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Background Migrants who have been forced to leave their home, such as refugees, asylum seekers, and internally displaced persons (IDP), are likely to experience stressors which may lead to mental health problems. The efficacy of interventions for mental health promotion, prevention, and treatment may differ in this population. Objectives With this overview of systematic reviews, we will map the characteristics and methodological quality of existing systematic reviews and registered systematic review protocols on the promotion of mental health and prevention and treatment of common mental disorders among refugees, asylum seekers, and IDPs. The findings from this overview will be used to prioritise and inform future Cochrane reviews on the mental health of involuntary migrants. Methods We searched Ovid MEDLINE (1945 onwards), Ovid Embase (1974 onwards), Ovid PsycINFO, ProQuest PTSDpubs, Web of Science Core Collection, Cochrane Database of Systematic Reviews, NIHR Journals Library, CRD databases (archived), DoPHER, Epistemonikos, Health Evidence, 3ie International Initiative for Impact Evaluation, and PROSPERO, to identify systematic reviews of mental health interventions for involuntary migrants. We did not apply any restrictions on date, language, or publication status to the searches. We included systematic reviews or protocols for systematic reviews of interventions aimed at refugees, asylum seekers, and internally displaced persons. Interventions must have been aimed at mental health promotion (for example, classroom‐based well‐being interventions for children), prevention of mental health problems (for example, trauma‐focussed Cognitive Behavioural Therapy to prevent post‐traumatic stress disorder), or treatment of common mental disorders and symptoms (for example, narrative exposure therapy to treat symptoms of trauma). After screening abstracts and full‐text manuscripts in duplicate, we extracted data on the characteristics of the reviews, the interventions examined in reviews, and the number of primary studies included in each review. Methodological quality of the included systematic reviews was assessed using AMSTAR 2. Main results The overview includes 23 systematic reviews and 15 registered systematic review protocols. Of the 23 published systematic reviews, meta‐analyses were conducted in eight reviews. It was more common for the search strategy or inclusion criteria of the reviews to state that studies involving refugees were eligible for inclusion (23/23), than for asylum seekers (14/23) or IDPs (7/23) to be explicitly mentioned. In most reviews, study eligiblity was either not restricted by participant age (9/23), or restricted to adults (10/23). Reviews commonly reported on studies of diagnosis or symptoms of post‐traumatic stress disorder or trauma (11/23) and were less likely to report on depression or anxiety (6/23). In 15 reviews the intervention of interest was focused on/ specific to psychological therapy. Across all 23 reviews, the interventions most commonly identified from primary studies were general Cognitive Behavioural Therapy, Narrative Exposure Therapy, and a range of different integrative and interpersonal therapies. Even though many reviews included studies of participants without a diagnosis of a mental health problem, they often assessed mental health treatments and did not usually distinguish between promotion, prevention, and treatment in the review aims. Together the 23 systematic reviews included 336 references, of which 175 were unique primary studies. Limitations to the methodological quality of reviews most commonly related to reporting of selection criteria (21/23), absence of a protocol (19/23), reporting of study design (20/23), search strategy (22/23), and funding sources of primary studies (19/23). Authors' conclusions Gaps exist in the evidence on mental health interventions for refugees, asylum seekers, and internally displaced persons. Most reviews do not specify that internally displaced persons are included in the selection criteria, even though they make up the majority of involuntary migrants worldwide. Reviews specific to mental health promotion and prevention of common mental disorders are missing, and there is more evidence available for adults or mixed populations than for children. The literature is focused on post‐traumatic stress disorder and trauma‐related symptoms, with less attention for depression and anxiety disorders. Better quality systematic reviews and better report of review design and methods would help those who may use these reviews to inform implementation of mental health interventions., Plain language summary An overview of systematic reviews on mental health interventions for involuntary migrants Refugees, asylum seekers, and internally displaced persons are involuntary migrants, who have often experienced distress when forced to leave their home, on the journey, and in the process of settling in a host country or new environment. Mental health promotion, prevention, and treatments for mental health problems such as depression, anxiety, and post‐traumatic stress disorder may work differently in these groups of people than for the general population. This overview of systematic reviews summarises the characteristics of reviews available on this topic, to help us determine which research questions are the most important to address in future Cochrane reviews. We searched for systematic reviews and protocols of systematic reviews on mental health promotion, prevention, and treatment of mental health problems for refugees, asylum seekers, and internally displaced persons. Mental health promotion may, for example, involve a classroom‐based well‐being intervention for children. An example of prevention is trauma‐focused therapy to prevent post‐traumatic stress disorder. Treatment may, for example, include psychological therapy for depression. We found 23 systematic reviews and 15 protocols of reviews in progress. Together the 23 published systematic reviews included 336 references, 175 of which were unique studies. Reviews more commonly included refugees and asylum seekers than internally displaced persons, and were more frequently focused on adults than children. There was more attention on the treatment of post‐traumatic stress disorder than there was for mental health promotion or prevention, or for the treatment of depression or anxiety. Studies of Cognitive Behavioural Therapy, Narrative Exposure Therapy, and integrative and interpersonal therapies were most likely to be included in reviews. The quality of reviews was limited by a range of issues, many of which related to poor reporting of the review methodology. The evidence available from systematic reviews may not match the need for evidence‐based interventions for the mental health of involuntary migrants. Review authors should consider relevant groups such as internally displaced persons, children, and people with depression or anxiety, and relevant interventions such as those for mental health promotion or prevention, and treatments other than psychological therapy.

Background Complex traumatic events associated with armed conflict, forcible displacement, childhood sexual abuse, and domestic violence are increasingly prevalent. People exposed to complex traumatic events are at risk of not only posttraumatic stress disorder (PTSD) but also other mental health comorbidities. Whereas evidence-based psychological and pharmacological treatments are effective for single-event PTSD, it is not known if people who have experienced complex traumatic events can benefit and tolerate these commonly available treatments. Furthermore, it is not known which components of psychological interventions are most effective for managing PTSD in this population. We performed a systematic review and component network meta-analysis to assess the effectiveness of psychological and pharmacological interventions for managing mental health problems in people exposed to complex traumatic events. Methods and findings We searched CINAHL, Cochrane Central Register of Controlled Trials, EMBASE, International Pharmaceutical Abstracts, MEDLINE, Published International Literature on Traumatic Stress, PsycINFO, and Science Citation Index for randomised controlled trials (RCTs) and non-RCTs of psychological and pharmacological treatments for PTSD symptoms in people exposed to complex traumatic events, published up to 25 October 2019. We adopted a nondiagnostic approach and included studies of adults who have experienced complex trauma. Complex-trauma subgroups included veterans; childhood sexual abuse; war-affected; refugees; and domestic violence. The primary outcome was reduction in PTSD symptoms. Secondary outcomes were depressive and anxiety symptoms, quality of life, sleep quality, and positive and negative affect. We included 116 studies, of which 50 were conducted in hospital settings, 24 were delivered in community settings, seven were delivered in military clinics for veterans or active military personnel, five were conducted in refugee camps, four used remote delivery via web-based or telephone platforms, four were conducted in specialist trauma clinics, two were delivered in home settings, and two were delivered in primary care clinics; clinical setting was not reported in 17 studies. Ninety-four RCTs, for a total of 6,158 participants, were included in meta-analyses across the primary and secondary outcomes; 18 RCTs for a total of 933 participants were included in the component network meta-analysis. The mean age of participants in the included RCTs was 42.6 ± 9.3 years, and 42% were male. Nine non-RCTs were included. The mean age of participants in the non-RCTs was 40.6 ± 9.4 years, and 47% were male. The average length of follow-up across all included studies at posttreatment for the primary outcome was 11.5 weeks. The pairwise meta-analysis showed that psychological interventions reduce PTSD symptoms more than inactive control (k = 46; n = 3,389; standardised mean difference [SMD] = −0.82, 95% confidence interval [CI] −1.02 to −0.63) and active control (k-9; n = 662; SMD = −0.35, 95% CI −0.56 to −0.14) at posttreatment and also compared with inactive control at 6-month follow-up (k = 10; n = 738; SMD = −0.45, 95% CI −0.82 to −0.08). Psychological interventions reduced depressive symptoms (k = 31; n = 2,075; SMD = −0.87, 95% CI −1.11 to −0.63; I2 = 82.7%, p = 0.000) and anxiety (k = 15; n = 1,395; SMD = −1.03, 95% CI −1.44 to −0.61; p = 0.000) at posttreatment compared with inactive control. Sleep quality was significantly improved at posttreatment by psychological interventions compared with inactive control (k = 3; n = 111; SMD = −1.00, 95% CI −1.49 to −0.51; p = 0.245). There were no significant differences between psychological interventions and inactive control group at posttreatment for quality of life (k = 6; n = 401; SMD = 0.33, 95% CI −0.01 to 0.66; p = 0.021). Antipsychotic medicine (k = 5; n = 364; SMD = –0.45; –0.85 to –0.05; p = 0.085) and prazosin (k = 3; n = 110; SMD = −0.52; −1.03 to −0.02; p = 0.182) were effective in reducing PTSD symptoms. Phase-based psychological interventions that included skills-based strategies along with trauma-focused strategies were the most promising interventions for emotional dysregulation and interpersonal problems. Compared with pharmacological interventions, we observed that psychological interventions were associated with greater reductions in PTSD and depression symptoms and improved sleep quality. Sensitivity analysis showed that psychological interventions were acceptable with lower dropout, even in studies rated at low risk of attrition bias. Trauma-focused psychological interventions were superior to non-trauma-focused interventions across trauma subgroups for PTSD symptoms, but effects among veterans and war-affected populations were significantly reduced. The network meta-analysis showed that multicomponent interventions that included cognitive restructuring and imaginal exposure were the most effective for reducing PTSD symptoms (k = 17; n = 1,077; mean difference = −37.95, 95% CI −60.84 to −15.16). Our use of a non-diagnostic inclusion strategy may have overlooked certain complex-trauma populations with severe and enduring mental health comorbidities. Additionally, the relative contribution of skills-based intervention components was not feasibly evaluated in the network meta-analysis. Conclusions In this systematic review and meta-analysis, we observed that trauma-focused psychological interventions are effective for managing mental health problems and comorbidities in people exposed to complex trauma. Multicomponent interventions, which can include phase-based approaches, were the most effective treatment package for managing PTSD in complex trauma. Establishing optimal ways to deliver multicomponent psychological interventions for people exposed to complex traumatic events is a research and clinical priority., Peter Coventry and colleagues investigate evidence for the effectiveness and acceptability of psychological and pharmacological treatments for mental health problems following complex traumatic events., Author summary Why was the study done? Complex traumatic events are of a multiple or prolonged nature and are increasingly prevalent owing to unprecedented levels of population displacement, armed conflict, and increased recognition of childhood sexual abuse and domestic violence. People exposed to complex traumatic events are at risk of not only posttraumatic stress disorder (PTSD) but also other mental health problems. There are evidence-based psychological and pharmacological treatments for single-event PTSD, but it is not known if people who have experienced complex traumatic events can benefit and tolerate commonly available treatments. To inform treatment guidelines and future research, a broad evidence synthesis is needed that goes beyond existing knowledge to identify candidate interventions for mental health problems associated with complex trauma. What did the researchers do and find? We undertook a systematic review and meta-analysis of the effectiveness and acceptability of psychological and pharmacological treatments for mental health problems in veterans, refugees, victims of childhood sexual abuse and domestic violence, and war-affected populations. We used network meta-analysis to disentangle the relative contribution of different components of psychological treatments. The meta-analysis showed that psychological treatments are effective for treating PTSD, anxiety, and depression and improving sleep in people with a history of complex traumatic events. Pharmacological interventions were less effective than psychological interventions for treating PTSD symptoms and improving sleep. Trauma-focused treatments were the most effective approaches, but these treatments tended to be less effective in veterans and war-affected populations. Multicomponent interventions that included two or more components were the most effective for treating PTSD symptoms, and these approaches were promising for the management of disturbances of self-organisation. What do these findings mean? Existing evidence-based trauma-focused psychological treatments can be effectively used as first-line therapy for PTSD and mental health comorbidities in people exposed to complex trauma. Because phasing of treatment was categorised as a constituent part of multicomponent interventions, there is a case to move beyond binary distinctions of phase-based versus non-phase-based interventions, which has hampered progress in PTSD research. Future studies could test the most effective means to deliver patient-centred and multicomponent interventions for people exposed to complex trauma, especially in those with higher levels of mental health comorbidity.

