NCT07386574

Brief Summary

The aim of study is to:

  1. 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Jan 2025Jun 2026

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 19, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

January 19, 2026

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility measures

    Feasibility will be determined by recruitment and retention rates of participants throughout the study.

    From enrollement to the end of intervention at 4 weeks

Study Arms (2)

e-mhGAP-IG-SUD Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

Participants randomized to this arm will continue with routine practices and standard care for SUD management as currently being delivered.

Other: Control

Interventions

8 bi-weekly training sessions of e-mhGAP IG SUD Module

e-mhGAP-IG-SUD Intervention Group
ControlOTHER

Routine practices or standard of care

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basic Health Unit

Karachi, Pakistan

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 4, 2026

Study Start

January 1, 2025

Primary Completion

March 15, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations