Effect of Adapted Relapse Prevention Module (RPM-08) for Patients With Substance Use Disorder in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Relapse Risk
研究概览
简要总结
The goal of this clinical trial is to learn if a culturally adapted Relapse Prevention Module (RPM-08) can reduce relapse risk in people with substance use disorders in Pakistan. The study also examines whether the adapted intervention is effective over time.
The main questions it aims to answer are:
Does the adapted RPM-08 reduce relapse risk compared to usual treatment? Are the effects of the intervention maintained after a follow-up period?
Researchers compared participants who received the adapted RPM-08 along with usual treatment to those who received usual treatment only to see if the intervention improves relapse outcomes.
Participants will:
Attend eight structured group sessions over eight weeks Receive usual treatment provided by the rehabilitation center Complete questionnaires at baseline, after the intervention, and at follow-up
详细描述
This study employed a sequential exploratory mixed-method design integrating qualitative and quantitative phases. The qualitative phase focused on the cultural adaptation of the Relapse Prevention Module (RPM-08) using the ADAPT-ITT framework and Bernal's Ecological Validity Model to ensure cultural and contextual appropriateness for individuals with substance use disorders in Pakistan.
The adaptation process involved expert consultation, iterative refinement, forward-backward translation procedures, and pilot testing to establish linguistic clarity, cultural relevance, and clinical applicability of the intervention.
The quantitative phase utilized a non-randomized two-group pretest-posttest quasi-experimental design with a follow-up component. Participants were recruited using purposive sampling from a residential rehabilitation setting in Punjab, Pakistan. Eligible participants included male individuals diagnosed with moderate substance use disorder who were clinically stable and able to participate in group-based intervention sessions.
Participants were allocated into experimental and control groups within the treatment setting. The experimental group received the adapted RPM-08 intervention in addition to Treatment-As-Usual (TAU), while the control group received TAU only. TAU consisted of standard rehabilitation services including medical care, counselling, and psychosocial support.
The adapted intervention was delivered as a structured group-based program consisting of eight sessions based on cognitive-behavioral relapse prevention principles. The sessions focused on relapse awareness, coping strategies, identification of high-risk situations, and development of relapse prevention plans, with culturally relevant modifications incorporated into content and delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This study was conducted as an open-label trial with no masking. Participants, care providers, and investigators were aware of group assignments due to the nature of the behavioral intervention.
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
- •Male participants diagnosed with moderate substance use disorder (DSM-5-TR)
- •Aged 17 to 56 years
- •Currently enrolled in a residential rehabilitation program
- •Medically and psychologically stable to participate in group sessions
- •Able to provide informed consent
排除标准
- •Individuals diagnosed with severe psychiatric disorders (e.g., bipolar disorder, psychotic depression)
- •Individuals with cognitive impairments affecting participation
- •Individuals currently undergoing detoxification or taking medications that may influence treatment outcomes
研究组 & 干预措施
RPM-08 + Treatment-As-Usual
Participants in this arm received the adapted Relapse Prevention Module (RPM-08) in addition to Treatment-As-Usual (TAU). The intervention consisted of eight structured group sessions delivered over eight weeks, focusing on relapse prevention strategies, coping skills, and management of high-risk situations.
干预措施: Adapted Relapse Prevention Module (RPM-08) (Behavioral)
Treatment-As-Usual
Participants in this arm received Treatment-As-Usual (TAU), which included standard rehabilitation services such as medical care, counselling, and psychosocial support provided by the treatment facility.
干预措施: Treatment as Usual (TAU) (Other)
结局指标
主要结局
Relapse Risk
时间窗: Baseline, post-intervention (8 weeks), and 45-day follow-up
Relapse risk was assessed using the Advance Warning of Relapse (AWARE) questionnaire to evaluate changes in relapse-related warning signs among participants across different assessment time points.
次要结局
- Change in Relapse Risk Over Time(Baseline, post-intervention (8 weeks), and 45-day follow-up)
研究者
Rabab Zahra
Doctoral Researcher
Universiti Sains Malaysia