Adapted RPM-08 for Substance Use Disorder in Pakistan

NCT07552623 | Completed

• 1 other identifier: RPM-08-UMP-2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Substance Use Disorder (SUD); Drug Abuse; Relapse

Keywords

Relapse Prevention; Cognitive Behavioral Therapy; Substance Use Disorder; Rehabilitation; Quasi-Experimental Study; Pakistan; Addiction Treatment; RPM-08

Outcome Measures

Primary Outcomes (1)

• Relapse Risk

  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.

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

Secondary Outcomes (1)

• Change in Relapse Risk Over Time

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

Study Arms (2)

RPM-08 + Treatment-As-Usual

EXPERIMENTAL

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.

Behavioral: Adapted Relapse Prevention Module (RPM-08)

Treatment-As-Usual

ACTIVE COMPARATOR

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.

Other: Treatment as Usual (TAU)

Interventions

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.

RPM-08 + Treatment-As-Usual

Treatment as Usual (TAU) OTHER

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

Treatment-As-Usual

Eligibility Criteria

• Age: 17 Years - 56 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Ghamkol Decent Rehab Center Addiction Treatment Center Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

• Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: Toward an integrative model of change. Journal of Consulting and Clinical Psychology. 1983;51(3):390-395.

  BACKGROUND

• Marlatt GA, Gordon JR. Relapse Prevention: Maintenance Strategies in the Treatment of Addictive Behaviors. New York: Guilford Press; 1985.

  BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Recurrence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rabab Zahra, PhD Candidate (Psychology)

  Universiti Utara Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Researcher

Model Details: This study used a non-randomized parallel group design with two arms. Participants were allocated into an experimental group receiving the adapted RPM-08 intervention in addition to Treatment-As-Usual (TAU) and a control group receiving TAU only. Both groups were assessed at baseline, post-intervention, and follow-up to evaluate changes over time.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: January 4, 2024
• Primary Completion: February 28, 2024
• Study Completion: April 13, 2024
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)