Competency-based Training in Problem Management Plus: a Randomized Controlled Trial (EQUIP-PM+)
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Standard Problem Management Plus training (training as usual)
Equip-based Problem Management Plus training
Sponsored by
About this trial
This is an interventional health services research trial for Depression focused on measuring Training, Competency, Psychological treatment
Eligibility Criteria
Inclusion Criteria:
- No prior mental health professional training
- Literate in Nepali
Exclusion Criteria:
- Any prior mental health professional training
Sites / Locations
- Transcultural Psychosocial Organization Nepal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Training as usual
Equip-based training
Arm Description
Standard Problem Management Plus training.
Training that uses the Equip platform to assess competencies and incorporate this information into trainers and supervisors activities.
Outcomes
Primary Outcome Measures
Enhancing Assessment of Common Therapeutic Factors (unabbreviated title: Enhancing Assessment of Common Therapeutic Factors)
15-item tool with 4 response levels, range is 15 to 60, with higher scores equating to more competency
Secondary Outcome Measures
Enhancing Assessment of Common Therapeutic Factors (unabbreviated title: Enhancing Assessment of Common Therapeutic Factors)
15-item tool with 4 response levels, range is 15 to 60, with higher scores equating to more competency
Problem Management Plus Competency Assessment (unabbreviated title: Problem Management Plus Competency Assessment)
12-item tool with 4 response levels, range is 12 to 48, with higher scores equating to more competency
Problem Management Plus Competency Assessment (unabbreviated title: Problem Management Plus Competency Assessment)
12-item tool with 4 response levels, range is 12 to 48, with higher scores equating to more competency
Group Facilitation Competency Assessment (unabbreviated title: Group Facilitation Competency Assessment)
8-item tool with 4 response levels, range is 8 to 32, with higher scores equating to more competency
Group Facilitation Competency Assessment (unabbreviated title: Group Facilitation Competency Assessment)
8-item tool with 4 response levels, range is 8 to 32, with higher scores equating to more competency
Full Information
NCT ID
NCT04954872
First Posted
June 29, 2021
Last Updated
September 27, 2022
Sponsor
George Washington University
Collaborators
Transcultural Psychosocial Organization Nepal
1. Study Identification
Unique Protocol Identification Number
NCT04954872
Brief Title
Competency-based Training in Problem Management Plus: a Randomized Controlled Trial
Acronym
EQUIP-PM+
Official Title
Comparing Strategies for Competency-based Training in Problem Management Plus to Improve Non-specialist Competencies for Responding to Psychological Distress: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
Collaborators
Transcultural Psychosocial Organization Nepal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Training, Competency, Psychological treatment
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Persons without mental health professional experience will be randomized to either training as usual to develop Problem Management Plus competencies or they will be randomized to Problem Management Plus training that uses Equip principles of competency-based training.
Masking
Care ProviderOutcomes Assessor
Masking Description
The persons without mental health professional training who are randomized to either training as usual or Equip-based training will not be informed about how the two training arms differ. Outcome assessors will not be told if the trainees are in training as usual or Equip-based training.
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training as usual
Arm Type
Active Comparator
Arm Description
Standard Problem Management Plus training.
Arm Title
Equip-based training
Arm Type
Experimental
Arm Description
Training that uses the Equip platform to assess competencies and incorporate this information into trainers and supervisors activities.
Intervention Type
Behavioral
Intervention Name(s)
Standard Problem Management Plus training (training as usual)
Intervention Description
10-day training on Problem Management Plus.
Intervention Type
Behavioral
Intervention Name(s)
Equip-based Problem Management Plus training
Intervention Description
Training and supervision for Problem Management Plus in which the trainers and supervisors use the EQUIP platform for competency assessment and feedback.
Primary Outcome Measure Information:
Title
Enhancing Assessment of Common Therapeutic Factors (unabbreviated title: Enhancing Assessment of Common Therapeutic Factors)
Description
15-item tool with 4 response levels, range is 15 to 60, with higher scores equating to more competency
Time Frame
Immediately after Problem Management Plus training (10-days post-baseline)
Secondary Outcome Measure Information:
Title
Enhancing Assessment of Common Therapeutic Factors (unabbreviated title: Enhancing Assessment of Common Therapeutic Factors)
Description
15-item tool with 4 response levels, range is 15 to 60, with higher scores equating to more competency
Time Frame
After Problem Management Plus supervision (approximately 45-days post-baseline)
Title
Problem Management Plus Competency Assessment (unabbreviated title: Problem Management Plus Competency Assessment)
Description
12-item tool with 4 response levels, range is 12 to 48, with higher scores equating to more competency
Time Frame
Immediately after Problem Management Plus training (10-days post-baseline)
Title
Problem Management Plus Competency Assessment (unabbreviated title: Problem Management Plus Competency Assessment)
Description
12-item tool with 4 response levels, range is 12 to 48, with higher scores equating to more competency
Time Frame
After Problem Management Plus supervision (approximately 45-days post-baseline)
Title
Group Facilitation Competency Assessment (unabbreviated title: Group Facilitation Competency Assessment)
Description
8-item tool with 4 response levels, range is 8 to 32, with higher scores equating to more competency
Time Frame
Immediately after Problem Management Plus training (10-days post-baseline)
Title
Group Facilitation Competency Assessment (unabbreviated title: Group Facilitation Competency Assessment)
Description
8-item tool with 4 response levels, range is 8 to 32, with higher scores equating to more competency
Time Frame
After Problem Management Plus supervision (approximately 45-days post-baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No prior mental health professional training
Literate in Nepali
Exclusion Criteria:
Any prior mental health professional training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon A Kohrt, MD, PhD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Transcultural Psychosocial Organization Nepal
City
Kathmandu
Country
Nepal
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Competency-based Training in Problem Management Plus: a Randomized Controlled Trial
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