Effectiveness of Depression and Substance Use Module for Patients With Co-occurring Disorders (D-SUD-M)
15 juli 2026 uppdaterad av: Somia Shabbir, International Islamic University, Islamabad
Adaptation And Effectiveness Of Depression And Substance Use Module For Patients With Substance Use Disorders And Depression in Pakistan
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.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
50
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Punjab Province
-
Rawalpindi, Punjab Province, Pakistan
- Najjat Trust
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
No module based treatment will be given to the participants of this group.
|
|
Aktiv komparator: Control Group
No exposure of special treatment module will be given to the participants of this group.
|
No module based treatment will be given to the participants of this group.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in symptoms severity of depression from baseline to post-intervention
Tidsram: 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).
|
Baseline to Post-intervention (5months) total weeks(22)
|
|
Change in Substance Use Disorder Severity from baseline to post-intervention
Tidsram: 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).
|
baseline to post-intervention (5months), total weeks (22)
|
Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 maj 2026
Primärt slutförande (Beräknad)
30 september 2026
Avslutad studie (Beräknad)
30 september 2026
Studieregistreringsdatum
Först inskickad
10 juli 2026
Först inskickad som uppfyllde QC-kriterierna
10 juli 2026
Första postat (Faktisk)
15 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IIUI/ORIC/Bioethics/110-
Läkemedels- och apparatinformation, studiedokument
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