DepressionD-SUD-MNCT07705113
Effectiveness of Depression and Substance Use Module for Patients With Co-occurring Disorders
A study testing Experimental Group: Treatment Module D-SUD-M in people with Depression and Substance Use Disorders, run by International Islamic University, Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 56 years, men only
- Conditions the study is for
- Depression, Substance Use Disorders
- What is being tested?
- Experimental Group: Treatment Module D-SUD-M
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 2 May 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 56 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Depression, Substance Use Disorders
- Being tested
- Experimental Group: Treatment Module D-SUD-M, Control Group
- Keywords
- Depression, Substance Use Disorders (SUDs), Comorbidity, Rehabilitation, Treatment Module D-SUD-M, Psychological Intervention
- Medical subject headings
- Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group: Treatment Module D-SUD-MBehavioural
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 GroupBehavioural
No module based treatment will be given to the participants of this group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: baseline to post-intervention (5months), total weeks (22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start2 May 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Islamic University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Somia Shabbir, International Islamic University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705113
- Sponsor's protocol ID
- IIUI/ORIC/Bioethics/110-
- Acronym
- D-SUD-M
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation And Effectiveness Of Depression And Substance Use Module For Patients With Substance Use Disorders And Depression in Pakistan
- ClinicalTrials.gov ID
- NCT07705113
- Acronym / sponsor ID
- D-SUD-M / IIUI/ORIC/Bioethics/110-
- Conditions
- Depression, Substance Use Disorders
- Keywords
- Depression, Substance Use Disorders (SUDs), Comorbidity, Rehabilitation, Treatment Module D-SUD-M, Psychological Intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- International Islamic University, IslamabadUniversity, hospital or other
- Study start
- 2 May 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Treatment Module D-SUD-M | Experimental | Behavioral: Experimental Group: Treatment Module D-SUD-M, Behavioral: Control GroupParticipants in this group will recieve special treatment module D-SUD-M for patients with Depression and Substance Abuse. |
| Control Group | Active comparator | Behavioral: Control GroupNo exposure of special treatment module will be given to the participants of this group. |
Who may qualify
- Ages
- 17 to 56 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Group: Treatment Module D-SUD-MA 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. | Behavioural | Experimental Group: Treatment Module D-SUD-M |
| Control GroupNo module based treatment will be given to the participants of this group. | Behavioural | Control Group, Experimental Group: Treatment Module D-SUD-M |
Primary outcome
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group: Treatment Module D-SUD-M in people with Depression and Substance Use Disorders, run by International Islamic University, Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptoms severity of depression from baseline to post-intervention (time frame: Baseline to Post-intervention (5months) total weeks(22)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.