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

NCT04885569 | Recruiting DMC

• 1 other identifier: PILL-CAMIAB-001
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Substance Use Disorder (SUD)

Outcome Measures

Primary Outcomes (2)

• Feasibility measures

  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%.

  From baseline to 3rd month (at the end of intervention)

• Acceptability measure

  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.

  From baseline to 3rd month (at the end of intervention)

Secondary Outcomes (4)

• 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

Study Arms (4)

Motivational Interviewing with CBT (MICBT)

EXPERIMENTAL

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

Behavioral: Motivational interviewing with CBT (MICBT)

Mindfulness based Relapse Prevention Group (MBRP)

EXPERIMENTAL

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

Behavioral: Mindfulness based Relapse Prevention (MBRP)

Integrated MICBT and MBRP Group (CAMIAB)

EXPERIMENTAL

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

Behavioral: CAMIAB

Treatment as usual (TAU)

NO INTERVENTION

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

Interventions

Motivational interviewing with CBT (MICBT) BEHAVIORAL

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

Motivational Interviewing with CBT (MICBT)

Mindfulness based Relapse Prevention (MBRP) 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.

Mindfulness based Relapse Prevention Group (MBRP)

CAMIAB BEHAVIORAL

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

Integrated MICBT and MBRP Group (CAMIAB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (1)

Pakistan Recovery Oasis

Lahore, Pakistan

RECRUITING

Related Publications (1)

• Asif M, Khoso AB, Husain MA, Shahzad S, Van Hout MC, Rafiq NU, Lane S, Chaudhry IB, Husain N. Culturally adapted motivational interviewing with cognitive behavior therapy and mindfulness-based relapse prevention for substance use disorder in Pakistan (CAMAIB): protocol for a feasibility factorial randomised controlled trial. Pilot Feasibility Stud. 2023 Apr 24;9(1):67. doi: 10.1186/s40814-023-01296-0.

  PMID: 37095571 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Imran Bashir Chaudhry, Prof.

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Bashir Chaudhry, Prof.

CONTACT

02135871845; imran.chaudhry@pill.org.pk

Muqaddas Asif, Ms.

CONTACT

04235775483; muqaddas.asif@pill.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: May 13, 2021
• Study Start: December 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)