n = 552 family dyads (including adolescents aged 10-18 and primary caregivers). Intervention sites (n = 20) received the 14-session parenting program delivered by local community members, including modules on family budgeting and savings. Control sites (n = 20) received a brief informational workshop. Emotional and physical violence against children/adolescents and each potential mediator were reported by adolescents and caregivers at baseline and 9-13 months post-randomisation. Structural equation modelling was used to test simultaneous hypothesized pathways to violence reduction. Results: Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare. Improved child behaviour was not a mediator, although it was associated with less violence. Conclusions: Simultaneously bolstering a set of family processes can reduce violence. Supporting self-care and positive coping for caregivers may be essential in challenging contexts. In countries with minimal or no economic safety nets, linking social learning parenting programs with economic strengthening skills may bring us closer to ending violence against children.

Social science & medicine (1982) · randomised controlled trial · 29 citationsread the source →

A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation.

Purpose: This study investigates the performance of a cardiac-based seizure detection algorithm (CBSDA) that automatically triggers VNS (NCT01325623). Methods: Thirty-one patients with drug resistant epilepsy were evaluated in an epilepsy monitoring unit (EMU) to assess algorithm performance and near-term clinical benefit. Long-term efficacy and safety were evaluated with combined open and closed-loop VNS. Results: Sixty-six seizures (n=16 patients) were available from the EMU for analysis. In 37 seizures (n=14 patients) a ≥ 20% heart rate increase was found and 11 (n=5 patients) were associated with ictal tachycardia (iTC, 55% or 35 bpm heart rate increase, minimum of 100 bpm). Multiple CBSDA settings achieved a sensitivity of ≥ 80%. False positives ranged from 0.5 to 7.2/h. 27/66 seizures were stimulated within ± 2 min of seizure onset. In 10/17 of these seizures, where triggered VNS overlapped with ongoing seizure activity, seizure activity stopped during stimulation. Physician-scored seizure severity (NHS3-scale) showed significant improvement for complex partial seizures (CPS) at EMU discharge and through 12 months (p<0.05). Patient-scored seizure severity (total SSQ score) showed significant improvement at 3 and 6 months. Quality of life (total QOLIE-31-P score) showed significant improvement at 12 months. The responder rate (≥ 50% reduction in seizure frequency) at 12 months was 29.6% (n=8/27). Safety profiles were comparable to prior VNS trials. Conclusions: The investigated CBSDA has a high sensitivity and an acceptable specificity for triggering VNS. Despite the moderate effects on seizure frequency, combined open- and closed-loop VNS may provide valuable improvements in seizure severity and QOL in refractory epilepsy patients.

Seizure · randomised controlled trial · 147 citationsread the source →

Exploring compassion: a meta-analysis of the association between self-compassion and psychopathology.

Compassion has emerged as an important construct in studies of mental health and psychological therapy. Although an increasing number of studies have explored relationships between compassion and different facets of psychopathology there has as yet been no systematic review or synthesis of the empirical literature. We conducted a systematic search of the literature on compassion and mental health. We identified 20 samples from 14 eligible studies. All studies used the Neff Self Compassion Scale (Neff, 2003b). We employed meta-analysis to explore associations between self-compassion and psychopathology using random effects analyses of Fisher's Z correcting for attenuation arising from scale reliability. We found a large effect size for the relationship between compassion and psychopathology of r=-0.54 (95% CI=-0.57 to -0.51; Z=-34.02; p<.0001). Heterogeneity was significant in the analysis. There was no evidence of significant publication bias. Compassion is an important explanatory variable in understanding mental health and resilience. Future work is needed to develop the evidence base for compassion in psychopathology, and explore correlates of compassion and psychopathology.

Clinical psychology review · meta-analysis · 641 citationsread the source →

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

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

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

The safety and efficacy of baclofen to reduce alcohol use in veterans with chronic hepatitis C: a randomized controlled trial.

Background and aims: Alcohol use disorders (AUDs) are common among people with chronic hepatitis C (HCV) and accelerate the development of fibrosis and cirrhosis caused by HCV. Baclofen, a gamma-aminobutyric acid (GABA) beta-receptor agonist, differs from medications for AUDs currently approved by the United States Food and Drug Administration (FDA), as it is metabolized primarily through the kidneys. The primary outcome of this study was to compare baclofen with a placebo in the percentage of days abstinent from alcohol. Design: A double-blind, placebo-controlled randomized trial. Setting: Hepatology clinics in four separate US Veteran Affairs Medical Centers in the United States. Participants: One hundred and eighty Veteran men and women older than 18 years with chronic HCV, a comorbid AUD and current alcohol use. Intervention and comparator: Oral baclofen was given at dosages of 0 (placebo) or 30 mg/day over 12 weeks with concomitant manual-guided counseling. Measurements: The primary measurement was percentage of days abstinent during the 12-week study period between the baclofen and placebo groups [measured by time-line follow-back (TLFB)]. Secondary measurements were the percentage of Veterans who achieved complete abstinence, the percentage of Veterans who achieved no heavy drinking between weeks 4 and 12 of the study, alcohol craving, anxiety, depression and post-traumatic stress disorder (PTSD). Findings: Primary outcome: compared with placebo, baclofen did not improve the percentage of days abstinent. For all subjects there were significant reductions from baseline to 12 weeks in percentage of days abstinent from 37.0% [standard error (SE) = 2.7] to 68.6% (SE = 2.8, F(1151.1)  = 66.1, P < 0.001). However, there was no statistically significant difference between groups for change in percentage of days abstinent over the 12-week study period [absolute difference 1.3% (-9.1 to 1.7%), F(1152.6)  = 0.005, P = 0.95]. Secondary outcomes: Of subjects who completed the first 4 weeks of the study, 8.9% (15 of 168) achieved complete abstinence; 10.1% (nine of 89) in the placebo group and 7.6% (six of 79) in the baclofen group [χ2(1)  = 0.33, odds ratio (OR) = 0.73 (0.24-2.15)]. The percentage of no heavy drinking for all subjects between weeks 4 and 12 was 20.2% (34 of 168), but no statistically significant differences were found between placebo 15.7% (14 of 89) and baclofen 25.3% (20 of 79) [χ2(1)  = 2.38, OR = 1.82 (0.85-3.90)]. There were significant reductions for all subjects in all other secondary variables over the course of the study, but no differences between groups. Measures of various biomarkers of alcohol use did not change significantly throughout the course of the study for either the baclofen or placebo groups. Conclusions: Baclofen administered at 30 mg/day does not appear to be superior to placebo in increasing abstinence or in reducing alcohol use, cravings for alcohol or anxiety among people with alcohol use disorder.

Addiction (Abingdon, England) · randomised controlled trial · 58 citationsread the source →

Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial.

Background: Obesity is associated with a reduction in life expectancy and an increase in mortality from cardiovascular diseases, cancer, and other causes. We therefore assessed the efficacy and safety of two doses of phentermine plus topiramate controlled-release combination as an adjunct to diet and lifestyle modification for weight loss and metabolic risk reduction in individuals who were overweight and obese, with two or more risk factors. Methods: In this 56-week phase 3 trial, we randomly assigned overweight or obese adults (aged 18-70 years), with a body-mass index of 27-45 kg/m(2) and two or more comorbidities (hypertension, dyslipidaemia, diabetes or prediabetes, or abdominal obesity) to placebo, once-daily phentermine 7·5 mg plus topiramate 46·0 mg, or once-daily phentermine 15·0 mg plus topiramate 92·0 mg in a 2:1:2 ratio in 93 centres in the USA. Drugs were administered orally. Patients were randomly assigned by use of a computer-generated algorithm that was implemented through an interactive voice response system, and were stratified by sex and diabetic status. Investigators, patients, and study sponsors were masked to treatment. Primary endpoints were the percentage change in bodyweight and the proportion of patients achieving at least 5% weight loss. Analysis was by intention to treat. This study is registered with Clinical Trials.gov, number NCT00553787. Findings: Of 2487 patients, 994 were assigned to placebo, 498 to phentermine 7·5 mg plus topiramate 46·0 mg, and 995 to phentermine 15·0 mg plus topiramate 92·0 mg; 979, 488, and 981 patients, respectively, were analysed. At 56 weeks, change in bodyweight was -1·4 kg (least-squares mean -1·2%, 95% CI -1·8 to -0·7), -8·1 kg (-7·8%, -8·5 to -7·1; p<0·0001), and -10·2 kg (-9·8%, -10·4 to -9·3; p<0·0001) in the patients assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively. 204 (21%) patients achieved at least 5% weight loss with placebo, 303 (62%; odds ratio 6·3, 95% CI 4·9 to 8·0; p<0·0001) with phentermine 7·5 mg plus topiramate 46·0 mg, and 687 (70%; 9·0, 7·3 to 11·1; p<0·0001) with phentermine 15·0 mg plus topiramate 92·0 mg; for ≥10% weight loss, the corresponding numbers were 72 (7%), 182 (37%; 7·6, 5·6 to 10·2; p<0·0001), and 467 (48%; 11·7, 8·9 to 15·4; p<0·0001). The most common adverse events were dry mouth (24 [2%], 67 [13%], and 207 [21%] in the groups assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively), paraesthesia (20 [2%], 68 [14%], and 204 [21%], respectively), constipation (59 [6%], 75 [15%], and 173 [17%], respectively), insomnia (47 [5%], 29 [6%], and 102 [10%], respectively), dizziness (31 [3%], 36 [7%], 99 [10%], respectively), and dysgeusia (11 [1%], 37 [7%], and 103 [10%], respectively). 38 (4%) patients assigned to placebo, 19 (4%) to phentermine 7·5 mg plus topiramate 46·0 mg, and 73 (7%) to phentermine 15·0 mg plus topiramate 92·0 mg had depression-related adverse events; and 28 (3%), 24 (5%), and 77 (8%), respectively, had anxiety-related adverse events. Interpretation: The combination of phentermine and topiramate, with office-based lifestyle interventions, might be a valuable treatment for obesity that can be provided by family doctors. Funding: Vivus.

Lancet (London, England) · randomised controlled trial · 667 citationsread the source →

Acute-phase and 1-year follow-up results of a randomized controlled trial of CBT versus Befriending for first-episode psychosis: the ACE project.

Background: The ACE project involved 62 participants with a first episode of psychosis randomly assigned to either a cognitive behaviour therapy (CBT) intervention known as Active Cognitive Therapy for Early Psychosis (ACE) or a control condition known as Befriending. The study hypotheses were that: (1) treating participants with ACE in the acute phase would lead to faster reductions in positive and negative symptoms and more rapid improvement in functioning than Befriending; (2) these improvements in symptoms and functioning would be sustained at a 1-year follow-up; and (3) ACE would lead to fewer hospitalizations than Befriending as assessed at the 1-year follow-up. Method: Two therapists treated the participants across both conditions. Participants could not receive any more than 20 sessions within 14 weeks. Participants were assessed by independent raters on four primary outcome measures of symptoms and functioning: at pretreatment, the middle of treatment, the end of treatment and at 1-year follow-up. An independent pair of raters assessed treatment integrity. Results: Both groups improved significantly over time. ACE significantly outperformed Befriending by improving functioning at mid-treatment, but it did not improve positive or negative symptoms. Past the mid-treatment assessment, Befriending caught up with the ACE group and there were no significant differences in any outcome measure and in hospital admissions at follow-up. Conclusions: There is some preliminary evidence that ACE promotes better early recovery in functioning and this finding needs to be replicated in other independent research centres with larger samples.

Psychological medicine · randomised controlled trial · 91 citationsread the source →

Implementation and Impact of Patient Lay Navigator-Led Advance Care Planning Conversations.

Context: Advance care planning (ACP) improves alignment between patient preferences for life-sustaining treatment and care received at end of life (EOL). Objectives: To evaluate implementation of lay navigator-led ACP. Methods: A convergent, parallel mixed-methods design was used to evaluate implementation of navigator-led ACP across 12 cancer centers. Data collection included 1) electronic navigation records, 2) navigator surveys (n = 45), 3) claims-based patient outcomes (n = 820), and 4) semistructured navigator interviews (n = 26). Outcomes of interest included 1) the number of ACP conversations completed, 2) navigator self-efficacy, 3) patient resource utilization, hospice use, and chemotherapy at EOL, and 4) navigator-perceived barriers and facilitators to ACP. Results: From June 1, 2014 to December 31, 2015, 50 navigators completed Respecting Choices® First Steps ACP Facilitator training. Navigators approached 18% of patients (1319/8704); 481 completed; 472 in process; 366 declined. Navigators were more likely to approach African American patients than Caucasian patients (20% vs. 14%, P < 0.001). Significant increases in ACP self-efficacy were observed after training. The mean score for feeling prepared to conduct ACP conversations increased from 5.6/10 to 7.5/10 (P < 0.001). In comparison with patients declining ACP participation (n = 171), decedents in their final 30 days of life who engaged in ACP (n = 437) had fewer hospitalizations (46% vs. 56%, P = 0.02). Key facilitators of successful implementation included physician buy-in, patient readiness, and prior ACP experience; barriers included space limitations, identifying the "right" time to start conversations, and personal discomfort discussing EOL. Conclusion: A navigator-led ACP program was feasible and may be associated with lower rates of resource utilization near EOL.

Journal of pain and symptom management · cohort or longitudinal · 91 citationsread the source →

A communication strategy and brochure for relatives of patients dying in the ICU.

Background: There is a need for close communication with relatives of patients dying in the intensive care unit (ICU). We evaluated a format that included a proactive end-of-life conference and a brochure to see whether it could lessen the effects of bereavement. Methods: Family members of 126 patients dying in 22 ICUs in France were randomly assigned to the intervention format or to the customary end-of-life conference. Participants were interviewed by telephone 90 days after the death with the use of the Impact of Event Scale (IES; scores range from 0, indicating no symptoms, to 75, indicating severe symptoms related to post-traumatic stress disorder [PTSD]) and the Hospital Anxiety and Depression Scale (HADS; subscale scores range from 0, indicating no distress, to 21, indicating maximum distress). Results: Participants in the intervention group had longer conferences than those in the control group (median, 30 minutes [interquartile range, 19 to 45] vs. 20 minutes [interquartile range, 15 to 30]; P<0.001) and spent more of the time talking (median, 14 minutes [interquartile range, 8 to 20] vs. 5 minutes [interquartile range, 5 to 10]). On day 90, the 56 participants in the intervention group who responded to the telephone interview had a significantly lower median IES score than the 52 participants in the control group (27 vs. 39, P=0.02) and a lower prevalence of PTSD-related symptoms (45% vs. 69%, P=0.01). The median HADS score was also lower in the intervention group (11, vs. 17 in the control group; P=0.004), and symptoms of both anxiety and depression were less prevalent (anxiety, 45% vs. 67%; P=0.02; depression, 29% vs. 56%; P=0.003). Conclusions: Providing relatives of patients who are dying in the ICU with a brochure on bereavement and using a proactive communication strategy that includes longer conferences and more time for family members to talk may lessen the burden of bereavement. (ClinicalTrials.gov number, NCT00331877.)

