Clinical Trials Directory

Trials / Completed

CompletedNCT05130944

Feasibility of Community Psychosocial Intervention for Women

Integrating Psychosocial Support Into Protection and Community Programs for Women in Ecuador and Panama

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
275 (actual)
Sponsor
Columbia University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

Summary

The purpose of the current protocol is to describe a cluster randomized feasibility trial examining the integration of a scalable stress management intervention into Entre Nosotras ('among/between us'), a community-based psychosocial intervention for migrant and host community women in Ecuador and Panamá. Specifically the study aims to: 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.

Detailed description

The proposed research directly targets two public health areas with major gaps in evidence in the field of humanitarian settings: (1) protection and safety, and (2) mental health and psychosocial wellbeing. This research will be conducted in three sites in Ecuador and Panama. Latin America has recently experienced increasing levels of forced migration due to political conflict, community violence, and other factors. Panamá and Ecuador host refugees, asylum seekers, and migrants from a range of Central and South American countries (e.g., Colombia, Nicaragua, Venezuela). Migrants in these contexts face mental health and psychosocial problems, threats to their safety, and disrupted social support systems. Gaps in psychosocial services to address these problems despite their high prevalence persist in both countries and have been exacerbated due to the COVID-19 pandemic.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEntre NosotrasA 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 wellbeing. 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 wellbeing of women.
BEHAVIORALDoing What Matters in Times of StressThe 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.

Timeline

Start date
2021-09-09
Primary completion
2022-03-08
Completion
2022-03-08
First posted
2021-11-23
Last updated
2024-05-02

Locations

2 sites across 2 countries: Ecuador, Panama

Source: ClinicalTrials.gov record NCT05130944. Inclusion in this directory is not an endorsement.