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Mental Health Wellness 1NCT05130944

Feasibility of Community Psychosocial Intervention for Women

A study testing Entre Nosotras and Doing What Matters in Times of Stress in people with Mental Health Wellness 1 and Psychological Distress, run by Columbia University at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Entre Nosotras and Doing What Matters in Times of Stress
Could I receive a placebo?
No, everyone receives an active treatment
How many people
275 participants
Where
2 sitesin 2 countries
Study dates
9 Sep 2021to 8 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Ecuador1 site

  • HIAS

    Quito

Other trials in Ecuador

Panama1 site

  • HIAS

    Panama City

Other trials in Panama

About this study

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

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.
Read the 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.

Being tested
Entre Nosotras, Doing What Matters in Times of Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Entre NosotrasBehavioural

    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 StressBehavioural

    Also called Stress management, coping skills

    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.

Study groups in NCT05130944
Study groupRoleWhat they receive
Entre Nosotras (group psychosocial intervention) + stress management interventionExperimentalExperimental 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.
Receives: Behavioral: Entre Nosotras; Behavioral: Doing What Matters in Times of Stress
Entre Nosostras (group psychosocial intervention)Active comparatorComparison condition: Women residing in the study community (displaced and host population) will receive group psychosocial intervention only.
Receives: Behavioral: Entre Nosotras

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Up to 5 weeks

  3. 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.

    Measured: 5 weeks

  4. Recruitment rate

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

    Measured: Study period

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: Up to 10 weeks

  7. 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.

    Measured: Up to 5 weeks

  8. 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.

    Measured: Up to 5 weeks

  9. 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.

    Measured: Up to 5 weeks

Secondary outcomes (5)

  1. 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).

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

  2. 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).

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

  3. 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".

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

  4. 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"

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2021
  2. Study start9 Sep 2021
  3. Primary completion8 Mar 2022
  4. Study completion8 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized comparative feasibility trial
Masking
Single blind
Who is masked
Participant
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05130944
Sponsor's protocol ID
AAAT7637
Other IDs
AID-OAAA17-00002
Status last verified
May 2024
First submitted
12 Nov 2021
Last updated
2 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wimer G, Larrea M, Streeter J, Hassan A, Angulo A, Armijos A, Bonz A, Tol WA, Greene MC. Accessibility and Perceived Impact of a Group Psychosocial Intervention for Women in Ecuador: A Comparative Analysis by Migration Status. Int J Environ Res Public Health. 2024 Mar 22;21(4):380. doi: 10.3390/ijerph21040380.

    PubMed 38673293

  • 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.

    PubMed 35706068

Questions about this trial

What is this clinical trial studying?

A study testing Entre Nosotras and Doing What Matters in Times of Stress in people with Mental Health Wellness 1 and Psychological Distress, run by Columbia University at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Ecuador, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of women screened who are eligible to participate (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05130944, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.

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