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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Nepal
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Training as usual
Standard Problem Management Plus training.
Behavioral: Standard Problem Management Plus training (training as usual)
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.
Behavioral: Equip-based Problem Management Plus training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
George Washington University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Transcultural Psychosocial Organization Nepal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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