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Adapting Group PM+ for Venezuelan Refugees and Migrants in Colombia

NCT05477355 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-07-28

No results posted yet for this study

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.

Conditions

  • Mental Health Wellness 1

Interventions

BEHAVIORAL

Group Problem Management Plus (PM+)

Group PM+ is a low-intensity, trans-diagnostic, brief psychological intervention developed by the WHO. Group PM+ consists of five sessions delivered in five consecutive weeks and includes strategies that are aimed towards decreasing symptoms of depression, anxiety, general distress, and other related conditions. Group PM+ is designed to be delivered by non-specialists, persons without a formal education and licensure in psychology or mental health.

Sponsors & Collaborators

  • Universidad del Norte

    collaborator OTHER

  • Columbia University

    collaborator OTHER

  • HIAS

    collaborator UNKNOWN

  • The New School

    lead OTHER

Principal Investigators

  • Adam Brown, PhD · The New School

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05477355 on ClinicalTrials.gov