An interventional study of Group Problem Management Plus (PM+) in Mental Health Wellness 1, sponsored by The New School. Status unknown at 1 site in Colombia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-28.
Sponsored by The New School · Not applicable, Interventional, and Supportive care
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 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:
The New School is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be provided the 5 session intervention.
Behavioral: Group Problem Management Plus (PM+)
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+)
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.
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.
Time frame: 4 months after baseline
Post-traumatic stress disorder Checklist (PCL-5)
a 20-item checklist that corresponds with the 20 DSM IV PTSD symptoms
Time frame: 4 months after baseline
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
Time frame: 4 months after baseline
Reducing Tension Checklist (RTC)
12-item assessment of psychological and behavioral skills related to PM+ to evaluate skill acquisition
Time frame: 4 months after baseline
Alcohol use disorders identification test (AUDIT)
This assessment measures hazardous and harmful alcohol use.
Time frame: 4 months after baseline
Plan to share: No — All participant data will anonymized when input into databases. Individual participant data will only be available to those on the research team.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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