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To provide recommendations for the selection of comparators for randomized controlled trials of health-related behavioral interventions. The National Institutes of Health Office of Behavioral and Social Science Research convened an expert panel to critically review the literature on control or comparison groups for behavioral trials and to develop strategies for improving comparator choices and for resolving controversies and disagreements about comparators. The panel developed a Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials. The model indicates that the optimal comparator is the one that best serves the primary purpose of the trial but that the optimal comparator's limitations and barriers to its use must also be taken into account. We developed best practice recommendations for the selection of comparators for health-related behavioral trials. Use of the Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials can improve the comparator selection process and help resolve disagreements about comparator choices.

Children with parents suffering from a psychiatric disorder are at higher risk for developing a mental disorder themselves. This systematic review and meta-analysis of randomized controlled trials aims to evaluate the efficacy of psychosocial interventions to prevent negative mental health outcomes in the offspring of parents with mental illness. Eight electronic databases, grey literature and a journal hand-search identified 14 095 randomized controlled trials with no backward limit to June 2021. Outcomes in children included incidence of mental disorders (same or different from parental ones) and internalizing and externalizing symptoms at post-test, short-term and long-term follow-up. Relative risks and standardized mean differences (SMD) for symptom severity were generated using random-effect meta-analyses. Twenty trials were selected (pooled n = 2689 children). The main therapeutic approaches found were cognitive-behavioural therapy and psychoeducation. A significant effect of interventions on the incidence of mental disorders in children was found with a risk reduction of almost 50% [combined relative risk = 0.53, 95% confidence interval (CI) 0.34–0.84]. Interventions also had a small but significant effect on internalizing symptoms at post-test (SMD = −0.25, 95% CI −0.37 to −0.14) and short-term follow-up (−0.20, 95% CI −0.37 to −0.03). For externalizing symptoms, a decreasing slope was observed at post-test follow-up, without reaching the significance level (−0.11, 95% CI −0.27 to 0.04). Preventive interventions targeting the offspring of parents with mental disorders showed not only a significant reduction of the incidence of mental illness in children, but also a diminution of internalizing symptoms in the year following the intervention.

Background The experience sampling method (ESM) builds an intensive time series of experiences and contexts in the flow of daily life, typically consisting of around 70 reports, collected at 8–10 random time points per day over a period of up to 10 days. Methods With the advent of widespread smartphone use, ESM can be used in routine clinical practice. Multiple examples of ESM data collections across different patient groups and settings are shown and discussed, varying from an ESM evaluation of a 6‐week randomized trial of mindfulness, to a twin study on emotion dynamics in daily life. Results Research shows that ESM‐based self‐monitoring and feedback can enhance resilience by strengthening the capacity to use natural rewards. Personalized trajectories of starting or stopping medication can be more easily initiated and predicted if sensitive feedback data are available in real time. In addition, personalized trajectories of symptoms, cognitive abilities, symptoms impacting on other symptoms, the capacity of the dynamic system of mental health to “bounce back” from disturbance, and patterns of environmental reactivity yield uniquely personal data to support shared decision making and prediction in clinical practice. Finally, ESM makes it possible to develop insight into previous implicit patterns of thought, experience, and behavior, particularly if rapid personalized feedback is available. Conclusions ESM enhances clinical practice and research. It is empowering, providing co‐ownership of the process of diagnosis, treatment evaluation, and routine outcome measurement. Blended care, based on a mix of face‐to‐face and ESM‐based outside‐the‐office treatment, may reduce costs and improve outcomes.

