Feasibility of Community Psychosocial Intervention for Women
NCT05130944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275
Last updated 2024-05-02
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.
Conditions
- Mental Health Wellness 1
- Psychological Distress
- Coping Skills
- Stress
Interventions
- BEHAVIORAL
-
Entre Nosotras
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 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.
- BEHAVIORAL
-
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.
Sponsors & Collaborators
-
University of Copenhagen
collaborator OTHER -
HIAS
collaborator UNKNOWN - lead OTHER
Principal Investigators
-
Claire Greene, PhD · Columbia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-09-09
- Primary Completion
- 2022-03-08
- Completion
- 2022-03-08
Countries
- Ecuador
- Panama
Study Locations
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