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

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

      • Kathmandu, Nepal
        • Transcultural Psychosocial Organization Nepal

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.
10-day training on Problem Management Plus.
Experimental: Equip-based training
Training that uses the Equip platform to assess competencies and incorporate this information into trainers and supervisors activities.
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.

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

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.

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