The New England journal of medicine · randomised controlled trial · 820 citationsread the source →

The mastery lifestyle intervention to reduce biopsychosocial risks for pregnant Latinas and African Americans and their infants: protocol for a randomized controlled trial.

Background: Pregnant Mexican Americans (hereafter called Latinas) and Black/African American women are at increased risk for psychological distress, contributing to preterm birth and low birthweight; acculturative stress combined with perceived stress elevates depressive symptoms in Latinas. Based on our prior research using a psychoneuroimmunology framework, we identified psychological and neuroendocrine risk factors as predictors of preterm birth in Latina women that are also identified as risk factors for Black/African American women. Methods/design: In this prospective, randomized controlled trial with parallel group design we will explore psychosocial, neuroendocrine, and birth outcome effects of the Mastery Lifestyle Intervention (MLI). The MLI is a culturally relevant, manualized, psychosocial, group intervention integrating two cognitive behavioral therapies for both pregnant Latinas and Black/African American women (total n = 221). Study inclusion criteria are: women with current pregnancy at 14-20 weeks gestation, ability to read and speak English or Spanish, self-identify as Latina of Mexican heritage or Black/African American, 18-45 years old, born in the US or Mexico, and currently living in the US. Participants must receive Medicaid or other government-supported insurance, and meet screening criteria for anxiety, depressive symptoms, or stress. Participants are randomly assigned to either the intervention (MLI) or usual care group (UCG) in groups of 6-8 participants that occur over 6 consecutive weeks. Data are collected at 3 time points: enrollment (14-20 weeks gestation), following treatment (20-26 weeks), and 6 weeks after treatment (32-36 weeks gestation). Additional outcome, mediating, and moderating data are collected from the electronic health record during pregnancy and at birth. Analyses will primarily use generalized linear mixed modeling (GLMM) to evaluate the relationships between predictors and outcomes. Discussion: This RCT will test the efficacy of two combined third generation cognitive behavioral therapies (the MLI), given in a group format over 6 sessions, as compared to a usual prenatal care group, for both Latina and African American pregnant women. If efficacious, it may be provided as an adjunct to routine prenatal care and improve mental health, as well as babies being born too small and too soon. Trial registration: The trial was retrospectively registered at ClinicalTrials.gov . Bethesda (MD): National Library of Medicine. Identifier NCT05012072 , Reducing Pregnancy Risks: The Mastery Lifestyle Intervention (MLI); August 19, 2021. The trial is currently recruiting participants.

BMC pregnancy and childbirth · clinical trial · 3 citationsread the source →

Alcoholics Anonymous and other 12-step programs for alcohol use disorder.

Background: Alcohol use disorder (AUD) confers a prodigious burden of disease, disability, premature mortality, and high economic costs from lost productivity, accidents, violence, incarceration, and increased healthcare utilization. For over 80 years, Alcoholics Anonymous (AA) has been a widespread AUD recovery organization, with millions of members and treatment free at the point of access, but it is only recently that rigorous research on its effectiveness has been conducted. Objectives: To evaluate whether peer-led AA and professionally-delivered treatments that facilitate AA involvement (Twelve-Step Facilitation (TSF) interventions) achieve important outcomes, specifically: abstinence, reduced drinking intensity, reduced alcohol-related consequences, alcohol addiction severity, and healthcare cost offsets. Search methods: We searched the Cochrane Drugs and Alcohol Group Specialized Register, Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, CINAHL and PsycINFO from inception to 2 August 2019. We searched for ongoing and unpublished studies via ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 15 November 2018. All searches included non-English language literature. We handsearched references of topic-related systematic reviews and bibliographies of included studies. Selection criteria: We included randomized controlled trials (RCTs), quasi-RCTs and non-randomized studies that compared AA or TSF (AA/TSF) with other interventions, such as motivational enhancement therapy (MET) or cognitive behavioral therapy (CBT), TSF treatment variants, or no treatment. We also included healthcare cost offset studies. Participants were non-coerced adults with AUD. Data collection and analysis: We categorized studies by: study design (RCT/quasi-RCT; non-randomized; economic); degree of standardized manualization (all interventions manualized versus some/none); and comparison intervention type (i.e. whether AA/TSF was compared to an intervention with a different theoretical orientation or an AA/TSF intervention that varied in style or intensity). For analyses, we followed Cochrane methodology calculating the standard mean difference (SMD) for continuous variables (e.g. percent days abstinent (PDA)) or the relative risk (risk ratios (RRs)) for dichotomous variables. We conducted random-effects meta-analyses to pool effects wherever possible. Main results: We included 27 studies containing 10,565 participants (21 RCTs/quasi-RCTs, 5 non-randomized, and 1 purely economic study). The average age of participants within studies ranged from 34.2 to 51.0 years. AA/TSF was compared with psychological clinical interventions, such as MET and CBT, and other 12-step program variants. We rated selection bias as being at high risk in 11 of the 27 included studies, unclear in three, and as low risk in 13. We rated risk of attrition bias as high risk in nine studies, unclear in 14, and low in four, due to moderate (> 20%) attrition rates in the study overall (8 studies), or in study treatment group (1 study). Risk of bias due to inadequate researcher blinding was high in one study, unclear in 22, and low in four. Risks of bias arising from the remaining domains were predominantly low or unclear. AA/TSF (manualized) compared to treatments with a different theoretical orientation (e.g. CBT) (randomized/quasi-randomized evidence) RCTs comparing manualized AA/TSF to other clinical interventions (e.g. CBT), showed AA/TSF improves rates of continuous abstinence at 12 months (risk ratio (RR) 1.21, 95% confidence interval (CI) 1.03 to 1.42; 2 studies, 1936 participants; high-certainty evidence). This effect remained consistent at both 24 and 36 months. For percentage days abstinent (PDA), AA/TSF appears to perform as well as other clinical interventions at 12 months (mean difference (MD) 3.03, 95% CI -4.36 to 10.43; 4 studies, 1999 participants; very low-certainty evidence), and better at 24 months (MD 12.91, 95% CI 7.55 to 18.29; 2 studies, 302 participants; low-certainty evidence) and 36 months (MD 6.64, 95% CI 1.54 to 11.75; 1 study, 806 participants; low-certainty evidence). For longest period of abstinence (LPA), AA/TSF may perform as well as comparison interventions at six months (MD 0.60, 95% CI -0.30 to 1.50; 2 studies, 136 participants; low-certainty evidence). For drinking intensity, AA/TSF may perform as well as other clinical interventions at 12 months, as measured by drinks per drinking day (DDD) (MD -0.17, 95% CI -1.11 to 0.77; 1 study, 1516 participants; moderate-certainty evidence) and percentage days heavy drinking (PDHD) (MD -5.51, 95% CI -14.15 to 3.13; 1 study, 91 participants; low-certainty evidence). For alcohol-related consequences, AA/TSF probably performs as well as other clinical interventions at 12 months (MD -2.88, 95% CI -6.81 to 1.04; 3 studies, 1762 participants; moderate-certainty evidence). For alcohol addiction severity, one study found evidence of a difference in favor of AA/TSF at 12 months (P < 0.05; low-certainty evidence). AA/TSF (non-manualized) compared to treatments with a different theoretical orientation (e.g. CBT) (randomized/quasi-randomized evidence) For the proportion of participants completely abstinent, non-manualized AA/TSF may perform as well as other clinical interventions at three to nine months follow-up (RR 1.71, 95% CI 0.70 to 4.18; 1 study, 93 participants; low-certainty evidence). Non-manualized AA/TSF may also perform slightly better than other clinical interventions for PDA (MD 3.00, 95% CI 0.31 to 5.69; 1 study, 93 participants; low-certainty evidence). For drinking intensity, AA/TSF may perform as well as other clinical interventions at nine months, as measured by DDD (MD -1.76, 95% CI -2.23 to -1.29; 1 study, 93 participants; very low-certainty evidence) and PDHD (MD 2.09, 95% CI -1.24 to 5.42; 1 study, 286 participants; low-certainty evidence). None of the RCTs comparing non-manualized AA/TSF to other clinical interventions assessed LPA, alcohol-related consequences, or alcohol addiction severity. Cost-effectiveness studies In three studies, AA/TSF had higher healthcare cost savings than outpatient treatment, CBT, and no AA/TSF treatment. The fourth study found that total medical care costs decreased for participants attending CBT, MET, and AA/TSF treatment, but that among participants with worse prognostic characteristics AA/TSF had higher potential cost savings than MET (moderate-certainty evidence). Authors' conclusions: There is high quality evidence that manualized AA/TSF interventions are more effective than other established treatments, such as CBT, for increasing abstinence. Non-manualized AA/TSF may perform as well as these other established treatments. AA/TSF interventions, both manualized and non-manualized, may be at least as effective as other treatments for other alcohol-related outcomes. AA/TSF probably produces substantial healthcare cost savings among people with alcohol use disorder.

The Cochrane database of systematic reviews · meta-analysis · 192 citationsread the source →

Video decision support tool for advance care planning in dementia: randomised controlled trial.

Objective: To evaluate the effect of a video decision support tool on the preferences for future medical care in older people if they develop advanced dementia, and the stability of those preferences after six weeks. Design: Randomised controlled trial conducted between 1 September 2007 and 30 May 2008. Setting Four primary care clinics (two geriatric and two adult medicine) affiliated with three academic medical centres in Boston. Participants: Convenience sample of 200 older people (>or=65 years) living in the community with previously scheduled appointments at one of the clinics. Mean age was 75 and 58% were women. Intervention: Verbal narrative alone (n=106) or with a video decision support tool (n=94). Main outcome measures: Preferred goal of care: life prolonging care (cardiopulmonary resuscitation, mechanical ventilation), limited care (admission to hospital, antibiotics, but not cardiopulmonary resuscitation), or comfort care (treatment only to relieve symptoms). Preferences after six weeks. The principal category for analysis was the difference in proportions of participants in each group who preferred comfort care. Results: Among participants receiving the verbal narrative alone, 68 (64%) chose comfort care, 20 (19%) chose limited care, 15 (14%) chose life prolonging care, and three (3%) were uncertain. In the video group, 81 (86%) chose comfort care, eight (9%) chose limited care, four (4%) chose life prolonging care, and one (1%) was uncertain (chi(2)=13.0, df=3, P=0.003). Among all participants the factors associated with a greater likelihood of opting for comfort care were being a college graduate or higher, good or better health status, greater health literacy, white race, and randomisation to the video arm. In multivariable analysis, participants in the video group were more likely to prefer comfort care than those in the verbal group (adjusted odds ratio 3.9, 95% confidence interval 1.8 to 8.6). Participants were re-interviewed after six weeks. Among the 94/106 (89%) participants re-interviewed in the verbal group, 27 (29%) changed their preferences (kappa=0.35). Among the 84/94 (89%) participants re-interviewed in the video group, five (6%) changed their preferences (kappa=0.79) (P<0.001 for difference). Conclusion: Older people who view a video depiction of a patient with advanced dementia after hearing a verbal description of the condition are more likely to opt for comfort as their goal of care compared with those who solely listen to a verbal description. They also have more stable preferences over time. Trial registration: Clinicaltrials.gov NCT00704886.

BMJ (Clinical research ed.) · randomised controlled trial · 207 citationsread the source →

Psychosocial and psychological interventions for relapse prevention in schizophrenia: a systematic review and network meta-analysis.

Background: Many psychosocial and psychological interventions are used in patients with schizophrenia, but their comparative efficacy in the prevention of relapse is not known. We aimed to evaluate the efficacy, acceptability, and tolerability of psychosocial and psychological interventions for relapse prevention in schizophrenia. Methods: To conduct this systematic review and network meta-analysis we searched for published and unpublished randomised controlled trials that investigated psychosocial or psychological interventions aimed at preventing relapse in patients with schizophrenia. We searched EMBASE, MEDLINE, PsycINFO, BIOSIS, Cochrane Library, WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov up to Jan 20, 2020, and searched PubMed up to April 14, 2020. We included open and masked studies done in adults with schizophrenia or related disorders. We excluded studies in which all patients were acutely ill, had a concomitant medical or psychiatric disorder, or were prodromal or "at risk of psychosis". Study selection and data extraction were done by two reviewers independently based on published and unpublished reports, and by contacting study authors. Data were extracted about efficacy, tolerability, and acceptability of the interventions; potential effect moderators; and study quality and characteristics. The primary outcome was relapse measured with operationalised criteria or psychiatric hospital admissions. We did random-effects network meta-analysis to calculate odds ratios (ORs) or standardised mean differences (SMDs) with 95% CIs. The study protocol was registered with PROSPERO, CRD42019147884. Findings: We identified 27 765 studies through the database search and 330 through references of previous reviews and studies. We screened 28 000 records after duplicates were removed. 24 406 records were excluded by title and abstract screening and 3594 full-text articles were assessed for eligibility. 3350 articles were then excluded for a variety of reasons, and 244 full-text articles corresponding to 85 studies were included in the qualitative synthesis. Of these, 72 studies with 10 364 participants (3939 females and 5716 males with sex indicated) were included in the network meta-analysis. The randomised controlled trials included compared 20 psychological interventions given mainly as add-on to antipsychotics. Ethnicity data were not available. Family interventions (OR 0·35, 95% CI 0·24-0·52), relapse prevention programmes (OR 0·33, 0·14-0·79), cognitive behavioural therapy (OR 0·45, 0·27-0·75), family psychoeducation (OR 0·56, 0·39-0·82), integrated interventions (OR 0·62, 0·44-0·87), and patient psychoeducation (OR 0·63, 0·42-0·94) reduced relapse more than treatment as usual at 1 year. The confidence in the estimates ranged from moderate to very low. We found no indication of publication bias. Interpretation: We found robust benefits in reducing the risk of relapse for family interventions, family psychoeducation, and cognitive behavioral therapy. These treatments should be the first psychosocial interventions to be considered in the long-term treatment for patients with schizophrenia. Funding: German Ministry for Education and Research.

