NCT05130944.

Study name	Feasibility of community psychosocial intervention for women
Methods	Study design: cluster‐RCT Country: Ecuador and Panamá
Participants	Migrant and host community women Inclusion criteria:  a. adult (18+ years) women residing in the study community who speak and understand Spanish; b. displaced or host community members. Exclusion criteria: a. severe psychological distress (Kessler‐6 ≥ 13); b. moderate or high risk of suicide; c. cognitive impairment. Stated purpose: 1) Explore the relevance, acceptability, and feasibility of integrating a stress management intervention into community‐based participatory women's group. 2) Examine the feasibility of conducting a fully‐powered cluster‐randomized controlled trial evaluating the effectiveness and implementation of integrating a stress management intervention into a community‐based participatory women's group as compared to community‐based participatory women's groups alone
Interventions	Intervention: Entre Nosotras (group psychosocial intervention) + stress management intervention Entre Nosotras is a community‐and strengths‐based intervention designed to mobilize social support, strengthen community connectedness, and stimulate collective action to promote the safety and well‐being of women. A series of five 2‐hour group sessions that are administered weekly by two trained female peer facilitators, who are selected by HIAS outreach workers and/or community leaders. The content of the sessions is based on the principles of Psychological First Aid and the Participatory Action Cycle, which is intended to generate community‐led problem‐solving around priority issues affecting their well‐being. Doing What Matters in Times of Stress: The stress management components are derived from the World Health Organization Doing What Matters in Times of Stress illustrated guide for coping with adversity (World Health Organization, 2020). The illustrated guide and accompanying audio files are publicly available: https://www.who.int/publications/i/item/9789240003927. During five sessions, the intervention involves 15‐20 minute exercises covering a range of stress management and coping skills. Control: Active control: Entre Nosostras (group psychosocial intervention only)
Outcomes	Participants'outcomes of interest for this review Quality of life – Personal Wellbeing Index (PWI) Mental health symptoms/distress/PTSD – Kessler‐6 Item Scale (K6) Psychological functioning and impairment (coping) – Coping Orientation to Problems Experienced Inventory (Brief‐COPE) Psychological functioning and impairment – World Health Organisation Disability Assessment Schedule (WHODAS) Social outcomes (social support) – Oslo Social Support Scale Score (OSSS) Economic outcomes Nil Time points: baseline, post‐intervention (5 weeks post‐intervention)
Starting date	9 September 2021
Contact information	Claire Greene, mg4069@cumc.columbia.edu
Notes	Source of funding: not specified Prospective trial registration number: NCT05130944