Feasibility of Community Psychosocial Intervention for Women
- Conditions
- Psychological DistressCoping SkillsMental Health Wellness 1Stress
- Interventions
- Behavioral: Entre NosotrasBehavioral: Doing What Matters in Times of Stress
- Registration Number
- NCT05130944
- Lead Sponsor
- Columbia University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 275
- Adult (18+ years) women residing in the study community who speak and understand Spanish
- Displaced or host community members
- Severe psychological distress (Kessler-6 >=13)
- Moderate or high risk of suicide
- Cognitive impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Entre Nosotras (group psychosocial intervention) + stress management intervention Doing What Matters in Times of Stress 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. Entre Nosotras (group psychosocial intervention) + stress management intervention Entre Nosotras 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. Entre Nosostras (group psychosocial intervention) Entre Nosotras Comparison condition: Women residing in the study community (displaced and host population) will receive group psychosocial intervention only.
- Primary Outcome Measures
Name Time Method Attrition - proportion of enrolled individuals who drop out of the study Up to 10 weeks The proportion of enrolled individuals who drop out of the study will be used to indicate the feasibility of a fully-powered definitive trial.
Proportion of eligible and enrolled women who engage in sessions and/or complete all five group sessions. Up to 5 weeks 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.
Proportion of women screened who are eligible to participate Baseline 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.
Intervention Usability Scale Score 5 weeks 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.
Number of baseline imbalances between study conditions Baseline 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.
Recruitment rate Study period The number of individuals enrolled per month will be used to determine the feasibility of a fully-powered definitive trial.
Contamination - proportion of sessions that did not include coping skills intervention components Up to 5 weeks 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.
Fidelity checklist score Up to 5 weeks 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.
Facilitator competence score Up to 5 weeks 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.
- Secondary Outcome Measures
Name Time Method Kessler 6 scale score Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks) 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).
Oslo Social Support Scale Score Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks) 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.
Brief COPE scale score Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks) 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".
Personal Wellbeing Index Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks) 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).WHODAS Score Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks) 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"
Trial Locations
- Locations (1)
HIAS
🇵🇦Panamá City, Panama