The lancet. Psychiatry · systematic review · 149 citationsread the source →

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

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

Translational psychiatry · systematic review · 80 citationsread the source →

Diagnosing cancer in the bush: a mixed-methods study of symptom appraisal and help-seeking behaviour in people with cancer from rural Western Australia.

Background: Previous studies have focused on the treatment received by rural cancer patients and have not examined their diagnostic pathways as reasons for poorer outcomes in rural Australia. Objectives: To compare and explore symptom appraisal and help-seeking behaviour in patients with breast, lung, prostate or colorectal cancer from rural Western Australia (WA). Methods: A mixed-methods study of people recently diagnosed with breast, lung, prostate or colorectal cancer from rural WA. The time from first symptom to diagnosis (i.e. total diagnostic interval, TDI) was calculated from interviews and medical records. Results: Sixty-six participants were recruited (24 breast, 20 colorectal, 14 prostate and 8 lung cancer patients). There was a highly significant difference in time from symptom onset to seeking help between cancers (P = 0.006). Geometric mean symptom appraisal for colorectal cancer was significantly longer than that for breast and lung cancers [geometric mean differences: 2.58 (95% confidence interval, CI: 0.64-4.53), P = 0.01; 3.97 (1.63-6.30), P = 0.001, respectively]. There was a significant overall difference in arithmetic mean TDI (P = 0.046); breast cancer TDI was significantly shorter than colorectal or prostate cancer TDI [mean difference : 266.3 days (95% CI: 45.9-486.8), P = 0.019; 277.0 days, (32.1-521.9), P = 0.027, respectively]. These differences were explained by the nature and personal interpretation of symptoms, perceived as well as real problems of access to health care, optimism, stoicism, machismo, fear, embarrassment and competing demands. Conclusions: Longer symptom appraisal was observed for colorectal cancer. Participants defined core characteristics of rural Australians as optimism, stoicism and machismo. These features, as well as access to health care, contribute to later presentation of cancer.

Family practice · cohort or longitudinal · 74 citationsread the source →

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

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

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

A double-blind, placebo-controlled trial of topiramate for pathological gambling.

Objectives: Pathological gambling (PG) is an impulse control disorder characterized by recurrent gambling thoughts and behaviours that impair social functioning. Earlier studies suggested that topiramate may be effective in treating some impulse control disorders. We conducted the first randomized, controlled trial of topiramate in PG. Methods: PG patients were randomized to topiramate (N = 20) or placebo (N = 22) in this 14-week, double-blind, placebo-controlled, parallel-group trial. The primary outcome measure was change in the obsessions subscale of the Yale-Brown Obsessive-Compulsive Scale Modified for Pathological Gambling. Results: Mixed regression models (time [weeks] × treatment) revealed no significant treatment effect of topiramate on the primary or secondary outcome measures. The most statistically robust findings involved reducing the Barratt Impulsiveness Scale (BIS) total score and Motor and Non-Planning subscale scores, for which topiramate outperformed placebo at merely a trend level (P < 0.1). Conclusions: The observed trend in BIS score reductions may warrant further investigation to study whether topiramate reduces clinically important impulsivity in PG. Treatment studies with larger samples and less stringent exclusion criteria are needed to produce results that can be generalized to pathological gamblers in the community.

The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry · randomised controlled trial · 41 citationsread the source →

A Review of Self-Compassion as an Active Ingredient in the Prevention and Treatment of Anxiety and Depression in Young People.

Previous meta-analyses have found higher self-compassion is associated with lower anxiety and depression. The aim of this study was to investigate the efficacy of self-compassion as an active ingredient in the treatment and prevention of anxiety and depression in youth. This was conducted through (i) a systematic review of the literature and (ii) qualitative consultation with young people and researchers in self-compassion. Fifty studies met our inclusion criteria. Eight studies evaluated self-compassion interventions among youth aged 14-24, and the remaining studies measured the association between self-compassion and anxiety, and/or depression among this age group. Qualitative interviews were conducted with four self-compassion researchers. Interviews were also conducted in two rounds of consultation with 20 young people (M age = 18.85 years, age range 14-24 years). Higher self-compassion was related to lower symptoms of anxiety, r =  - 0.49, 95% CI (- 0.57, - 0.42), and depression, r =  - 0.50, 95% CI (- 0.53, - 0.47). There was evidence for self-compassion interventions in decreasing anxiety and depression in young people. Consultation with young people indicated they were interested in self-compassion interventions; however, treatment should be available in a range of formats and tailored to address diversity. Self-compassion experts emphasised the importance of decreasing self-criticism as a reason why self-compassion interventions work. The importance of targeting self-criticism is supported by the preferences of young people who said they would be more likely to engage in a treatment reducing self-criticism than increasing self-kindness. Future research is required to add to the emerging evidence for self-compassion interventions decreasing symptoms of anxiety and depression in young people.

Administration and policy in mental health · systematic review · 42 citationsread the source →

Acculturation and biological stress markers: A systematic review.

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

Psychoneuroendocrinology · systematic review · 26 citationsread the source →

Parenting for Lifelong Health for Young Children: a randomized controlled trial of a parenting program in South Africa to prevent harsh parenting and child conduct problems.

Background: Parenting programs suitable for delivery at scale in low-resource contexts are urgently needed. We conducted a randomized trial of Parenting for Lifelong Health (PLH) for Young Children, a low-cost 12-session program designed to increase positive parenting and reduce harsh parenting and conduct problems in children aged 2-9. Methods: Two hundred and ninety-six caregivers, whose children showed clinical levels of conduct problems (Eyberg Child Behavior Inventory Problem Score, >15), were randomly assigned using a 1:1 ratio to intervention or control groups. At t0 , and at 4-5 months (t1 ) and 17 months (t2 ) after randomization, research assistants blind to group assignment assessed (through caregiver self-report and structured observation) 11 primary outcomes: positive parenting, harsh parenting, and child behavior; four secondary outcomes: parenting stress, caregiver depression, poor monitoring/supervision, and social support. Trial registration: ClinicalTrials.gov (NCT02165371); Pan African Clinical Trial Registry (PACTR201402000755243); Violence Prevention Trials Register (http://www.preventviolence.info/Trials?ID=24). Results: Caregivers attended on average 8.4 sessions. After adjustment for 30 comparisons, strongest results were as follows: at t1 , frequency of self-reported positive parenting strategies (10% higher in the intervention group, p = .003), observed positive parenting (39% higher in the intervention group, p = .003), and observed positive child behavior (11% higher in the intervention group, p = .003); at t2, both observed positive parenting and observed positive child behavior were higher in the intervention group (24%, p = .003; and 17%, p = .003, respectively). Results with p-values < .05 prior to adjustment were as follows: At t1 , the intervention group self-reported 11% fewer child problem behaviors, 20% fewer problems with implementing positive parenting strategies, and less physical and psychological discipline (28% and 14% less, respectively). There were indications that caregivers reported 20% less depression but 7% more parenting stress at t1 . Group differences were nonsignificant for observed negative child behavior, and caregiver-reported child behavior, poor monitoring or supervision, and caregiver social support. Conclusions: PLH for Young Children shows promise for increasing positive parenting and reducing harsh parenting.

Journal of child psychology and psychiatry, and allied disciplines · randomised controlled trial · 88 citationsread the source →

Virtual reality compared with in vivo exposure in the treatment of social anxiety disorder: a three-arm randomised controlled trial.

BackgroundPeople with social anxiety disorder (SAD) fear social interactions and may be reluctant to seek treatments involving exposure to social situations. Social exposure conducted in virtual reality (VR), embedded in individual cognitive-behavioural therapy (CBT), could be an answer. AimsTo show that conducting VR exposure in CBT for SAD is effective and is more practical for therapists than conducting exposure in vivoMethodParticipants were randomly assigned to either VR exposure (n = 17), in vivo exposure (n = 22) or waiting list (n = 20). Participants in the active arms received individual CBT for 14 weekly sessions and outcome was assessed with questionnaires and a behaviour avoidance test. (Trial registration number ISRCTN99747069)ResultsImprovements were found on the primary (Liebowitz Social Anxiety Scale) and all five secondary outcome measures in both CBT groups compared with the waiting list. Conducting exposure in VR was more effective at post-treatment than in vivo on the primary outcome measure and on one secondary measure. Improvements were maintained at the 6-month follow-up. VR was significantly more practical for therapists than in vivo exposure. ConclusionsUsing VR can be advantageous over standard CBT as a potential solution for treatment avoidance and as an efficient, cost-effective and practical medium of exposure.

The British journal of psychiatry : the journal of mental science · randomised controlled trial · 157 citationsread the source →

The copenhagen psychosocial questionnaire II (COPSOQ II) in Spain--a tool for psychosocial risk assessment at the workplace.

Aims: To describe the second version of the Spanish Copenhagen Psychosocial Questionnaire and to present evidence of its validity and reliability. Methods: The original Danish long COPSOQ II questionnaire was adapted to the labor market, cultural, and linguistic setting of Spain and included in the 2010 Spanish Psychosocial Risks Survey. Analysis involved the assessment of psychometric characteristics and associations among psychosocial scales and health scales. Medium and short versions were derived from the long one. Results: The long questionnaire was configured with 24 dimensions (92 items); medium-length questionnaire with 20 dimensions (69 items); and short questionnaire with 14 dimensions (28 items). All scales showed acceptable reliability and concordance between versions. Most associations among psychosocial scales and Mental Health, Stress, and Burnout scales were in the expected direction, except the scale of Influence, that showed some incongruent associations. Conclusion: Results support the validity and reliability of Spanish COPSOQ II questionnaires as tools for psychosocial risk assessment at the workplace, however, better scales should be developed specially for the dimension of Influence.

American journal of industrial medicine · cohort or longitudinal · 61 citationsread the source →

Cardiac rehabilitation using the Family-Centered Empowerment Model versus home-based cardiac rehabilitation in patients with myocardial infarction: a randomised controlled trial.

Objective: To determine if a hybrid cardiac rehabilitation (CR) programme using the Family-Centered Empowerment Model (FCEM) as compared with standard CR will improve patient quality of life, perceived stress and state anxiety of patients with myocardial infarction (MI). Methods: We conducted a randomised controlled trial in which patients received either standard home CR or CR using the FCEM strategy. Patient empowerment was measured with FCEM questionnaires preintervention and postintervention for a total of 9 assessments. Quality of life, perceived stress, and state and trait anxiety were assessed using the 36-Item Short Form Health Survey (SF-36), the 14-item Perceived Stress, and the 20-item State and 20-item Trait Anxiety questionnaires, respectively. Results: 70 patients were randomised. Baseline characteristics were similar. Ejection fraction was significantly higher in the intervention group at measurements 2 (p=0.01) and 3 (p=0.001). Exercise tolerance measured as walking distance was significantly improved in the intervention group throughout the study. The quality of life results in the FCEM group showed significant improvement both within the group over time (p<0.0001) and when compared with control (p<0.0001). Similarly, the perceived stress and state anxiety results showed significant improvement both within the FCEM group over time (p<0.0001) and when compared with control (p<0.0001). No significant difference was found either within or between groups for trait anxiety. Conclusions: The family-centred empowerment model may be an effective hybrid cardiac rehabilitation method for improving the physical and mental health of patients post-MI; however, further study is needed to validate these findings. Clinical Trials.gov identifier NCT02402582. Trial registration number: NCT02402582.

Open heart · 36 citationsread the source →

Safety and efficacy of maintenance ketamine treatment in patients with treatment-refractory generalised anxiety and social anxiety disorders.

Objective: In this maintenance treatment study, we sought to evaluate the effect on anxiety ratings, safety and tolerability of 3 months of weekly ketamine in 20 patients with treatment-refractory DSM IV generalised anxiety disorder (GAD) and/or social anxiety disorder (SAD), and subsequent assessment of remission post-treatment. Methods: This was an uncontrolled open-label study in 20 patients who had been responders in an ascending dose ketamine study. The study was undertaken in a university clinic. Patients received one or two weekly ketamine doses of 1 mg/kg injected subcutaneously for 3 months. Data were collected from December 2015-June 2017. Results: There were 10 women (50%) and 10 men (50%); 15 patients (75%) met criteria for GAD and 18 (90%) for SAD. One hour after dosing, Fear Questionnaire ratings decreased by ~50%, as did Hamilton Anxiety ratings. Clinician Administered Dissociative States Scale mean scores declined over time, from 20 points at week 1 to 8.8 points at week 14. Compared with pre-dose values, mean systolic and diastolic blood pressure increased by ~10 mm Hg at 30 min. The most common adverse events were nausea, dizziness and blurred vision. Of the 20 patients, 18 reported improved social functioning and/or work functioning during maintenance treatment. Conclusions: Weekly ketamine dosing was safe and well tolerated, and post-dose dissociative symptoms tended to reduce after repeated dosing. Patients reported marked improvements in functionality and in their personal lives. Maintenance ketamine may be a therapeutic alternative for patients with treatment refractory GAD/SAD. Trial registration: http://www.anzctr.org.au/ACTRN12615000617561.

Journal of psychopharmacology (Oxford, England) · clinical trial · 48 citationsread the source →

Integrating a Behavioural Sleep Intervention into Smoking Cessation Treatment for Smokers with Insomnia: A Randomised Pilot Study.

Introduction: Sleep disturbance is common among cigarette smokers and predicts smoking cessation failure. Aims: The purpose of this study was to conduct a pilot test of whether provision of a sleep intervention might bolster smoking cessation outcomes among this vulnerable group. Methods: Smokers with insomnia (N = 19) seeking smoking cessation treatment were randomly assigned to receive 8 sessions over 10 weeks of either: (1) cognitive-behavioural therapy for insomnia + smoking cessation counselling (CBT-I+SC; n = 9) or (2) smoking cessation counselling alone (SC; n = 10). Counselling commenced 4 weeks prior to a scheduled quit date, and nicotine patch therapy was also provided for 6 weeks starting on the quit date. Results: There was no significant effect of counselling condition on smoking cessation outcomes. Most participants had difficulty initiating and maintaining smoking abstinence in that 7-day point prevalence abstinence rates at end of treatment (CBT-I+SC: 1/7, 14%; SC: 2/10, 20%) and follow-up (CBT-I+SC: 1/7, 14%; SC: 0/10, 0%) were low for both conditions. CBT-I+SC participants reported improvements in sleep efficiency, quality, duration and insomnia symptoms. Sleep changes were not associated with the likelihood of achieving smoking abstinence. Conclusions: This randomised pilot study suggests that behavioural interventions may improve sleep among smokers with insomnia, but a larger sample is needed to replicate this finding and evaluate whether these changes facilitate smoking cessation.