BackgroundBehavioural activation is a brief psychotherapeutic approach that seeks to change the way a person interacts with their environment. Behavioural activation is increasingly receiving attention as a potentially cost‐effective intervention for depression, which may require less resources and may be easier to deliver and implement than other types of psychotherapy. ObjectivesTo examine the effects of behavioural activation compared with other psychological therapies for depression in adults. To examine the effects of behavioural activation compared with medication for depression in adults. To examine the effects of behavioural activation compared with treatment as usual/waiting list/placebo no treatment for depression in adults. Search methodsWe searched CCMD‐CTR (all available years), CENTRAL (current issue), Ovid MEDLINE (1946 onwards), Ovid EMBASE (1980 onwards), and Ovid PsycINFO (1806 onwards) on the 17 January 2020 to identify randomised controlled trials (RCTs) of 'behavioural activation', or the main elements of behavioural activation for depression in participants with clinically diagnosed depression or subthreshold depression. We did not apply any restrictions on date, language or publication status to the searches. We searched international trials registries via the World Health Organization's trials portal (ICTRP) and ClinicalTrials.gov to identify unpublished or ongoing trials. Selection criteriaWe included randomised controlled trials (RCTs) of behavioural activation for the treatment of depression or symptoms of depression in adults aged 18 or over. We excluded RCTs conducted in inpatient settings and with trial participants selected because of a physical comorbidity. Studies were included regardless of reported outcomes. Data collection and analysisTwo review authors independently screened all titles/abstracts and full‐text manuscripts for inclusion. Data extraction and 'Risk of bias' assessments were also performed by two review authors in duplicate. Where necessary, we contacted study authors for more information. Main results Fifty‐three studies with 5495 participants were included; 51 parallel group RCTs and two cluster‐RCTs. We found moderate‐certainty evidence that behavioural activation had greater short‐term efficacy than treatment as usual (risk ratio (RR) 1.40, 95% confidence interval (CI) 1.10 to 1.78; 7 RCTs, 1533 participants), although this difference was no longer evident in sensitivity analyses using a worst‐case or intention‐to‐treat scenario. Compared with waiting list, behavioural activation may be more effective, but there were fewer data in this comparison and evidence was of low certainty (RR 2.14, 95% CI 0.90 to 5.09; 1 RCT, 26 participants). No evidence on treatment efficacy was available for behavioural activation versus placebo and behavioural activation versus no treatment. We found moderate‐certainty evidence suggesting no evidence of a difference in short‐term treatment efficacy between behavioural activation and CBT (RR 0.99, 95% CI 0.92 to 1.07; 5 RCTs, 601 participants). Fewer data were available for other comparators. No evidence of a difference in short term‐efficacy was found between behavioural activation and third‐wave CBT (RR 1.10, 95% CI 0.91 to 1.33; 2 RCTs, 98 participants; low certainty), and psychodynamic therapy (RR 1.21, 95% CI 0.74 to 1.99; 1 RCT,60 participants; very low certainty). Behavioural activation was more effective than humanistic therapy (RR 1.84, 95% CI 1.15 to 2.95; 2 RCTs, 46 participants; low certainty) and medication (RR 1.77, 95% CI 1.14 to 2.76; 1 RCT; 141 participants; moderate certainty), but both of these results were based on a small number of trials and participants. No evidence on treatment efficacy was available for comparisons between behavioural activation versus interpersonal, cognitive analytic, and integrative therapies. There was moderate‐certainty evidence that behavioural activation might have lower treatment acceptability (based on dropout rate) than treatment as usual in the short term, although the data did not confirm a difference and results lacked precision (RR 1.64, 95% CI 0.81 to 3.31; 14 RCTs, 2518 participants). Moderate‐certainty evidence did not suggest any difference in short‐term acceptability between behavioural activation and waiting list (RR 1.17, 95% CI 0.70 to 1.93; 8 RCTs. 359 participants), no treatment (RR 0.97, 95% CI 0.45 to 2.09; 3 RCTs, 187 participants), medication (RR 0.52, 95% CI 0.23 to 1.16; 2 RCTs, 243 participants), or placebo (RR 0.72, 95% CI 0.31 to 1.67; 1 RCT; 96 participants; low‐certainty evidence). No evidence on treatment acceptability was available comparing behavioural activation versus psychodynamic therapy. Low‐certainty evidence did not show a difference in short‐term treatment acceptability (dropout rate) between behavioural activation and CBT (RR 1.03, 95% CI 0.85 to 1.25; 12 RCTs, 1195 participants), third‐wave CBT (RR 0.84, 95% CI 0.33 to 2.10; 3 RCTs, 147 participants); humanistic therapy (RR 1.06, 95% CI 0.20 to 5.55; 2 RCTs, 96 participants) (very low certainty), and interpersonal, cognitive analytic, and integrative therapy (RR 0.84, 95% CI 0.32 to 2.20; 4 RCTs, 123 participants). Results from medium‐ and long‐term primary outcomes, secondary outcomes, subgroup analyses, and sensitivity analyses are summarised in the text. Authors' conclusions This systematic review suggests that behavioural activation may be more effective than humanistic therapy, medication, and treatment as usual, and that it may be no less effective than CBT, psychodynamic therapy, or being placed on a waiting list. However, our confidence in these findings is limited due to concerns about the certainty of the evidence. We found no evidence of a difference in short‐term treatment acceptability (based on dropouts) between behavioural activation and most comparison groups (CBT, humanistic therapy, waiting list, placebo, medication, no treatment or treatment as usual). Again, our confidence in all these findings is limited due to concerns about the certainty of the evidence.No data were available about the efficacy of behaioural activation compared with placebo, or about treatment acceptability comparing behavioural activation and psychodynamic therapy, interpersonal, cognitive analytic and integrative therapies. The evidence could be strengthened by better reporting and better quality RCTs of behavioural activation and by assessing working mechanisms of behavioural activation.

