Adaptation And Effectiveness Of Depression And Substance Use Module For Patients With Substance Use Disorders And Depression in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in symptoms severity of depression from baseline to post-intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 17 Years 至 56 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Experimental Group: Treatment Module D-SUD-M (Behavioral)
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.
干预措施: Control Group (Behavioral)
Control Group
No exposure of special treatment module will be given to the participants of this group.
干预措施: Control Group (Behavioral)
结局指标
主要结局
Change in symptoms severity of depression from baseline to post-intervention
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点
研究者
Somia Shabbir
Principal Investigator
International Islamic University, Islamabad