Journal of smoking cessation · 30 citationsread the source →

Group cognitive and behavioral therapy and bibliotherapy for hoarding: a pilot trial.

Background: Group cognitive behavioral treatments (GCBTs) for hoarding have produced modest benefits. The current study examined whether the outcomes of a specialized GCBT improve upon bibliotherapy (BIB) for hoarding, as part of a stepped care model. We also explored whether additional home assistance enhanced GCBT outcomes. Methods: Hoarding patients (n = 38) were randomized and completed one of three conditions: (1) GCBT with nonclinician home assistants (GCBT+HA; N = 11), (2) GCBT without HA (CGBT; N = 14), and (3) BIB (N = 13). All GCBT participants received 20 weekly group sessions and four home visits by a group co-therapist. GCBT+HA groups received four additional visits by a nonclinician coach. BIB participants were assigned a self-help book describing specific skills to reduce hoarding over the 20-week period. All participants were assessed by self-report at baseline, mid-treatment, and posttreatment. The sample averaged 57 years old and was mainly female, White, highly educated, employed, and living alone. Results: GCBT+HA and GCBT participants showed significant reductions on hoarding and depression symptoms, whereas BIB did not. GCBT+HA and GCBT benefited substantially and similarly on the saving inventory-revised (reductions of 29.9 and 23.3%, respectively) and SI-R (Saving Inventory-Revised) (reductions of 26.5 and 25.4%), whereas BIB participants showed very limited improvement (9% reduction) on both measures. Conclusion: This study provides support for the efficacy of GCBT for hoarding. The effect of adding nonclinician home assistance was not significant in this small sample. BIB was not sufficient to improve hoarding symptoms. The findings have implications for a stepped care model for treating hoarding (e.g., the benefits of psycho-education via BIB, added benefits of extra in-home visits) and suggest the need to further examine the role of in-home hoarding coaches.

Depression and anxiety · randomised controlled trial · 38 citationsread the source →

Family-centered advance care planning for teens with cancer.

Importance: Advance care planning (ACP) prepares patients and their families for future health care decisions; however, the needs of adolescent oncology patients for participation in ACP have not been well studied. Objective: To examine the efficacy of family-centered ACP. Design and setting: Two-group randomized controlled trial in a pediatric oncology program. Participants: Sixty adolescents aged 14 to 21 years with cancer and their surrogates or families were enrolled in the study between January 17, 2011, and March 29, 2012. Intervention: Thirty dyads received 3- to 60-minute sessions 1 week apart. Intervention dyads completed (1) the Lyon Family-Centered ACP Survey, (2) the Respecting Choices interview, and (3) Five Wishes. Control subjects received standard care plus information. Main outcome measures: Statement of treatment preferences and Decisional Conflict Scale score. Results: The mean age of the adolescents was 16 years; 36 (60%) were male, 30 (50%) white, 26 (43%) black, and 4 (7%) Asian. Diagnoses were as follows: leukemia (14 patients [47%]), brain tumor (8 [27%]), solid tumor (6 [20%]), and lymphoma (2 [7%]). Significantly increased congruence was observed for intervention dyads compared with controls for 4 of the 6 disease-specific scenarios; for example, for situation 2 ("treatment would extend my life by not more than 2 to 3 months"), intervention dyads demonstrated higher congruence (κ = 0.660; P < .001) vs control dyads (κ = -0.0636; P = .70). Intervention adolescents (100%) wanted their families to do what is best at the time, whereas fewer control adolescents (62%) gave families this leeway. Intervention adolescents were significantly better informed about end-of-life decisions (t = 2.93; effect size, 0.961; 95% CI, 0.742-1.180; P = .007). Intervention families were more likely to concur on limiting treatments than controls. An ethnic difference was found in only one situation. Conclusions: Advance care planning enabled families to understand and honor their adolescents' wishes. Intervention dyads were more likely than controls to limit treatments. Underserved African American families were willing to participate.

JAMA pediatrics · randomised controlled trial · 149 citationsread the source →

The roles of repetitive negative thinking and perfectionism in explaining the relationship between sleep onset difficulties and depressed mood in adolescents.

Objective: The present study investigated the relationship between difficulty initiating sleep and depressed mood and whether it is mediated by repetitive negative thinking. A moderating role of perfectionism was also examined. Methods: We surveyed 393 adolescents aged 14 to 20 years (M = 17.32, SD = 1.90) via an online questionnaire that assessed difficulty initiating sleep, repetitive negative thinking, perfectionism, and depressed mood. Results: Results indicated that repetitive negative thinking fully mediated the relationship between difficulty initiating sleep and depressed mood. In addition, this relationship was moderated by perfectionism, specifically, the relationship between repetitive negative thinking and depressed mood was stronger among more perfectionistic adolescents. Conclusions: These findings highlight that repetitive negative thinking is significantly associated with both difficulty initiating sleep and depressed mood, supporting the conceptualization of repetitive negative thinking as a transdiagnostic process. Further, individual differences in perfectionism may amplify the relationship between repetitive negative thinking and mood. The role of repetitive negative thinking and perfectionism in explaining the link between sleep onset problems and depressed mood has important clinical implications through providing possible treatment targets.

Sleep health · 19 citationsread the source →

Mothers and Fathers Experience Stress of Congenital Heart Disease Differently: Recommendations for Pediatric Critical Care.

Objective: To inform pediatric critical care practice by examining how mothers and fathers experience the stress of caring for a young child with congenital heart disease and use hospital and community supports. Design: Qualitative study of mothers and fathers of young children with congenital heart disease. Setting: Tertiary care pediatric hospital in the Mid-Atlantic region of the United States. Subjects: Thirty-four parents (20 mothers, 14 fathers) from diverse backgrounds whose child previously underwent cardiac surgery during infancy. Interventions: Subjects participated in semi-structured, individual interviews about their experiences and psychosocial needs at the time of congenital heart disease diagnosis, surgical admission, and discharge to home after surgery. Qualitative interview data were coded, and consistent themes related to emotional states, stressors, and supports were identified. Measurements and main results: Fathers experience and respond to the stressors and demands of congenital heart disease in unique ways. Fathers often described stress from not being able to protect their child from congenital heart disease and the associated surgeries/pain and from difficulties balancing employment with support for their partner and care of their congenital heart disease child in the hospital. Fathers were more likely than mothers to discuss support from the work environment (coworkers/managers, flexible scheduling, helpful distraction) and were less likely to describe the use of hospital-based resources or congenital heart disease peer-to-peer supports. Conclusions: This study highlights the importance of understanding the paternal experience and tailoring interventions to the unique needs of both mothers and fathers. Opportunities for critical care practice change to promote the mental health of mothers and fathers following a diagnosis of congenital heart disease are discussed.

Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 89 citationsread the source →

Parent Perspectives on Family-Based Psychosocial Interventions for Congenital Heart Disease.

Objectives: To identify parents' preferences for goals and structure of intervention programs to support the psychosocial needs of families impacted by congenital heart disease (CHD). Study design: Information about parent priorities for psychosocial programs was obtained in this mixed-methods study conducted at a pediatric hospital in the Mid-Atlantic region of the US. Participants were parents (N = 34; 20 mothers, 14 fathers) of children with CHD between the ages of 1 and 3 years who had cardiac surgery at less than 6 months of age. Qualitative data were excerpts from semistructured interviews. Quantitative data were participant choices regarding their ideal psychosocial program resulting from a card sort. Results: Parents reported that psychosocial interventions should support partnership in their child's care, promote self-care, facilitate communication with providers, prepare parents for challenges after hospitalization, provide education about child neurodevelopment, and help parents engage social support. Parents reported needing formalized support across care, brief intervention models, in-person individualized or small group support, and involvement of multidisciplinary providers and peer mentors in the delivery of interventions. Conclusions: Parents of children with CHD need psychosocial interventions that empower them to act as primary caregivers and effective advocates for their child. Individualized, formalized, and multidisciplinary approaches to psychosocial care are necessary to best accommodate the dynamic stressors related to parenting a child with CHD and may mitigate the impact of parent mental health problems on child outcomes.

The Journal of pediatrics · 46 citationsread the source →

Characteristics of Hospital Workers Using a Wellbeing Center Implemented During the COVID-19 Pandemic to Prevent the Emotional Impacts of the Crisis.

Introduction: The COVID-19 pandemic has posed an unprecedented challenge worldwide for healthcare workers (HCWs) and other hospital employees. Disruptions in work and personal life may have led to mental health problems. To prevent or limit the severity of such issues, a local initiative has been implemented in a French hospital: a dedicated lounge, also called "Bulle" (literally bubble and meaning safe space) has been created to provide a quiet caring environment and health support. Other similar wellbeing centers have been implemented in other countries, but very little data are available on their practical effectiveness. The purpose of our study was to assess what type of hospital workers have frequented the Bulle and to describe their psychological state in terms of anxiety, depression, and post-traumatic stress disorder (PTSD) just after the first wave, compared to those who had not come to the Bulle. Methods: From 15 July to 1 October 2020, a cross-sectional survey was conducted among all workers, collecting demographic information, professional data (experience and satisfaction), emotional experience during the first wave of COVID-19, and psychological specificities, including a history of burnout or symptoms of anxiety, depression, and PTSD. We asked them if they had accessed the Bulle or not. Results: A total of 675 employees (out of 2,408; 28.0%) fully completed the survey. Approximately 199 respondents (29%) reported having accessed the Bulle during the first wave of the pandemic. Significant symptoms of anxiety, depression, and PTSD were reported by, respectively, 41, 20, and 14% of the participants. Logistic regression analysis showed no relationship between the use of the Bulle and the prevalence of later psychological symptoms. However, employees who benefit from the solicitation of the psychological support team in their hospital unit were secondarily more prone to come to the Bulle [odds ratio (OR), 2.24; 95% confidence interval (95% CI): 1.09; 4.59]. Conclusion: Anxiety, depression, and PTSD were common after the first part of the COVID-19 pandemic, and the attendance in quiet and wellbeing spaces seemed easier with direct internal proactive intervention by psychological teams.

Frontiers in public health · 1 citationsread the source →

Effects of DMT on mental health outcomes in healthy volunteers.

Psilocybin, a serotonergic psychedelic, is being increasingly researched in clinical studies for the treatment of psychiatric disorders. The relatively lengthy duration of oral psilocybin's acute effects (4-6 h) may have pragmatic and cost-effectiveness limitations. Here, we explored the effects of intravenous (IV) N,N-Dimethyltryptamine (DMT), a closely related, but faster-acting psychedelic intervention, on mental health outcomes in healthy volunteers. Data is reported from two separate analyses: (1) A comparison of mental health-related variables 1 week after 7, 14, 18, and 20 mg of IV DMT versus IV saline placebo (n = 13) and, (2) A prospective dataset assessing effects before versus 2 weeks after 20 mg of IV DMT (n = 17). Mental health outcomes included measures of depression severity (QIDS-SR16), trait anxiety (STAI-T), Neuroticism (NEO-FFI), wellbeing (WHO-5), meaning in life (MLQ), optimism (LOT-R), and gratitude (GQ-6). In both the prospective and placebo-controlled datasets, significant improvements in scores of depression were found 1-2 weeks after DMT administration. Significant reductions in trait Neuroticism were only found for the placebo-controlled sample. Finally, changes in depression and trait anxiety correlated with acute peak experiences (assessed via 'Oceanic Boundlessness'). While the use of two separate cohorts in pooled analysis limits the generalizability of these correlational findings, these results suggest that DMT may reduce depressive symptomatology by inducing peak experiences. The short half-life of IV DMT and its potential for flexible dosing via controlled infusions makes it an appealing candidate for psychedelic medicine. Further research in clinical samples is needed to corroborate the therapeutic potential of DMT.

Scientific reports · 26 citationsread the source →

Therapist competencies necessary for the delivery of compassion-focused therapy: A Delphi study.

Objectives: Compassion-focused therapy (CFT) has shown promising results for a range of clinical presentations. This study explored the therapeutic competencies required to deliver CFT and organized these into a coherent framework. Design: The Delphi method was used to explore and refine competencies for delivering CFT in three rounds of data collection. Methods: The first round involved interviews with 12 experts in CFT. Data were analysed using template analysis to generate a draft competency framework. The main competencies were used to create a survey for rounds two and three involving CFT experts and practitioners. Data collected from the surveys were used to refine the competencies. Results: The CFT competency framework (CFT-CF) that was produced comprised 25 main competencies within six key areas of competence. The areas were as follows: competencies in creating safeness, meta-skills, non-phase-specific skills, phase-specific skills, knowledge and understanding and use of supervision. The main competencies included several subcompetencies specifying knowledge, skills and attributes needed to demonstrate the main competence. Overall, there was consensus on 14 competencies and 20 competencies exceeded an 80% agreement level. Conclusions: Some of the CFT competencies overlapped with existing therapies, whilst others were specific to CFT. The CFT-CF provides useful guidance for clinicians, supervisors and training programmes. Further research could develop the CFT-CF into a therapist rating scale in order to measure the outcome of training and to assess treatment fidelity in clinical trials. Practitioner points: The compassion-focused therapy competency framework (CFT-CF) identifies therapeutic competencies that overlap with existing treatments as well as those specific to compassion-focused therapy (CFT). The CFT-CF builds guidance for the competencies required to deliver CFT in a range of clinical settings. The CFT-CF provides guidance for those training CFT therapists. The CFT-CF could be used as a basis to develop a therapist rating scale.

Psychology and psychotherapy · 8 citationsread the source →

Prenatal stress-induced alterations in major physiological systems correlate with gut microbiota composition in adulthood.