This is the protocol for a review and there is no abstract. The objectives are as follows: (1) Primary objective: to examine effectiveness of psychotherapy in comparison with non-treatment, waiting-list control or treatment as usual in the treatment of depression in children and adolescents (2) Secondary objective: to examine adverse effects of psychotherapy in comparison with non-treatment, waiting-list control or treatment as usual in the treatment of depression in children and adolescents (3) To examine cost-effectiveness of structured psychotherapy in comparison with non-treatment, waiting-list control or treatment as usual in the treatment of depression in children and adolescents

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the efficacy and acceptability of early pharmacological interventions in adults experiencing acute traumatic stress symptoms, and to generate clinically useful rankings of pharmacological interventions according to their efficacy and acceptability by performing a network meta‐analysis.

This is a protocol for a Cochrane Review (Qualitative). The objectives are as follows:Main objective: To identify the factors that create barriers or facilitate physical activity for people with a diagnosis of bipolar disorder from the perspectives of service users, carers, service providers and practitioners to help inform the design and implementation of interventions that promote physical activity.The overall aim of this review is to identify, appraise, and synthesise qualitative research evidence on the barriers and facilitators to engaging in physical activity in general lifestyle settings or as part of an intervention designed to increase physical activity for people with bipolar disorder. This will allow us to identify factors that create barriers and facilitators of physical activity in this population to inform the development, design, and implementation of future interventions. We will communicate our findings to public health commissioners and other stakeholders.

This is a protocol for a Cochrane Review (Qualitative). The objectives are as follows:. Main objective: To identify the factors that create barriers or facilitate physical activity for people with a diagnosis of anxiety or depression from the perspectives of service users, carers, service providers and practitioners to help inform the design and implementation of interventions that promote physical activity. The overall aim of this review is to identify, appraise, and synthesise qualitative research evidence on the barriers and facilitators to engaging in physical activity in general lifestyle settings or as part of an intervention designed to increase physical activity for people with anxiety and depression. This will allow us to identify factors that create barriers and facilitators of physical activity in this population to inform the development, design, and implementation of future interventions. We will also integrate the findings from the QES with the two associated effectiveness reviews (Cooney 2014; Larun 2006). We will communicate our findings to public health commissioners and other stakeholders.

Objectives Cognitive behavioral therapy (CBT) is an effective treatment for depression. Different CBT delivery formats (face-to-face [F2F], multimedia, and hybrid) and intensities have been used to expand access to the treatment. The aim of this study is to estimate the long-term cost-effectiveness of different CBT delivery modes. Methods A decision-analytic model was developed to evaluate the cost-effectiveness of different CBT delivery modes and variations in intensity in comparison with treatment as usual (TAU). The model covered an average treatment period of 4 months with a 5-year follow-up period. The model was populated using a systematic review of randomized controlled trials and various sources from the literature. Results Incremental cost-effectiveness ratios of treatments compared with the next best option after excluding all the dominated and extended dominated options are: £209/quality-adjusted life year (QALY) for 6 (sessions) × 30 (minutes) F2F-CBT versus TAU; £4 453/QALY for 8 × 30 F2F versus 6 × 30 F2F; £12 216/QALY for 8 × 60 F2F versus 8 × 30 F2F; and £43 072/QALY for 16 × 60 F2F versus 8 × 60 F2F. The treatment with the highest net monetary benefit for thresholds of £20 000 to £30 000/QALY was 8 × 30 F2F-CBT. Probabilistic sensitivity analysis illustrated 6 × 30 F2F-CBT had the highest probability (32.8%) of being cost-effective at £20 000/QALY; 16 × 60 F2F-CBT had the highest probability (31.0%) at £30 000/QALY. Conclusions All CBT delivery modes on top of TAU were found to be more cost-effective than TAU alone. Four F2F-CBT options (6 × 30, 8 × 30, 8 × 60, 16 × 60) are on the cost-effectiveness frontier. F2F-CBT with intensities of 6 × 30 and 16 × 60 had the highest probabilities of being cost-effective. The results, however, should be interpreted with caution owing to the high level of uncertainty.

Digital technology, including the internet, smartphones, and wearables, provides the possibility to bridge the mental health treatment gap by offering flexible and tailored approaches to mental health care that are more accessible and potentially less stigmatising than those currently available. However, the evidence base for digital mental health interventions, including demonstration of clinical effectiveness and cost-effectiveness in real-world settings, remains inadequate. The James Lind Alliance Priority Setting Partnership for digital technology in mental health care was established to identify research priorities that reflect the perspectives and unmet needs of people with lived experience of mental health problems and use of mental health services, their carers, and health-care practitioners. 644 participants contributed 1369 separate questions, which were reduced by qualitative thematic analysis into six overarching themes. Following removal of out-of-scope questions and a comprehensive search of existing evidence, 134 questions were verified as uncertainties suitable for research. These questions were then ranked online and in workshops by 628 participants to produce a shortlist of 26. The top ten research priorities, which were identified by consensus at a stakeholder workshop, should inform research policy and funding in this field. Identified priorities primarily relate to the safety and efficacy of digital technology interventions in comparison with face-to-face interventions, evidence of population reach, mechanisms of therapeutic change, and the ways in which the effectiveness of digital interventions in combination with human support might be optimised.

Background A focus on equity in health can be seen in many global development goals and reports, research and international declarations. With the development of a relevant framework and methods, the Campbell and Cochrane Equity Methods Group has encouraged the application of an ‘equity lens’ to systematic reviews, and many organizations publish reviews intended to address health equity. The purpose of the Evidence for Equity (E4E) project was to conduct a priority-setting exercise and apply an equity lens by developing a knowledge translation product comprising summaries of systematic reviews from the Cochrane Library. E4E translates evidence from systematic reviews into ‘friendly front end’ summaries for policy makers. Methods The following topic areas with high burdens of disease globally, were selected for the pilot: diabetes/obesity, HIV/AIDS, malaria, nutrition, and mental health/depression. For each topic area, a “stakeholder panel” was assembled that included policymakers and researchers. A systematic search of Cochrane reviews was conducted for each area to identify equity-relevant interventions with a meaningful impact. Panel chairs developed a rating sheet which was used by all panels to rank the importance of these interventions by: 1) Ease of Implementation; 2) Health System Requirements; 3)Universality/Generalizability/Share of Burden; and 4) Impact on Inequities/Effect on equity. The ratings of panel members were averaged for each intervention and criterion, and interventions were ordered according to the average overall ratings. Results Stakeholder panels identified the top 10 interventions from their respective topic areas. The evidence on these interventions is being summarized with an equity focus and the results posted online, at http://methods.cochrane.org/equity/e4e-series. Conclusions This method provides an explicit approach to setting priorities by systematic review groups and funders for providing decision makers with evidence for the most important equity-relevant interventions. Electronic supplementary material The online version of this article (10.1186/s12939-017-0697-5) contains supplementary material, which is available to authorized users.

New approaches to evidence synthesis, which use human effort and machine automation in mutually reinforcing ways, can enhance the feasibility and sustainability of living systematic reviews. Human effort is a scarce and valuable resource, required when automation is impossible or undesirable, and includes contributions from online communities (“crowds”) as well as more conventional contributions from review authors and information specialists. Automation can assist with some systematic review tasks, including searching, eligibility assessment, identification and retrieval of full-text reports, extraction of data, and risk of bias assessment. Workflows can be developed in which human effort and machine automation can each enable the other to operate in more effective and efficient ways, offering substantial enhancement to the productivity of systematic reviews. This paper describes and discusses the potential—and limitations—of new ways of undertaking specific tasks in living systematic reviews, identifying areas where these human/machine “technologies” are already in use, and where further research and development is needed. While the context is living systematic reviews, many of these enabling technologies apply equally to standard approaches to systematic reviewing.

