Feasibility of Community Psychosocial Intervention for Women

NCT05130944 | Completed

• 2 other identifiers: AAAT7637AID-OAAA17-00002
• Study Type: interventional
• Target: 275
• Locations: 2 countries
• Sites: 2

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. 1.Explore the relevance, acceptability, and feasibility of integrating a stress management intervention into community-based participatory women's group
2. 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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• Recruitment rate

  The number of individuals enrolled per month will be used to determine the feasibility of a fully-powered definitive trial.

  Study period

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Personal Wellbeing Index

  Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)

• Kessler 6 scale score

  Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)

• Brief COPE scale score

  Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)

• WHODAS Score

  Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)

• Oslo Social Support Scale Score

  Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks)

Study Arms (2)

Entre Nosotras (group psychosocial intervention) + stress management intervention

EXPERIMENTAL

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.

Behavioral: Entre Nosotras; Behavioral: Doing What Matters in Times of Stress

Entre Nosostras (group psychosocial intervention)

ACTIVE COMPARATOR

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

Behavioral: Entre Nosotras

Interventions

Entre Nosotras 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.

Entre Nosostras (group psychosocial intervention); Entre Nosotras (group psychosocial intervention) + stress management intervention

Doing What Matters in Times of Stress 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.

Also known as: Stress management, coping skills

Entre Nosotras (group psychosocial intervention) + stress management intervention

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18+ years) women residing in the study community who speak and understand Spanish
• Displaced or host community members

You may not qualify if:

• Severe psychological distress (Kessler-6 \>=13)
• Moderate or high risk of suicide
• Cognitive impairment

Sponsors & Collaborators

• Columbia University: lead
• University of Copenhagen: collaborator
• HIAS: collaborator

Study Sites (2)

HIAS

Quito, Ecuador

Location

HIAS

Panama City, Panama

Location

Related Publications (1)

• 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.

  PMID: 35706068 DERIVED

MeSH Terms

Interventions

Coping Skills

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Claire Greene, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized comparative feasibility trial

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 23, 2021
• Study Start: September 9, 2021
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1); EC (1)