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NCT Number: NCT07705113

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Chemically-Induced Disorders Mental Disorders Substance Use Disorders Substance-Related Disorders

Age range

17 year–56 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Najjat Trust

Rawalpindi, Punjab Province, Pakistan

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants identified by the rehabilitation centre
  • Only male participants will be taken,
  • Age range lies between 17 to 56 years,
  • Screening of depression by using the Beck Depression Inventory (BDI-II) and for Substance Use Disorders using Drug Abuse Screening Test (DAST-10),
  • Diagnosed patients based on DSM-5 clinical diagnostic criteria will be taken into study.

Exclusion criteria

  • Diagnosed cases of other psychopathology including bipolar disorder, psychotic depression, and others will not be taken in study,
  • Cases of cognitive impairment linked to physical illness will not be part of the study.

Treatment and study plan

Experimental Group: Treatment Module D-SUD-M

Behavioral

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.

Control Group

Behavioral

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

Primary outcomes

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

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

    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).

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

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

    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).

Sponsors and collaborators

Lead sponsor

International Islamic University, Islamabad

Other

Registry information

Official study title

Adaptation And Effectiveness Of Depression And Substance Use Module For Patients With Substance Use Disorders And Depression in Pakistan

Acronym: D-SUD-M

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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