Early-life adverse experiences, including prenatal stress (PNS), are associated with a higher prevalence of neurodevelopmental, cardiovascular and metabolic disorders in affected offspring. Here, in a rat model of chronic PNS, we investigate the impact of late gestational stress on physiological outcomes in adulthood. Sprague-Dawley pregnant dams were subjected to repeated restraint stress from embryonic day 14 to day 20, and their male offspring were assessed at 4 months of age. PNS induced an exaggeration of the hypothalamic-pituitary-adrenal (HPA) axis response to stress, as well as an elevation of blood pressure and impairment of cognitive function. Altered respiratory control was also observed, as demonstrated by increased variability in basal respiratory frequency and abnormal frequency responses to both hypoxic and hypercapnic challenges. PNS also affected gastrointestinal neurodevelopment and function, as measured by a decrease in the innervation density of distal colon and an increase in the colonic secretory response to catecholaminergic stimulation. Finally, PNS induced long lasting alterations in the intestinal microbiota composition. 16S rRNA gene 454 pyrosequencing revealed a strong trend towards decreased numbers of bacteria in the Lactobacillus genus, accompanied by elevated abundance of the Oscillibacter, Anaerotruncus and Peptococcus genera in PNS animals. Strikingly, relative abundance of distinct bacteria genera significantly correlated with certain respiratory parameters and the responsiveness of the HPA axis to stress. Together, these findings provide novel evidence that PNS induces long-term maladaptive alterations in the gastrointestinal and respiratory systems, accompanied by hyper-responsiveness to stress and alterations in the gut microbiota.

Psychoneuroendocrinology · 212 citationsread the source →

When emotions remain unnamed: alexithymia and rejection sensitivity fuel aggression via anger rumination.

Aggressive behavior has been consistently associated with difficulties in emotion regulation, yet the mechanisms through which interpersonal vulnerability and impaired emotional awareness contribute to aggression remain insufficiently specified. Rejection sensitivity (RS) and alexithymia are established cognitive-affective risk factors, but their joint pathways to aggression warrant clarification. The present study aimed to test a theoretically grounded structural model in which anger rumination functions as a proximal cognitive-affective mechanism linking RS and alexithymia to aggressive behavior. In a community sample of women (n = 666; M = 34.62, SD = 8.35), we tested a structural equation model (SEM) in which anger rumination was specified as a mediator linking RS and alexithymia to aggression. Participants completed validated self-report measures of RS, alexithymia (PAQ), anger rumination (ARS), and aggression (AQ). Measurement models were supported via CFA. SEM with robust maximum likelihood estimation was conducted, controlling for age and education. Indirect effects were evaluated using bias-corrected bootstrapping. The model demonstrated a good fit. RS (β = .34, p < .001) and alexithymia (β = .21, p < .001) were significantly associated with anger rumination, which, in turn, was linked to aggression (β = .37, p < .001). Both RS (β = .14, 95% CI [.08, .20]) and alexithymia (β = .07, 95% CI [.01, .12]) showed significant indirect effects on aggression via anger rumination. Anger rumination emerges as a key cognitive-affective pathway linking interpersonal hypersensitivity and emotional unawareness to aggression. Targeting rumination and emotional clarity may enhance interventions for aggression in rejection-sensitive individuals.

Psychology, health & medicineread the source →

Effect of cannabis use in people with chronic non-cancer pain prescribed opioids: findings from a 4-year prospective cohort study.

Background: Interest in the use of cannabis and cannabinoids to treat chronic non-cancer pain is increasing, because of their potential to reduce opioid dose requirements. We aimed to investigate cannabis use in people living with chronic non-cancer pain who had been prescribed opioids, including their reasons for use and perceived effectiveness of cannabis; associations between amount of cannabis use and pain, mental health, and opioid use; the effect of cannabis use on pain severity and interference over time; and potential opioid-sparing effects of cannabis. Methods: The Pain and Opioids IN Treatment study is a prospective, national, observational cohort of people with chronic non-cancer pain prescribed opioids. Participants were recruited through community pharmacies across Australia, completed baseline interviews, and were followed up with phone interviews or self-complete questionnaires yearly for 4 years. Recruitment took place from August 13, 2012, to April 8, 2014. Participants were asked about lifetime and past year chronic pain conditions, duration of chronic non-cancer pain, pain self-efficacy, whether pain was neuropathic, lifetime and past 12-month cannabis use, number of days cannabis was used in the past month, and current depression and generalised anxiety disorder. We also estimated daily oral morphine equivalent doses of opioids. We used logistic regression to investigate cross-sectional associations with frequency of cannabis use, and lagged mixed-effects models to examine temporal associations between cannabis use and outcomes. Findings: 1514 participants completed the baseline interview and were included in the study from Aug 20, 2012, to April 14, 2014. Cannabis use was common, and by 4-year follow-up, 295 (24%) participants had used cannabis for pain. Interest in using cannabis for pain increased from 364 (33%) participants (at baseline) to 723 (60%) participants (at 4 years). At 4-year follow-up, compared with people with no cannabis use, we found that participants who used cannabis had a greater pain severity score (risk ratio 1·14, 95% CI 1·01-1·29, for less frequent cannabis use; and 1·17, 1·03-1·32, for daily or near-daily cannabis use), greater pain interference score (1·21, 1·09-1·35; and 1·14, 1·03-1·26), lower pain self-efficacy scores (0·97, 0·96-1·00; and 0·98, 0·96-1·00), and greater generalised anxiety disorder severity scores (1·07, 1·03-1·12; and 1·10, 1·06-1·15). We found no evidence of a temporal relationship between cannabis use and pain severity or pain interference, and no evidence that cannabis use reduced prescribed opioid use or increased rates of opioid discontinuation. Interpretation: Cannabis use was common in people with chronic non-cancer pain who had been prescribed opioids, but we found no evidence that cannabis use improved patient outcomes. People who used cannabis had greater pain and lower self-efficacy in managing pain, and there was no evidence that cannabis use reduced pain severity or interference or exerted an opioid-sparing effect. As cannabis use for medicinal purposes increases globally, it is important that large well designed clinical trials, which include people with complex comorbidities, are conducted to determine the efficacy of cannabis for chronic non-cancer pain. Funding: National Health and Medical Research Council and the Australian Government.

The Lancet. Public health · 166 citationsread the source →

The Effects of Expressive Writing Interventions for Patients With Cancer: A Meta-Analysis.

Purpose/objectives: To evaluate the effects of expressive writing (EW) interventions in patients with cancer.
. Data sources: Electronic databases searched included both international and Korean databases through January 2015.
. Data synthesis: Of the 20 trials that met the eligibility criteria of this review, a meta-analysis was conducted of 14 articles involving 13 randomized and 1 nonrandomized trials with 1,718 patients with cancer. EW interventions were compared with a neutral writing intervention or usual care (no writing). A significant small effect was noted on relieving cancer symptoms; however, the effects on psychological and cognitive outcomes were not significant. When subgroup analysis by control condition was performed, a significant effect on health-related quality of life was found between the EW intervention group and the usual care group. 
. Conclusions: EW had significant small effects only on cancer symptoms. The findings suggest that the traditional EW intervention protocol may need to be intensified to confirm its effect on patients with cancer.
. Implications for nursing: Current evidence for EW as a nursing intervention for improving physical, psychological, and cognitive outcomes among patients with cancer is promising, but not conclusive.

Oncology nursing forum · meta-analysis · 14 citationsread the source →

Forced migration and human trafficking: survivors' narratives of strength and survival upon first arrival in Germany.

Background: Human trafficking poses a major public health challenge to the international community, with significant health and social consequences for those affected. Forced migrants are particularly vulnerable to becoming victims of human trafficking due to language barriers and migration-related hardships. These include social and economic deprivation. To better understand the lived experiences within this already vulnerable group, it is essential to examine individual cases in relation to risk factors, experiences of exploitation and exit, and resilience. Methods: Using a qualitative approach, this study examines social determinants and risk factors of forced migrants who survived human trafficking. It explores their experiences, eventual escape, and sheds light on their resilience. For this purpose, semi-structured interviews regarding the trafficking experiences were conducted with newly arrived forced migrants at a reception and registration centre in Germany. The presence of human trafficking was determined through an initial screening procedure and then confirmed in a personal interview. Additionally, we assessed the refugees' mental health burden with brief screening questionnaires for post-traumatic stress disorder, depression, anxiety, and the overall stress level (PC-PTSD-5, GAD-2, PHQ-2, RHS-15 distress thermometer). Findings: A total of 20 interviews were conducted with 14 female and 6 male participants. The participants came from 9 different countries. Most of them experienced sexual exploitation (N = 11), labour exploitation (N = 7). Few were trafficked but not exploited (N = 3). Participants reported that financial hardship was the main benefitting exploitation risk, and in many cases, they had been recruited by individuals they already knew. Spiritual rituals were sometimes used to increase pressure and control. Various forms of violence were inherent to the trafficking situations. In most cases, those affected managed to free themselves. Interpersonal connections and religious beliefs played a crucial role in coping with these experiences, however the screening for common mental disorders among refugees still indicated high levels of psychological distress. The results are discussed in relation to existing literature and implications for support and intervention are presented.

International journal for equity in healthread the source →

Health Benefits of Digital Videogames for the Aging Population: A Systematic Review.

Objective: This article presents the results of a systematic review of the latest, state-of-the-art research on videogames designed for older adults (i.e., those aged 65 or older) and the health benefits derived from playing these games. Findings from each study that met the inclusion criteria were analyzed and summarized into emergent themes to determine the impact of digital games in promoting healthy behaviors and benefits among these older adults. Materials and Methods: Five databases (PubMed, ScienceDirect, IEEE Xplore, ACM Digital Library, and Google Scholar) were searched for studies that evaluated interventions of videogames for older adults aged 65 and older. The initial search yielded 806 articles. After evaluating them against the inclusion criteria, 23 studies remained. Results: Out of the 23 studies we reviewed, 20 reported the significant impact of videogame interventions on the elderly's physical health. In addition, 14 studies reported effects on the elderly's mental health. Exergame is the most popular type of game used in these videogame-based interventions. This review also includes the details of study design (e.g., type of intervention, length, frequency), population sample, and measurements used in the studies. Conclusions: This systematic review demonstrates that videogame-based interventions are helpful in promoting physical health (i.e., balance, mobility, strength, physical fitness, and walking performance/gait parameters) and mental health (i.e., balance confidence, executive functions, reaction time, and processing speed) among older adults. It can also be used by researchers in this field to inform their design decisions. We have listed guidelines that can be used to frame future research in the area and enhance its quality.

Games for health journal · systematic review · 29 citationsread the source →

Life course health consequences and associated annual costs of adverse childhood experiences across Europe and North America: a systematic review and meta-analysis.

Background: An increasing number of studies are identifying associations between adverse childhood experiences (ACEs) and ill health throughout the life course. We aimed to calculate the proportions of major risk factors for and causes of ill health that are attributable to one or multiple types of ACE and the associated financial costs. Methods: In this systematic review and meta-analysis, we searched for studies in which risk data in individuals with ACEs were compared with these data in those without ACEs. We searched six electronic databases (MEDLINE, CINAHL, PsycINFO, Applied Social Sciences Index and Abstracts, Criminal Justice Databases, and the Education Resources Information Center) for quantitative studies published between Jan 1, 1990, and July 11, 2018, that reported risks of health-related behaviours and causes of ill health in adults that were associated with cumulative measures of ACEs (ie, number of ACEs). We included studies in adults in populations that did not have a high risk of ACEs, that had sample sizes of at least 1000 people, and that provided ACE prevalence data. We calculated the pooled RR for risk factors (harmful alcohol use, illicit drug use, smoking, and obesity) and causes of ill health (cancer, diabetes, cardiovascular disease, respiratory disease, anxiety, and depression) associated with ACEs. RRs were used to estimate the population-attributable fractions (PAFs) of risk attributable to ACEs and the disability-adjusted life-years (DALYs) and financial costs associated with ACEs. This study was prospectively registered in PROSPERO (CRD42018090356). Findings: Of 4387 unique articles found following our initial search, after review of the titles (and abstracts, when the title was relevant), we assessed 880 (20%) full-text articles. We considered 221 (25%) full-text articles for inclusion, of which 23 (10%) articles met all selection criteria for our meta-analysis. We found a pooled prevalence of 23·5% of individuals (95% CI 18·7-28·5) with one ACE and 18·7% (14·7-23·2) with two or more ACEs in Europe (from ten studies) and of 23·4% of individuals (22·0-24·8) with one ACE and 35·0% (31·6-38·4) with two or more ACEs in north America (from nine studies). Illicit drug use had the highest PAFs associated with ACEs of all the risk factors assessed in both regions (34·1% in Europe; 41·1% in north America). In both regions, PAFs of causes of ill health were highest for mental illness outcomes: ACEs were attributed to about 30% of cases of anxiety and 40% of cases of depression in north America and more than a quarter of both conditions in Europe. Costs of cardiovascular disease attributable to ACEs were substantially higher than for most other causes of ill health because of higher DALYs for this condition. Total annual costs attributable to ACEs were estimated to be US$581 billion in Europe and $748 billion in north America. More than 75% of these costs arose in individuals with two or more ACEs. Interpretation: Millions of adults across Europe and north America live with a legacy of ACEs. Our findings suggest that a 10% reduction in ACE prevalence could equate to annual savings of 3 million DALYs or $105 billion. Programmes to prevent ACEs and moderate their effects are available. Rebalancing expenditure towards ensuring safe and nurturing childhoods would be economically beneficial and relieve pressures on health-care systems. Funding: World Health Organization Regional Office for Europe.

The Lancet. Public health · meta-analysis · 660 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 →

Self-regulatory behaviour change techniques in interventions to promote healthy eating, physical activity, or weight loss: a meta-review.

Poor quality diet, physical inactivity, and obesity are prevalent, covariant risk factors for chronic disease, suggesting that behaviour change techniques (BCTs) that effectively change one risk factor might also improve the others. To examine that question, registered meta-review CRD42019128444 synthesised evidence from 30 meta-analyses published between 2007 and 2017 aggregating data from 409,185 participants to evaluate whether inclusion of 14 self-regulatory BCTs in health promotion interventions was associated with greater improvements in outcomes. Study populations and review quality varied, with minimal overlap among summarised studies. AMSTAR-2 ratings averaged 37.31% (SD = 16.21%; range 8.33-75%). All BCTs were examined in at least one meta-analysis; goal setting and self-monitoring were evaluated in 18 and 20 reviews, respectively. No BCT was consistently related to improved outcomes. Although results might indicate that BCTs fail to benefit diet and activity self-regulation, we suggest that a Type 3 error occurred, whereby the meta-analytic research design implemented to analyse effects of multi-component intervention trials designed for a different purpose was mismatched to the question of how BCTs affect health outcomes. An understanding of independent and interactive effects of individual BCTs on different health outcomes and populations is needed urgently to ground a cumulative science of behaviour change.

Health psychology review · meta-analysis · 55 citationsread the source →

A Meta-Analysis of Compassion-Based Interventions: Current State of Knowledge and Future Directions.

