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

N/AActive Not RecruitingNCT07705113

International Islamic University, Islamabad50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Interventions

Experimental Group: Treatment Module D-SUD-MBEHAVIORAL

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 GroupBEHAVIORAL

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

Eligibility

Sex: MALEMin age: 17 YearsMax age: 56 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

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)