Background It is common for peoples not to take antidepressant medication as prescribed, with around 50% of people likely to prematurely discontinue taking their medication after six months. Community pharmacists may be well placed to have a role in antidepressant management because of their unique pharmacotherapeutic knowledge and ease of access for people. Pharmacists are in an ideal position to offer proactive interventions to people with depression or depressive symptoms. However, the effectiveness and acceptability of existing pharmacist-based interventions is not yet well understood. The degree to which a pharmacy-based management approach might be beneficial, acceptable to people, and effective as part of the overall management for those with depression is, to date, unclear. A systematic review of randomised controlled trials (RCTs) will help answer these questions and add important knowledge to the currently sparse evidence base. Objectives To examine the effects of pharmacy-based management interventions compared with active control (e.g. patient information materials or any other active intervention delivered by someone other than the pharmacist or the pharmacy team), waiting list, or treatment as usual (e.g. standard pharmacist advice or antidepressant education, signposting to support available in primary care services, brief medication counselling, and/or (self-)monitoring of medication adherence offered by a healthcare professional outside the pharmacy team) at improving depression outcomes in adults. Search methods We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMD-CTR) to June 2016; the Cochrane Library (Issue 11, 2018); and Ovid MEDLINE, Embase, and PsycINFO to December 2018. We searched theses and dissertation databases and international trial registers for unpublished/ongoing trials. We applied no restrictions on date, language, or publication status to the searches. SELECTION CRITERIA: We included all RCTs and cluster-RCTs where a pharmacy-based intervention was compared with treatment as usual, waiting list, or an alternative intervention in the management of depression in adults over 16 years of age. Eligible studies had to report at least one of the following outcomes at any time point: depression symptom change, acceptability of the intervention, diagnosis of depression, non-adherence to medication, frequency of primary care appointments, quality of life, social functioning, or adverse events. DATA COLLECTION AND ANALYSIS: Two authors independently, and in duplicate, conducted all stages of study selection, data extraction, and quality assessment (including GRADE). We discussed disagreements within the team until we reached consensus. Where data did not allow meta-analyses, we synthesised results narratively. MAIN RESULTS: Twelve studies (2215 participants) met the inclusion criteria and compared pharmacy-based management with treatment as usual. Two studies (291 participants) also included an active control (both used patient information leaflets providing information about the prescribed antidepressant). Neither of these studies reported depression symptom change. A narrative synthesis of results on acceptability of the intervention was inconclusive, with one study reporting better acceptability of pharmacy-based management and the other better acceptability of the active control. One study reported that participants in the pharmacy-based management group had better medication adherence than the control participants. One study reported adverse events with no difference between groups. The studies reported no other outcomes. Meta-analyses comparing pharmacy-based management with treatment as usual showed no evidence of a difference in the effect of the intervention on depression symptom change (dichotomous data; improvement in symptoms yes/no: risk ratio (RR), 0.95, 95% confidence interval (CI) 0.86 to 1.05; 4 RCTs, 475 participants; moderate-quality evidence; continuous data: standard mean difference (SMD) -0.04, 95% CI -0.19 to 0.10; 5 RCTs, 718 participants; high-certainty evidence), or acceptability of the intervention (RR 1.09, 95% CI 0.81 to 1.45; 12 RCTs, 2072 participants; moderate-certainty evidence). The risk of non-adherence was reduced in participants receiving pharmacy-based management (RR 0.73, 95% CI 0.61 to 0.87; 6 RCTs, 911 participants; high-certainty evidence). We were unable to meta-analyse data on diagnosis of depression, frequency of primary care appointments, quality of life, or social functioning. Authors' conclusions We found no evidence of a difference between pharmacy-based management for depression in adults compared with treatment as usual in facilitating depression symptom change. Based on numbers of participants leaving the trials early, there may be no difference in acceptability between pharmacy-based management and controls. However, there was uncertainty due to the low-certainty evidence.

This is a protocol for a Cochrane Review (Prognosis). The objectives are as follows: Primary objective To summarise the predictive performance of prognostic models developed to predict the risk of relapse, recurrence, sustained remission or recovery in adults with depression who meet criteria for remission. Secondary objectives To describe the characteristics of models identified, including predictors and method of derivation (e.g. regression, machine learning, neural networks etc.). To review the net benefit of identified models, where this has been reported. To summarise the value of updating or modifying an existing prognostic model or identify whether the development of a novel prognostic model to predict relapse and recurrence in depression is required. We will make this decision through discussion involving the whole team and will be guided by risk of bias assessment and applicability of methods as well as predictive performance. Investigation of sources of heterogeneity between studies We anticipate between‐study heterogeneity in model performance. Sources of heterogeneity in this case are likely to relate to population/case mix (e.g. age of participants and multimorbidity), study setting of models (e.g. differences between models developed in primary and secondary care settings), study design (e.g. follow‐up time, source of data, outcome definition and sample size). All of these could prove to be significant sources of heterogeneity in this review and we will take them into account in the event that a meta‐analysis is undertaken.

Background: The prevalence of mental and physical comorbidities is unknown in South Asia, as estimates of mental ill health in patients with non-communicable diseases (NCDs) have predominantly come from studies based in the United States, Europe and Australasia. This systematic review and meta-analysis summarises evidence and provides pooled estimates of the prevalence of common mental disorders in adults with non-communicable diseases in South Asia. Methods: We included prevalence studies of depression and anxiety in adults with diabetes, cancer, cardiovascular disease, and chronic respiratory conditions in Bangladesh, India, and Pakistan, published from 1990 onwards in international and country-specific databases. Results: Out of 96 included studies, 83 provided data for random effects meta-analyses. The pooled prevalence of depression was 44% (95% confidence interval (CI) = 26 to 62) for patients with COPD, 40% (95% CI = 34 to 45) for diabetes, 39% (95% CI = 23 to 56) for stroke, 38% (95% CI = 32 to 45) for hypertension, and 37% (95% CI = 30 to 45) for cancer. The pooled prevalence of anxiety based on 28 studies was 29% (95% CI = 22 to 36). Many quality issues were identified in a critical appraisal of included studies, mostly relating to the sampling frame and selection process, the description of the methods and basic data, and the description of non-responders. Conclusions: Depression and anxiety are prevalent and underdiagnosed in people with physical comorbidities in Bangladesh, India, and Pakistan.

BACKGROUND: Depression is usually managed in primary care, but most antidepressant trials are of patients from secondary care mental health services, with eligibility criteria based on diagnosis and severity of depressive symptoms. Antidepressants are now used in a much wider group of people than in previous regulatory trials. We investigated the clinical effectiveness of sertraline in patients in primary care with depressive symptoms ranging from mild to severe and tested the role of severity and duration in treatment response.METHODS: The PANDA study was a pragmatic, multicentre, double-blind, placebo-controlled randomised trial of patients from 179 primary care surgeries in four UK cities (Bristol, Liverpool, London, and York). We included patients aged 18 to 74 years who had depressive symptoms of any severity or duration in the past 2 years, where there was clinical uncertainty about the benefit of an antidepressant. This strategy was designed to improve the generalisability of our sample to current use of antidepressants within primary care. Patients were randomly assigned (1:1) with a remote computer-generated code to sertraline or placebo, and were stratified by severity, duration, and site with random block length. Patients received one capsule (sertraline 50 mg or placebo orally) daily for one week then two capsules daily for up to 11 weeks, consistent with evidence on optimal dosages for efficacy and acceptability. The primary outcome was depressive symptoms 6 weeks after randomisation, measured by Patient Health Questionnaire, 9-item version (PHQ-9) scores. Secondary outcomes at 2, 6 and 12 weeks were depressive symptoms and remission (PHQ-9 and Beck Depression Inventory-II), generalised anxiety symptoms (Generalised Anxiety Disorder Assessment 7-item version), mental and physical health-related quality of life (12-item Short-Form Health Survey), and self-reported improvement. All analyses compared groups as randomised (intention-to-treat). The study is registered with EudraCT, 2013-003440-22 (protocol number 13/0413; version 6.1) and ISRCTN, ISRCTN84544741, and is closed to new participants.FINDINGS: Between Jan 1, 2015, and Aug 31, 2017, we recruited and randomly assigned 655 patients-326 (50%) to sertraline and 329 (50%) to placebo. Two patients in the sertraline group did not complete a substantial proportion of the baseline assessment and were excluded, leaving 653 patients in total. Due to attrition, primary outcome analyses were of 550 patients (266 in the sertraline group and 284 in the placebo group; 85% follow-up that did not differ by treatment allocation). We found no evidence that sertraline led to a clinically meaningful reduction in depressive symptoms at 6 weeks. The mean 6-week PHQ-9 score was 7·98 (SD 5·63) in the sertraline group and 8·76 (5·86) in the placebo group (adjusted proportional difference 0·95, 95% CI 0·85-1·07; p=0·41). However, for secondary outcomes, we found evidence that sertraline led to reduced anxiety symptoms, better mental (but not physical) health-related quality of life, and self-reported improvements in mental health. We observed weak evidence that depressive symptoms were reduced by sertraline at 12 weeks. We recorded seven adverse events-four for sertraline and three for placebo, and adverse events did not differ by treatment allocation. Three adverse events were classified as serious-two in the sertraline group and one in the placebo group. One serious adverse event in the sertraline group was classified as possibly related to study medication.INTERPRETATION: Sertraline is unlikely to reduce depressive symptoms within 6 weeks in primary care but we observed improvements in anxiety, quality of life, and self-rated mental health, which are likely to be clinically important. Our findings support the prescription of SSRI antidepressants in a wider group of participants than previously thought, including those with mild to moderate symptoms who do not meet diagnostic criteria for depression or generalised anxiety disorder.FUNDING: National Institute for Health Research.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: The primary objective is to examine the effects of behavioural activation compared to any control group for the treatment of depression in adults with non‐communicable diseases (NCDs). The secondary objectives is to examine the effects of behavioural activation compared to each control group separately (no treatment, waiting list, other psychological therapy, pharmacological treatment, or any other type of treatment as usual) for the treatment of depression in adults with NCDs.

