Feasibility Study of Culturally Adapted Cognitive Behavioral Therapy Based Integrated Motivational Interviewing and Mindfulness Intervention for Substance Use Disorder in Pakistan (CAMIAB)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Feasibility measures
Study Overview
Brief Summary
The study has both quantitative and qualitative components. The aim of study is to:
- Culturally adapt and integrate the existing Motivational Interviewing with Cognitive Behavioral Therapy(MICBT) and Mindfulness based Relapse Prevention (MBRP) for people with Substance Use Disorder (SUD) in Pakistan
- Test the feasibility and acceptability of the integrated intervention called CAMIAB ('CAMIAB' means success in Urdu) in a randomized control trial (RCT).
Detailed Description
This study aims to culturally adapt the existing Motivational Interviewing with CBT (MICBT) and integrate this with Mindfulness-Based Relapse Prevention (MBRP) intervention for people with SUD and to test the feasibility, and acceptability of the intervention in a randomized control trial (RCT). First phase will be cultural adaptation of intervention through focus groups and individual interviews with key stakeholders . Phase two will be to test integrated MICBT and MBRP on a small group of participants N=12.
Third phase will be a feasibility factorial randomized control trial with 260 participants with SUD (n=65). Participants will be recruited from primary care hospitals and drug rehabilitation centers in Karachi, Lahore, Rawalpindi, Hyderabad, and Peshawar Pakistan. Intervention will take place weekly over a period of 12 weeks. The intervention will consist of individual as well as group sessions. Assessments will be completed at baseline, after completion of intervention (12th week) and 24th week post randomization. All assessments will be administered by masked research assistants (RAs), not involved in delivering intervention sessions. The therapists delivering the intervention will be trained and will be provided ongoing supervisions by a senior therapist.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants with substance use disorder
- •Meeting DSM-V criteria for substance use disorder
- •Age 18 years and above
- •Being able to understand spoken or written Urdu
- •Have undergone through the process of detoxification before study intervention
Exclusion Criteria
- •Any evidence of organic brain disease, clinically significant cooccurring medical illness or mental illness to the extent that can impede their ability to provide informed consent or engagement in the intervention.
Arms & Interventions
Motivational Interviewing with CBT (MICBT)
Participants in this arm will receive a total of 12 weekly sessions of CBT based Motivational Interviewing over a period of 12 weeks.
Intervention: Motivational interviewing with CBT (MICBT) (Behavioral)
Mindfulness based Relapse Prevention Group (MBRP)
Participants in this arm will receive a total of 12 weekly sessions of mindfulness intervention over a period of 12 weeks.
Intervention: Mindfulness based Relapse Prevention (MBRP) (Behavioral)
Integrated MICBT and MBRP Group (CAMIAB)
This will be integrated MICBT plus MBRP intervention. Participants will receive a total of 12 weekly sessions of this integrated CAMIAB intervention.
Intervention: CAMIAB (Behavioral)
Treatment as usual (TAU)
This will be routine care psychological treatment that they will be receiving.
Outcomes
Primary Outcomes
Feasibility measures
Time Frame: From baseline to 3rd month (at the end of intervention)
Feasibility will be determined by recruitment rates, adherence rate and retention rates. The criterion for success of feasibility is to recruit \>50% of eligible participants, adherence rate (number of home assignments completed; \> 50%) and retention rate of 70%.
Acceptability measure
Time Frame: From baseline to 3rd month (at the end of intervention)
Acceptability will be determined based on the number of sessions attended by participants and success criterion for intervention acceptability is mean attendance rate of at least 8 sessions.
Secondary Outcomes
- The Maudsley Addiction Profile(Change in problem scores from Baseline to 3rd Month and 6th month)
- The Short Warwick-Edinburgh Mental Well-being Scale(Change in scores from baseline to 3rd Month and 6th month)
- EuroQol-5(Change in scores from baseline to 3rd Month and 6th month)
- Client service receipt inventory(Changes from baseline to 3rd Month and 6th month)