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Completed

NCT Number: NCT07552623

Adapted RPM-08 for Substance Use Disorder in Pakistan

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

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Key information

Age range

17 year–56 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ghamkol Decent Rehab Center Addiction Treatment Center Lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Data were collected at multiple time points to examine changes over time and differences between groups. Statistical analyses were conducted using appropriate non-parametric tests and covariance-based methods to evaluate intervention effects while accounting for baseline differences and relevant covariates.

This study was registered retrospectively after completion of data collection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Adapted Relapse Prevention Module (RPM-08)

Behavioral

The adapted Relapse Prevention Module (RPM-08) is a structured cognitive-behavioral intervention designed to reduce relapse risk among individuals with substance use disorders. It is based on relapse prevention principles and the stages of change model, focusing on identifying high-risk situations, recognizing early warning signs, and developing coping strategies. The intervention was culturally adapted for the Pakistani context and delivered in a group format. It consisted of eight structured sessions conducted over eight weeks. The sessions included psychoeducation, cognitive restructuring, emotional regulation, coping skills training, and relapse prevention planning. Cultural adaptations incorporated locally relevant examples, family-oriented perspectives, and context-specific coping strategies to enhance engagement and applicability.

Treatment as usual (TAU)

Other

Standard rehabilitation care provided by the treatment facility, including medical monitoring, counselling sessions, and psychosocial support services.

Primary outcomes

  1. Relapse Risk

    Time frame: 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.

Secondary outcomes

  1. Change in Relapse Risk Over Time

    Time frame: Baseline, post-intervention (8 weeks), and 45-day follow-up

    Changes in relapse risk scores measured using the Advance Warning of Relapse (AWARE) questionnaire across baseline, post-intervention, and follow-up assessments to evaluate differences over time and between study groups.

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

Effect of Adapted Relapse Prevention Module (RPM-08) for Patients With Substance Use Disorder in Pakistan

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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