This is a protocol for a Cochrane Review (Overview). The objectives are as follows: To map the characteristics and methodological quality of existing systematic reviews and published review protocols on the promotion of mental health and prevention and treatment of common mental disorders among refugees, asylum seekers, and internally displaced persons. Characteristics of interest are: the type of systematic review (Cochrane, non‐Cochrane, meta‐analysis, narrative synthesis); population (refugees, asylum seekers, internally displaced persons, age, mental health diagnosis); setting (country of origin and study setting); types of studies (randomised controlled trials, other designs); types of interventions (promotion, prevention, treatment; CBT, other psychotherapy, transdiagnostic, medication); types of comparators (no treatment, placebo, waiting list, treatment as usual, other treatment); intervention provider (professional, lay health worker); review characteristics (number of included studies, review quality). Whereas an overview of systematic reviews, would normally seek to answer questions related to the effectiveness or efficacy results of studies included in the identified reviews, this overview will provide a description of the depth and breadth of the literature available and will not answer questions of effectiveness. Data on study characteristics are extracted to give an overview of systematic reviews, ongoing or published, on this topic. This review is part of a Cochrane Global Mental Health satellite project to identify priorities for Cochrane Reviews in global mental health. We will produce an evidence map, which will represent a lay summary of literature identified in the overview, which will provide a basis to engage with stakeholders within and outside of academia to prioritise Cochrane Reviews of mental health of refugees, asylum seekers and internally displaced persons. This will ensure that the Cochrane Global Mental Health Satellite takes forward research questions seen as a priority by stakeholders to promote a strong evidence base in global mental health.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:\ud\udTo assess the efficacy and acceptability of pharmacological interventions for preventing post‐traumatic stress disorder (PTSD) in adults exposed to a traumatic event and to generate a clinically useful ranking of pharmacological interventions according to their efficacy and acceptability by performing a network meta‐analysis.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the efficacy and acceptability of antidepressants for the treatment of MDD in older people.

Cognitive-behavioural therapy (CBT) is an effective treatment for depressed adults. CBT interventions are complex, as they include multiple content components and can be delivered in different ways. We compared the effectiveness of different types of therapy, different components and combinations of components and aspects of delivery used in CBT interventions for adult depression. We conducted a systematic review of randomised controlled trials in adults with a primary diagnosis of depression, which included a CBT intervention. Outcomes were pooled using a component-level network meta-analysis. Our primary analysis classified interventions according to the type of therapy and delivery mode. We also fitted more advanced models to examine the effectiveness of each content component or combination of components. We included 91 studies and found strong evidence that CBT interventions yielded a larger short-term decrease in depression scores compared to treatment-as-usual, with a standardised difference in mean change of −1.11 (95% credible interval −1.62 to −0.60) for face-to-face CBT, −1.06 (−2.05 to −0.08) for hybrid CBT, and −0.59 (−1.20 to 0.02) for multimedia CBT, whereas wait list control showed a detrimental effect of 0.72 (0.09 to 1.35). We found no evidence of specific effects of any content components or combinations of components. Technology is increasingly used in the context of CBT interventions for depression. Multimedia and hybrid CBT might be as effective as face-to-face CBT, although results need to be interpreted cautiously. The effectiveness of specific combinations of content components and delivery formats remain unclear. Wait list controls should be avoided if possible.

IntroductionThis article describes two randomised controlled trials that will evaluate the effectiveness and cost-effectiveness of Self-Help Plus (SH+), a group self-help intervention developed by the WHO to reduce distress. In these trials SH+ is being tested as a preventative intervention to lower the incidence of mental disorders in asylum seekers and refugees with psychological distress resettled in Europe and Turkey.Methods and analysisTwo prospective, multicentre, randomised, rater-blinded, parallel-group studies will follow participants over a period of 12 months. One trial will be conducted in Europe and one in Turkey. In each trial, 600 asylum seekers and refugees screening positive on the General Health Questionnaire (≥3), but without a formal diagnosis of any mental disorders according to the Mini International Neuropsychiatric Interview, will be randomly allocated to SH+or to enhanced treatment-as-usual. The primary outcome will be a lower incidence of mental disorders at 6 month follow-up. Secondary outcomes will include the evaluation of psychological symptoms, functioning, well-being, treatment acceptability and indicators of intervention cost-effectiveness.Ethics and disseminationThe two trials received ethical clearance from the local Ethics Committees of the participating sites (seven sites), as well as from the WHO Ethics Committee. All participants will provide informed consent before screening and before study inclusion (a two-step procedure). The results of the trials will be disseminated in agreement with a dissemination plan that includes publication(s) in peer-reviewed journals and presentations at relevant national and international conferences and meetings.Trials registration numbersNCT03571347,NCT03587896.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: 1. To examine the effects of behavioural activation compared to all other psychological therapies for acute depression in adults. 2. To examine the effects of behavioural activation compared to all medication for acute depression in adults. 3. To examine the effects of behavioural activation compared to treatment as usual/ waiting list/ attention placebo/ psychological placebo control conditions for acute depression in adults.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects of pharmacological, behaviour change, and organisational interventions compared to comparator intervention in preventing diabetes among people with mental illness in LMICs.

BackgroundLeishmaniasis is a neglected tropical parasitic disease endemic in South Asia, East Africa, South America and the Middle East. It is associated with low socioeconomic status (SES) and responsible for considerable mortality and morbidity. Reports suggest that patients with leishmaniasis may have a higher risk of mental illness (MI), psychosocial morbidity (PM) and reduced quality of life (QoL), but this is not well characterised. The aim of this study was to conduct a systematic review to assess the reported impact of leishmaniasis on mental health and psychosocial wellbeing.MethodsA systematic review of the literature was carried out. Pre-specified criteria were applied to identify publications including observational quantitative studies or systematic reviews. Two reviewers screened all of the titles, abstracts and full-studies and a third reviewer was consulted for disagreements. Data was extracted from papers meeting the criteria and quality appraisal of the methods was performed using the Newcastle-Ottowa Scale or the Risk of Bias in Systematic Review tool.ResultsA total of 14 studies were identified from 12,517 records. Nine cross-sectional, three case-control, one cohort study and one systematic review were included. Eleven assessed MI outcomes and were measured with tools specifically designed for this; nine measured PM and 12 measured QoL using validated measurement tools. Quality appraisal of the studies showed that six were of good quality. Cutaneous leishmaniasis and post kala-azar dermal leishmaniasis showed evidence of associated MI and PM including depression, anxiety and stigma, while all forms of disease showed decreased QoL. The findings were used to inform a proposed model and conceptual framework to show the possible links between leishmaniasis and mental health outcomes.ConclusionThere is evidence that leishmaniasis has an impact on MI, PM or QoL of patients and their families and this occurs in all the main subtypes of the disease. There are however large gaps in the evidence. Further research is required to understand the full extent of this problem and its mechanistic basis.AUTHOR SUMMARYLeishmaniasis is a parasitic disease prevalent in many low-and middle-income countries worldwide. In this study the authors looked for evidence as to whether leishmaniasis affected the mental health and quality of life of patients. To conduct the review, a wide search of the literature was conducted, where a total of 14 full articles were included and analysed. It was found that different forms of leishmaniasis (visceral leishmaniasis, cutaneous leishmaniasis and post kala-azar dermal leishmaniasis) do cause a significant impact on patients’ mental health and quality of life through societal factors such as stigma, lack of knowledge, culture and low self-esteem among others. However, no evidence of biological mechanisms was found linking leishmaniasis to mental illness or decreased quality of life. Despite being a very incapacitating disease physically, leishmaniasis also leads to mental illness and decreased quality of life, and should therefore be a priority on the global health agenda for both researchers and policy makers.

AimsIn the past few years, there has been an unprecedented increase in the number of forcibly displaced migrants worldwide, of which a substantial proportion is refugees and asylum seekers. Refugees and asylum seekers may experience high levels of psychological distress, and show high rates of mental health conditions. It is therefore timely and particularly relevant to assess whether current evidence supports the provision of psychosocial interventions for this population. We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) assessing the efficacy and acceptability of psychosocial interventions compared with control conditions (treatment as usual/no treatment, waiting list, psychological placebo) aimed at reducing mental health problems in distressed refugees and asylum seekers.MethodsWe used Cochrane procedures for conducting a systematic review and meta-analysis of RCTs. We searched for published and unpublished RCTs assessing the efficacy and acceptability of psychosocial interventions in adults and children asylum seekers and refugees with psychological distress. Post-traumatic stress disorder (PTSD), depressive and anxiety symptoms at post-intervention were the primary outcomes. Secondary outcomes include: PTSD, depressive and anxiety symptoms at follow-up, functioning, quality of life and dropouts due to any reason.ResultsWe included 26 studies with 1959 participants. Meta-analysis of RCTs revealed that psychosocial interventions have a clinically significant beneficial effect on PTSD (standardised mean difference [SMD] = −0.71; 95% confidence interval [CI] −1.01 to −0.41; I2 = 83%; 95% CI 78–88; 20 studies, 1370 participants; moderate quality evidence), depression (SMD = −1.02; 95% CI −1.52 to −0.51; I2 = 89%; 95% CI 82–93; 12 studies, 844 participants; moderate quality evidence) and anxiety outcomes (SMD = −1.05; 95% CI −1.55 to −0.56; I2 = 87%; 95% CI 79–92; 11 studies, 815 participants; moderate quality evidence). This beneficial effect was maintained at 1 month or longer follow-up, which is extremely important for populations exposed to ongoing post-migration stressors. For the other secondary outcomes, we identified a non-significant trend in favour of psychosocial interventions. Most evidence supported interventions based on cognitive behavioural therapies with a trauma-focused component. Limitations of this review include the limited number of studies collected, with a relatively low total number of participants, and the limited available data for positive outcomes like functioning and quality of life.ConclusionsConsidering the epidemiological relevance of psychological distress and mental health conditions in refugees and asylum seekers, and in view of the existing data on the effectiveness of psychosocial interventions, these interventions should be routinely made available as part of the health care of distressed refugees and asylum seekers. Evidence-based guidelines and implementation packages should be developed accordingly.