Objective: Scientific research into compassion has burgeoned over the past 20 years and interventions aiming to cultivate compassion towards self and others have been developed. This meta-analysis examined the effects of compassion-based interventions on a range of outcome measures. Method: Twenty-one randomized controlled trials (RCTs) from the last 12 years were included in the meta-analysis, with data from 1,285 participants analyzed. Effect sizes were standardized mean differences calculated using the difference in pre-post change in the treatment group and control group means, divided by the pooled pre-intervention standard deviation. Results: Significant between-group differences in change scores were found on self-report measures of compassion (d = 0.55, k = 4, 95% CI [0.33-0.78]), self-compassion (d = 0.70, k = 13, 95% CI [0.59-0.87]), mindfulness (d = 0.54, k = 6, 95% CI [0.38-0.71]), depression (d = 0.64, k = 9, 95% CI [0.45-0.82]), anxiety (d = 0.49, k = 9, 95% CI [0.30-0.68]), psychological distress (d = 0.47, k = 14, 95% CI [0.19-0.56]), and well-being (d = 0.51, k = 8, 95% CI [0.30-0.63]). These results remained when including active control comparisons. Evaluations of risk of bias across studies pointed towards a relative lack of publication bias and robustness of findings. However, the evidence base underpinning compassion interventions relies predominantly on small sample sizes. Conclusions: Future directions are provided for compassion research, including the need for improved methodological rigor, larger scale RCTs, increased specificity on the targets of compassion, and examination of compassion across the lifespan. Although further research is warranted, the current state of evidence highlights the potential benefits of compassion-based interventions on a range of outcomes.

Behavior therapy · meta-analysis · 288 citationsread the source →

Non-medical prescribing versus medical prescribing for acute and chronic disease management in primary and secondary care.

Background: A range of health workforce strategies are needed to address health service demands in low-, middle- and high-income countries. Non-medical prescribing involves nurses, pharmacists, allied health professionals, and physician assistants substituting for doctors in a prescribing role, and this is one approach to improve access to medicines. Objectives: To assess clinical, patient-reported, and resource use outcomes of non-medical prescribing for managing acute and chronic health conditions in primary and secondary care settings compared with medical prescribing (usual care). Search methods: We searched databases including CENTRAL, MEDLINE, Embase, and five other databases on 19 July 2016. We also searched the grey literature and handsearched bibliographies of relevant papers and publications. Selection criteria: Randomised controlled trials (RCTs), cluster-RCTs, controlled before-and-after (CBA) studies (with at least two intervention and two control sites) and interrupted time series analysis (with at least three observations before and after the intervention) comparing: 1. non-medical prescribing versus medical prescribing in acute care; 2. non-medical prescribing versus medical prescribing in chronic care; 3. non-medical prescribing versus medical prescribing in secondary care; 4 non-medical prescribing versus medical prescribing in primary care; 5. comparisons between different non-medical prescriber groups; and 6. non-medical healthcare providers with formal prescribing training versus those without formal prescribing training. Data collection and analysis: We used standard methodological procedures expected by Cochrane. Two review authors independently reviewed studies for inclusion, extracted data, and assessed study quality with discrepancies resolved by discussion. Two review authors independently assessed risk of bias for the included studies according to EPOC criteria. We undertook meta-analyses using the fixed-effect model where studies were examining the same treatment effect and to account for small sample sizes. We compared outcomes to a random-effects model where clinical or statistical heterogeneity existed. Main results: We included 46 studies (37,337 participants); non-medical prescribing was undertaken by nurses in 26 studies and pharmacists in 20 studies. In 45 studies non-medical prescribing as a component of care was compared with usual care medical prescribing. A further study compared nurse prescribing supported by guidelines with usual nurse prescribing care. No studies were found with non-medical prescribing being undertaken by other health professionals. The education requirement for non-medical prescribing varied with country and location.A meta-analysis of surrogate markers of chronic disease (systolic blood pressure, glycated haemoglobin, and low-density lipoprotein) showed positive intervention group effects. There was a moderate-certainty of evidence for studies of blood pressure at 12 months (mean difference (MD) -5.31 mmHg, 95% confidence interval (CI) -6.46 to -4.16; 12 studies, 4229 participants) and low-density lipoprotein (MD -0.21, 95% CI -0.29 to -0.14; 7 studies, 1469 participants); we downgraded the certainty of evidence from high due to considerations of serious inconsistency (considerable heterogeneity), multifaceted interventions, and variable prescribing autonomy. A high-certainty of evidence existed for comparative studies of glycated haemoglobin management at 12 months (MD -0.62, 95% CI -0.85 to -0.38; 6 studies, 775 participants). While there appeared little difference in medication adherence across studies, a meta-analysis of continuous outcome data from four studies showed an effect favouring patient adherence in the non-medical prescribing group (MD 0.15, 95% CI 0.00 to 0.30; 4 studies, 700 participants). We downgraded the certainty of evidence for adherence to moderate due to the serious risk of performance bias. While little difference was seen in patient-related adverse events between treatment groups, we downgraded the certainty of evidence to low due to indirectness, as the range of adverse events may not be related to the intervention and selective reporting failed to adequately report adverse events in many studies. Patients were generally satisfied with non-medical prescriber care (14 studies, 7514 participants). We downgraded the certainty of evidence from high to moderate due to indirectness, in that satisfaction with the prescribing component of care was only addressed in one study, and there was variability of satisfaction measures with little use of validated tools. A meta-analysis of health-related quality of life scores (SF-12 and SF-36) found a difference favouring usual care for the physical component score (MD 1.17, 95% CI 0.16 to 2.17), but not the mental component score (MD 0.58, 95% CI -0.40 to 1.55). However, the quality of life measurement may more appropriately reflect composite care rather than the prescribing component of care, and for this reason we downgraded the certainty of evidence to moderate due to indirectness of the measure of effect. A wide variety of resource use measures were reported across studies with little difference between groups for hospitalisations, emergency department visits, and outpatient visits. In the majority of studies reporting medication use, non-medical prescribers prescribed more drugs, intensified drug doses, and used a greater variety of drugs compared to usual care medical prescribers. The risk of bias across studies was generally low for selection bias (random sequence generation), detection bias (blinding of outcome assessment), attrition bias (incomplete outcome data), and reporting bias (selective reporting). There was an unclear risk of selection bias (allocation concealment) and for other biases. A high risk of performance bias (blinding of participants and personnel) existed. Authors' conclusions: The findings suggest that non-medical prescribers, practising with varying but high levels of prescribing autonomy, in a range of settings, were as effective as usual care medical prescribers. Non-medical prescribers can deliver comparable outcomes for systolic blood pressure, glycated haemoglobin, low-density lipoprotein, medication adherence, patient satisfaction, and health-related quality of life. It was difficult to determine the impact of non-medical prescribing compared to medical prescribing for adverse events and resource use outcomes due to the inconsistency and variability in reporting across studies. Future efforts should be directed towards more rigorous studies that can clearly identify the clinical, patient-reported, resource use, and economic outcomes of non-medical prescribing, in both high-income and low-income countries.

The Cochrane database of systematic reviews · meta-analysis · 128 citationsread the source →

Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions.

Background: Medical circumcisions are among the most common surgical procedures performed in males. The usual indications are phimosis (inability to completely retract the foreskin and expose the glans due to a congenital or acquired constriction of the prepuce), paraphimosis (when the foreskin is not pulled back over the glans after retraction resulting in a tight constricting band which causes swelling of the distal penis and acute discomfort), balanoposthitis (erythema and edema of the prepuce and glans) and balanitis (inflammation is confined to the glans; the foreskin is usually non-retractile). Circumcision devices have been developed to shorten the operative time, simplify techniques, and improve safety and cosmetic outcomes. The devices generally aim to crush the foreskin while simultaneously creating hemostasis, the foreskin is then excised or allowed to slough off. Their use is supposedly safer and easier to replicate than the standard dissection techniques. There are at least 20 devices for male circumcision on the market, yet their effectiveness has not been reviewed to date. Objectives: To assess the effects of device-based circumcisions compared with standard surgical techniques in adolescent and adult males (10 years old and above). Search methods: We performed a comprehensive search with no restrictions to the language of publication or publication status. We searched the Cochrane Library, MEDLINE (PubMed), Embase, Web of Science, trials registries, grey literature sources and conference proceedings up to 16 April 2020. Selection criteria: We included randomized controlled trials of device-based circumcisions (crush or ligature circumcision devices) compared to standard surgical dissection-based circumcision conducted by health professionals in a medical setting. Data collection and analysis: At least two review authors independently assessed study eligibility and extracted data from the included studies. We classified adverse events into serious, moderate or mild. We reported study results as risk ratios (RR) or mean differences (MD) using 95% confidence intervals (CI) and a random-effects model. We used the GRADE approach to evaluate the overall certainty of the evidence for each outcome. Main results: Eighteen trials met the inclusion criteria. Trials were conducted in China, South Africa, Kenya and Zambia, Mozambique, Rwanda, Uganda and Zimbabwe. Primary outcomes Serious adverse events: there were no serious adverse events in either treatment arm (11 trials, 3472 participants). Moderate adverse events: there may be a slight increase in moderate adverse events when devices are used compared to standard surgical techniques (RR 1.31, 95% CI 0.55 to 3.10; I²= 68%; 10 trials, 3370 participants; low-certainty evidence); this corresponds to 8 more (ranging from 15 fewer to 84 more) moderate adverse events per 1000 participants. We downgraded the certainty of the evidence for study limitations and imprecision. Secondary outcomes Mild adverse events: we are uncertain about the difference in mild adverse events between groups when devices are used compared to standard surgical techniques (RR 1.09, 95% CI 0.44 to 2.72; I² = 91%; 10 trials, 3370 participants; very low-certainty evidence). We downgraded the certainty of the evidence for study limitations, imprecision and unexplained inconsistency. Operative time: operative time is probably about 17 minutes shorter when using a device rather than standard surgical techniques, which constitutes a clinically meaningful decrease in a procedure (MD -17.26 minutes, 95% CI -19.96 to -14.57; I² = 99%; 14 trials, 4812 participants; moderate-certainty evidence). We downgraded the certainty of the evidence for serious study limitations. The standard surgical technique generally takes about 24 minutes. There may be less postoperative pain during the first 24 hours when circumcision devices are used compared to standard surgical techniques (measured using a visual analog scale [VAS]; MD 1.30 cm lower, 95% CI 2.37 lower to 0.22 lower; I² = 99%; 9 trials, 3022 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained heterogeneity. There may be little or no difference in postoperative pain experienced during the first seven days when compared with standard surgical techniques (measured using a VAS; MD 0.11 cm higher, 95% CI 0.89 lower to 1.11 higher; I² = 94%; 4 trials, 1430 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained inconsistency. A higher score on the VAS indicates greater pain. Participants may slightly prefer circumcision devices compared to standard surgical techniques (RR 1.19, 95% CI 1.04 to 1.37; I² = 97%; 15 trials, 4501 participants; low-certainty evidence). We downgraded the certainty of the evidence for study limitations and unexplained inconsistency. We recorded satisfaction as a dichotomous outcome. Higher rates reflected greater satisfaction. Authors' conclusions: We found that there were no serious adverse events reported when using a circumcision device compared to standard surgical techniques, but they may slightly increase moderate adverse effects, and it is unclear whether there is a difference in mild adverse effects. Use of circumcision devices probably reduces the time of the procedure by about 17 minutes, a clinically meaningful time saving. For patients, use of the circumcision device may result in lower pain scores during the first 24 hours and patients may be slightly more satisfied with it compared with standard surgical techniques. Clinicians, patients and policymakers can use these results in conjunction with their own contextual factors to inform the approach that best suits their healthcare settings. High-quality trials evaluating this intervention are needed to provide further certainty regarding the rates of adverse effects and postoperative pain of using devices compared to standard approaches.

The Cochrane database of systematic reviews · meta-analysis · 15 citationsread the source →

Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the COVID-19 pandemic.

Background: Before the COVID-19 pandemic, coronaviruses caused two noteworthy outbreaks: severe acute respiratory syndrome (SARS), starting in 2002, and Middle East respiratory syndrome (MERS), starting in 2012. We aimed to assess the psychiatric and neuropsychiatric presentations of SARS, MERS, and COVID-19. Methods: In this systematic review and meta-analysis, MEDLINE, Embase, PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature databases (from their inception until March 18, 2020), and medRxiv, bioRxiv, and PsyArXiv (between Jan 1, 2020, and April 10, 2020) were searched by two independent researchers for all English-language studies or preprints reporting data on the psychiatric and neuropsychiatric presentations of individuals with suspected or laboratory-confirmed coronavirus infection (SARS coronavirus, MERS coronavirus, or SARS coronavirus 2). We excluded studies limited to neurological complications without specified neuropsychiatric presentations and those investigating the indirect effects of coronavirus infections on the mental health of people who are not infected, such as those mediated through physical distancing measures such as self-isolation or quarantine. Outcomes were psychiatric signs or symptoms; symptom severity; diagnoses based on ICD-10, DSM-IV, or the Chinese Classification of Mental Disorders (third edition) or psychometric scales; quality of life; and employment. Both the systematic review and the meta-analysis stratified outcomes across illness stages (acute vs post-illness) for SARS and MERS. We used a random-effects model for the meta-analysis, and the meta-analytical effect size was prevalence for relevant outcomes, I2 statistics, and assessment of study quality. Findings: 1963 studies and 87 preprints were identified by the systematic search, of which 65 peer-reviewed studies and seven preprints met inclusion criteria. The number of coronavirus cases of the included studies was 3559, ranging from 1 to 997, and the mean age of participants in studies ranged from 12·2 years (SD 4·1) to 68·0 years (single case report). Studies were from China, Hong Kong, South Korea, Canada, Saudi Arabia, France, Japan, Singapore, the UK, and the USA. Follow-up time for the post-illness studies varied between 60 days and 12 years. The systematic review revealed that during the acute illness, common symptoms among patients admitted to hospital for SARS or MERS included confusion (36 [27·9%; 95% CI 20·5-36·0] of 129 patients), depressed mood (42 [32·6%; 24·7-40·9] of 129), anxiety (46 [35·7%; 27·6-44·2] of 129), impaired memory (44 [34·1%; 26·2-42·5] of 129), and insomnia (54 [41·9%; 22·5-50·5] of 129). Steroid-induced mania and psychosis were reported in 13 (0·7%) of 1744 patients with SARS in the acute stage in one study. In the post-illness stage, depressed mood (35 [10·5%; 95% CI 7·5-14·1] of 332 patients), insomnia (34 [12·1%; 8·6-16·3] of 280), anxiety (21 [12·3%; 7·7-17·7] of 171), irritability (28 [12·8%; 8·7-17·6] of 218), memory impairment (44 [18·9%; 14·1-24·2] of 233), fatigue (61 [19·3%; 15·1-23·9] of 316), and in one study traumatic memories (55 [30·4%; 23·9-37·3] of 181) and sleep disorder (14 [100·0%; 88·0-100·0] of 14) were frequently reported. The meta-analysis indicated that in the post-illness stage the point prevalence of post-traumatic stress disorder was 32·2% (95% CI 23·7-42·0; 121 of 402 cases from four studies), that of depression was 14·9% (12·1-18·2; 77 of 517 cases from five studies), and that of anxiety disorders was 14·8% (11·1-19·4; 42 of 284 cases from three studies). 446 (76·9%; 95% CI 68·1-84·6) of 580 patients from six studies had returned to work at a mean follow-up time of 35·3 months (SD 40·1). When data for patients with COVID-19 were examined (including preprint data), there was evidence for delirium (confusion in 26 [65%] of 40 intensive care unit patients and agitation in 40 [69%] of 58 intensive care unit patients in one study, and altered consciousness in 17 [21%] of 82 patients who subsequently died in another study). At discharge, 15 (33%) of 45 patients with COVID-19 who were assessed had a dysexecutive syndrome in one study. At the time of writing, there were two reports of hypoxic encephalopathy and one report of encephalitis. 68 (94%) of the 72 studies were of either low or medium quality. Interpretation: If infection with SARS-CoV-2 follows a similar course to that with SARS-CoV or MERS-CoV, most patients should recover without experiencing mental illness. SARS-CoV-2 might cause delirium in a significant proportion of patients in the acute stage. Clinicians should be aware of the possibility of depression, anxiety, fatigue, post-traumatic stress disorder, and rarer neuropsychiatric syndromes in the longer term. Funding: Wellcome Trust, UK National Institute for Health Research (NIHR), UK Medical Research Council, NIHR Biomedical Research Centre at University College London Hospitals NHS Foundation Trust and University College London.

