Feasibility of Community Psychosocial Intervention for Women

Columbia University

Status: Completed

Conditions: Mental Health Wellness 1; Coping Skills; Stress; Psychological Distress

Treatments: Behavioral: Doing What Matters in Times of Stress; Behavioral: Entre Nosotras

Study type: Interventional

Funder types: Other

Identifiers

NCT05130944

AAAT7637

AID-OAAA17-00002 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 275 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult (18+ years) women residing in the study community who speak and understand Spanish
• Displaced or host community members

Exclusion criteria

• Severe psychological distress (Kessler-6 >=13)
• Moderate or high risk of suicide
• Cognitive impairment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

275 participants in 2 patient groups

Entre Nosotras (group psychosocial intervention) + stress management intervention

Experimental group

Description:

Experimental condition: Women residing in the study community (displaced and host population) will receive both group psychosocial intervention and stress management intervention. Participants will be given the Spanish version of the Doing What Matters in Times of Stress illustrated guide, that is published and made publicly available by the World Health Organization.

Treatment:

Behavioral: Entre Nosotras

Behavioral: Doing What Matters in Times of Stress

Entre Nosostras (group psychosocial intervention)

Active Comparator group

Description:

Comparison condition: Women residing in the study community (displaced and host population) will receive group psychosocial intervention only.

Treatment:

Behavioral: Entre Nosotras