Mental disorders in children and young people represent a significant burden of disease, requiring enhanced efforts in terms of both prevention and treatment. Directing scarce research resources to address important gaps and answer meaningful questions is critical and engaging stakeholders including young people, their family members, clinicians, academic researchers etc. is key to this process. We have embarked on a large programme of work to establish and prioritise research questions for the Cochrane Common Mental Disorders-Children and Young People Satellite. In 2019, we conducted a cross-sectional online survey with 295 participants. More than a third of respondents were young people, nearly one-half reported lived experience of mental health difficulties and more than 40% were involved in caregiving responsbilities for people experiencing mental health difficulties. Results from the ranking exercise showed respondents believe anxiety, depression and suicide are the most important issues to be addressed. Multiple factors that respondents believe can make young people vulnerable to mental disorders were described and results highlighted the need for service reforms, and strengthening parenting and educational responses as important ways to address mental disorders. We believe that identifying relevant research questions for evidence synthesis is essential to ensure that research funding is used for maximum benefit for this age group.

BackgroundObsessive–compulsive disorder (OCD) is a relatively common and disabling condition.ObjectivesTo determine the clinical effectiveness, acceptability and cost-effectiveness of pharmacological and psychological interventions for the treatment of OCD in children, adolescents and adults.Data sourcesWe searched the Cochrane Collaboration Depression, Anxiety and Neurosis Trials Registers, which includes trials from routine searches of all the major databases. Searches were conducted from inception to 31 December 2014.Review methodsWe undertook a systematic review and network meta-analysis (NMA) of the clinical effectiveness and acceptability of available treatments. Outcomes for effectiveness included mean differences in the total scores of the Yale–Brown Obsessive–Compulsive Scale or its children’s version and total dropouts for acceptability. For the cost-effectiveness analysis, we developed a probabilistic model informed by the results of the NMA. All analyses were performed using OpenBUGS version 3.2.3 (members of OpenBUGS Project Management Group; seewww.openbugs.net).ResultsWe included 86 randomised controlled trials (RCTs) in our systematic review. In the NMA we included 71 RCTs (54 in adults and 17 in children and adolescents) for effectiveness and 71 for acceptability (53 in adults and 18 in children and adolescents), comprising 7643 and 7942 randomised patients available for analysis, respectively. In general, the studies were of medium quality. The results of the NMA showed that in adults all selective serotonin reuptake inhibitors (SSRIs) and clomipramine had greater effects than drug placebo. There were no differences between SSRIs, and a trend for clomipramine to be more effective did not reach statistical significance. All active psychological therapies had greater effects than drug placebo. Behavioural therapy (BT) and cognitive therapy (CT) had greater effects than psychological placebo, but cognitive–behavioural therapy (CBT) did not. BT and CT, but not CBT, had greater effects than medications, but there are considerable uncertainty and methodological limitations that should be taken into account. In children and adolescents, CBT and BT had greater effects than drug placebo, but differences compared with psychological placebo did not reach statistical significance. SSRIs as a class showed a trend for superiority over drug placebo, but the difference did not reach statistical significance. However, the superiority of some individual drugs (fluoxetine, sertraline) was marginally statistically significant. Regarding acceptability, all interventions except clomipramine had good tolerability. In adults, CT and BT had the highest probability of being most cost-effective at conventional National Institute for Health and Care Excellence thresholds. In children and adolescents, CBT or CBT combined with a SSRI were more likely to be cost-effective. The results are uncertain and sensitive to assumptions about treatment effect and the exclusion of trials at high risk of bias.LimitationsThe majority of psychological trials included patients who were taking medications. There were few studies in children and adolescents.ConclusionsIn adults, psychological interventions, clomipramine, SSRIs or combinations of these are all effective, whereas in children and adolescents, psychological interventions, either as monotherapy or combined with specific SSRIs, were more likely to be effective. Future RCTs should improve their design, in particular for psychotherapy or combined interventions.Study registrationThe study is registered as PROSPERO CRD42012002441.Funding detailsThe National Institute for Health Research Health Technology Assessment programme.

Summary Background Several interventions are available for management of obsessive-compulsive disorder in adults, but few studies have compared their relative efficacy in a single analysis. We aimed to simultaneously compare all available treatments using both direct and indirect data. Methods In this systematic review and network meta-analysis, we searched the two controlled trials registers maintained by the Cochrane Collaboration Common Mental Disorders group for trials published up to Feb 16, 2016. We selected randomised controlled trials in which an active psychotherapeutic or pharmacological intervention had been used in adults with obsessive-compulsive disorder. We allowed all comorbidities except for schizophrenia or bipolar disorder. We excluded studies that focused exclusively on treatment-resistant patient populations defined within the same study. We extracted data from published reports. The primary outcome was symptom severity as measured by the Yale-Brown Obsessive Compulsive Scale. We report mean differences with 95% credible intervals compared with placebo. This study is registered with PROSPERO, number CRD42012002441. Findings We identified 1480 articles in our search and included 53 articles (54 trials; 6652 participants) in the network meta-analysis. Behavioural therapy (mean difference −14·48 [95% credible interval −18·61 to −10·23]; 11 trials and 287 patients), cognitive therapy (−13·36 [–18·40 to −8·21]; six trials and 172 patients), behavioural therapy and clomipramine (−12·97 [–19·18 to −6·74]; one trial and 31 patients), cognitive behavioural therapy and fluvoxamine (−7·50 [–13·89 to −1·17]; one trial and six patients), cognitive behavioural therapy (−5·37 [–9·10 to −1·63]; nine trials and 231 patients), clomipramine (−4·72 [–6·85 to −2·60]; 13 trials and 831 patients), and all SSRIs (class effect −3·49 [95% credible interval −5·12 to −1·81]; 37 trials and 3158 patients) had greater effects than did drug placebo. Clomipramine was not better than were SSRIs (−1·23 [–3·41 to 0·94]). Psychotherapeutic interventions had a greater effect than did medications, but a serious limitation was that most psychotherapeutic trials included patients who were taking stable doses of antidepressants (12 [80%] of the 15 psychotherapy trials explicitly allowed antidepressants). Interpretation A range of interventions is effective in the management of obsessive-compulsive disorder, but considerable uncertainty and limitations exist regarding their relative efficacy. Taking all the evidence into account, the combination of psychotherapeutic and psychopharmacological interventions is likely to be more effective than are psychotherapeutic interventions alone, at least in severe obsessive-compulsive disorder. Funding National Institute for Health Research.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: 1) To determine the efficacy of reboxetine in comparison with other antidepressive agents in alleviating the acute symptoms of depression. 2) To investigate acceptability of treatment with reboxetine in comparison with other antidepressive agents. 3) To investigate the adverse effects of reboxetine in comparison with other antidepressive agents.

To develop ROBIS, a new tool for assessing the risk of bias in systematic reviews (rather than in primary studies).We used four-stage approach to develop ROBIS: define the scope, review the evidence base, hold a face-to-face meeting, and refine the tool through piloting.ROBIS is currently aimed at four broad categories of reviews mainly within health care settings: interventions, diagnosis, prognosis, and etiology. The target audience of ROBIS is primarily guideline developers, authors of overviews of systematic reviews ("reviews of reviews"), and review authors who might want to assess or avoid risk of bias in their reviews. The tool is completed in three phases: 1) assess relevance (optional), 2) identify concerns with the review process, and 3) judge risk of bias. Phase 2 covers four domains through which bias may be introduced into a systematic review: 1) study eligibility criteria; 2) identification and selection of studies; 3) data collection and study appraisal; and 4) synthesis and findings. Phase 3 assesses the overall risk of bias in the interpretation of review findings and whether this considered limitations identified in any of the phase 2 domains. Signaling questions are included to help judge concerns with the review process (phase 2) and the overall risk of bias in the review (phase 3); these questions flag aspects of review design related to the potential for bias and aim to help assessors judge risk of bias in the review process, results, and conclusions.ROBIS is the first rigorously developed tool designed specifically to assess the risk of bias in systematic reviews.

© 2018 The Cochrane Collaboration. This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the comparative efficacy and tolerability of different content and delivery cognitive behavioural therapy (CBT) components, and combination of components of CBT for the treatment of depression in adults using a component-level network meta-analysis.

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: Our primary objective is to examine mental health and well‐being, mental health service usage, and adverse effects of Mental Health First Aid (MHFA) training on recipients of the intervention. We have three secondary objectives: 1. To examine the effects of MHFA training on recipients of the trainees' intervention, in terms of their knowledge about mental health and attitudes towards mental health problems. 2. To examine the effects of MHFA training on trainees' knowledge about mental health, attitudes towards mental health problems, number of encounters with people with mental health problems, and their own mental health and well‐being. 3. To examine the effects on organisations, looking at measures of absenteeism and productivity at work.

