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Introduction The complex relationship between intimate partner violence and psychological distress warrants an integrated intervention approach. In this study we examined the relevance, acceptability, and feasibility of evaluating a multi-sectoral integrated violence- and mental health-focused intervention (Nguvu). Methods We enrolled 311 Congolese refugee women from Nyarugusu refugee camp in Tanzania with past-year intimate partner violence and elevated psychological distress in a feasibility cluster randomized trial. Women were recruited from local women’s groups that were randomized to the Nguvu intervention or usual care. Participants from women’s groups randomized to Nguvu received 8 weekly sessions delivered by lay refugee incentive workers. Psychological distress, intimate partner violence, other wellbeing, and process indicators were assessed at baseline and 9-weeks post-enrollment to evaluate relevance, acceptability, and feasibility of implementing and evaluating Nguvu in refugee contexts. Results We found that Nguvu was relevant to the needs of refugee women affected by intimate partner violence. We found reductions in some indicators of psychological distress, but did not identify sizeable changes in partner violence over time. Overall, we found that Nguvu was acceptable and feasible. However, challenges to the research protocol included baseline imbalances between study conditions, differential intervention completion related to intimate partner violence histories, differences between Nguvu groups and facilitators, and some indication that Nguvu may be less beneficial for participants with more severe intimate partner violence profiles. Conclusions We found evidence supporting the relevance of Nguvu to refugee women affected by partner violence and psychological distress and moderate evidence supporting the acceptability and feasibility of evaluating and implementing this intervention in a complex refugee setting. A definitive cluster randomized trial requires further adaptations for recruitment and eligibility screening, randomization, and retention. Trial registration ISRCTN65771265, June 27, 2016.

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Background Community- and strengths-based psychosocial interventions are central to mental health and psychosocial support guidelines, but rigorous evidence regarding the effectiveness of these interventions is limited. The complexity and variability that is inherent to many community-based psychosocial interventions requires innovative strategies in order to facilitate the comparability and synthesis across research studies without compromising the fit and appropriateness of interventions to specific study populations and context. Entre Nosotras is a community-based psychosocial intervention developed for migrant and host community women that is designed to be flexible enough to enable integration of external intervention components and adaptable to diverse study contexts and populations. This protocol describes a study that aims to evaluate the appropriateness, acceptability, and feasibility of integrating a standardized stress management intervention into Entre Nosotras. Methods This study will evaluate the appropriateness, acceptability, feasibility, and safety of intervention and research procedures for a cluster randomized comparative effectiveness trial conducted in Ecuador and Panamá with migrant and host community women. In this feasibility trial, we will allocate communities nested within the three study sites to the integrated Entre Nosotras + stress management intervention versus Entre Nosotras alone through stratified randomization. Migrant and host community women residing in these study communities who report low to moderate levels of distress will be allocated to the intervention condition that their community is assigned (n = 220 total). We will collect quantitative measures of psychosocial wellbeing, psychological distress, coping, social support, and functioning from study participants. We will collect quantitative measures of fidelity and facilitator competencies through observation and facilitator self-assessment. Data on appropriateness, acceptability, feasibility, and safety will be gathered from participants and facilitators through quantitative assessments at 0, 5, and 10 weeks post-enrollment and qualitative interviews conducted with all facilitators and a subset of 70 study participants during the post-intervention follow-up period. Discussion Results from this feasibility trial will determine whether a multi-site cluster randomized comparative effectiveness trial of an adaptable community-based psychosocial intervention for migrant and host community women is relevant, acceptable, and feasible. Trial registration ClinicalTrials.gov identifier: NCT05130944. Registered November 23, 2021—retrospectively registered.