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Effectiveness of Depression and Substance Use Module for Patients With Co-occurring Disorders (D-SUD-M)

15. juli 2026 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan
        • Najjat Trust

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Experimental 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.
Adfærdsmæssigt: Control 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.
Adfærdsmæssigt: Control Group
No module based treatment will be given to the participants of this group.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in symptoms severity of depression from baseline to post-intervention
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

International Islamic University, Islamabad

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. maj 2026

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

30. september 2026

Datoer for studieregistrering

Først indsendt

10. juli 2026

Først indsendt, der opfyldte QC-kriterier

10. juli 2026

Først opslået (Faktiske)

15. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IIUI/ORIC/Bioethics/110-

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