Psychological and social interventions for the promotion of mental health in people living in low- and middle-income countries affected by humanitarian crises.

BACKGROUND: Because of wars, conflicts, persecutions, human rights violations, and humanitarian crises, about 84 million people are forcibly displaced around the world; the great majority of them live in low- and middle-income countries (LMICs). People living in humanitarian settings are affected by a constellation of stressors that threaten their mental health. Psychosocial interventions for people affected by humanitarian crises may be helpful to promote positive aspects of mental health, such as mental well-being, psychosocial functioning, coping, and quality of life. Previous reviews have focused on treatment and mixed promotion and prevention interventions. In this review, we focused on promotion of positive aspects of mental health. OBJECTIVES: To assess the effects of psychosocial interventions aimed at promoting mental health versus control conditions (no intervention, intervention as usual, or waiting list) in people living in LMICs affected by humanitarian crises. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and seven other databases to January 2023. We also searched the World Health Organization's (WHO) International Clinical Trials Registry Platform and ClinicalTrials.gov to identify unpublished or ongoing studies, and checked the reference lists of relevant studies and reviews. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing psychosocial interventions versus control conditions (no intervention, intervention as usual, or waiting list) to promote positive aspects of mental health in adults and children living in LMICs affected by humanitarian crises. We excluded studies that enrolled participants based on a positive diagnosis of mental disorder (or based on a proxy of scoring above a cut-off score on a screening measure). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were mental well-being, functioning, quality of life, resilience, coping, hope, and prosocial behaviour. The secondary outcome was acceptability, defined as the number of participants who dropped out of the trial for any reason. We used GRADE to assess the certainty of evidence for the outcomes of mental well-being, functioning, and prosocial behaviour. MAIN RESULTS: We included 13 RCTs with 7917 participants. Nine RCTs were conducted on children/adolescents, and four on adults. All included interventions were delivered to groups of participants, mainly by paraprofessionals. Paraprofessional is defined as an individual who is not a mental or behavioural health service professional, but works at the first stage of contact with people who are seeking mental health care. Four RCTs were carried out in Lebanon; two in India; and single RCTs in the Democratic Republic of the Congo, Jordan, Haiti, Bosnia and Herzegovina, the occupied Palestinian Territories (oPT), Nepal, and Tanzania. The mean study duration was 18 weeks (minimum 10, maximum 32 weeks). Trials were generally funded by grants from academic institutions or non-governmental organisations. For children and adolescents, there was no clear difference between psychosocial interventions and control conditions in improving mental well-being and prosocial behaviour at study endpoint (mental well-being: standardised mean difference (SMD) 0.06, 95% confidence interval (CI) -0.17 to 0.29; 3 RCTs, 3378 participants; very low-certainty evidence; prosocial behaviour: SMD -0.25, 95% CI -0.60 to 0.10; 5 RCTs, 1633 participants; low-certainty evidence), or at medium-term follow-up (mental well-being: mean difference (MD) -0.70, 95% CI -2.39 to 0.99; 1 RCT, 258 participants; prosocial behaviour: SMD -0.48, 95% CI -1.80 to 0.83; 2 RCT, 483 participants; both very low-certainty evidence). Interventions may improve functioning (MD -2.18, 95% CI -3.86 to -0.50; 1 RCT, 183 participants), with sustained effects at follow-up (MD -3.33, 95% CI -5.03 to -1.63; 1 RCT, 183 participants), but evidence is very uncertain as the data came from one RCT (both very low-certainty evidence). Psychosocial interventions may improve mental well-being slightly in adults at study endpoint (SMD -0.29, 95% CI -0.44 to -0.14; 3 RCTs, 674 participants; low-certainty evidence), but they may have little to no effect at follow-up, as the evidence is uncertain and future RCTs might either confirm or disprove this finding. No RCTs measured the outcomes of functioning and prosocial behaviour in adults. AUTHORS' CONCLUSIONS: To date, there is scant and inconclusive randomised evidence on the potential benefits of psychological and social interventions to promote mental health in people living in LMICs affected by humanitarian crises. Confidence in the findings is hampered by the scarcity of studies included in the review, the small number of participants analysed, the risk of bias in the studies, and the substantial level of heterogeneity. Evidence on the efficacy of interventions on positive mental health outcomes is too scant to determine firm practice and policy implications. This review has identified a large gap between what is known and what still needs to be addressed in the research area of mental health promotion in humanitarian settings.

Effectiveness of combining prevention psychological interventions with interventions that address the social determinants of mental health in low and middle-income countries: protocol of a systematic review and meta-analysis.