The lancet. Psychiatry · meta-analysis · 1531 citationsread the source →

Transcutaneous electrical nerve stimulation (TENS) for fibromyalgia in adults.

Background: Fibromyalgia is characterised by persistent, widespread pain; sleep problems; and fatigue. Transcutaneous electrical nerve stimulation (TENS) is the delivery of pulsed electrical currents across the intact surface of the skin to stimulate peripheral nerves and is used extensively to manage painful conditions. TENS is inexpensive, safe, and can be self-administered. TENS reduces pain during movement in some people so it may be a useful adjunct to assist participation in exercise and activities of daily living. To date, there has been only one systematic review in 2012 which included TENS, amongst other treatments, for fibromyalgia, and the authors concluded that TENS was not effective. Objectives: To assess the analgesic efficacy and adverse events of TENS alone or added to usual care (including exercise) compared with placebo (sham) TENS; no treatment; exercise alone; or other treatment including medication, electroacupuncture, warmth therapy, or hydrotherapy for fibromyalgia in adults. Search methods: We searched the following electronic databases up to 18 January 2017: CENTRAL (CRSO); MEDLINE (Ovid); Embase (Ovid); CINAHL (EBSCO); PsycINFO (Ovid); LILACS; PEDRO; Web of Science (ISI); AMED (Ovid); and SPORTDiscus (EBSCO). We also searched three trial registries. There were no language restrictions. Selection criteria: We included randomised controlled trials (RCTs) or quasi-randomised trials of TENS treatment for pain associated with fibromyalgia in adults. We included cross-over and parallel-group trial designs. We included studies that evaluated TENS administered using non-invasive techniques at intensities that produced perceptible TENS sensations during stimulation at either the site of pain or over nerve bundles proximal (or near) to the site of pain. We included TENS administered as a sole treatment or TENS in combination with other treatments, and TENS given as a single treatment or as a course of treatments. Data collection and analysis: Two review authors independently determined study eligibility by assessing each record and reaching agreement by discussion. A third review author acted as arbiter. We did not anonymise the records of studies before assessment. Two review authors independently extracted data and assessed risk of bias of included studies before entering information into a 'Characteristics of included studies' table. Primary outcomes were participant-reported pain relief from baseline of 30% or greater or 50% or greater, and Patient Global Impression of Change (PGIC). We assessed the evidence using GRADE and added 'Summary of findings' tables. Main results: We included eight studies (seven RCTs, one quasi-RCT, 315 adults (299 women), aged 18 to 75 years): six used a parallel-group design and two used a cross-over design. Sample sizes of intervention arms were five to 43 participants. Two studies, one of which was a cross-over design, compared TENS with placebo TENS (82 participants), one study compared TENS with no treatment (43 participants), and four studies compared TENS with other treatments (medication (two studies, 74 participants), electroacupuncture (one study, 44 participants), superficial warmth (one cross-over study, 32 participants), and hydrotherapy (one study, 10 participants)). Two studies compared TENS plus exercise with exercise alone (98 participants, 49 per treatment arm). None of the studies measured participant-reported pain relief of 50% or greater or PGIC. Overall, the studies were at unclear or high risk of bias, and in particular all were at high risk of bias for sample size. Only one study (14 participants) measured the primary outcome participant-reported pain relief of 30% or greater. Thirty percent achieved 30% or greater reduction in pain with TENS and exercise compared with 13% with exercise alone. One study found 10/28 participants reported pain relief of 25% or greater with TENS compared with 10/24 participants using superficial warmth (42 °C). We judged that statistical pooling was not possible because there were insufficient data and outcomes were not homogeneous. There were no data for the primary outcomes participant-reported pain relief from baseline of 50% or greater and PGIC.There was a paucity of data for secondary outcomes. One pilot cross-over study of 43 participants found that the mean (95% confidence intervals (CI)) decrease in pain intensity on movement (100-mm visual analogue scale (VAS)) during one 30-minute treatment was 11.1 mm (95% CI 5.9 to 16.3) for TENS and 2.3 mm (95% CI 2.4 to 7.7) for placebo TENS. There were no significant differences between TENS and placebo for pain at rest. One parallel group study of 39 participants found that mean ± standard deviation (SD) pain intensity (100-mm VAS) decreased from 85 ± 20 mm at baseline to 43 ± 20 mm after one week of dual-site TENS; decreased from 85 ± 10 mm at baseline to 60 ± 10 mm after single-site TENS; and decreased from 82 ± 20 mm at baseline to 80 ± 20 mm after one week of placebo TENS. The authors of seven studies concluded that TENS relieved pain but the findings of single small studies are unlikely to be correct. One study found clinically important improvements in Fibromyalgia Impact Questionnaire (FIQ) subscales for work performance, fatigue, stiffness, anxiety, and depression for TENS with exercise compared with exercise alone. One study found no additional improvements in FIQ scores when TENS was added to the first three weeks of a 12-week supervised exercise programme. No serious adverse events were reported in any of the studies although there were reports of TENS causing minor discomfort in a total of 3 participants. The quality of evidence was very low. We downgraded the GRADE rating mostly due to a lack of data; therefore, we have little confidence in the effect estimates where available. Authors' conclusions: There was insufficient high-quality evidence to support or refute the use of TENS for fibromyalgia. We found a small number of inadequately powered studies with incomplete reporting of methodologies and treatment interventions.

The Cochrane database of systematic reviews · meta-analysis · 48 citationsread the source →

Omega-3 fatty acid addition during pregnancy.

Background: Higher intakes of foods containing omega-3 long-chain polyunsaturated fatty acids (LCPUFA), such as fish, during pregnancy have been associated with longer gestations and improved perinatal outcomes. This is an update of a review that was first published in 2006. Objectives: To assess the effects of omega-3 LCPUFA, as supplements or as dietary additions, during pregnancy on maternal, perinatal, and neonatal outcomes and longer-term outcomes for mother and child. Search methods: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (16 August 2018), and reference lists of retrieved studies. Selection criteria: Randomised controlled trials (RCTs) comparing omega-3 fatty acids (as supplements or as foods, stand-alone interventions, or with a co-intervention) during pregnancy with placebo or no omega-3, and studies or study arms directly comparing omega-3 LCPUFA doses or types. Trials published in abstract form were eligible for inclusion. Data collection and analysis: Two review authors independently assessed study eligibility, extracted data, assessed risk of bias in trials and assessed quality of evidence for prespecified birth/infant, maternal, child/adult and health service outcomes using the GRADE approach. Main results: In this update, we included 70 RCTs (involving 19,927 women at low, mixed or high risk of poor pregnancy outcomes) which compared omega-3 LCPUFA interventions (supplements and food) compared with placebo or no omega-3. Overall study-level risk of bias was mixed, with selection and performance bias mostly at low risk, but there was high risk of attrition bias in some trials. Most trials were conducted in upper-middle or high-income countries; and nearly half the trials included women at increased/high risk for factors which might increase the risk of adverse maternal and birth outcomes. Preterm birth < 37 weeks (13.4% versus 11.9%; risk ratio (RR) 0.89, 95% confidence interval (CI) 0.81 to 0.97; 26 RCTs, 10,304 participants; high-quality evidence) and early preterm birth < 34 weeks (4.6% versus 2.7%; RR 0.58, 95% CI 0.44 to 0.77; 9 RCTs, 5204 participants; high-quality evidence) were both lower in women who received omega-3 LCPUFA compared with no omega-3. Prolonged gestation > 42 weeks was probably increased from 1.6% to 2.6% in women who received omega-3 LCPUFA compared with no omega-3 (RR 1.61 95% CI 1.11 to 2.33; 5141 participants; 6 RCTs; moderate-quality evidence).For infants, there was a possibly reduced risk of perinatal death (RR 0.75, 95% CI 0.54 to 1.03; 10 RCTs, 7416 participants; moderate-quality evidence: 62/3715 versus 83/3701 infants) and possibly fewer neonatal care admissions (RR 0.92, 95% CI 0.83 to 1.03; 9 RCTs, 6920 participants; moderate-quality evidence - 483/3475 infants versus 519/3445 infants). There was a reduced risk of low birthweight (LBW) babies (15.6% versus 14%; RR 0.90, 95% CI 0.82 to 0.99; 15 trials, 8449 participants; high-quality evidence); but a possible small increase in large-for-gestational age (LGA) babies (RR 1.15, 95% CI 0.97 to 1.36; 6 RCTs, 3722 participants; moderate-quality evidence, for omega-3 LCPUFA compared with no omega-3. Little or no difference in small-for-gestational age or intrauterine growth restriction (RR 1.01, 95% CI 0.90 to 1.13; 8 RCTs, 6907 participants; moderate-quality evidence) was seen. For the maternal outcomes, there is insufficient evidence to determine the effects of omega-3 on induction post-term (average RR 0.82, 95% CI 0.22 to 2.98; 3 trials, 2900 participants; low-quality evidence), maternal serious adverse events (RR 1.04, 95% CI 0.40 to 2.72; 2 trials, 2690 participants; low-quality evidence), maternal admission to intensive care (RR 0.56, 95% CI 0.12 to 2.63; 2 trials, 2458 participants; low-quality evidence), or postnatal depression (average RR 0.99, 95% CI 0.56 to 1.77; 2 trials, 2431 participants; low-quality evidence). Mean gestational length was greater in women who received omega-3 LCPUFA (mean difference (MD) 1.67 days, 95% CI 0.95 to 2.39; 41 trials, 12,517 participants; moderate-quality evidence), and pre-eclampsia may possibly be reduced with omega-3 LCPUFA (RR 0.84, 95% CI 0.69 to 1.01; 20 trials, 8306 participants; low-quality evidence).For the child/adult outcomes, very few differences between antenatal omega-3 LCPUFA supplementation and no omega-3 were observed in cognition, IQ, vision, other neurodevelopment and growth outcomes, language and behaviour (mostly low-quality to very low-quality evidence). The effect of omega-3 LCPUFA on body mass index at 19 years (MD 0, 95% CI -0.83 to 0.83; 1 trial, 243 participants; very low-quality evidence) was uncertain. No data were reported for development of diabetes in the children of study participants. Authors' conclusions: In the overall analysis, preterm birth < 37 weeks and early preterm birth < 34 weeks were reduced in women receiving omega-3 LCPUFA compared with no omega-3. There was a possibly reduced risk of perinatal death and of neonatal care admission, a reduced risk of LBW babies; and possibly a small increased risk of LGA babies with omega-3 LCPUFA.For our GRADE quality assessments, we assessed most of the important perinatal outcomes as high-quality (e.g. preterm birth) or moderate-quality evidence (e.g. perinatal death). For the other outcome domains (maternal, child/adult and health service outcomes) GRADE ratings ranged from moderate to very low, with over half rated as low. Reasons for downgrading across the domain were mostly due to design limitations and imprecision. Omega-3 LCPUFA supplementation during pregnancy is an effective strategy for reducing the incidence of preterm birth, although it probably increases the incidence of post-term pregnancies. More studies comparing omega-3 LCPUFA and placebo (to establish causality in relation to preterm birth) are not needed at this stage. A further 23 ongoing trials are still to report on over 5000 women, so no more RCTs are needed that compare omega-3 LCPUFA against placebo or no intervention. However, further follow-up of completed trials is needed to assess longer-term outcomes for mother and child, to improve understanding of metabolic, growth and neurodevelopment pathways in particular, and to establish if, and how, outcomes vary by different types of omega-3 LCPUFA, timing and doses; or by characteristics of women.

The Cochrane database of systematic reviews · meta-analysis · 254 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 →

Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews.