The effectiveness of post-deployment screening for mental disorders has not been assessed in a randomised controlled trial. We aimed to assess whether post-deployment screening for post-traumatic stress disorder (PTSD), depression, anxiety, or alcohol misuse was effective. We defined screening as the presumptive identification of a previously unrecognised disorder using tests to distinguish those who probably had the disorder from those who probably did not so that those people with a probable disorder could be referred appropriately, and assessed effectiveness and consequences for help-seeking by the odds ratio at follow-up between those receiving tailored help-seeking advice and those who received general mental health advice. We did a cluster randomised controlled trial among Royal Marines and Army personnel in the UK military after deployment to Afghanistan. Platoons were randomly assigned (1:1 initially, then 2:1) by stratified block randomisation with randomly varying block sizes of two and four to the screening group, which received tailored help-seeking advice, or the control group, which received general mental health advice. Initial assessment took place 6–12 weeks after deployment; follow-up assessments were done 10–24 months later. Follow-up measures were the PTSD Checklist–Civilian Version, Patient Health Questionnaire-9, Generalised Anxiety Disorder-7 scale, Alcohol Use Disorder Identification Test (AUDIT), and self-reported help-seeking from clinical and welfare providers comparing those receiving tailored advice and those receiving only general advice. All participants and all investigators other than the person who analysed the data were masked to allocation. The primary outcomes were PTSD, depression or generalised anxiety disorder, and alcohol misuse at follow-up. A key secondary outcome was assessment of whether post-deployment screening followed by tailored advice would modify help-seeking behaviour. Comparisons were made between screening and control groups, with primary analyses by intention to treat. This trial is registered with the ISRCTN Registry, number ISRCTN19965528. Between Oct 24, 2011, and Oct 31, 2014, 434 platoons comprising 10 190 personnel were included: 274 (6350 personnel) in the screening group and 160 (3840 personnel) in the control group. 5577 (88%) of 6350 personnel received screening and 3996 (63%) completed follow-up, whereas 3149 (82%) of 3840 received the control questionnaire and 2369 (62%) completed follow-up. 1958 (35%) of 5577 personnel in the screening group declined to see the tailored advice, but those with PTSD (83%) or anxiety or depression (84%) were more likely than non-cases (64%) to view the advice (both p<0·0001). At follow-up, there were no significant differences in prevalence between groups for PTSD (adjusted odds ratio 0·92, 95% CI 0·75–1·14), depression or anxiety (0·91, 0·71–1·16), alcohol misuse (0·88, 0·73–1·06), or seeking support for mental disorders (0·92, 0·78–1·08). Post-deployment screening for mental disorders based on tailored advice was not effective at reducing prevalence of mental health disorders nor did it increase help-seeking. Countries that have implemented post-deployment screening programmes for mental disorders should consider monitoring the outcomes of their programmes. The US Army Medical Research and Materiel Command–Military Operational Medicine Research Program (USAMRMC–MOMRP).

ObjectivesCommon mental disorders (CMDs) are a major cause of rising disability benefit expenditures. We urgently need evidence on programmes that can increase work participation in CMDs. The aim of this study was to evaluate the effectiveness of work-focused cognitive–behavioural therapy (CBT) and individual job support for people struggling with work participation due to CMDs.MethodsA randomised controlled multicentre trial (RCT) including 1193 participants was conducted. Participants were on sick leave, at risk of going on sick leave or on long-term benefits. The intervention integrated work-focused CBT with individual job support. The control group received usual care. The main outcome was objectively ascertained work participation at 12 months follow-up, with changes in mental health and health-related quality of life as secondary outcomes.ResultsA larger proportion of participants in the intervention group had increased or maintained their work participation at follow-up compared to the control group (44.2% vs 37.2%, p=0.015). The difference remained significant after 18 months (difference 7.8%, p=0.018), and was even stronger for those on long-term benefits (difference 12.2%, p=0.007). The intervention also reduced depression (t=3.23, p≤0.001) and anxiety symptoms (t=2.52, p=0.012) and increased health-related quality of life (t=2.24, p=0.026) more than usual care.ConclusionsA work-focused CBT and individual job support was more effective than usual care in increasing or maintaining work participation for people with CMDs. The effects were profound for people on long-term benefits. This is the first large-scale RCT to demonstrate an effect of a behavioural intervention on work participation for the large group of workers with CMDs.Trial registration numberClinicalTrials.gov, registration number: NCT01146730.