INTRODUCTION: Common mental health conditions (CMHCs), including depression, anxiety and post-traumatic stress disorder (PTSD), are highly prevalent in low and middle-income countries (LMICs). Preventive strategies combining psychological interventions with interventions addressing the social determinants of mental health may represent a key strategy for effectively preventing CMHCs. However, no systematic reviews have evaluated the effectiveness of these combined intervention strategies for preventing CMHCs. METHODS AND ANALYSIS: This systematic review will include randomised controlled trials (RCTs) focused on the effectiveness of interventions that combine preventive psychological interventions with interventions that address the social determinants of mental health in LMICs. Primary outcome is the frequency of depression, anxiety or PTSD at postintervention as determined by a formal diagnostic tool or any other standardised criteria. We will search Epistemonikos, Cochrane Controlled Trials Register (CENTRAL), MEDLINE, Embase, PsycINFO, CINAHL, Global Index Medicus, ClinicalTrials.gov (Ctgov), International Clinical Trials Registry Platform (ICTRP). Two reviewers will independently extract the data and evaluate the risk of bias of included studies using the Cochrane risk of bias tool 2. Random-effects meta-analyses will be performed, and certainty of evidence will be rated using the Grading of Recommendations Assessment, Development and Evaluation approach. ETHICS AND DISSEMINATION: This study uses data from published studies; therefore, ethical review is not required. Findings will be presented in a published manuscript. TRIAL REGISTRATION NUMBER: CRD42023451072.

Mapping the evidence on psychosocial interventions for migrant populations: Descriptive analysis of a living database of randomized studies.

Migrant mental health is a pressing public health issue with wide-ranging implications. Many randomized controlled trials (RCTs) have been conducted in this population to assess the effects of psychosocial interventions. However, the available evidence is characterized by controversy and fragmentation, with studies focusing on different migrant populations, interventions, outcomes, delivery modalities and settings. Aiming to promote systematic reviews of the effectiveness of psychosocial interventions in different migrant groups, we have developed a living database of existing RCTs. The development of the database provides an opportunity to map the existing RCT evidence in this population. A total of 135 studies involving 24,859 participants were included in the living database. The distribution of studies by year of publication aligns with the increasing global migrant population in recent years. Most studies focus primarily on adult participants, with a limited representation of children and adolescents, and a prevalence of female participants, which is consistent with epidemiological data, except for older adults, who are underrepresented in research. Studies predominantly focus on refugees and asylum seekers, likely due to their elevated risk of mental health issues, despite the substantial presence of economic migrants worldwide. While studies mainly involve migrants from the Middle East and East Asia, epidemiological data suggest a broader geographic representation, with migrants coming from Eastern Europe, Latin America and South Asia. The present descriptive analysis of RCTs on mental health and psychosocial interventions for migrant populations provides valuable insights into the existing research landscape. It should be used to inform future research efforts, ensuring that studies are more representative of the global migrant population and more responsive to the mental health needs of migrants in different contexts.

Psychotherapies for Generalized Anxiety Disorder in Adults: A Systematic Review and Network Meta-Analysis of Randomized Clinical Trials.

Importance: Generalized anxiety disorder (GAD) is one of the most common mental disorders in adults. Psychotherapies are among the most recommended treatments for GAD, but which should be considered as first-line treatment needs to be clarified. Objective: To use a network meta-analysis to examine the short- and long-term associations of different psychotherapies with outcomes of effectiveness and acceptability in adults with GAD. Data Sources: MEDLINE, Embase, PsycINFO, and the Cochrane Register of Controlled Trials were searched from database inception to January 1, 2023, to identify randomized clinical trials (RCTs) of psychotherapies for adults with GAD. Study Selection: RCTs comparing any type of psychotherapy against another or with a control condition for the treatment of adults (≥18 years, both sexes) with a primary diagnosis of GAD were eligible for inclusion. Data Extraction and Synthesis: This study followed Cochrane standards for extracting data and assessing data quality and used the PRISMA guideline for reporting. Risk of bias of individual studies was assessed using the second version of the Cochrane risk of bias tool, and the Confidence in Network Meta-Analysis was used to rate the certainty of evidence for meta-analytical results. Main Outcomes and Measures: Eight psychotherapies were compared against one another and with 2 control conditions. Primary outcomes were severity of GAD symptoms and acceptability of the psychotherapies. Random-effects model pairwise and network meta-analyses were conducted. For effectiveness, standardized mean differences (SMDs) were pooled, and for acceptability, relative risks with 95% CIs were calculated. Results: Data from 65 RCTs were included. Effect size estimates on data from 5048 participants (mean [SD], 70.9% [11.9%] women; mean [SD] age, 42.2 [12.5] years) suggested that third-wave cognitive behavior therapies (CBTs) (SMD, -0.76 [95% CI, -1.15 to -0.36]; certainty, moderate), CBT (SMD, -0.74 [95% CI, -1.09 to -0.38]; certainty, moderate), and relaxation therapy (SMD, -0.59 [95% CI, -1.07 to -0.11]; certainty, low) were associated with reduced GAD symptoms vs treatment as usual. Relative risks for all-cause discontinuation (indication of acceptability) signaled no differences compared with treatment as usual for all psychotherapies (eg, relative risk, 1.04 [95% CI, 0.64-1.67] for CBT vs treatment as usual). When excluding studies at high risk of bias, relaxation therapy lost its superiority over treatment as usual (SMD, -0.47; 95% CI, -1.18 to 0.23). When considering anxiety severity at 3 to 12 months after completion of the intervention, only CBT remained significantly associated with greater effectiveness than treatment as usual (SMD, -0.60; 95% CI, -0.99 to -0.21). Conclusions and Relevance: Given the evidence in this systematic review and network meta-analysis for its associations with both acute and long-term effectiveness, CBT may represent the first-line therapy of GAD. Third-wave CBTs and relaxation therapy were associated with short-term effectiveness and may also be offered.

