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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Substance Use Disorder (SUD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Motivational interviewing with CBT (MICBT)

Intervention Type BEHAVIORAL

The culturally adapted MICBT will include approaches of motivational interviewing and offer ways of managing difficulties from a cognitive behavioural formulation.

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.

Group Type EXPERIMENTAL

Mindfulness based Relapse Prevention (MBRP)

Intervention Type BEHAVIORAL

MBRP will incorporate cognitive-behavioural skills (i.e., effective coping skills, self-efficacy, and recognizing common antecedents of relapse) with mindfulness-based practices to decrease the probability of relapse by increasing awareness and flexible responding in the presence of substance use triggers.

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.

Group Type EXPERIMENTAL

CAMIAB

Intervention Type BEHAVIORAL

This will be integrated CBT based motivational interviewing plus mindfulness based relapse prevention intervention group.

Treatment as usual (TAU)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Motivational interviewing with CBT (MICBT)

The culturally adapted MICBT will include approaches of motivational interviewing and offer ways of managing difficulties from a cognitive behavioural formulation.

Intervention Type BEHAVIORAL

Mindfulness based Relapse Prevention (MBRP)

MBRP will incorporate cognitive-behavioural skills (i.e., effective coping skills, self-efficacy, and recognizing common antecedents of relapse) with mindfulness-based practices to decrease the probability of relapse by increasing awareness and flexible responding in the presence of substance use triggers.

Intervention Type BEHAVIORAL

CAMIAB

This will be integrated CBT based motivational interviewing plus mindfulness based relapse prevention intervention group.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No