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Abstract Introduction: Self-Help Plus (SH+) is a group-based psychological intervention developed by the World Health Organization for managing stress. Objective: To assess the effectiveness of SH+ in preventing mental disorders in refugees and asylum seekers in Western Europe. Methods: We conducted a randomized controlled trial in 5 European countries. Refugees and asylum seekers with psychological distress (General Health Questionnaire score ≥3), but without a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) or ICD/10 diagnosis of mental disorder, as assessed with the Mini International Neuropsychiatric Interview (MINI), were randomized to SH+ or enhanced treatment as usual (ETAU). The primary outcome was the frequency of mental disorders with the MINI at 6 months. Secondary outcomes included the frequency of mental disorders at postintervention, self-identified problems, psychological symptoms, and other outcomes. Results: Four hundred fifty-nine individuals were randomly assigned to SH+ or ETAU. For the primary outcome, we found no difference in the frequency of mental disorders at 6 months (Cramer V = 0.007, p = 0.90, RR = 0.96; 95% CI 0.52–1.78), while the difference significantly favored SH+ at after the intervention (secondary outcome, measured within 2 weeks from the last session; Cramer V = 0.13, p = 0.01, RR = 0.50; 95% CI 0.29–0.87). Conclusions: This is the first randomized indicated prevention study with the aim of preventing the onset of mental disorders in asylum seekers and refugees in Western Europe. As a prevention effect of SH+ was not observed at 6 months, but rather after the intervention only, modalities to maintain its beneficial effect in the long term need to be identified.

Background Climate extremes in Africa threaten the food security of war-affected refugees, who often experience mental health challenges that hinder their capacity for agricultural adaptation. Cost-effective, climate-smart farming interventions are crucial for addressing food insecurity in humanitarian contexts, yet evidence on their effectiveness is limited, and the potential benefits of integrating them with mental health interventions remain unexplored. We hypothesize that the success of agricultural interventions, especially under adversity, is influenced by mental health and psychological functioning. Methods This study employs a three-arm, parallel-group, cluster-randomized controlled trial (cRCT) in the Nakivale refugee settlement, Uganda. Thirty villages within the settlement will be randomized in a 1:1:1 allocation ratio to one of three conditions: Enhanced Usual Care, a Home Gardening Intervention (HGI) or HGI combined with the peer-delivered psychosocial intervention Self-Help Plus (SH + HGI). A total of 900 refugee mothers and their children (aged 3–4 years) will be enrolled, with 30 dyads per village. The primary outcome is food insecurity at 12 months post-intervention, assessed using the Food Insecurity Experience Scale (FIES). Secondary outcomes include dietary diversity, child malnutrition and mothers’ psychological distress. Data will be collected at baseline, 3-month and 12-month follow-ups. Primary analyses will use an intention-to-treat (ITT) approach. Discussion This study will shed light on the role of mental health in agricultural adaptation for food security, evaluating the efficacy of scalable, cost-effective interventions in a refugee setting. The findings will have implications for the design and implementation of integrated food security and mental health programs in humanitarian and other resource-constrained settings. Trial registration ClinicalTrials.gov NCT06425523. Registered on 24 May 2024.

Background University students in Indonesia are exposed to stressors such as high academic task load, financial strains, and relationship problems. Therefore, they are at risk of developing symptoms of common mental disorders, such as depression and anxiety (i.e., psychological distress). However, there is a gap between the number of mental health professionals and the number of students in need of a psychological intervention. Self-Help Plus (SH+), a guided group-based stress management intervention developed by the WHO, was adapted to the population and context to address barriers in accessing mental health care among students in Indonesia. The aim of the APRESIASI study is to assess the effectiveness and cost-effectiveness of SH + in reducing psychological distress among university students in Indonesia. Methods The SH + intervention will be tested in a pragmatic superior randomized controlled trial (RCT) with two parallel arms. SH + will be tested among Indonesian university students with symptoms of psychological distress (Patient Health Questionnaire-9; PHQ-9 ≥ 5.5 < 20). The participants ( n  = 296) will be randomized into either the intervention group that receives SH + with enhanced care as usual (ECAU), or into the ECAU only with a 1:1 allocation ratio. The primary outcome is the reduction in psychological distress assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) at three-month follow-up. The secondary outcomes are symptoms of depression, anxiety, perceived stress, functioning, resilience, quality of life, identified problems, treatment acceptability, and cost-effectiveness. Discussion To our knowledge, SH + is the first a transdiagnostic, face-to-face, and group-based intervention to be tested for its effectiveness in reducing psychological distress in Indonesia. If shown to be effective, SH + has the potential to be scaled up across university settings. Trial registration ISRCTN15761598, 14/07/2023.

Evidence on the effectiveness and implementation of mental health and psychosocial support (MHPSS) interventions for men in humanitarian settings is limited. Moreover, engagement and retention of men in such interventions has been challenging. Adaptations may therefore be required to improve the appropriateness and acceptability of these interventions for men. This study conducted formative research and examined the feasibility of combining an MHPSS intervention, Self-Help Plus, with a brief intervention to reduce harmful alcohol use among refugee men in Uganda. We conducted a cluster randomized feasibility trial comparing the combined alcohol intervention and Self-Help Plus, Self-Help Plus alone and enhanced usual care. Participants were 168 South Sudanese refugee men in Rhino Settlement who reported moderate or high levels of psychological distress. Session attendance was adequate: all sessions had at least 69% of participants present. Participant outcome measures, including symptoms of psychological distress, functional impairment, self-defined problems, depressive symptoms, post-traumatic stress symptoms, overall substance use risk, substance specific risk (alcohol, cannabis, stimulants and sedatives) and well-being, were sensitive to change. A combined approach to addressing mental health and alcohol use appears feasible among men in refugee settings, but further research is needed to examine the effectiveness of combined interventions among men.

Scalable psychological interventions such as the WHO's Self-Help Plus (SH+) have been developed for clinical and non-clinical populations in need of psychological support. SH+ has been successfully implemented to prevent common mental disorders among asylum seekers and refugees who are growing in number due to increasing levels of forced migration. These populations are often exposed to multiple, severe sources of traumatisation, and evidence of the effect of such events on treatment is insufficient, especially for non-clinical populations. We aim to study the effect of potentially traumatic experiences (PTEs) and the mediating role of symptoms of posttraumatic stress disorder (PTSD) on the improvement following SH+. Participants allocated to SH+ who received at least three sessions (  = 345) were extracted from two large, randomised, European prevention trials involving asylum seekers and refugees. Measures of distress, depression, functional impairment, and post-traumatic stress symptoms were administered at baseline and 6 months post-intervention, together with measures of well-being and quality of life. Adjusted models were constructed to examine the effect of PTEs on post-intervention improvement. The possible mediating role of PTSD symptoms in this relationship was then tested. Increasing numbers of PTEs decreased the beneficial effect of SH+ for all measures. This relationship was mediated by symptoms of PTSD when analysing measures of well-being and quality of life. However, this did not apply for measures of mental health problems. Exposure to PTEs may largely reduce benefits from SH+. PTSD symptomatology plays a specific, mediating role on psychological well-being and quality of life of participants who experienced PTE. Healthcare professionals and researchers should consider the role of PTEs and PTSD symptoms in the treatment of migrants and refugees and explore possible feasible add-on solutions for cases exposed to multiple PTEs.

We explore multi-sectoral integration as a model for scaling up evidence-based mental health and psychosocial support interventions in humanitarian settings. We introduce Self Help Plus 360, designed to support humanitarian partners across different sectors to integrate a psychosocial intervention into their programming and more holistically address population needs.

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.