Perspectives on competency-based feedback for training non-specialists to deliver psychological interventions: multi-site qualitative study of the EQUIP competency-based approach.

BACKGROUND: The use of feedback to address gaps and reinforce skills is a key component of successful competency-based mental health and psychosocial support intervention training approaches. Competency-based feedback during training and supervision for personnel delivering psychological interventions is vital for safe and effective care. AIMS: For non-specialists trained in low-resource settings, there is a lack of standardised feedback systems. This study explores perspectives on competency-based feedback, using structured role-plays that are featured on the Ensuring Quality in Psychosocial and Mental Health Care (EQUIP) platform developed by the World Health Organization and United Nations Children's Fund. METHOD: Qualitative data were collected from supervisors, trainers and trainees from multiple EQUIP training sites (Ethiopia, Kenya, Lebanon, Peru and Uganda), from 18 key informant interviews and five focus group discussions (N = 41 participants). Qualitative analysis was conducted in Dedoose, using a codebook with deductively and inductively developed themes. RESULTS: Four main themes demonstrated how a competency-based structure enhanced the feedback process: (a) competency-based feedback was personalised and goal-specific, (b) competency-based feedback supported a feedback loop, (c) competency-based feedback supported a comfortable and objective feedback environment, and (d) competency-based feedback created greater opportunities for flexibility in training and supervision. CONCLUSIONS: A better understanding of the role of feedback supports the implementation of competency-based training that is systematic and effective for trainers and supervisors, which ultimately benefits the learning process for trainees.

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.

Nurturing families: A feasibility randomised controlled trial of a whole-family intervention with vulnerable families in Jordan.

Armed conflict and forced displacement can significantly strain nurturing family environments, which are essential for child well-being. Yet, limited evidence exists on the effectiveness of family-systemic interventions in these contexts. We conducted a two-arm, single-masked, feasibility Randomised Controlled Trial (fRCT) of a whole-family intervention with Syrian, Iraqi and Jordanian families in Jordan. We aimed to determine the feasibility of intervention and study procedures to inform a fully-powered RCT. Eligible families were randomised to receive the Nurturing Families intervention or enhanced usual care (1:1). Masked assessors measured outcomes at baseline and endline; primary outcome measures were caregiver psychological distress, family functioning, and parenting practices. Families and implementing staff participated in qualitative interviews at endline. Of the 62 families screened, 60 (98%) were eligible, 97% completed the baseline and 90% completed the endline. Qualitative feedback indicated specific improvements in adolescent well-being, caregiver distress and parenting, and family relationships. Data highlighted high participant engagement and adequate facilitator fidelity and competence. Outcome measures had good psychometric properties (most α > 0.80) and sensitivity to change, with significant changes seen on most measures in the intervention but not control group. Findings indicate the acceptability and feasibility of intervention and study procedures. Subsequent full-scale evaluation is needed to determine effectiveness.

Strategies to improve the implementation and effectiveness of community-based psychosocial support interventions for displaced, migrant and host community women in Latin America.

As evidence supporting the effectiveness of mental health and psychosocial interventions grows, more research is needed to understand optimal strategies for improving their implementation in diverse contexts. We conducted a qualitative process evaluation of a multicomponent psychosocial intervention intended to promote well-being among refugee, migrant and host community women in three diverse contexts in Ecuador and Panamá. The objective of this study is to describe the relationships among implementation determinants, strategies and outcomes of this community-based psychosocial intervention. The five implementation strategies used in this study included stakeholder engagement, promoting intervention adaptability, group and community-based delivery format, task sharing and providing incentives. We identified 10 adaptations to the intervention and its implementation, most of which were made during pre-implementation. Participants (n = 77) and facilitators (n = 30) who completed qualitative interviews reported that these strategies largely improved the implementation of the intervention across key outcomes and aligned with the study's intervention and implementation theory of change models. Participants and facilitators also proposed additional strategies for improving reach, implementation and maintenance of this community-based psychosocial intervention.

Accessibility and Perceived Impact of a Group Psychosocial Intervention for Women in Ecuador: A Comparative Analysis by Migration Status.

There is increasing guidance promoting the provision of mental health and psychosocial support programs to both migrant and host community members in humanitarian settings. However, there is a lack of information on the respective experiences and benefits for migrant and host community members who are participating in mental health and psychosocial support programming. We evaluated a community-based psychosocial program for migrant and host community women, Entre Nosotras, which was implemented with an international non-governmental organization in Ecuador in 2021. Data on participant characteristics and psychosocial wellbeing were collected via pre/post surveys with 143 participants, and qualitative interviews were conducted with a subset (n = 61) of participants. All quantitative analyses were conducted in STATA, and qualitative analysis was done in NVivo. Attendance was higher for host community members. Specifically, 71.4% of host community members attended 4-5 sessions, whereas only 37.4% of migrants attended 4-5 sessions (p = 0.004). Qualitative analysis shows that the intervention was less accessible for migrants due to a variety of structural barriers. However, this analysis also demonstrated that both groups of women felt a greater sense of social connectedness after participating in the program and expressed gratitude for the bonds they formed with other women. Some migrant women described negative experiences with the host community because they felt as though they could not confide in host community women and speak freely in front of them. These results underscore how the migratory context influences the implementation of mental health and psychosocial support (MHPSS) programs. As humanitarian guidelines continue to emphasize the integration of host community members and displaced persons, it is critical to account for how the same intervention may impact these populations differently.

Improving Retention in Mental Health and Psychosocial Support Interventions: An Analysis of Completion Rates across a Multi-Site Trial with Refugee, Migrant, and Host Communities in Latin America.

Research on mental health and psychosocial support (MHPSS) interventions within refugee and migrant communities has increasingly focused on evaluating implementation, including identifying strategies to promote retention in services. This study examines the relationship between participant characteristics, study setting, and reasons for intervention noncompletion using data from the Entre Nosotras feasibility trial, a community-based MHPSS intervention targeting refugee, migrant, and host community women in Ecuador and Panama that aimed to promote psychosocial wellbeing. Among 225 enrolled women, approximately half completed the intervention, with varying completion rates and reasons for nonattendance across study sites. Participants who were older, had migrated for family reasons, had spent more time in the study community, and were living in Panamá (vs. Ecuador) were more likely to complete the intervention. The findings suggest the need to adapt MHPSS interventions to consider the duration of access to the target population and explore different delivery modalities including the role of technology and cellular devices as reliable or unreliable source for engaging with participants. Engaging younger, newly arrived women is crucial, as they showed lower completion rates. Strategies such as consulting scheduling preferences, providing on-site childcare, and integrating MHPSS interventions with other programs could enhance intervention attendance.

Effectiveness and cost-effectiveness of a transdiagnostic intervention for alcohol misuse and psychological distress in humanitarian settings: study protocol for a randomised controlled trial in Uganda.

BACKGROUND: The war in South Sudan has displaced more than four million people, with Uganda hosting the largest number of South Sudanese refugees. Research in Uganda has shown elevated levels of alcohol misuse and psychological distress among these refugees. The World Health Organization (WHO) has developed a trans-diagnostic scalable psychological intervention called Problem Management Plus (PM +) to reduce psychological distress among populations exposed to adversities. Our study aims to evaluate the effectiveness and cost-effectiveness of the CHANGE intervention, which builds on PM + , to also address alcohol misuse through problem-solving therapy and selected behavioural strategies for dealing with alcohol use disorders. We hypothesise that the CHANGE intervention together with enhanced usual care (EUC) will be superior to EUC alone in increasing the percentage of days abstinent. METHODS: A parallel-arm individually randomised controlled trial will be conducted in the Rhino Camp and Imvepi settlements in Uganda. Five hundred adult male South Sudanese refugees with (i) elevated levels of alcohol use (between 8 and 20 on the Alcohol Use Disorder Identification Test [AUDIT]); and (ii) psychological distress (> 16 on the Kessler Psychological Distress Scale) will be randomly assigned 1:1 to EUC or CHANGE and EUC. CHANGE will be delivered by lay healthcare providers over 6 weeks. Outcomes will be assessed at 3 and 12 months post-randomisation. The primary outcome is the percentage of days abstinent, measured by the timeline follow-back measure at 3 months. Secondary outcomes include percentage of days abstinent at 12 months and alcohol misuse (measured by the AUDIT), psychological distress (i.e. depression, anxiety, posttraumatic stress disorder), functional disability, perpetration of intimate partner violence, and health economic indicators at 3 and 12 months. A mixed-methods process evaluation will investigate competency, dose, fidelity, feasibility, and acceptability. Primary analyses will be intention-to-treat. DISCUSSION: CHANGE aims to address alcohol misuse and psychological distress with male refugees in a humanitarian setting. If it is proven to be effective, it can help fill an important under-researched gap in humanitarian service delivery. TRIAL REGISTRATION: ISRCTN ISRCTN10360385. Registered on 30 January 2023.

Using theory of change to plan for the implementation of a psychological intervention addressing alcohol use disorder and psychological distress in Uganda.

In conflict-affected settings, prevalence of alcohol use disorders (AUDs) can be high. However, limited practical information exists on AUD management in low-income settings. Using a theory of change (ToC) approach, we aimed to identify pathways influencing the implementation and maintenance of a new transdiagnostic psychological intervention ("CHANGE"), targeting both psychological distress and AUDs in humanitarian settings. Three half-day workshops in Uganda engaged 41 stakeholders to develop a ToC map. ToC is a participatory program theory approach aiming to create a visual representation of how and why an intervention leads to specific outcomes. Additionally, five semi-structured interviews were conducted to explore experiences of stakeholders that participated in the ToC workshops. Two necessary pathways influencing the implementation and maintenance of CHANGE were identified: policy impact, and mental health service delivery. Barriers identified included policy gaps, limited recognition of social determinants and the need for integrated follow-up care. Interviewed participants valued ToC's participatory approach and expressed concerns about its adaptability in continuously changing contexts (e.g., humanitarian settings). Our study underscores ToC's value in delineating context-specific outcomes and identifies areas requiring further attention. It emphasizes the importance of early planning and stakeholder engagement for sustainable implementation of psychological interventions in humanitarian settings.

Strengthening self-regulation and reducing poverty to prevent adolescent depression and anxiety: Rationale, approach and methods of the ALIVE interdisciplinary research collaboration in Colombia, Nepal and South Africa.

AIMS: Depression and anxiety are the leading contributors to the global burden of disease among young people, accounting for over a third (34.8%) of years lived with disability. Yet there is limited evidence for interventions that prevent adolescent depression and anxiety in low- and middle-income countries (LMICs), where 90% of adolescents live. This article introduces the 'Improving Adolescent mentaL health by reducing the Impact of poVErty (ALIVE)' study, its conceptual framework, objectives, methods and expected outcomes. The aim of the ALIVE study is to develop and pilot-test an intervention that combines poverty reduction with strengthening self-regulation to prevent depression and anxiety among adolescents living in urban poverty in Colombia, Nepal and South Africa. METHODS: This aim will be achieved by addressing four objectives: (1) develop a conceptual framework that identifies the causal mechanisms linking poverty, self-regulation and depression and anxiety; (2) develop a multi-component selective prevention intervention targeting self-regulation and poverty among adolescents at high risk of developing depression or anxiety; (3) adapt and validate instruments to measure incidence of depression and anxiety, mediators and implementation parameters of the prevention intervention; and (4) undertake a four-arm pilot cluster randomised controlled trial to assess the feasibility, acceptability and cost of the selective prevention intervention in the three study sites. RESULTS: The contributions of this study include the active engagement and participation of adolescents in the research process; a focus on the causal mechanisms of the intervention; building an evidence base for prevention interventions in LMICs; and the use of an interdisciplinary approach. CONCLUSIONS: By developing and evaluating an intervention that addresses multidimensional poverty and self-regulation, ALIVE can make contributions to evidence on the integration of mental health into broader development policy and practice.

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.

Mixed-methods evaluation of a group psychosocial intervention for refugee, migrant and host community women in Ecuador and Panamá: Results from the Entre Nosotras cluster randomized feasibility trial.

Community-based psychosocial interventions are key elements of mental health and psychosocial support; yet evidence regarding their effectiveness and implementation in humanitarian settings is limited. This study aimed to assess the appropriateness, acceptability, feasibility and safety of conducting a cluster randomized trial evaluating two versions of a group psychosocial intervention. Nine community clusters in Ecuador and Panamá were randomized to receive the standard version of the Entre Nosotras intervention, a community-based group psychosocial intervention co-designed with community members, or an enhanced version of Entre Nosotras that integrated a stress management component. In a sample of 225 refugees, migrants and host community women, we found that both versions were safe, acceptable and appropriate. Training lay facilitators to deliver the intervention was feasible. Challenges included slow recruitment related to delays caused by the COVID-19 pandemic, high attrition due to population mobility and other competing priorities, and mixed psychometric performance of psychosocial outcome measures. Although the intervention appeared promising, a definitive cluster randomized comparative effectiveness trial requires further adaptations to the research protocol. Within this pilot study we identified strategies to overcome these challenges that may inform adaptations. This comparative effectiveness design may be a model for identifying effective components of psychosocial interventions.

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.

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.

Testing a Screening, Brief Intervention, and Referral to Treatment Intervention Approach for Addressing Unhealthy Alcohol and Other Drug Use in Humanitarian Settings: Protocol of the Ukuundapwa Chapamo Randomised Controlled Trial.

Refugees and other displaced persons are exposed to many risk factors for unhealthy alcohol and other drug (AOD) use and concomitant mental health problems. Evidence-based services for AOD use and mental health comorbidities are rarely available in humanitarian settings. In high income countries, screening, brief intervention and referral to treatment (SBIRT) systems can provide appropriate care for AOD use but have rarely been used in low- and middle-income countries and to our knowledge never tested in a humanitarian setting. This paper describes the protocol for a randomised controlled trial to compare the effectiveness of an SBIRT system featuring the Common Elements Treatment Approach (CETA) to treatment as usual in reducing unhealthy AOD use and mental health comorbidities among refugees from the Democratic Republic of the Congo and host community members in an integrated settlement in northern Zambia. The trial is an individually randomised, single-blind, parallel design with outcomes assessed at 6-months (primary) and 12-months post-baseline. Participants are Congolese refugees and Zambians in the host community, 15 years of age or older with unhealthy alcohol use. Outcomes are: unhealthy alcohol use (primary), other drug use, depression, anxiety and traumatic stress. The trial will explore SBIRT acceptability, appropriateness, cost-effectiveness, feasibility, and reach.

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.

Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries.

BACKGROUND: Harmful alcohol use is defined as unhealthy alcohol use that results in adverse physical, psychological, social, or societal consequences and is among the leading risk factors for disease, disability and premature mortality globally. The burden of harmful alcohol use is increasing in low- and middle-income countries (LMICs) and there remains a large unmet need for indicated prevention and treatment interventions to reduce harmful alcohol use in these settings. Evidence regarding which interventions are effective and feasible for addressing harmful and other patterns of unhealthy alcohol use in LMICs is limited, which contributes to this gap in services. OBJECTIVES: To assess the efficacy and safety of psychosocial and pharmacologic treatment and indicated prevention interventions compared with control conditions (wait list, placebo, no treatment, standard care, or active control condition) aimed at reducing harmful alcohol use in LMICs. SEARCH METHODS: We searched for randomized controlled trials (RCTs) indexed in the Cochrane Drugs and Alcohol Group (CDAG) Specialized Register, the Cochrane Clinical Register of Controlled Trials (CENTRAL) in the Cochrane Library, PubMed, Embase, PsycINFO, CINAHL, and the Latin American and Caribbean Health Sciences Literature (LILACS) through 12 December 2021. We searched clinicaltrials.gov, the World Health Organization International Clinical Trials Registry Platform, Web of Science, and Opengrey database to identify unpublished or ongoing studies. We searched the reference lists of included studies and relevant review articles for eligible studies. SELECTION CRITERIA: All RCTs comparing an indicated prevention or treatment intervention (pharmacologic or psychosocial) versus a control condition for people with harmful alcohol use in LMICs were included. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 66 RCTs with 17,626 participants. Sixty-two of these trials contributed to the meta-analysis. Sixty-three studies were conducted in middle-income countries (MICs), and the remaining three studies were conducted in low-income countries (LICs). Twenty-five trials exclusively enrolled participants with alcohol use disorder. The remaining 51 trials enrolled participants with harmful alcohol use, some of which included both cases of alcohol use disorder and people reporting hazardous alcohol use patterns that did not meet criteria for disorder. Fifty-two RCTs assessed the efficacy of psychosocial interventions; 27 were brief interventions primarily based on motivational interviewing and were compared to brief advice, information, or assessment only. We are uncertain whether a reduction in harmful alcohol use is attributable to brief interventions given the high levels of heterogeneity among included studies (Studies reporting continuous outcomes: Tau² = 0.15, Q =139.64, df =16, P<.001, I² = 89%, 3913 participants, 17 trials, very low certainty; Studies reporting dichotomous outcomes: Tau²=0.18, Q=58.26, df=3, P<.001, I² =95%, 1349 participants, 4 trials, very low certainty). The other types of psychosocial interventions included a range of therapeutic approaches such as behavioral risk reduction, cognitive-behavioral therapy, contingency management, rational emotive therapy, and relapse prevention. These interventions were most commonly compared to usual care involving varying combinations of psychoeducation, counseling, and pharmacotherapy. We are uncertain whether a reduction in harmful alcohol use is attributable to psychosocial treatments due to high levels of heterogeneity among included studies (Heterogeneity: Tau² = 1.15; Q = 444.32, df = 11, P<.001; I²=98%, 2106 participants, 12 trials, very low certainty). Eight trials compared combined pharmacologic and psychosocial interventions with placebo, psychosocial intervention alone, or another pharmacologic treatment. The active pharmacologic study conditions included disulfiram, naltrexone, ondansetron, or topiramate. The psychosocial components of these interventions included counseling, encouragement to attend Alcoholics Anonymous, motivational interviewing, brief cognitive-behavioral therapy, or other psychotherapy (not specified). Analysis of studies comparing a combined pharmacologic and psychosocial intervention to psychosocial intervention alone found that the combined approach may be associated with a greater reduction in harmful alcohol use (standardized mean difference (standardized mean difference (SMD))=-0.43, 95% confidence interval (CI): -0.61 to -0.24; 475 participants; 4 trials; low certainty). Four trials compared pharmacologic intervention alone with placebo and three with another pharmacotherapy. Drugs assessed were: acamprosate, amitriptyline, baclofen disulfiram, gabapentin, mirtazapine, and naltrexone. None of these trials evaluated the primary clinical outcome of interest, harmful alcohol use.   Thirty-one trials reported rates of retention in the intervention. Meta-analyses revealed that rates of retention between study conditions did not differ in any of the comparisons (pharmacologic risk ratio (RR) = 1.13, 95% CI: 0.89 to 1.44, 247 participants, 3 trials, low certainty; pharmacologic in addition to psychosocial intervention: RR = 1.15, 95% CI: 0.95 to 1.40, 363 participants, 3 trials, moderate certainty). Due to high levels of heterogeneity, we did not calculate pooled estimates comparing retention in brief (Heterogeneity: Tau² = 0.00; Q = 172.59, df = 11, P<.001; I2 = 94%; 5380 participants; 12 trials, very low certainty) or other psychosocial interventions (Heterogeneity: Tau² = 0.01; Q = 34.07, df = 8, P<.001; I2 = 77%; 1664 participants; 9 trials, very low certainty). Two pharmacologic trials and three combined pharmacologic and psychosocial trials reported on side effects. These studies found more side effects attributable to amitriptyline relative to mirtazapine, naltrexone and topiramate relative to placebo, yet no differences in side effects between placebo and either acamprosate or ondansetron. Across all intervention types there was substantial risk of bias. Primary threats to validity included lack of blinding and differential/high rates of attrition. AUTHORS' CONCLUSIONS: In LMICs there is low-certainty evidence supporting the efficacy of combined psychosocial and pharmacologic interventions on reducing harmful alcohol use relative to psychosocial interventions alone. There is insufficient evidence to determine the efficacy of pharmacologic or psychosocial interventions on reducing harmful alcohol use largely due to the substantial heterogeneity in outcomes, comparisons, and interventions that precluded pooling of these data in meta-analyses. The majority of studies are brief interventions, primarily among men, and using measures that have not been validated in the target population. Confidence in these results is reduced by the risk of bias and significant heterogeneity among studies as well as the heterogeneity of results on different outcome measures within studies. More evidence on the efficacy of pharmacologic interventions, specific types of psychosocial interventions are needed to increase the certainty of these results.

Mental health and psychosocial support in humanitarian settings: research priorities for 2021-30.

We describe an effort to develop a consensus-based research agenda for mental health and psychosocial support (MHPSS) interventions in humanitarian settings for 2021-30. By engaging a broad group of stakeholders, we generated research questions through a qualitative study (in Indonesia, Lebanon, and Uganda; n=101), consultations led by humanitarian agencies (n=259), and an expert panel (n=227; 51% female participants and 49% male participants; 84% of participants based in low-income and middle-income countries). The expert panel selected and rated a final list of 20 research questions. After rating, the MHPSS research agenda favoured applied research questions (eg, regarding workforce strengthening and monitoring and evaluation practices). Compared with research priorities for the previous decade, there is a shift towards systems-oriented implementation research (eg, multisectoral integration and ensuring sustainability) rather than efficacy research. Answering these research questions selected and rated by the expert panel will require improved partnerships between researchers, practitioners, policy makers, and communities affected by humanitarian crises, and improved equity in funding for MHPSS research in low-income and middle-income countries.

Psychological flexibility in South Sudanese female refugees in Uganda as a mechanism for change within a guided self-help intervention.

OBJECTIVE: To examine the role of psychological flexibility as a potential mediator in the relationship between involvement in a guided self-help intervention, Self-Help Plus, and psychological distress in a sample of South Sudanese refugee women living in northern Uganda. METHOD: We conducted secondary analysis of data from a cluster randomized controlled trial conducted in 2018. We used multilevel mediation modeling to explore the relationship of psychological flexibility, as measured by the Acceptance and Action Questionnaire (AAQ-II), as a mediating factor in the relationship between Self-Help Plus involvement and general psychological distress as measured by the Kessler Psychological Distress Scale-6 (K6). RESULTS: We found strong multilevel mediation of decreased K6 scores in the treatment group by AAQ-II scores (multilevel b = -3.28). A more pronounced mediation effect was discovered immediately post intervention (b = -1.09) compared to 3-month follow-up (b = -0.84). This is in line with the current literature that demonstrates the role of psychological flexibility as a primary mechanism of change in ACT-based interventions. CONCLUSIONS: Psychological flexibility is a contributing component in the theory of change for this ACT-based intervention. Identifying the core components of interventions allows for more effective adaptation and implementation of relevant services, especially in low-resource contexts. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Understanding Nepali widows' experiences for the adaptation of an instrument to assess Prolonged Grief Disorder.

The experience of grief varies across different cultures and contexts. Women in Nepal who lose their husbands confront discrimination, social isolation, and abuse that influence their experience of grief. Through eight focus group discussions with Nepali widows, we elicited socially sanctioned grief reactions and local idioms used to describe common cognitive, behavioral, and emotional symptoms of grief. Accordingly, modifications to an existing instrument for Prolonged Grief Disorder, the PG-13, are suggested to capture grief symptoms as experienced by Nepali widows. Items in the PG-13 were translated to colloquial Nepali and adapted to maintain comprehensibility, acceptability, relevance, and completeness. Based on the grief-related issues reported in the focus group discussions, the addition of five new items and a new criterion to capture symptoms related to social discrimination are proposed. Widows perceived elevated symptoms one year after the loss to be problematic. It is thus recommended that the duration criterion in the original PG-13 be adjusted from at least six months to at least one year after the loss. These proposed modifications to the instrument should be validated through future psychometric testing.