NCT05130944

Feasibility of Community Psychosocial Intervention for Women

Completed NA Last updated 2 May 2024

What this trial tests

NA trial testing Entre Nosotras in Mental Health Wellness 1 in 275 participants. Completed in 8 March 2022.

Timeline

9 September 2021

Primary endpoint
8 March 2022

8 March 2022

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	275
Start date	9 September 2021
Primary completion	8 March 2022
Estimated completion	8 March 2022
Sites	2 locations across Panama, Ecuador

Drugs / interventions tested

• Entre Nosotras
• Doing What Matters in Times of Stress

Conditions studied

• Mental Health Wellness 1 — all drugs for Mental Health Wellness 1 →
• Psychological Distress — all drugs for Psychological Distress →
• Coping Skills — all drugs for Coping Skills →
• Stress — all drugs for Stress →

Sponsor

Columbia University

Who can join

18 and older, female only, with Mental Health Wellness 1 or Psychological Distress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Primary-level and community worker interventions for the prevention of mental disorders and the promotion of well-being in low- and middle-income countries.
   Purgato M, Prina E, Ceccarelli C, Cadorin C, et al · · 2023 · cited 17× · PMID 37873968 · DOI 10.1002/14651858.cd014722.pub2
2. Mixed-methods evaluation of a group psychosocial intervention for refugee, migrant and host community women in Ecuador and Panamá: Results from the <i>Entre Nosotras</i> cluster randomized feasibility trial.
   Greene MC, Bonz AG, Cristobal M, Angulo A, et al · · 2023 · cited 8× · PMID 37854436 · DOI 10.1017/gmh.2023.37
3. Evaluating the feasibility of a group psychosocial intervention for migrant and host community women in Ecuador and Panamá: protocol for a multi-site feasibility cluster trial.
   Greene MC, Bonz A, Cristobal M, Vega C, et al · · 2022 · cited 5× · PMID 35706068 · DOI 10.1186/s40814-022-01085-1
4. Accessibility and Perceived Impact of a Group Psychosocial Intervention for Women in Ecuador: A Comparative Analysis by Migration Status.
   Wimer G, Larrea M, Streeter J, Hassan A, et al · · 2024 · cited 2× · PMID 38673293 · DOI 10.3390/ijerph21040380
5. Improving Retention in Mental Health and Psychosocial Support Interventions: An Analysis of Completion Rates across a Multi-Site Trial with Refugee, Migrant, and Host Communities in Latin America.
   Fernández Capriles I, Armijos A, Angulo A, Schojan M, et al · · 2024 · cited 1× · PMID 38673310 · DOI 10.3390/ijerph21040397
6. Strategies to improve the implementation and effectiveness of community-based psychosocial support interventions for displaced, migrant and host community women in Latin America.
   Greene MC, Wimer G, Larrea M, Mejia Jimenez I, et al · · 2024 · PMID 38572247 · DOI 10.1017/gmh.2024.29