Clinical trial NCT04885569: Culturally Adapted Motivational Interviewing With CBT and Mindfulness Based Relapse Prevention for Substance Use Disorder in Pakistan (CAMIAB)
Official title: Feasibility Study of Culturally Adapted Cognitive Behavioral Therapy Based Integrated Motivational Interviewing and Mindfulness Intervention for Substance Use Disorder in Pakistan (CAMIAB)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorder (SUD)
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Feasibility measures
timeFrame: From baseline to 3rd month (at the end of intervention)
measure: Acceptability measure
timeFrame: From baseline to 3rd month (at the end of intervention)
Secondary outcomes:
measure: The Maudsley Addiction Profile
timeFrame: Change in problem scores from Baseline to 3rd Month and 6th month
measure: The Short Warwick-Edinburgh Mental Well-being Scale
timeFrame: Change in scores from baseline to 3rd Month and 6th month
measure: EuroQol-5
timeFrame: Change in scores from baseline to 3rd Month and 6th month
measure: Client service receipt inventory
timeFrame: Changes from baseline to 3rd Month and 6th month
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Recovery Oasis
Study officials:
affiliation: Pakistan Institute of Living and Learning
name: Imran Bashir Chaudhry, Prof.
role: PRINCIPAL_INVESTIGATOR
References: