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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05130944
Study type Interventional
Source Columbia University
Contact
Status Active, not recruiting
Phase N/A
Start date September 9, 2021
Completion date March 2024

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