Background: The conduct and publication of scientific research are increasingly open and collaborative. There is growing interest in Web-based platforms that can effectively enable global, multidisciplinary scientific teams and foster networks of scientists in areas of shared research interest. Designed to facilitate Web-based collaboration in research evidence synthesis, TaskExchange highlights the potential of these kinds of platforms. Objective: This paper describes the development, growth, and future of TaskExchange, a Web-based platform facilitating collaboration in research evidence synthesis. Methods: The original purpose of TaskExchange was to create a platform that connected people who needed help with their Cochrane systematic reviews (rigorous syntheses of health research) with people who had the time and expertise to help. The scope of TaskExchange has now been expanded to include other evidence synthesis tasks, including guideline development. The development of TaskExchange was initially undertaken in 5 agile development phases with substantial user engagement. In each phase, software was iteratively deployed as it was developed and tested, enabling close cycles of development and refinement. Results: TaskExchange enables users to browse and search tasks and members by keyword or nested filters, post and respond to tasks, sign up to notification emails, and acknowledge the work of TaskExchange members. The pilot platform has been open access since August 2016, has over 2300 members, and has hosted more than 630 tasks, covering a wide range of research synthesis-related tasks. Response rates are consistently over 75%, and user feedback has been positive. Conclusions: TaskExchange demonstrates the potential for new technologies to support Web-based collaboration in health research. Development of a relatively simple platform for peer-to-peer exchange has provided opportunities for systematic reviewers to get their reviews completed more quickly and provides an effective pathway for people to join the global health evidence community.

Background Depressive symptoms are usually managed within primary care and antidepressant medication constitutes the first-line treatment. It remains unclear at present which people are more likely to benefit from antidepressant medication. This paper describes the protocol for a randomised controlled trial (PANDA) to investigate the severity and duration of depressive symptoms that are associated with a clinically significant response to sertraline compared to placebo, in people presenting to primary care with depression. Methods/design PANDA is a randomised, double blind, placebo controlled trial in which participants are individually randomised to sertraline or placebo. Eligible participants are those who are between the ages of 18 to 74; have presented to primary care with depression or low mood during the past 2 years; have not received antidepressant or anti-anxiety medication in the 8 weeks prior to enrolment in the trial and there is clinical equipoise about the benefits of selective serotonin reuptake inhibitor (SSRI) medication. Participants who consent to participate in the trial are randomised to receive either sertraline or matching placebo, starting at 50 mg daily for 1 week, increasing to 100 mg daily for up to 11 weeks (with the option of increasing to 150 mg if required). Participants, general practitioners (GPs) and the research team will be blind to treatment allocation. The primary outcome will be depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) at 6 weeks post randomisation, measured as a continuous outcome. Secondary outcomes include depressive symptoms measured with the PHQ-9 at 2 and 12 weeks as a continuous outcome and at 2, 6 and 12 weeks as a binary outcome; follow-up scores on depressive symptoms measured with the Beck Depression Inventory-II, anxiety symptoms measured by the Generalized Anxiety Disorder-7 and quality of life measured with the Euroqol-5D-5L and Short Form-12; emotional processing task scores measured at baseline, 2 and 6 weeks; and costs associated with healthcare use, time off work and personal costs. Discussion The PANDA trial uses a simple self-administered measure to establish the severity and duration of depressive symptoms associated with a clinically significant response to sertraline. The evidence from the trial will inform primary care prescribing practice by identifying which patients are more likely to benefit from antidepressants. Trial registration Controlled Trials ISRCTN Registry, ISRCTN84544741. Registered on 20 March 2014. EudraCT Number: 2013-003440-22; Protocol Number: 13/0413 (version 6.1). Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2253-4) contains supplementary material, which is available to authorized users.

While it is important for the evidence supporting practice guidelines to be current, that is often not the case. The advent of living systematic reviews has made the concept of "living guidelines" realistic, with the promise to provide timely, up-to-date and high-quality guidance to target users. We define living guidelines as an optimization of the guideline development process to allow updating individual recommendations as soon as new relevant evidence becomes available. A major implication of that definition is that the unit of update is the individual recommendation and not the whole guideline. We then discuss when living guidelines are appropriate, the workflows required to support them, the collaboration between living systematic reviews and living guideline teams, the thresholds for changing recommendations, and potential approaches to publication and dissemination. The success and sustainability of the concept of living guideline will depend on those of its major pillar, the living systematic review. We conclude that guideline developers should both experiment with and research the process of living guidelines.

BackgroundFibromyalgia (FM) is a chronic, debilitating pain disorder. Dissatisfaction with conventional medicine can lead people with FM to turn to complementary and alternative medicine (CAM). Two previous overviews of systematic reviews of CAM for FM have been published, but they did not assessed for risk of bias in the review process.MethodsFive databases Medline, Embase, AMED (via OVID), Web of Science and Central were searched from their inception to December 2015. Reference lists were hand-searched. We had two aims: the first was to provide an up-to-date and rigorously conducted synthesis of systematic reviews of CAM literature on FM; the second was to evaluate the quality of the available systematic review evidence using two different tools: AMSTAR (Shea et al. BMC Med Res Methodol 15; 7:10, 2007) and a more recently developed tool ROBIS (Whiting et al. J Clin Epidemiol 69:225-34, 2016) specifically designed to assess risk of bias in systematic reviews. Any review that assessed one of eight CAM therapies for participants diagnosed with FM was considered. The individual studies had to be randomised controlled trials where the intervention was compared to placebo, treatment as usual or waitlist controls to be included. The primary outcome measure was pain, and the secondary outcome measure was adverse events.ResultsWe identified 15 reviews that met inclusion criteria. There was low-quality evidence that acupuncture improves pain compared to no treatment or standard treatment, but good evidence that it is no better than sham acupuncture. The evidence for homoeopathy, spinal manipulation and herbal medicine was limited.ConclusionsOverall, five reviews scored 6 or above using the AMSTAR scale and the inter-rater agreement was good (83.6%), whereas seven reviews achieved a low risk of bias rating using ROBIS and the inter-rater agreement was fair (60.0%). No firm conclusions were drawn for efficacy of either spinal manipulation or homoeopathy for FM. There is limited evidence for topical Capsicum, but further research is required. There is some evidence to support the effectiveness of acupuncture for FM, but further high-quality trials are needed to investigate its benefits, harms and mechanisms of action, compared with no or standard treatment.Systematic review registrationPROSPERO CRD42016035846.

A living systematic review (LSR) should keep the review current as new research evidence emerges. Any meta-analyses included in the review will also need updating as new material is identified. If the aim of the review is solely to present the best current evidence standard meta-analysis may be sufficient, provided reviewers are aware that results may change at later updates. If the review is used in a decision-making context, more caution may be needed. When using standard meta-analysis methods, the chance of incorrectly concluding that any updated meta-analysis is statistically significant when there is no effect (the type I error) increases rapidly as more updates are performed. Inaccurate estimation of any heterogeneity across studies may also lead to inappropriate conclusions. This paper considers four methods to avoid some of these statistical problems when updating meta-analyses: two methods, that is, law of the iterated logarithm and the Shuster method control primarily for inflation of type I error and two other methods, that is, trial sequential analysis and sequential meta-analysis control for type I and II errors (failing to detect a genuine effect) and take account of heterogeneity. This paper compares the methods and considers how they could be applied to LSRs.

Systematic reviews are difficult to keep up to date, but failure to do so leads to a decay in review currency, accuracy, and utility. We are developing a novel approach to systematic review updating termed "Living systematic review" (LSR): systematic reviews that are continually updated, incorporating relevant new evidence as it becomes available. LSRs may be particularly important in fields where research evidence is emerging rapidly, current evidence is uncertain, and new research may change policy or practice decisions. We hypothesize that a continual approach to updating will achieve greater currency and validity, and increase the benefits to end users, with feasible resource requirements over time.

Background Over the years randomized controlled trials (RCTs) of various psychotherapies for treating depression have provided evidence to demonstrate the interventions’ efficacy/effectiveness. However, recent researches suggest that the quality of some RCTs were actually less than ideal, which could hence have biased their results. The present study aims to assess (1) the changes in characteristics of RCTs of psychotherapies for treating adult depression; (2) the temporal changes in their trial quality, and (3) the quality differences among different therapeutic approaches. Methods We included 135 RCTs of psychotherapies treating adult depression published from year 1969 to 2011. Temporal changes in trials’ characteristics including their quantity and quality were assessed at study-level and arm-level. Quality differences among different schools of psychotherapy were assessed at arm-level. Results Changes in quantity and improvements in methodological quality were found at study-level. Positive changes in trial quality at arm-level were observed in most aspects. Comparisons made across different schools of psychotherapy revealed statistically significant differences among them, with earlier behavior therapy trials doing worst and more recent third wave cognitive-behavior therapy doing best. Limitations We could not determine whether the observed changes in quality resulted from actual improvement in trial quality and/or from improved reporting. The relatively smaller number of arms for several types of interventions could weaken the representativeness when making comparisons across psychotherapeutic approaches. Conclusion Our study revealed positive temporal changes in both trial quantity and quality over the past five decades and has also spotted possible areas for further improvement.

