Contextualization and Digitalization of WHO's Mental Health Action Gap Intervention Guide Substance Use Disorders Module

April 29, 2026 updated by: Pakistan Institute of Living and Learning

Testing a Contextualized and Digitalized WHO's Mental Health Action Gap Intervention Guide Substance Use Disorders Module in Primary Care Settings of Pakistan: A Feasibility Cluster Randomized Controlled Trial

The aim of study is to:

  1. To contextualize, adapt, customize and digitalize WHO's Mental Health Gap Action Programme Intervention Guide (e-mhGAP-IG); Substance Use Disorders Module (SUD module) V 2.0 for primary care settings (PCPs) in Pakistan.
  2. To test the feasibility and acceotability of the e-mhGAP-IG (SUD module) training program in a feasibility cluster randomized controlled (cRCT) trial to enable mental health services in primary health care settings in Pakistan.

The proposed study includes contextualization, adaptation, customization, and a feasibility cRCT of e-mhGAP-IG (SUD module) V 2.0 by constituting a combination of traditional and technological approaches of eHealth (mHealth, blended learning, and telemedicine) enabling mental health services in primary care settings to be well informed and accessible. This intervention will empower 300 Primary Care Physicians (PCPs) based in Primary Care Units (PCUs) from urban settlements and Basic Health Units (BHUs) from rural settlements in three major cities, Karachi, Lahore, and Rawalpindi, Pakistan.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

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 Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Primary and non-specialized healthcare providers working in the identified health facilities for this study across three targeted cities; willing to give informed consent for participation in this trial.

Exclusion Criteria:

  • Any primary and non-specialized healthcare provider who is not permanently working in the selected health facilities, has no access to a smart mobile phone and/or internet connection; and is uncomfortable using a mobile phone.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: e-mhGAP-IG-SUD Intervention Group
Participants randomized to this arm will receive a total of eight bi-weekly training sessions on the use of the adapted e-mhGAP-IG-SUD-Urdu mobile application. Training will focus on improving screening, diagnosis, and management of young people with SUD and referral to specialized services where needed.
Other: mhGap IG SUD Module Intervention Training
8 bi-weekly training sessions of e-mhGAP IG SUD Module
Active Comparator: Control Group
Participants randomized to this arm will continue with routine practices and standard care for SUD management as currently being delivered.
Other: Control
Routine practices or standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility measures
Time Frame: From enrollement to the end of intervention at 4 weeks
Feasibility will be determined by recruitment and retention rates of participants throughout the study.
From enrollement to the end of intervention at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Living and Learning

Collaborators

Capaital University of Sceince of Technology

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)

January 1, 2025

Primary Completion (Actual)

March 15, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mhGAP-IG-SUD-001
  • 16645 (Other Grant/Funding Number: HEC-NRPU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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