Umbrella Systematic Review and Meta-Analysis: Physical Activity as an Effective Therapeutic Strategy for Improving Psychosocial Outcomes in Children and Adolescents.

OBJECTIVE: Physical activity (PA) interventions are part of many interdisciplinary programs for the management of children and adolescents with or without physical or psychological conditions or disabilities. Aiming to summarize the available evidence, we conducted an umbrella review of meta-analyses of PA interventions that included psychosocial outcomes in populations of children and adolescents. METHOD: Literature searches were conducted in PubMed, Cochrane Central, Web of Science, Medline, SPORTDiscus, and PsychInfo from January 1, 2010, to May 6, 2022. Meta-analyses of randomized and quasi-randomized studies investigating the efficacy of PA interventions for psychosocial outcomes in children and adolescents were included. Summary effects were recalculated using common metric and random-effects models. We assessed between-study heterogeneity, predictive intervals, publication bias, small study effects, and whether the results of the observed positive studies were greater than expected due to chance. On the basis of these calculations, strength of associations was assessed using quantitative umbrella review criteria, and credibility of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Quality was assessed using the AMSTAR 2 tool. This study is registered with the Open Science Framework, https://osf.io/ap8qu. RESULTS: A total of 112 studies from 18 meta-analyses generating 12 new meta-analyses comprising 21,232 children and adolescents in population groups including attention-deficit/hyperactivity disorder, cancer, cerebral palsy, chronic respiratory diseases, depression, neuromotor impairment, and obesity and in general populations were included. PA interventions were efficacious in reducing psychological symptoms in all meta-analyses across the different population groups using random-effects models. However, umbrella review criteria suggested a weak strength of association for this outcome, and GRADE credibility of evidence ranged from moderate to very low. For psychological well-being, 3 out of 5 meta-analyses identified significant effects, but the strength of these associations was weak, and GRADE credibility of evidence ranged from moderate to very low. Similarly, for social outcomes, meta-analyses reported a significant summary effect, but the strength of association was weak, and GRADE credibility of evidence ranged from moderate to very low. For self-esteem, one meta-analysis in children with obesity failed to show any effect. CONCLUSION: Even though existing meta-analyses suggested a beneficial effect of PA interventions on psychosocial outcomes across different population groups, the strength of associations was weak, and the credibility of evidence was variable depending on the target population, outcome, and condition or disability. Randomized studies of PA interventions in children and adolescents with and without different physical and psychological conditions or disabilities should always include psychosocial outcomes as an important dimension of social and mental health. STUDY PREREGISTRATION INFORMATION: Prenatal Maternal Infection and Adverse Neurodevelopment: A Structural Equation Modelling Approach to Downstream Environmental Hits; https://osf.io/; ap8qu.

Implementation outcomes in psychosocial intervention studies for children and adolescents living in low- and middle-income countries: A systematic review.

Psychosocial interventions play a key role in addressing mental health and substance use needs for children and adolescents living in low- and middle-income countries (LMICs). While research efforts have primarily focused on their effectiveness, implementation outcomes also require examining. We conducted a systematic review of qualitative, quantitative, and mixed-methods studies (PROSPERO: CRD42022335997) to synthesize the literature on implementation outcomes for psychosocial interventions for children and adolescents in LMICs. We searched Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Web of Science, PsychINFO, and Global Health through April 2023. Data were extracted and quality appraised through the Mixed Methods Appraisal Tool (MMAT) independently by two reviewers. A total of 13,380 records were screened, and 87 studies met inclusion criteria. Feasibility was the most reported implementation outcome (69, 79%), followed by acceptability (60, 69%), and fidelity (32, 37%). Appropriateness was assessed in 11 studies (13%), implementation costs in 10 (11%), and sustainability in one (1%). None of the included studies reported on penetration or adoption. Despite a growing body of evidence for implementation research in child and adolescent global mental health, most research focused on earlier-stage implementation outcomes, assessing them in research-controlled settings. To overcome this, future efforts should focus on assessing interventions in routine care, assessing later-stage implementation outcomes through standardized tools.

Addressing mental health problems among persons without stable housing in the context of the COVID-19 pandemic: study protocol for a randomised trial. RESPOND - France.

BACKGROUND: The COVID-19 pandemic has had an impact on population-wide mental health and well-being. Although people experiencing socioeconomic disadvantage may be especially vulnerable, they experience barriers in accessing mental health care. To overcome these barriers, the World Health Organization (WHO) designed two scalable psychosocial interventions, namely the web-based Doing What Matters in Times of Stress (DWM) and the face-to-face Problem Management Plus (PM+), to help people manage stressful situations. Our study aims to test the effectiveness of a stepped-care program using DWM and PM + among individuals experiencing unstable housing in France - a majority of whom are migrant or have sought asylum. METHODS: This is a randomised controlled trial to evaluate the effectiveness and cost effectiveness of a stepped-care program using DWM and PM + among persons with psychological distress and experiencing unstable housing, in comparison to enhanced care as usual (eCAU). Participants (N = 210) will be randomised to two parallel groups: eCAU or eCAU plus the stepped-care program. The main study outcomes are symptoms of depression and anxiety measured using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). DISCUSSION: This randomised controlled trial will contribute to a better understanding of effective community-based scalable strategies that can help address the mental health needs of persons experiencing socioeconomic disadvantage, whose needs are high yet who frequently have limited access to mental health care services. TRIAL REGISTRATION: this randomised trial has been registered at ClinicalTrials.gov under the number NCT05033210.

