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Recruiting NCT04885569

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

No phase Interventional Substance Use Disorder (SUD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Motivational interviewing with CBT (MICBT), Mindfulness based Relapse Prevention (MBRP), CAMIAB.
Who it may be relevant to
Registry conditions: Substance Use Disorder (SUD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Feasibility Study of Culturally Adapted Cognitive Behavioral Therapy Based Integrated Motivational Interviewing and Mindfulness Intervention for Substance Use Disorder in Pakistan (CAMIAB)

Overview

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).

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.

Interventions

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

Primary outcome measures

  • Feasibility measures [Time frame: From baseline to 3rd month (at the end of intervention)]
  • Acceptability measure [Time frame: From baseline to 3rd month (at the end of intervention)]
Secondary outcome measures (4)
  • The Maudsley Addiction Profile [Time frame: Change in problem scores from Baseline to 3rd Month and 6th month]
  • The Short Warwick-Edinburgh Mental Well-being Scale [Time frame: Change in scores from baseline to 3rd Month and 6th month]
  • EuroQol-5 [Time frame: Change in scores from baseline to 3rd Month and 6th month]
  • Client service receipt inventory [Time frame: Changes from baseline to 3rd Month and 6th month]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Pakistan Recovery Oasis — Lahore

Publications

  • 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/s40814-023-0129 PMID 37095571

Identifiers

NCT: NCT04885569 · PILL-CAMIAB-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