Integrated therapy module aims to tackle dual burden of depression and addiction in pakistani men

NCT ID NCT07705113

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tests a specially designed psychological treatment module for men in Pakistan who struggle with both depression and substance use disorders. The module combines several therapy approaches and is culturally adapted. Half of the participants receive this 12-session program, while the other half get standard care. The goal is to see if the new module reduces depressive symptoms and substance use more effectively than routine treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a culturally adapted psychological intervention called the Depression and Substance Use Disorder Module (D-SUD-M), combining behavior therapy, cognitive behavior therapy, relapse prevention, and group therapy over 12 sessions
What this could lead to
If effective, this module could provide an integrated, culturally tailored treatment option for men with both depression and substance use disorders in Pakistan, potentially improving outcomes in a region with limited mental health resources.
What could go wrong
This is a small early-stage trial with only 50 male participants, so results may not apply to women or other populations. The intervention may not show significant benefit over standard care, and long-term effects are unknown.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

May 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

17 to 56 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants identified by the rehabilitation centre 2. Only male participants will be taken, 3. Age range lies between 17 to 56 years, 4. Screening of depression by using the Beck Depression Inventory (BDI-II) and for Substance Use Disorders using Drug Abuse Screening Test (DAST-10), 5. Diagnosed patients based on DSM-5 clinical diagnostic criteria will be taken into study. Exclusion Criteria: 1. Diagnosed cases of other psychopathology including bipolar disorder, psychotic depression, and others will not be taken in study, 2. Cases of cognitive impairment linked to physical illness will not be part of the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Najjat Trust

    Rawalpindi, Punjab Province, Pakistan

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