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Active, not recruitingNCT07705113D-SUD-MUpdated Jul 16, 2026

Effectiveness of Depression and Substance Use Module for Patients With Co-occurring Disorders

An interventional study of Experimental Group: Treatment Module D-SUD-M and Control Group in Depression and Substance Use Disorders, sponsored by International Islamic University, Islamabad. Active, not recruiting at 1 site in Pakistan. Open to male participants aged 17 Years to 56 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by International Islamic University, Islamabad · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
17 Years to 56 Years
Sex
Male
01

Study summary

The purpose of this study is to evaluate the adaptation and effectiveness of an integrated treatment module, the Depression and Substance Use Disorder Module (D-SUD-M), for male patients experiencing co-occurring depression and substance use disorders in Pakistan.

Participants are divided into two groups: an experimental group receiving the structured D-SUD-M intervention-based sessions and a control group receiving standard routine treatment sessions within the rehabilitation center.

The primary objective is to evaluate whether the specialized intervention module significantly reduces depressive symptoms and substance use severity compared to routine standard care.

Read the detailed description

A total of 50 male participants aged 17 to 56 years admitted to a rehabilitation facility are enrolled in this parallel-group interventional study.

The research is structured as follows:

  1. Pre-Assessment Screening: All participants are initially screened using the Beck Depression Inventory (BDI-II) to assess depression levels and the Drug Abuse Screening Test (DAST-10) to assess substance use severity.
  2. Group Assignment: Participants are allocated to either the experimental group or the control group. The experimental group undergoes the designated treatment module (D-SUD-M) over a 12-session course spanning approximately 5 months (22 weeks). The control group undergoes routine rehabilitation facility program care without the specific D-SUD-M intervention.
  3. Post-Assessment Screening: Following the completion of the intervention period at 22 weeks, both groups are re-evaluated using the exact same screening instruments (BDI-II and DAST-10) to statistically analyze symptom reduction and measure module effectiveness.
02

Conditions studied

  • Depression
  • Substance Use Disorders

Keywords

  • Depression
  • Substance Use Disorders (SUDs)
  • Comorbidity
  • Rehabilitation
  • Treatment Module D-SUD-M
  • Psychological Intervention
03

In context

Depression

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

This study's enrollment of 50 is below the median of 81 across 7,063 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

International Islamic University, Islamabad is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 56 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 clinical diagnostic criteria will be taken into study.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Experimental Group: Treatment Module D-SUD-M

    Participants in this group will recieve special treatment module D-SUD-M for patients with Depression and Substance Abuse.

    Behavioral: Experimental Group: Treatment Module D-SUD-M · Behavioral: Control Group

  • Active comparator
    Control Group

    No exposure of special treatment module will be given to the participants of this group.

    Behavioral: Control Group

Interventions

  • BehavioralExperimental Group: Treatment Module D-SUD-M

    A specialized psychological Intervention based module design for reducing the symptoms and to check the effectiveness of module on patients with depression and substance use disorder. This module is translated and culturally adapted. A manual treatment booklet was written in which eclectic approaches were used like Behaviour therapy, Cognitive behaviour therapy, relapse prevention, group therapy along with activity sheets for each session. 12 intervention based sessions will be given to the participants of this group.

  • BehavioralControl Group

    No module based treatment will be given to the participants of this group.

06

What researchers measure

Primary outcomes

  1. Change in symptoms severity of depression from baseline to post-intervention

    Assessed using the Beck Depression Inventory (BDI-II). The BDI-II is a 21-item self-report scale measuring characteristics and symptoms of depression. Total scores range from 0 to 63, with higher scores indicating a worse outcome (greater depressive symptom severity).

    Time frame: Baseline to Post-intervention (5months) total weeks(22)

  2. Change in Substance Use Disorder Severity from baseline to post-intervention

    Assessed using the Drug Abuse Screening Test (DAST-10). The DAST -10 is a self-report instrument used to evaluate consequences related to drug misuse. Total scores range from 0 to 10, with higher scores indicating a worse outcome (greater severity of substance use-related problems).

    Time frame: baseline to post-intervention (5months), total weeks (22)

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Sep 2026, 4 months after the start.

Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 4 months is below that.

Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 10, 2026
First posted
Jul 15, 2026
StartActual
May 2, 2026
Primary completionEst.
Sep 30, 2026
CompletionEst.
Sep 30, 2026
Last update
Jul 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07705113
Lead sponsor
International Islamic University, Islamabad
Responsible party
Somia Shabbir (Principal Investigator, International Islamic University, Islamabad) — Principal investigator
First posted
Jul 15, 2026
Start date
May 2, 2026
Primary completion
Sep 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jul 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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