Clinical trial NCT05130944: Feasibility of Community Psychosocial Intervention for Women
Official title: Integrating Psychosocial Support Into Protection and Community Programs for Women in Ecuador and Panama
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Psychological Distress
Coping Skills
Stress
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: HIAS
First posted: 2021-11-23
Enrollment: 275
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized comparative feasibility trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Proportion of women screened who are eligible to participate
timeFrame: Baseline
measure: Proportion of eligible and enrolled women who engage in sessions and/or complete all five group sessions.
timeFrame: Up to 5 weeks
measure: Intervention Usability Scale Score
timeFrame: 5 weeks
measure: Recruitment rate
timeFrame: Study period
measure: Number of baseline imbalances between study conditions
timeFrame: Baseline
measure: Attrition - proportion of enrolled individuals who drop out of the study
timeFrame: Up to 10 weeks
measure: Contamination - proportion of sessions that did not include coping skills intervention components
timeFrame: Up to 5 weeks
measure: Fidelity checklist score
timeFrame: Up to 5 weeks
measure: Facilitator competence score
timeFrame: Up to 5 weeks
Secondary outcomes:
measure: Personal Wellbeing Index
timeFrame: Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)
measure: Kessler 6 scale score
timeFrame: Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)
measure: Brief COPE scale score
timeFrame: Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)
measure: WHODAS Score
timeFrame: Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)
measure: Oslo Social Support Scale Score
timeFrame: Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)
Other outcomes:
Locations:
city: Quito
country: Ecuador
facility: HIAS
city: Panamá City
country: Panama
facility: HIAS
Study officials:
affiliation: Columbia University
name: Claire Greene, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.