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

NCT07705113 | Active Not Recruiting

• 1 other identifier: IIUI/ORIC/Bioethics/110-
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Substance Use Disorders

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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).

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

• 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).

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

Study Arms (2)

Experimental Group: Treatment Module D-SUD-M

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Behavioral: Control Group

Interventions

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.

Experimental Group: Treatment Module D-SUD-M

Control Group BEHAVIORAL

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

Control Group; Experimental Group: Treatment Module D-SUD-M

Eligibility Criteria

• Age: 17 Years - 56 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Islamic University, Islamabad: lead

Study Sites (1)

Najjat Trust

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Depression; Substance-Related Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are divided into two groups: An experimental group, which receives routine counseling sessions along with this treatment module. A control group, which receives only routine counseling sessions in the rehabilitation center during the same period.

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: May 2, 2026
• Primary Completion: September 30, 2026
• Study Completion: September 30, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

PA (1)