Mental Health Wellness 1NCT05477355
Adapting Group PM+ for Venezuelan Refugees and Migrants in Colombia
A study testing Group Problem Management Plus (PM+) in people with Mental Health Wellness 1, run by The New School at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Group Problem Management Plus (PM+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteColombia
- Study dates
- 1 Feb 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
HIAS
Barranquilla
Jennifer Diaz, 212-967-4100, Jennifer Diaz <jennifer.diaz@hias.org>
Camilo Ramirez, camilo.ramirez@hias.org
About this study
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
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.
Read the 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:
- 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]
- 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,
- change in primary and secondary outcomes amongst participants in the intervention arm compared to participants who do not receive the intervention during Phase 1.
- Conditions
- Mental Health Wellness 1
- Being tested
- Group Problem Management Plus (PM+)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Problem Management Plus (PM+)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will be provided the 5 session intervention. Receives: 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+. Receives: Behavioral: Group Problem Management Plus (PM+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months after baseline
Secondary outcomes (4)
Post-traumatic stress disorder Checklist (PCL-5)
a 20-item checklist that corresponds with the 20 DSM IV PTSD symptoms
Measured: 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
Measured: 4 months after baseline
Reducing Tension Checklist (RTC)
12-item assessment of psychological and behavioral skills related to PM+ to evaluate skill acquisition
Measured: 4 months after baseline
Alcohol use disorders identification test (AUDIT)
This assessment measures hazardous and harmful alcohol use.
Measured: 4 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Feb 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The intervention is Group Problem Management Plus (PM+).
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The New School
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad del Norte, Columbia University, HIAS
- Responsible party
- Sponsor
- Investigators
- Adam Brown, PhD, Principal investigator, The New School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477355
- Sponsor's protocol ID
- GR20920
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participant data will anonymized when input into databases. Individual participant data will only be available to those on the research team.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05477355
- Acronym / sponsor ID
- GR20920
- Conditions
- Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The New SchoolUniversity, hospital or other
- Collaborators
- Universidad del Norte, Columbia University, HIAS
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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]
- 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,
- change in primary and secondary outcomes amongst participants in the intervention arm compared to participants who do not receive the intervention during Phase 1.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention is Group Problem Management Plus (PM+).
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Group Problem Management Plus (PM+)Participants will be provided the 5 session intervention. |
| Wait list control arm | Active comparator | 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+. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Arm, Wait list control arm |
Primary outcome
Patient Health Questionnaire 9 (PHQ-9)
Time frame: 4 months after baseline
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 secondary outcomes
Post-traumatic stress disorder Checklist (PCL-5)
Time frame: 4 months after baseline
Psychological Outcome Profiles (PSCYHLOPS)
Time frame: 4 months after baseline
Reducing Tension Checklist (RTC)
Time frame: 4 months after baseline
Alcohol use disorders identification test (AUDIT)
Time frame: 4 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No. All participant data will anonymized when input into databases. Individual participant data will only be available to those on the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Brown, PhD principal investigator
The New School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Problem Management Plus (PM+) in people with Mental Health Wellness 1, run by The New School at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manaswi Sangraula, PhD (5712308443, sangraum@newschool.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire 9 (PHQ-9) (time frame: 4 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.