Dismantling and personalising task-sharing psychosocial interventions for common mental disorders: a study protocol for an individual participant data component network meta-analysis.

INTRODUCTION: Common mental disorders, including depression, anxiety and related somatic health symptoms, are leading causes of disability worldwide. Especially in low-resource settings, psychosocial interventions delivered by non-specialist providers through task-sharing modalities proved to be valid options to expand access to mental healthcare. However, such interventions are usually eclectic multicomponent interventions consisting of different combinations of evidence-based therapeutic strategies. Which of these various components (or combinations thereof) are more efficacious (and for whom) to reduce common mental disorder symptomatology is yet to be substantiated by evidence. METHODS AND ANALYSIS: Comprehensive search was performed in electronic databases MEDLINE, Embase, PsycINFO and the Cochrane Register of Controlled Trials-CENTRAL from database inception to 15 March 2023 to systematically identify all randomised controlled trials that compared any single component or multicomponent psychosocial intervention delivered through the task-sharing modality against any active or inactive control condition in the treatment of adults suffering from common mental disorders. From these trials, individual participant data (IPD) of all measured outcomes and covariates will be collected. We will dismantle psychosocial interventions creating a taxonomy of components and then apply the IPD component network meta-analysis (IPD-cNMA) methodology to assess the efficacy of individual components (or combinations thereof) according to participant-level prognostic factors and effect modifiers. ETHICS AND DISSEMINATION: Ethics approval is not applicable for this study since no original data will be collected. Results from this study will be published in peer-reviewed journals and presented at relevant conferences.

Effectiveness of a scalable, remotely delivered stepped-care intervention to reduce symptoms of psychological distress among Polish migrant workers in the Netherlands: study protocol for the RESPOND randomised controlled trial.

BACKGROUND: The COVID-19 pandemic has negatively affected the mental health of international migrant workers (IMWs). IMWs experience multiple barriers to accessing mental health care. Two scalable interventions developed by the World Health Organization (WHO) were adapted to address some of these barriers: Doing What Matters in times of stress (DWM), a guided self-help web application, and Problem Management Plus (PM +), a brief facilitator-led program to enhance coping skills. This study examines whether DWM and PM + remotely delivered as a stepped-care programme (DWM/PM +) is effective and cost-effective in reducing psychological distress, among Polish migrant workers with psychological distress living in the Netherlands. METHODS: The stepped-care DWM/PM + intervention will be tested in a two-arm, parallel-group, randomized controlled trial (RCT) among adult Polish migrant workers with self-reported psychological distress (Kessler Psychological Distress Scale; K10 > 15.9). Participants (n = 212) will be randomized into either the intervention group that receives DWM/PM + with psychological first aid (PFA) and care-as-usual (enhanced care-as-usual or eCAU), or into the control group that receives PFA and eCAU-only (1:1 allocation ratio). Baseline, 1-week post-DWM (week 7), 1-week post-PM + (week 13), and follow-up (week 21) self-reported assessments will be conducted. The primary outcome is psychological distress, assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). Secondary outcomes are self-reported symptoms of depression, anxiety, posttraumatic stress disorder (PTSD), resilience, quality of life, and cost-effectiveness. In a process evaluation, stakeholders' views on barriers and facilitators to the implementation of DWM/PM + will be evaluated. DISCUSSION: To our knowledge, this is one of the first RCTs that combines two scalable, psychosocial WHO interventions into a stepped-care programme for migrant populations. If proven to be effective, this may bridge the mental health treatment gap IMWs experience. TRIAL REGISTRATION: Dutch trial register NL9630, 20/07/2021, https://www.onderzoekmetmensen.nl/en/trial/27052.

Primary-level and community worker interventions for the prevention of mental disorders and the promotion of well-being in low- and middle-income countries.