Objective Various control conditions have been employed in psychotherapy trials, but there is growing suspicion that they may lead to different effect size estimates. The present study aims to examine the differences among control conditions including waiting list (WL), no treatment (NT) and psychological placebo (PP). Method We comprehensively searched for all randomized controlled trials (RCTs) comparing cognitive-behaviour therapies (CBT) against various control conditions in the acute phase treatment of depression, and applied network meta-analysis (NMA) to combine all direct and indirect comparisons among the treatment and control arms. Results We identified 49 RCTs (2730 participants) comparing WL, NT, PP and CBT. This network of evidence was consistent, and the effect size estimates for CBT were substantively different depending on the control condition. The odds ratio of response for NT over WL was statistically significant at 2.9 (95% CI: 1.3–5.7). However, the quality of evidence, including publication bias, was less than ideal and none of the preplanned sensitivity analyses limiting to high-quality studies could be conducted, while findings of significant differences did not persist in post hoc sensitivity analyses trying to adjust for publication bias. Conclusion There may be important differences in control conditions currently used in psychotherapy trials.

The “Dodo bird verdict,” which claims that all psychotherapies are equally effective, has been a source of bewilderment and intense controversy among psychiatrists and psychologists. To examine this issue, we focused on cognitive-behavior therapy (CBT) and applied the newly developed review method known as multiple treatments meta-analysis (MTM). We identified randomized controlled trials comparing CBT against a psychological placebo (PP) and/or no treatment (NT) controls during the acute phase treatment of adults with depression. A random-effects MTM was conducted within a Bayesian framework. All the analyses were performed on an intention-to-treat basis. The MTM of the evidence network from 18 studies (39 treatment arms, 1,153 participants) revealed that CBT was significantly more likely to yield a response than NT (OR 2.24, 1.32–3.88) and that CBT was nominally, but not significantly, superior to PP (OR 1.30, 0.53–2.94), which in turn was superior to NT (OR 1.73, 0.67–4.84). The intervention effects in MTM were associated with the number of sessions, and the specificity of CBT increased as the number of sessions increased. The specific component of CBT was estimated to constitute 50.4 % (19.7–85.0) when CBT was given for ten or more sessions. Despite the quantitatively and qualitatively limited body of randomized evidence examining this issue, the present study strongly suggested a non-null specific component of CBT when given for an adequate length.

Non-randomized studies of the effects of interventions are critical to many areas of health care evaluation, but their results may be biased. It is therefore important to understand and appraise their strengths and weaknesses. We developed ROBINS-I (“Risk Of Bias In Non-randomized Studies - of Interventions”), a new tool for evaluating risk of bias in estimates of the comparative effectiveness (harm or benefit) of interventions from studies that did not use randomization to allocate units (individuals or clusters of individuals) to comparison groups. The tool will be particularly useful to those undertaking systematic reviews that include non-randomized studies.

BackgroundChild maltreatment is a substantial social problem that affects large numbers of children and young people in the UK, resulting in a range of significant short- and long-term psychosocial problems.ObjectivesTo synthesise evidence of the effectiveness, cost-effectiveness and acceptability of interventions addressing the adverse consequences of child maltreatment.Study designFor effectiveness, we included any controlled study. Other study designs were considered for economic decision modelling. For acceptability, we included any study that asked participants for their views.ParticipantsChildren and young people up to 24 years 11 months, who had experienced maltreatment before the age of 17 years 11 months.InterventionsAny psychosocial intervention provided in any setting aiming to address the consequences of maltreatment.Main outcome measuresPsychological distress [particularly post-traumatic stress disorder (PTSD), depression and anxiety, and self-harm], behaviour, social functioning, quality of life and acceptability.MethodsYoung Persons and Professional Advisory Groups guided the project, which was conducted in accordance with Cochrane Collaboration and NHS Centre for Reviews and Dissemination guidance. Departures from the published protocol were recorded and explained. Meta-analyses and cost-effectiveness analyses of available data were undertaken where possible.ResultsWe identified 198 effectiveness studies (including 62 randomised trials); six economic evaluations (five using trial data and one decision-analytic model); and 73 studies investigating treatment acceptability. Pooled data on cognitive–behavioural therapy (CBT) for sexual abuse suggested post-treatment reductions in PTSD [standardised mean difference (SMD) –0.44 (95% CI –4.43 to –1.53)], depression [mean difference –2.83 (95% CI –4.53 to –1.13)] and anxiety [SMD –0.23 (95% CI –0.03 to –0.42)]. No differences were observed for post-treatment sexualised behaviour, externalising behaviour, behaviour management skills of parents, or parental support to the child. Findings from attachment-focused interventions suggested improvements in secure attachment [odds ratio 0.14 (95% CI 0.03 to 0.70)] and reductions in disorganised behaviour [SMD 0.23 (95% CI 0.13 to 0.42)], but no differences in avoidant attachment or externalising behaviour. Few studies addressed the role of caregivers, or the impact of the therapist–child relationship. Economic evaluations suffered methodological limitations and provided conflicting results. As a result, decision-analytic modelling was not possible, but cost-effectiveness analysis using effectiveness data from meta-analyses was undertaken for the most promising intervention: CBT for sexual abuse. Analyses of the cost-effectiveness of CBT were limited by the lack of cost data beyond the cost of CBT itself.ConclusionsIt is not possible to draw firm conclusions about which interventions are effective for children with different maltreatment profiles, which are of no benefit or are harmful, and which factors encourage people to seek therapy, accept the offer of therapy and actively engage with therapy. Little is known about the cost-effectiveness of alternative interventions.LimitationsStudies were largely conducted outside the UK. The heterogeneity of outcomes and measures seriously impacted on the ability to conduct meta-analyses.Future workStudies are needed that assess the effectiveness of interventions within a UK context, which address the wider effects of maltreatment, as well as specific clinical outcomes.Study registrationThis study is registered as PROSPERO CRD42013003889.FundingThe National Institute for Health Research Health Technology Assessment programme.

OBJECTIVE: To conduct a comprehensive, systematic review and meta-analysis of the efficacy and tolerability of mirtazapine over other antidepressants in the acute-phase treatment of major depression. DATA SOURCES: Studies were initially identified through electronic searches of the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register up to June 2006. The following search terms were used: depress*, dysthymi*, adjustment disorder*, mood disorder*, affective disorder, affective symptoms, and mirtazapine. No language restriction was imposed. The reference lists of the included studies, previous relevant systematic reviews, and trial registers were also hand searched. Pharmaceutical companies and experts in the field were contacted for more studies. STUDY SELECTION: Twenty-five randomized controlled trials were included. DATA EXTRACTION: Two independent assessors examined the quality of the trials and extracted data on an intention-to-treat basis. DATA SYNTHESIS: The primary outcome measure was the relative risk (RR) of response (99% CIs) at the conclusion of acute-phase treatment. In relation to the early phase of treatment (at 2 weeks), there were no statistically significant differences between mirtazapine and the tricyclics in terms of the response (RR = 0.90, 99% CI = 0.69 to 1.18, p = .30 [8 trials contributed to this outcome]) or remission (RR = 0.87, 99% CI = 0.52 to 1.47, p = .50 [8 trials]) outcomes, but mirtazapine was superior to the selective serotonin reuptake inhibitors (SSRIs) in terms of both the response (RR = 1.36, 99% CI = 1.13 to 1.64, p < .0001 [12 trials]) and remission (RR = 1.68, 99% CI = 1.20 to 2.36, p < .0001 [12 trials]). In the subgroup analyses, mirtazapine significantly produced more response than paroxetine (RR = 2.02, 99% CI = 1.09 to 3.75, p = .003 [3 trials]) and venlafaxine (RR = 1.77, 99% CI = 1.08 to 2.89, p = .003 [2 trials]). At the end of acute-phase treatment (6-12 weeks, all trials), no significant differences were observed in the efficacy outcomes. No significant differences were observed between mirtazapine and the other antidepressants in terms of either the total number of dropouts due to any reason (21 trials) or the total number of dropouts due to the development of side effect (23 trials) during the trials. CONCLUSIONS: Although mirtazapine is likely to have a faster onset of action than SSRIs, no significant differences were observed at the end of 6 to 12 weeks' treatment. Clinicians should focus on other practically relevant considerations to tailor treatment to best fit the needs of individual patients.

In this issue of Evidence-Based Mental Health , Gartlehner and Gaynes1 comment (see page 98) on our recently published systematic review2 that investigated the comparative efficacy and acceptability of 12 new generation antidepressants (see page 107) . In their view, methodological shortcomings limit the validity of our results and the conclusions reached. In this commentary, our aim is to explain the rationale for doing this systematic review, outline its main findings and address the points raised by Gartlehner and Gaynes.1 Scientific debate can illuminate and clarify complex analyses and we are, therefore, delighted to respond to their critique. While we consider that some of the issues raised are substantive and merit reasoned response, we also believe that some of their criticisms seem rather overstated. We understand that Gartlehner and Gaynes too have published an analysis comparing antidepressants and we note that this is now the third occasion on which they have published similar criticisms of our work.3 ,4 In most countries, demonstration of a difference against placebo, and not against an active comparator, makes a new drug eligible for registration. The European Medicines Agency, for example, is willing to evaluate new antidepressants in the absence of comparison with active existing treatments.5 In situations where no (or a few) active treatments are available, this may not be important. In the field of antidepressants, however, where many potentially effective agents are already available, this process has serious implications. The approval of a new antidepressant as effective and safe in comparison solely with placebo allows the marketing of new drugs that may, in fact, be potentially more effective, similarly effective or even less effective than others currently in use. Many antidepressants have never been directly compared with each other. The picture is further complicated by …