Substance Use Disorder (SUD)NCT07386574
Contextualization and Digitalization of WHO's Mental Health Action Gap Intervention Guide Substance Use Disorders Module
A study testing mhGap IG SUD Module Intervention Training in people with Substance Use Disorder (SUD), run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- mhGap IG SUD Module Intervention Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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.
- 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.
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- mhGap IG SUD Module Intervention Training, Control
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mhGap IG SUD Module Intervention TrainingOther
8 bi-weekly training sessions of e-mhGAP IG SUD Module
ControlOther
Routine practices or standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measures
Feasibility will be determined by recruitment and retention rates of participants throughout the study.
Measured: From enrollement to the end of intervention at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Jan 2025
- Primary completion20 Jun 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- Capaital University of Sceince of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386574
- Sponsor's protocol ID
- mhGAP-IG-SUD-001
- Other IDs
- 16645
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07386574
- Acronym / sponsor ID
- mhGAP-IG-SUD-001
- Conditions
- Substance Use Disorder (SUD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- Capaital University of Sceince of Technology
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of study is to:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-mhGAP-IG-SUD Intervention Group | Experimental | Other: mhGap IG SUD Module Intervention TrainingParticipants 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. |
| Control Group | Active comparator | Other: ControlParticipants randomized to this arm will continue with routine practices and standard care for SUD management as currently being delivered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mhGap IG SUD Module Intervention Training8 bi-weekly training sessions of e-mhGAP IG SUD Module | Other | e-mhGAP-IG-SUD Intervention Group |
| ControlRoutine practices or standard of care | Other | Control Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mhGap IG SUD Module Intervention Training in people with Substance Use Disorder (SUD), run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility measures (time frame: From enrollement to the end of intervention at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.