BACKGROUND: There is a significant research gap in the field of universal, selective, and indicated prevention interventions for mental health promotion and the prevention of mental disorders. Barriers to closing the research gap include scarcity of skilled human resources, large inequities in resource distribution and utilization, and stigma. OBJECTIVES: To assess the effectiveness of delivery by primary workers of interventions for the promotion of mental health and universal prevention, and for the selective and indicated prevention of mental disorders or symptoms of mental illness in low- and middle-income countries (LMICs). To examine the impact of intervention delivery by primary workers on resource use and costs. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL, Global Index Medicus, PsycInfo, WHO ICTRP, and ClinicalTrials.gov from inception to 29 November 2021. SELECTION CRITERIA: Randomized controlled trials (RCTs) of primary-level and/or community health worker interventions for promoting mental health and/or preventing mental disorders versus any control conditions in adults and children in LMICs. DATA COLLECTION AND ANALYSIS: Standardized mean differences (SMD) or mean differences (MD) were used for continuous outcomes, and risk ratios (RR) for dichotomous data, using a random-effects model. We analyzed data at 0 to 1, 1 to 6, and 7 to 24 months post-intervention. For SMDs, 0.20 to 0.49 represented small, 0.50 to 0.79 moderate, and ≥ 0.80 large clinical effects. We evaluated the risk of bias (RoB) using Cochrane RoB2. MAIN RESULTS: Description of studies We identified 113 studies with 32,992 participants (97 RCTs, 19,570 participants in meta-analyses) for inclusion. Nineteen RCTs were conducted in low-income countries, 27 in low-middle-income countries, 2 in middle-income countries, 58 in upper-middle-income countries and 7 in mixed settings. Eighty-three RCTs included adults and 30 RCTs included children. Cadres of primary-level workers employed primary care health workers (38 studies), community workers (71 studies), both (2 studies), and not reported (2 studies). Interventions were universal prevention/promotion in 22 studies, selective in 36, and indicated prevention in 55 RCTs. Risk of bias The most common concerns over risk of bias were performance bias, attrition bias, and reporting bias. Intervention effects 'Probably', 'may', or 'uncertain' indicates 'moderate-', 'low-', or 'very low-'certainty evidence. *Certainty of the evidence (using GRADE) was assessed at 0 to 1 month post-intervention as specified in the review protocol. In the abstract, we did not report results for outcomes for which evidence was missing or very uncertain. Adults Promotion/universal prevention, compared to usual care: - probably slightly reduced anxiety symptoms (MD -0.14, 95% confidence interval (CI) -0.27 to -0.01; 1 trial, 158 participants) - may slightly reduce distress/PTSD symptoms (SMD -0.24, 95% CI -0.41 to -0.08; 4 trials, 722 participants) Selective prevention, compared to usual care: - probably slightly reduced depressive symptoms (SMD -0.69, 95% CI -1.08 to -0.30; 4 trials, 223 participants) Indicated prevention, compared to usual care: - may reduce adverse events (1 trial, 547 participants) - probably slightly reduced functional impairment (SMD -0.12, 95% CI -0.39 to -0.15; 4 trials, 663 participants) Children Promotion/universal prevention, compared to usual care: - may improve the quality of life (SMD -0.25, 95% CI -0.39 to -0.11; 2 trials, 803 participants) - may reduce adverse events (1 trial, 694 participants) - may slightly reduce depressive symptoms (MD -3.04, 95% CI -6 to -0.08; 1 trial, 160 participants) - may slightly reduce anxiety symptoms (MD -2.27, 95% CI -3.13 to -1.41; 1 trial, 183 participants) Selective prevention, compared to usual care: - probably slightly reduced depressive symptoms (SMD 0, 95% CI -0.16 to -0.15; 2 trials, 638 participants) - may slightly reduce anxiety symptoms (MD 4.50, 95% CI -12.05 to 21.05; 1 trial, 28 participants) - probably slightly reduced distress/PTSD symptoms (MD -2.14, 95% CI -3.77 to -0.51; 1 trial, 159 participants) Indicated prevention, compared to usual care: - decreased slightly functional impairment (SMD -0.29, 95% CI -0.47 to -0.10; 2 trials, 448 participants) - decreased slightly depressive symptoms (SMD -0.18, 95% CI -0.32 to -0.04; 4 trials, 771 participants) - may slightly reduce distress/PTSD symptoms (SMD 0.24, 95% CI -1.28 to 1.76; 2 trials, 448 participants). AUTHORS' CONCLUSIONS: The evidence indicated that prevention interventions delivered through primary workers - a form of task-shifting - may improve mental health outcomes. Certainty in the evidence was influenced by the risk of bias and by substantial levels of heterogeneity. A supportive network of infrastructure and research would enhance and reinforce this delivery modality across LMICs.

Prevention and promotion effects of Self Help Plus: secondary analysis of cluster randomised controlled trial data among South Sudanese refugee women in Uganda.

INTRODUCTION: Evidence-based and scalable prevention and promotion focused mental health and psychosocial support interventions are needed for conflict-affected populations in humanitarian settings. This study retrospectively assessed whether participation in Self Help Plus (SH+) versus enhanced usual care (EUC) resulted in reduced incidence of probable mental disorder and increased positive mental health and well-being post-intervention among South Sudanese refugee women in Uganda. METHODS: This study used secondary data from treatment-oriented pilot (n=50) and fully-powered cluster randomised controlled trials (cRCT)s (n=694) of SH+ versus EUC. Data from baseline and post-intervention assessments were combined. A composite latent indicator for mental health problems was generated using mental health and well-being measures included in both cRCTs. In order to assess incidence, a binary variable approximating probable mental disorder was created to exclude those with probable mental disorder from the analysis sample and as the primary prevention outcome. The promotive effects of SH+ relative to EUC were examined in the same sample by assessing subjective well-being and psychological flexibility scale scores. RESULTS: A single factor for mental health problems was identified with all factor loadings >0.30 and acceptable internal consistency (α=0.70). We excluded 161 women who met criteria for probable mental disorder at baseline. Among those with at least moderate psychological distress but without probable mental disorder at baseline and with follow-up data (n=538), the incidence of probable mental disorder at post-intervention was lower among those who participated in SH+ relative to EUC (Risk ratio =0.16, 95% CI: 0.05 to 0.53). Participation in SH+ versus EUC was also associated with increased subjective well-being (ß=2.62, 95% CI: 1.63 to 3.60) and psychological flexibility (ß=4.55, 95% CI: 2.92 to 6.18) at post-intervention assessment. CONCLUSIONS: These results support the use and further testing of SH+ as a selective and indicated prevention and promotion focused psychosocial intervention in humanitarian settings. TRIAL REGISTRATION NUMBER: ISRCTN50148022.

