Clinical trial NCT05477355: Adapting Group PM+ for Venezuelan Refugees and Migrants in Colombia
Official title: Increasing Mental Health and Psychosocial Social Support for Venezuelan Refugees and Migrants: Adapting Group Problem Management Plus (Group PM+) for Venezuelan Refugees and Migrants in Colombia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Wellness 1
Lead sponsor: The New School
Sponsor class: OTHER
Collaborators: name: Universidad del Norte
name: Columbia University
name: HIAS
First posted: 2022-07-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The intervention is Group Problem Management Plus (PM+).
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a type 2 hybrid implementation design, which aims to evaluate the utility and effectiveness of an intervention while simultaneously assessing implementation outcomes, such as adoption, fidelity, and maintenance. The aim is to compare participant level outcomes when the intervention is delivered by facilitators that are trained and supervised by psychologists versus by lay-supervisors. Group PM+ will be delivered to participants in two phases: first, with high levels of technical support through intensive training and supervision by mental health professionals and a second phase with routine service delivery and supervision. Non-specialist community members who are trained and supervised by psychologists to deliver PM+ as part of Phase 1 will be trained to become supervisors and train and support a cohort of new non-specialist facilitators for Group PM+ delivery in Phase 2. This model employs a train-the-trainers model to replicate routine service delivery especially in settings where mental health specialists may not be available to provide robust technical support and supervision to lay PM+ facilitators. The aim is to compare effectiveness and implementation outcomes of Group PM+ when delivered within routine care, to identify best practices for implementation, and ultimately, to shorten the time lag between intervention research and routine uptake.

Detailed description: This study is a type 2 hybrid implementation design, which aims to evaluate the utility and effectiveness of an intervention while simultaneously assessing implementation outcomes, such as adoption, fidelity, and maintenance. The aim is to compare participant level outcomes when the intervention is delivered by facilitators that are trained and supervised by psychologists versus by lay-supervisors. Group PM+ will be delivered to participants in two phases: first, with high levels of technical support through intensive training and supervision by mental health professionals and a second phase with routine service delivery and supervision. Non-specialist community members who are trained and supervised by psychologists to deliver PM+ as part of Phase 1 will be trained to become supervisors and train and support a cohort of new non-specialist facilitators for Group PM+ delivery in Phase 2. This model employs a train-the-trainers model to replicate routine service delivery especially in settings where mental health specialists may not be available to provide robust technical support and supervision to lay PM+ facilitators. The aim is to compare effectiveness and implementation outcomes of Group PM+ when delivered within routine care, to identify best practices for implementation, and ultimately, to shorten the time lag between intervention research and routine uptake.

This research design offers a few points of comparison:

1. change in primary and secondary outcomes at 1-week follow-up and 3-month follow-up amongst participants that receive Group PM+ with research support (Phase 1) compared to those that receive the intervention with standard care and implementation (Phase 2), \[Primary objective\]
2. differences in implementation indicators (ex. Facilitator competencies, fidelity to PM+, participant retention, cost effectiveness, adverse events, human resource involvement and more) in Phase 1 of implementation compared to Phase 2,
3. change in primary and secondary outcomes amongst participants in the intervention arm compared to participants who do not receive the intervention during Phase 1.

Eligibility criteria: Inclusion Criteria:

* must identify as a woman
* over 18 years of age
* must state that they are planning to live in Barranquilla for at least three months after the date of screening
* moderate functional impairment as indicated by scoring greater than 16 on the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) for health and disability
* moderate psychological distress as indicated by scoring greater than 2 on the General Health Questionnaire 12 (GHQ-12)

Exclusion Criteria:

* imminent risk of suicide and state that they have plans for attempting suicide
* show severe cognitive impairment (e.g. severe intellectual disability or dementia) or a severe disability as identified by the Ten Questions (TQ-10)

Primary outcomes:
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: 4 months after baseline
Secondary outcomes:
measure: Post-traumatic stress disorder Checklist (PCL-5)
timeFrame: 4 months after baseline
measure: Psychological Outcome Profiles (PSCYHLOPS)
timeFrame: 4 months after baseline
measure: Reducing Tension Checklist (RTC)
timeFrame: 4 months after baseline
measure: Alcohol use disorders identification test (AUDIT)
timeFrame: 4 months after baseline
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: HIAS
Study officials:
affiliation: The New School
name: Adam Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References: