- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04954872
Competency-based Training in Problem Management Plus: a Randomized Controlled Trial (EQUIP-PM+)
September 27, 2022 updated by: Brandon A Kohrt, MD, PhD, George Washington University
Comparing Strategies for Competency-based Training in Problem Management Plus to Improve Non-specialist Competencies for Responding to Psychological Distress: a Randomized Controlled Trial
The proposed study in Nepal will evaluate if non-specialists participating in Equip-based Problem Management Plus training show greater competencies compared to non-specialists participating in standard Problem Management Plus training.
The proposed study is a randomized controlled trial with mixed-methods components evaluating both quantitative outcomes and qualitative outcomes among non-specialists participating in the training and their trainers.
Study Overview
Status
Completed
Conditions
Detailed Description
There is increasing recognition of the high burden of psychological distress among populations around the world.
Increasingly, non-specialists (persons who do not have expertise in formal mental health training) are being used to deliver psychological services.
There is a long history of successful implementation of psychological services by non-specialists in Nepal.
Recently, a cluster randomized controlled trial of Problem Management Plus showed modest benefit over enhanced care as usual in southeastern Nepal.
A recent initiative by the World Health Organization is being rolled out to improve the competencies of non-specialists participating in Problem Management Plus and similar trainings.
This initiative is Ensuring Quality in Psychological Services (Equip).
The proposed study in Nepal will evaluate if non-specialists participating in Equip-based Problem Management Plus training show greater competencies compared to non-specialists participating in standard Problem Management Plus training.
The proposed study is a randomized controlled trial with mixed-methods components evaluating both quantitative outcomes and qualitative outcomes among non-specialists participating in the training and their trainers.
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kathmandu, Nepal
- Transcultural Psychosocial Organization Nepal
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- No prior mental health professional training
- Literate in Nepali
Exclusion Criteria:
- Any prior mental health professional training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Training as usual
Standard Problem Management Plus training.
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10-day training on Problem Management Plus.
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Experimental: Equip-based training
Training that uses the Equip platform to assess competencies and incorporate this information into trainers and supervisors activities.
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Training and supervision for Problem Management Plus in which the trainers and supervisors use the EQUIP platform for competency assessment and feedback.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enhancing Assessment of Common Therapeutic Factors (unabbreviated title: Enhancing Assessment of Common Therapeutic Factors)
Time Frame: Immediately after Problem Management Plus training (10-days post-baseline)
|
15-item tool with 4 response levels, range is 15 to 60, with higher scores equating to more competency
|
Immediately after Problem Management Plus training (10-days post-baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enhancing Assessment of Common Therapeutic Factors (unabbreviated title: Enhancing Assessment of Common Therapeutic Factors)
Time Frame: After Problem Management Plus supervision (approximately 45-days post-baseline)
|
15-item tool with 4 response levels, range is 15 to 60, with higher scores equating to more competency
|
After Problem Management Plus supervision (approximately 45-days post-baseline)
|
|
Problem Management Plus Competency Assessment (unabbreviated title: Problem Management Plus Competency Assessment)
Time Frame: Immediately after Problem Management Plus training (10-days post-baseline)
|
12-item tool with 4 response levels, range is 12 to 48, with higher scores equating to more competency
|
Immediately after Problem Management Plus training (10-days post-baseline)
|
|
Problem Management Plus Competency Assessment (unabbreviated title: Problem Management Plus Competency Assessment)
Time Frame: After Problem Management Plus supervision (approximately 45-days post-baseline)
|
12-item tool with 4 response levels, range is 12 to 48, with higher scores equating to more competency
|
After Problem Management Plus supervision (approximately 45-days post-baseline)
|
|
Group Facilitation Competency Assessment (unabbreviated title: Group Facilitation Competency Assessment)
Time Frame: Immediately after Problem Management Plus training (10-days post-baseline)
|
8-item tool with 4 response levels, range is 8 to 32, with higher scores equating to more competency
|
Immediately after Problem Management Plus training (10-days post-baseline)
|
|
Group Facilitation Competency Assessment (unabbreviated title: Group Facilitation Competency Assessment)
Time Frame: After Problem Management Plus supervision (approximately 45-days post-baseline)
|
8-item tool with 4 response levels, range is 8 to 32, with higher scores equating to more competency
|
After Problem Management Plus supervision (approximately 45-days post-baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Brandon A Kohrt, MD, PhD, George Washington University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
June 29, 2021
First Submitted That Met QC Criteria
June 29, 2021
First Posted (Actual)
July 8, 2021
Study Record Updates
Last Update Posted (Actual)
September 29, 2022
Last Update Submitted That Met QC Criteria
September 27, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCR191797-v2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Researchers can contact the principal investigator for access to data.
IPD Sharing Time Frame
After publication of primary results
IPD Sharing Access Criteria
Submit a proposal for intended analysis to the principal investigator.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.