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children?

Adverse Events (AEs) are defined as any unfavorable and unintended sign or symptom, that may occur during or after receipt of any intervention. The principle of non-maleficence requires careful consideration to ensure that existing or new psychological interventions are not harmful before they can be considered beneficial. In this context, the safety of psychological interventions, including the possible occurrence of AEs, is increasingly important for patients, families, and clinicians. The evaluation of AEs is crucial to obtain a complete understanding of the risk/benefit balance of psychological interventions. There is a need for researchers and clinicians to assess and report AEs comprehensively and in a coordinated manner. It is necessary to have more accurate data on the recording of AEs in protocols to enhance transparency and consistency, as well as to improve practice. Finally, and to facilitate this process, there is a need for standards for data collection.

Self-Help Plus for refugees and asylum seekers: an individual participant data meta-analysis.

QUESTION: Refugees and asylum seekers are at high risk of mental disorders due to various stressors before, during and after forceful displacement. The WHO Self-Help Plus (SH+) intervention was developed to manage psychological distress and a broad range of mental health symptoms in vulnerable populations. This study aimed to examine the effects and moderators of SH+ compared with Enhanced Care as Usual (ECAU) in reducing depressive symptoms among refugees and asylum seekers. STUDY SELECTION AND ANALYSIS: Three randomised trials were identified with 1795 individual participant data (IPD). We performed an IPD meta-analysis to estimate the effects of SH+, primarily on depressive symptoms and second on post-traumatic stress, well-being, self-identified problems and functioning. Effects were also estimated at 5-6 months postrandomisation (midterm). FINDINGS: There was no evidence of a difference between SH+ and ECAU+ in reducing depressive symptoms at postintervention. However, SH+ had significantly larger effects among participants who were not employed (ß=1.60, 95% CI 0.20 to 3.00) and had lower mental well-being levels (ß=0.02, 95% CI 0.001 to 0.05). At midterm, SH+ was significantly more effective than ECAU in improving depressive symptoms (ß=-1.13, 95% CI -1.99 to -0.26), self-identified problems (ß=-1.56, 95% CI -2.54 to -0.59) and well-being (ß=6.22, 95% CI 1.60 to 10.90). CONCLUSIONS: Although SH+ did not differ significantly from ECAU in reducing symptoms of depression at postintervention, it did present benefits for particularly vulnerable participants (ie, unemployed and with lower mental well-being levels), and benefits were also evident at midterm follow-up. These results are promising for the use of SH+ in the management of depressive symptoms and improvement of well-being and self-identified problems among refugees and asylum seekers.

Effectiveness of a mental health stepped-care programme for healthcare workers with psychological distress in crisis settings: a multicentre randomised controlled trial.

BACKGROUND: Evidence-based mental health interventions to support healthcare workers (HCWs) in crisis settings are scarce. OBJECTIVE: To evaluate the capacity of a mental health intervention in reducing anxiety and depression symptoms in HCWs, relative to enhanced care as usual (eCAU), amidst the COVID-19 pandemic. METHODS: We conducted an analyst-blind, parallel, multicentre, randomised controlled trial. We recruited HCWs with psychological distress from Madrid and Catalonia (Spain). The intervention arm received a stepped-care programme consisting of two WHO-developed interventions adapted for HCWs: Doing What Matters in Times of Stress (DWM) and Problem Management Plus (PM+). Each intervention lasted 5 weeks and was delivered remotely by non-specialist mental health providers. HCWs reporting psychological distress after DWM completion were invited to continue to PM+. The primary endpoint was self-reported anxiety/depression symptoms (Patient Health Questionnaire-Anxiety and Depression Scale) at week 21. FINDINGS: Between 3 November 2021 and 31 March 2022, 115 participants were randomised to stepped care and 117 to eCAU (86% women, mean age 37.5). The intervention showed a greater decrease in anxiety/depression symptoms compared with eCAU at the primary endpoint (baseline-adjusted difference 4.4, 95% CI 2.1 to 6.7; standardised effect size 0.8, 95% CI 0.4 to 1.2). No serious adverse events occurred. CONCLUSIONS: Brief stepped-care psychological interventions reduce anxiety and depression during a period of stress among HCWs. CLINICAL IMPLICATIONS: Our results can inform policies and actions to protect the mental health of HCWs during major health crises and are potentially rapidly replicable in other settings where workers are affected by global emergencies. TRIAL REGISTRATION NUMBER: NCT04980326.

Task-sharing psychosocial interventions for the prevention of common mental disorders in the perinatal period in low- and middle-income countries: A systematic review and meta-analysis.

AIM: to assess the efficacy of psychosocial interventions delivered through task-sharing approaches for preventing perinatal common mental disorders among women in low- and middle-income countries. METHODS: We conducted a systematic review of randomized controlled trials following a prespecified protocol registered in the Open Science Framework (osf.io/qt4y3). We searched MEDLINE, Web of Science, PsycINFO, and Cochrane Central Register of Controlled Trials (CENTRAL) through June 2022. Two reviewers independently extracted the data and evaluated the risk of bias of included studies using the Cochrane risk of bias tool. We performed random-effects meta-analyses and rated the certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. RESULTS: We included 23 studies with 24,442 participants. At post-intervention, task-shared psychosocial interventions, were effective in preventing the development of mental disorders in general (RR 0.57, 95% CI [0.35, 0.91]), and specifically depression (RR 0.51, 95% CI [0.35, 0.75]), but not anxiety disorders (RR 0.46, 95% CI [0.06, 3.33]). Similarly, psychosocial interventions reduced psychological distress (SMD -1.32, 95% CI [-2.28, -0.35]), and depressive symptoms (SMD -0.50, 95% CI [-0.80, -0.16]), and increased parenting self-efficacy (SMD -0.76, 95% CI [-1.13, -0.38]) and social support (SMD -0.72, 95% CI [-1.22, -0.22]). No effect was detected for anxiety symptoms at post-intervention. At follow-up the beneficial effects of interventions progressively decreased. CONCLUSIONS: Psychosocial interventions delivered through the task-sharing modality are effective in preventing perinatal common mental disorders and fostering positive mental health among women in low- and middle-income countries. However, our findings are tentative, due to the low number of preventative intervention strategies considering outcomes as the incidence of mental disorders, especially in the long-term. This evidence supports calls to implement and scale up psychosocial prevention interventions for perinatal common mental disorders in low- and middle-income countries.

CBT treatment delivery formats for panic disorder: a systematic review and network meta-analysis of randomised controlled trials.

Several in-person and remote delivery formats of cognitive-behavioural therapy (CBT) for panic disorder are available, but up-to-date and comprehensive evidence on their comparative efficacy and acceptability is lacking. Our aim was to evaluate the comparative efficacy and acceptability of all CBT delivery formats to treat panic disorder. To answer our question we performed a systematic review and network meta-analysis of randomised controlled trials. We searched MEDLINE, Embase, PsycINFO, and CENTRAL, from inception to 1st January 2022. Pairwise and network meta-analyses were conducted using a random-effects model. Confidence in the evidence was assessed using Confidence in Network Meta-Analysis (CINeMA). The protocol was published in a peer-reviewed journal and in PROSPERO. We found a total of 74 trials with 6699 participants. Evidence suggests that face-to-face group [standardised mean differences (s.m.d.) -0.47, 95% confidence interval (CI) -0.87 to -0.07; CINeMA = moderate], face-to-face individual (s.m.d. -0.43, 95% CI -0.70 to -0.15; CINeMA = Moderate), and guided self-help (SMD -0.42, 95% CI -0.77 to -0.07; CINeMA = low), are superior to treatment as usual in terms of efficacy, whilst unguided self-help is not (SMD -0.21, 95% CI -0.58 to -0.16; CINeMA = low). In terms of acceptability (i.e. all-cause discontinuation from the trial) CBT delivery formats did not differ significantly from each other. Our findings are clear in that there are no efficacy differences between CBT delivered as guided self-help, or in the face-to-face individual or group format in the treatment of panic disorder. No CBT delivery format provided high confidence in the evidence at the CINeMA evaluation.

Views and experiences of migrants and stakeholders involved in social and health care for migrants in Italy during the COVID-19 pandemic: a qualitative study.

BACKGROUND: The COVID-19 pandemic has had major and potentially long-lasting effects on mental health and wellbeing across populations worldwide. However, these impacts were not felt equally, leading to an exacerbation of health inequalities, especially affecting vulnerable populations such as migrants, refugees and asylum seekers. Aiming to inform the adaptation and implementation of psychological intervention programmes, the present study investigated priority mental health needs in this population group. METHODS: Participants were adult asylum seekers, refugees and migrants (ARMs) and stakeholders with experience in the field of migration living in Verona, Italy, and fluent in Italian and English. A two-stage process was carried out to examine their needs using qualitative methods including free listing interviews and focus group discussions, according to Module One of the DIME (Design, Implementation, Monitoring, and Evaluation) manual. Data were analyzed using an inductive thematic analyses approach. RESULTS: A total of 19 participants (12 stakeholders, 7 ARMs) completed the free listing interviews and 20 participants (12 stakeholders and 8 ARMs) attended focus group discussions. Salient problems and functions that emerged during free listing interviews were discussed during the focus group discussions. During the COVID-19 pandemic, ARMs struggled with many everyday living difficulties in their resettlement country due to social and economic issues, revealing a strong influence of contextual factors in determining mental health. Both ARMs and stakeholders highlighted a mismatch between needs, expectations and interventions as factors that may hamper proper implementation of health and social programmes. CONCLUSIONS: The present findings could help in the adaptation and implementation of psychological interventions targeting the needs of asylum seekers, refugees and migrants aiming to find a match between needs, expectations, and the corresponding interventions. TRIAL REGISTRATION: Registration number 2021-UNVRCLE-0106707, February 11 2021.

