Feasibility of Community Psychosocial Intervention for Women

Stress Clinical Trial

Official title:

Integrating Psychosocial Support Into Protection and Community Programs for Women in Ecuador and Panama

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05130944
• Other study ID #: AAAT7637
• Secondary ID: AID-OAAA17-00002
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 9, 2021
• Est. completion date: March 2024

Study information

• Verified date: April 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 275
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Ecuador	HIAS	Quito
Panama	HIAS	Panamá City

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	HIAS, University of Copenhagen

Countries where clinical trial is conducted

Ecuador,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women screened who are eligible to participate	This is to measure relevance of the intervention in the source population. Appropriateness of the intervention to population needs will be measured using quantitative indicators and qualitative reports from participants and facilitators during the process evaluation.	Baseline
Primary	Proportion of eligible and enrolled women who engage in sessions and/or complete all five group sessions.	This is to measure the acceptability of the intervention. Safety, an indicator of acceptability, will also be assessed by adverse events reported during study period. Qualitative interviews with participants and facilitators will inquire about acceptability and will be integrated with quantitative estimates of intervention engagement and completion.	Up to 5 weeks
Primary	Intervention Usability Scale Score	Usability will be measured using the 10-item Intervention Usability Scale, which will be completed by facilitators after the final session of the intervention. Scores are scaled to range from 0-100 with scores exceeding 68 considered to indicate usable interventions.	5 weeks
Primary	Recruitment rate	The number of individuals enrolled per month will be used to determine the feasibility of a fully-powered definitive trial.	Study period
Primary	Number of baseline imbalances between study conditions	The number of socio-demographic or study outcome imbalances between the intervention and comparison condition will be used to determine the feasibility of a fully-powered definitive trial and the success of the randomization process.	Baseline
Primary	Attrition - proportion of enrolled individuals who drop out of the study	The proportion of enrolled individuals who drop out of the study will be used to indicate the feasibility of a fully-powered definitive trial.	Up to 10 weeks
Primary	Contamination - proportion of sessions that did not include coping skills intervention components	The proportion of experimental sessions that did not include coping skills intervention components and the proportion of control sessions that did include coping skills intervention components from the Doing What Matters in Times of Stress intervention.	Up to 5 weeks
Primary	Fidelity checklist score	Average level of compliance with the intervention activities as intended within the manual. Assessed using a fidelity checklist with average item scores ranging from 0 = not implemented to 2 = implemented well. Scores between 0 and 2 indicate that the activities were partially implemented and/or could be improved.	Up to 5 weeks
Primary	Facilitator competence score	This is to measure the feasibility of the intervention. Facilitator competencies assessed using items from ENACT along qualitative interviews with facilitators will be assessed together. For the quantitative items, we selected six domains that are each scored on a scale from 1=needs improvement to 3=done well.	Up to 5 weeks
Secondary	Personal Wellbeing Index	This is to measure psychosocial wellbeing; Subscales include satisfaction with standard of living, health, life achievement, personal relationships, personal safety, community connectedness, and future security.; Each of the nine items is measured on a 0-to-10 scale (0 = No satisfaction at all; 10 = Very satisfied).	Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)
Secondary	Kessler 6 scale score	This is to measure psychological distress. The Kessler 6 includes six items measured on 5-point Likert scale where respondents indicate the frequency they have experienced a given symptom (from none of the time to all of the time).	Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)
Secondary	Brief COPE scale score	This is to measure coping. The 28-item scale rates the frequency of using certain coping skills on a 4-point Likert scale from "I haven't been using this at all" to "I've been doing this a lot".	Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)
Secondary	WHODAS Score	This is to measure functioning. This 12-item scale rates the difficulty individuals have had completing certain tasks on a 5-point Likert Scale from "none" to "extreme or cannot do"	Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)
Secondary	Oslo Social Support Scale Score	This is to measure social support. This 3-item measure assesses different domains of social support on a 5-point Likert scale with higher values indicating greater levels of social support. Response options vary by item.	Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)