Adapting Group PM+ for Venezuelan Refugees and Migrants in Colombia

Mental Health Wellness 1 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05477355
• Other study ID #: GR20920
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: The New School
• Contact: Manaswi Sangraula, PhD
• Phone: 5712308443
• Email: sangraum[@]newschool.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

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.

Locations

Country	Name	City	State
Colombia	HIAS	Barranquilla

Sponsors (4)

Lead Sponsor	Collaborator
The New School	Columbia University, HIAS, Universidad del Norte

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-traumatic stress disorder Checklist (PCL-5)	a 20-item checklist that corresponds with the 20 DSM IV PTSD symptoms	4 months after baseline
Secondary	Psychological Outcome Profiles (PSCYHLOPS)	This instrument seeks participants perspectives on their psychological distress related to the problems they are facing and well-being scored on a 0 to 5 scale	4 months after baseline
Secondary	Reducing Tension Checklist (RTC)	12-item assessment of psychological and behavioral skills related to PM+ to evaluate skill acquisition	4 months after baseline
Secondary	Alcohol use disorders identification test (AUDIT)	This assessment measures hazardous and harmful alcohol use.	4 months after baseline