Feasibility of Community Psychosocial Intervention for Women

NCT ID: NCT05130944

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2022-03-08

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Entre Nosotras (group psychosocial intervention) + stress management intervention

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.

Group Type: EXPERIMENTAL

Entre Nosotras

Intervention Type: BEHAVIORAL

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.

Doing What Matters in Times of Stress

Intervention Type: BEHAVIORAL

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.

Entre Nosostras (group psychosocial intervention)

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

Group Type: ACTIVE_COMPARATOR

Entre Nosotras

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Stress management, coping skills

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

HIAS

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire Greene, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

HIAS

Quito, , Ecuador

HIAS

Panama City, , Panama

Countries

Ecuador; Panama

References

Greene MC, Bonz A, Cristobal M, Vega C, Andersen LS, Angulo A, Armijos A, Guevara ME, Benavides L, de la Cruz A, Lopez MJ, Moyano A, Murcia A, Noboa MJ, Rodriguez A, Solis J, Vergara D, Scharf J, Dutt P, Wainberg M, Tol WA. Evaluating the feasibility of a group psychosocial intervention for migrant and host community women in Ecuador and Panama: protocol for a multi-site feasibility cluster trial. Pilot Feasibility Stud. 2022 Jun 15;8(1):126. doi: 10.1186/s40814-022-01085-1.

Reference Type: DERIVED

PMID: 35706068 (View on PubMed)

Other Identifiers

AID-OAAA17-00002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AAAT7637

Identifier Type: -

Identifier Source: org_study_id