Background: Chronic pain is defined as pain lasting beyond normal tissue healing time, generally taken to be 12 weeks. It contributes to disability, anxiety, depression, sleep disturbances, poor quality of life, and healthcare costs. Chronic pain has a weighted mean prevalence in adults of 20%.For many years, the treatment choice for chronic pain included recommendations for rest and inactivity. However, exercise may have specific benefits in reducing the severity of chronic pain, as well as more general benefits associated with improved overall physical and mental health, and physical functioning. Physical activity and exercise programmes are increasingly being promoted and offered in various healthcare systems, and for a variety of chronic pain conditions. It is therefore important at this stage to establish the efficacy and safety of these programmes, and furthermore to address the critical factors that determine their success or failure. Objectives: To provide an overview of Cochrane Reviews of adults with chronic pain to determine (1) the effectiveness of different physical activity and exercise interventions in reducing pain severity and its impact on function, quality of life, and healthcare use; and (2) the evidence for any adverse effects or harm associated with physical activity and exercise interventions. Methods: We searched theCochrane Database of Systematic Reviews (CDSR) on the Cochrane Library (CDSR 2016, Issue 1) for systematic reviews of randomised controlled trials (RCTs), after which we tracked any included reviews for updates, and tracked protocols in case of full review publication until an arbitrary cut-off date of 21 March 2016 (CDSR 2016, Issue 3). We assessed the methodological quality of the reviews using the AMSTAR tool, and also planned to analyse data for each painful condition based on quality of the evidence. We extracted data for (1) self-reported pain severity, (2) physical function (objectively or subjectively measured), (3) psychological function, (4) quality of life, (5) adherence to the prescribed intervention, (6) healthcare use/attendance, (7) adverse events, and (8) death. Due to the limited data available, we were unable to directly compare and analyse interventions, and have instead reported the evidence qualitatively. Main results: We included 21 reviews with 381 included studies and 37,143 participants. Of these, 264 studies (19,642 participants) examined exercise versus no exercise/minimal intervention in adults with chronic pain and were used in the qualitative analysis. Pain conditions included rheumatoid arthritis, osteoarthritis, fibromyalgia, low back pain, intermittent claudication, dysmenorrhoea, mechanical neck disorder, spinal cord injury, postpolio syndrome, and patellofemoral pain. None of the reviews assessed 'chronic pain' or 'chronic widespread pain' as a general term or specific condition. Interventions included aerobic, strength, flexibility, range of motion, and core or balance training programmes, as well as yoga, Pilates, and tai chi. Reviews were well performed and reported (based on AMSTAR), and included studies had acceptable risk of bias (with inadequate reporting of attrition and reporting biases). However the quality of evidence was low due to participant numbers (most included studies had fewer than 50 participants in total), length of intervention and follow-up (rarely assessed beyond three to six months). We pooled the results from relevant reviews where appropriate, though results should be interpreted with caution due to the low quality evidence. Pain severity: several reviews noted favourable results from exercise: only three reviews that reported pain severity found no statistically significant changes in usual or mean pain from any intervention. However, results were inconsistent across interventions and follow-up, as exercise did not consistently bring about a change (positive or negative) in self-reported pain scores at any single point. Physical function: was the most commonly reported outcome measure. Physical function was significantly improved as a result of the intervention in 14 reviews, though even these statistically significant results had only small-to-moderate effect sizes (only one review reported large effect sizes). Psychological function and quality of life: had variable results: results were either favourable to exercise (generally small and moderate effect size, with two reviews reporting significant, large effect sizes for quality of life), or showed no difference between groups. There were no negative effects. Adherence to the prescribed intervention: could not be assessed in any review. However, risk of withdrawal/dropout was slightly higher in the exercising group (82.8/1000 participants versus 81/1000 participants), though the group difference was non-significant. Healthcare use/attendance: was not reported in any review. Adverse events, potential harm, and death: only 25% of included studies (across 18 reviews) actively reported adverse events. Based on the available evidence, most adverse events were increased soreness or muscle pain, which reportedly subsided after a few weeks of the intervention. Only one review reported death separately to other adverse events: the intervention was protective against death (based on the available evidence), though did not reach statistical significance. Authors' conclusions: The quality of the evidence examining physical activity and exercise for chronic pain is low. This is largely due to small sample sizes and potentially underpowered studies. A number of studies had adequately long interventions, but planned follow-up was limited to less than one year in all but six reviews. There were some favourable effects in reduction in pain severity and improved physical function, though these were mostly of small-to-moderate effect, and were not consistent across the reviews. There were variable effects for psychological function and quality of life. The available evidence suggests physical activity and exercise is an intervention with few adverse events that may improve pain severity and physical function, and consequent quality of life. However, further research is required and should focus on increasing participant numbers, including participants with a broader spectrum of pain severity, and lengthening both the intervention itself, and the follow-up period.

The Cochrane database of systematic reviews · meta-analysis · 484 citationsread the source →

Physical activity for women with breast cancer after adjuvant therapy.

Background: Women with a diagnosis of breast cancer may experience short- and long-term disease and treatment-related adverse physiological and psychosocial outcomes. These outcomes can negatively impact prognosis, health-related quality of life (HRQoL), and psychosocial and physical function. Physical activity may help to improve prognosis and may alleviate the adverse effects of adjuvant therapy. Objectives: To assess effects of physical activity interventions after adjuvant therapy for women with breast cancer. Search methods: We searched the Cochrane Breast Cancer Group (CBCG) Specialised Registry, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Physiotherapy Evidence Database (PEDro), SPORTDiscus, PsycINFO, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform, on 18 September 2015. We also searched OpenGrey and Healthcare Management Information Consortium databases. Selection criteria: We searched for randomised and quasi-randomised trials comparing physical activity interventions versus control (e.g. usual or standard care, no physical activity, no exercise, attention control, placebo) after adjuvant therapy (i.e. after completion of chemotherapy and/or radiation therapy, but not hormone therapy) in women with breast cancer. Data collection and analysis: Two review authors independently selected studies, assessed risk of bias, and extracted data. We contacted trial authors to ask for additional information when needed. We calculated an overall effect size with 95% confidence intervals (CIs) for each outcome and used GRADE to assess the quality of evidence for the most important outcomes. Main results: We included 63 trials that randomised 5761 women to a physical activity intervention (n = 3239) or to a control (n = 2524). The duration of interventions ranged from 4 to 24 months, with most lasting 8 or 12 weeks (37 studies). Twenty-eight studies included aerobic exercise only, 21 involved aerobic exercise and resistance training, and seven used resistance training only. Thirty studies described the comparison group as usual or standard care, no intervention, or control. One-fifth of studies reported at least 20% intervention attrition and the average physical activity adherence was approximately 77%.No data were available on effects of physical activity on breast cancer-related and all-cause mortality, or on breast cancer recurrence. Analysis of immediately postintervention follow-up values and change from baseline to end of intervention scores revealed that physical activity interventions resulted in significant small-to-moderate improvements in HRQoL (standardised mean difference (SMD) 0.39, 95% CI 0.21 to 0.57, 22 studies, 1996 women; SMD 0.78, 95% CI 0.39 to 1.17, 14 studies, 1459 women, respectively; low-quality evidence), emotional function (SMD 0.21, 95% CI 0.10 to 0.32, 26 studies, 2102 women, moderate-quality evidence; SMD 0.31, 95% CI 0.09 to 0.53, 15 studies, 1579 women, respectively; low-quality evidence), perceived physical function (SMD 0.33, 95% CI 0.18 to 0.49, 25 studies, 2129 women; SMD 0.60, 95% CI 0.23 to 0.97, 13 studies, 1433 women, respectively; moderate-quality evidence), anxiety (SMD -0.57, 95% CI -0.95 to -0.19, 7 studies, 326 women; SMD -0.37, 95% CI -0.63 to -0.12, 4 studies, 235 women, respectively; low-quality evidence), and cardiorespiratory fitness (SMD 0.44, 95% CI 0.30 to 0.58, 23 studies, 1265 women, moderate-quality evidence; SMD 0.83, 95% CI 0.40 to 1.27, 9 studies, 863 women, respectively; very low-quality evidence).Investigators reported few minor adverse events. Small improvements in physical activity interventions were sustained for three months or longer postintervention in fatigue (SMD -0.43, 95% CI -0.60 to -0.26; SMD -0.47, 95% CI -0.84 to -0.11, respectively), cardiorespiratory fitness (SMD 0.36, 95% CI 0.03 to 0.69; SMD 0.42, 95% CI 0.05 to 0.79, respectively), and self-reported physical activity (SMD 0.44, 95% CI 0.17 to 0.72; SMD 0.51, 95% CI 0.08 to 0.93, respectively) for both follow-up values and change from baseline scores. However, evidence of heterogeneity across trials was due to variation in intervention components (i.e. mode, frequency, intensity, duration of intervention and sessions) and measures used to assess outcomes. All trials reviewed were at high risk of performance bias, and most were also at high risk of detection, attrition, and selection bias. In light of the aforementioned issues, we determined that the evidence was of very low, low, or moderate quality. Authors' conclusions: No conclusions regarding breast cancer-related and all-cause mortality or breast cancer recurrence were possible. However, physical activity interventions may have small-to-moderate beneficial effects on HRQoL, and on emotional or perceived physical and social function, anxiety, cardiorespiratory fitness, and self-reported and objectively measured physical activity. The positive results reported in the current review must be interpreted cautiously owing to very low-to-moderate quality of evidence, heterogeneity of interventions and outcome measures, imprecision of some estimates, and risk of bias in many trials. Future studies with low risk of bias are required to determine the optimal combination of physical activity modes, frequencies, intensities, and durations needed to improve specific outcomes among women who have undergone adjuvant therapy.

The Cochrane database of systematic reviews · meta-analysis · 165 citationsread the source →

Adherence to a Mediterranean-Style Diet and Its Influence on Cardiovascular Risk Factors in Postmenopausal Women.

Background: A Mediterranean-style diet (MedSD) is associated with positive health outcomes, particularly reduced risk of cardiovascular disease. It is of interest to assess the feasibility of adherence to a MedSD in a subset of older adults in the United States. Objective: To assess the efficacy of implementing a MedSD intervention in a subset of postmenopausal women living in the United States, and to detect the influence of this dietary pattern on blood lipid levels. Design: A partial feeding, nutrition counseling, pilot study with a one-group longitudinal design. Participants: Sixteen healthy, postmenopausal, American women living in suburban communities in Farmington, CT, with a mean±standard deviation age of 77±6.8 years and a body mass index of 26.1±3.1. Intervention: Participants were counseled by a registered dietitian nutritionist on how to follow a MedSD, which included increased sources of n-3 polyunsaturated fatty acids, fruits, and vegetables, and decreased saturated fat, n-6 polyunsaturated fatty acids, and simple sugars for 12 weeks. To maintain isocaloric conditions, participants were asked to substitute sources of saturated fat and refined carbohydrates for extra virgin olive oil (3 T/day), walnuts (1.5 oz/day), and fatty fish (3 to 5 servings/wk), which were provided at 3-week intervals. Main outcome measures: Dietary adherence measures included the Mediterranean Diet Score, 3-day diet records, and serum fatty acid and lipid profiles. Statistical analyses: Mixed model longitudinal analyses were conducted to assess changes over time (Weeks 0, 12, and 24) in the outcome variables. Results: Mediterranean Diet Score increased by 8.9 points (P<0.001) after the MedSD phase. Dietary sugar decreased by 10.8 g (P<0.05), total dietary n-3 increased by 1.6 g (P<0.01), total dietary n-6 increased by 5.5 g (P<0.01), and dietary n-6:n3 ratio decreased by 3.6 units (P<0.01). In serum, 22:6 (n-3), 20:5 (n-3), and 18:3 (n-3) increased (P<0.001, P<0.01, and P<0.001, respectively), and 14:0, 16:0, 17:0, 20:4 (n-6), 22:4 (n-6) declined after the intervention (P<0.01, P<0.001, P<0.01, P<0.01, and P<0.001, respectively), which support a change in dietary intake toward a MedSD. Serum high-density lipoprotein cholesterol levels increased by 3.8 mg/dL (0.098 mmol/L) (P<0.05) and serum triglyceride levels decreased by 11.6 mg/dL (0.131 mmol/L) (P<0.10). Conclusions: A pilot study of a 12-week MedSD intervention with counseling from a registered dietitian nutritionist can favorably influence the dietary pattern and lipid profile of postmenopausal women living in the United States.

Journal of the Academy of Nutrition and Dietetics · 13 citationsread the source →

What to do with a patient who smokes.

Despite the reality that smoking remains the most important preventable cause of death and disability, most clinicians underperform in helping smokers quit. Of the 46 million current smokers in the United States, 70% say they would like to quit, but only a small fraction are able to do so on their own because nicotine is so highly addictive. One third to one half of all smokers die prematurely. Reasons clinicians avoid helping smokers quit include time constraints, lack of expertise, lack of financial incentives, respect for a smoker's privacy, fear that a negative message might lose customers, pessimism because most smokers are unable to quit, stigma, and clinicians being smokers. The gold standard for cessation treatment is the 5 As (ask, advise, assess, assist, and arrange). Yet, only a minority of physicians know about these, and fewer put them to use. Acceptable shortcuts are asking, advising, and referring to a telephone "quit line" or an internal referral system. Successful treatment combines counseling with pharmacotherapy (nicotine replacement therapy with or without psychotropic medication such as bupropion). Nicotine replacement therapy comes in long-acting (patch) or short-acting (gum, lozenge, nasal spray, or inhaler) forms. Ways to counter clinicians' pessimism about cessation include the knowledge that most smokers require multiple quit attempts before they succeed, that rigorous studies show long-term quit rates of 14% to 20%, with 1 report as high as 35%, that cessation rates for users of telephone quit lines and integrated health care systems are comparable with those of individual clinicians, and that no other clinical intervention can offer such a large potential benefit.

JAMA · 201 citationsread the source →

Gut microbiome remodeling and metabolomic profile improves in response to protein pacing with intermittent fasting versus continuous caloric restriction.

The gut microbiome (GM) modulates body weight/composition and gastrointestinal functioning; therefore, approaches targeting resident gut microbes have attracted considerable interest. Intermittent fasting (IF) and protein pacing (P) regimens are effective in facilitating weight loss (WL) and enhancing body composition. However, the interrelationships between IF- and P-induced WL and the GM are unknown. The current randomized controlled study describes distinct fecal microbial and plasma metabolomic signatures between combined IF-P (n = 21) versus a heart-healthy, calorie-restricted (CR, n = 20) diet matched for overall energy intake in free-living human participants (women = 27; men = 14) with overweight/obesity for 8 weeks. Gut symptomatology improves and abundance of Christensenellaceae microbes and circulating cytokines and amino acid metabolites favoring fat oxidation increase with IF-P (p < 0.05), whereas metabolites associated with a longevity-related metabolic pathway increase with CR (p < 0.05). Differences indicate GM and metabolomic factors play a role in WL maintenance and body composition. This novel work provides insight into the GM and metabolomic profile of participants following an IF-P or CR diet and highlights important differences in microbial assembly associated with WL and body composition responsiveness. These data may inform future GM-focused precision nutrition recommendations using larger sample sizes of longer duration. Trial registration, March 6, 2020 (ClinicalTrials.gov as NCT04327141), based on a previous randomized intervention trial.

Nature communications · randomised controlled trial · 61 citationsread the source →