Culturally Adapted Motivational Interviewing With CBT and Mindfulness Based Relapse Prevention for Substance Use Disorder in Pakistan (CAMIAB)

Pakistan Institute of Living and Learning

Status: Enrolling

Conditions: Substance Use Disorder (SUD)

Treatments: Behavioral: Mindfulness based Relapse Prevention (MBRP); Behavioral: Motivational interviewing with CBT (MICBT); Behavioral: CAMIAB

Study type: Interventional

Funder types: Other

Identifiers

NCT04885569

PILL-CAMIAB-001

Details and patient eligibility

About

The study has both quantitative and qualitative components. The aim of study is to:

1. 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
2. Test the feasibility and acceptability of the integrated intervention called CAMIAB ('CAMIAB' means success in Urdu) in a randomized control trial (RCT).

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 4 patient groups

Motivational Interviewing with CBT (MICBT)

Experimental group

Description:

Participants in this arm will receive a total of 12 weekly sessions of CBT based Motivational Interviewing over a period of 12 weeks.

Treatment:

Behavioral: Motivational interviewing with CBT (MICBT)

Mindfulness based Relapse Prevention Group (MBRP)

Experimental group

Description:

Participants in this arm will receive a total of 12 weekly sessions of mindfulness intervention over a period of 12 weeks.

Treatment:

Behavioral: Mindfulness based Relapse Prevention (MBRP)

Integrated MICBT and MBRP Group (CAMIAB)

Experimental group

Description:

This will be integrated MICBT plus MBRP intervention. Participants will receive a total of 12 weekly sessions of this integrated CAMIAB intervention.

Treatment:

Behavioral: CAMIAB

Treatment as usual (TAU)

No Intervention group

Description:

This will be routine care psychological treatment that they will be receiving.