COVID-19 and common mental health symptoms in the early phase of the pandemic: An umbrella review of the evidence.

BACKGROUND: There remains uncertainty about the impact of the Coronavirus Disease 2019 (COVID-19) pandemic on mental health. This umbrella review provides a comprehensive overview of the association between the pandemic and common mental disorders. We qualitatively summarized evidence from reviews with meta-analyses of individual study-data in the general population, healthcare workers, and specific at-risk populations. METHODS AND FINDINGS: A systematic search was carried out in 5 databases for peer-reviewed systematic reviews with meta-analyses of prevalence of depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms during the pandemic published between December 31, 2019 until August 12, 2022. We identified 123 reviews of which 7 provided standardized mean differences (SMDs) either from longitudinal pre- to during pandemic study-data or from cross-sectional study-data compared to matched pre-pandemic data. Methodological quality rated with the Assessment of Multiple Systematic Reviews checklist scores (AMSTAR 2) instrument was generally low to moderate. Small but significant increases of depression, anxiety, and/or general mental health symptoms were reported in the general population, in people with preexisting physical health conditions, and in children (3 reviews; SMDs ranged from 0.11 to 0.28). Mental health and depression symptoms significantly increased during periods of social restrictions (1 review; SMDs of 0.41 and 0.83, respectively) but anxiety symptoms did not (SMD: 0.26). Increases of depression symptoms were generally larger and longer-lasting during the pandemic (3 reviews; SMDs depression ranged from 0.16 to 0.23) than those of anxiety (2 reviews: SMDs 0.12 and 0.18). Females showed a significantly larger increase in anxiety symptoms than males (1 review: SMD 0.15). In healthcare workers, people with preexisting mental disorders, any patient group, children and adolescents, and in students, no significant differences from pre- to during pandemic were found (2 reviews; SMD's ranging from -0.16 to 0.48). In 116 reviews pooled cross-sectional prevalence rates of depression, anxiety, and PTSD symptoms ranged from 9% to 48% across populations. Although heterogeneity between studies was high and largely unexplained, assessment tools and cut-offs used, age, sex or gender, and COVID-19 exposure factors were found to be moderators in some reviews. The major limitations are the inability to quantify and explain the high heterogeneity across reviews included and the shortage of within-person data from multiple longitudinal studies. CONCLUSIONS: A small but consistent deterioration of mental health and particularly depression during early pandemic and during social restrictions has been found in the general population and in people with chronic somatic disorders. Also, associations between mental health and the pandemic were stronger in females and younger age groups than in others. Explanatory individual-level, COVID-19 exposure, and time-course factors were scarce and showed inconsistencies across reviews. For policy and research, repeated assessments of mental health in population panels including vulnerable individuals are recommended to respond to current and future health crises.

Risk of SARS-CoV-2 infection, severe COVID-19 illness and COVID-19 mortality in people with pre-existing mental disorders: an umbrella review.

INTRODUCTION: The COVID-19 pandemic has posed a serious health risk, especially in vulnerable populations. Even before the pandemic, people with mental disorders had worse physical health outcomes compared to the general population. This umbrella review investigated whether having a pre-pandemic mental disorder was associated with worse physical health outcomes due to the COVID-19 pandemic. METHODS: Following a pre-registered protocol available on the Open Science Framework platform, we searched Ovid MEDLINE All, Embase (Ovid), PsycINFO (Ovid), CINAHL, and Web of Science up to the 6th of October 2021 for systematic reviews on the impact of COVID-19 on people with pre-existing mental disorders. The following outcomes were considered: risk of contracting the SARS-CoV-2 infection, risk of severe illness, COVID-19 related mortality risk, risk of long-term physical symptoms after COVID-19. For meta-analyses, we considered adjusted odds ratio (OR) as effect size measure. Screening, data extraction and quality assessment with the AMSTAR 2 tool have been done in parallel and duplicate. RESULTS: We included five meta-analyses and four narrative reviews. The meta-analyses reported that people with any mental disorder had an increased risk of SARS-CoV-2 infection (OR: 1.71, 95% CI 1.09-2.69), severe illness course (OR from 1.32 to 1.77, 95%CI between 1.19-1.46 and 1.29-2.42, respectively) and COVID-19 related mortality (OR from 1.38 to 1.52, 95%CI between 1.15-1.65 and 1.20-1.93, respectively) as compared to the general population. People with anxiety disorders had an increased risk of SAR-CoV-2 infection, but not increased mortality. People with mood and schizophrenia spectrum disorders had an increased COVID-19 related mortality but without evidence of increased risk of severe COVID-19 illness. Narrative reviews were consistent with findings from the meta-analyses. DISCUSSION AND CONCLUSIONS: As compared to the general population, there is strong evidence showing that people with pre-existing mental disorders suffered from worse physical health outcomes due to the COVID-19 pandemic and may therefore be considered a risk group similar to people with underlying physical conditions. Factors likely involved include living accommodations with barriers to social distancing, cardiovascular comorbidities, psychotropic medications and difficulties in accessing high-intensity medical care.