Adapting Group PM+ for Venezuelan Refugees and Migrants in Colombia

NCT05477355 | Unknown DMC

• 1 other identifier: GR20920
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Wellness 1

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire 9 (PHQ-9)

  a well-known 10-item instrument that measures symptoms of depression and general distress. It has been used in prior PM+ studies as the primary participant level outcome. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.

  4 months after baseline

Secondary Outcomes (4)

• Post-traumatic stress disorder Checklist (PCL-5)

  4 months after baseline

• Psychological Outcome Profiles (PSCYHLOPS)

  4 months after baseline

• Reducing Tension Checklist (RTC)

  4 months after baseline

• Alcohol use disorders identification test (AUDIT)

  4 months after baseline

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants will be provided the 5 session intervention.

Behavioral: Group Problem Management Plus (PM+)

Wait list control arm

ACTIVE COMPARATOR

Participants will not be provided Group PM+ in Phase 1 but will be provided the intervention after all participants in the initial intervention arm receive Group PM+.

Behavioral: Group Problem Management Plus (PM+)

Interventions

Group Problem Management Plus (PM+) BEHAVIORAL

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.

Intervention Arm; Wait list control arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants that self-identify as women are eligible for the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• The New School: lead
• Universidad del Norte: collaborator
• Columbia University: collaborator
• HIAS: collaborator

Study Sites (1)

HIAS

Barranquilla, Colombia

RECRUITING

Study Officials

• Adam Brown, PhD

  The New School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manaswi Sangraula, PhD

CONTACT

5712308443; sangraum@newschool.edu

Adam Brown, PhD

CONTACT

6468318657; brownad@newschool.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants in wait list control (WLC) are explained that they will be receiving the intervention at a later time.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention is Group Problem Management Plus (PM+).

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 28, 2022
• Study Start: February 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)