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

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ClinicalTrials.gov Identifier: NCT04885569
Recruitment Status : Recruiting
First Posted : May 13, 2021
Last Update Posted : March 5, 2024
Sponsor:
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

Tracking Information
First Submitted Date  ICMJE April 25, 2021
First Posted Date  ICMJE May 13, 2021
Last Update Posted Date March 5, 2024
Actual Study Start Date  ICMJE December 1, 2023
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2022)
  • Feasibility measures [ Time Frame: From baseline to 3rd month (at the end of intervention) ]
    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%.
  • Acceptability measure [ Time Frame: From baseline to 3rd month (at the end of intervention) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2021)
  • Feasibility measures [ Time Frame: From baseline to 3rd month (at the end of intervention) ]
    Feasibility will be determined by recruitment rates and retention rates. The criterion for success of feasibility is to recruit >50% of eligible participants and retention rate of 70%.
  • Acceptability measure [ Time Frame: From baseline to 3rd month (at the end of intervention) ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2021)
  • The Maudsley Addiction Profile [ Time Frame: Change in problem scores from Baseline to 3rd Month and 6th month ]
    The Maudsley Addiction Profile is a brief, questionnaire that measures problems in four domains: substance use, health risk behaviour, physical and psychological health, and personal/social functions.
  • The Short Warwick-Edinburgh Mental Well-being Scale [ Time Frame: Change in scores from baseline to 3rd Month and 6th month ]
    The Short Warwick-Edinburgh Mental Well-being Scale is a 7 items measure that will be used to measure mental wellbeing. It consists of 7 statements on a 5 point Likert scale. The minimum scale score is 7 and the maximum is 35. The high score indicates high mental wellbeing.
  • EuroQol-5 [ Time Frame: Change in scores from baseline to 3rd Month and 6th month ]
    Quality of life will be measured using EuroQoL (EQ-5D) scale. This is a standardized instrument to measure health status and associated population utility weights. It measures five dimensions of health (mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression) at different levels that include "no problems, slight problems, moderate problems, severe problems, and unable to do/extreme".
  • Client service receipt inventory [ Time Frame: Changes from baseline to 3rd Month and 6th month ]
    CSRI will be used to estimate the health and social services received.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2021)
  • The Maudsley Addiction Profile [ Time Frame: Change in problem scores from Baseline to 3rd Month and 6th month ]
    The Maudsley Addiction Profile is a brief, questionnaire that measures problems in four domains: substance use, health risk behaviour, physical and psychological health, and personal/social functions.
  • The Short Warwick-Edinburgh Mental Well-being Scale [ Time Frame: Change in scores from baseline to 3rd Month and 6th month ]
    The Short Warwick-Edinburgh Mental Well-being Scale is a 7 items measure that will be used to measure mental wellbeing. It consists of 7 statements on a 5 point Likert scale. The minimum scale score is 7 and the maximum is 35. The high score indicates high mental wellbeing.
  • EuroQol-5 Dimensions (EQ5-D) [ Time Frame: Change in scores from baseline to 3rd Month and 6th month ]
    Quality of life will be measured using EuroQoL (EQ-5D) scale. This is a standardized instrument to measure health status and associated population utility weights. It measures five dimensions of health (mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression) at different levels that include "no problems, slight problems, moderate problems, severe problems, and unable to do/extreme".
  • Client service receipt inventory [ Time Frame: Changes from baseline to 3rd Month and 6th month ]
    CSRI will be used to estimate the health and social services received.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Culturally Adapted Motivational Interviewing With CBT and Mindfulness Based Relapse Prevention for Substance Use Disorder in Pakistan (CAMIAB)
Official Title  ICMJE Feasibility Study of Culturally Adapted Cognitive Behavioral Therapy Based Integrated Motivational Interviewing and Mindfulness Intervention for Substance Use Disorder in Pakistan (CAMIAB)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Substance Use Disorder (SUD)
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Motivational interviewing with CBT (MICBT)
  • Experimental: 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.
    Intervention: Behavioral: Mindfulness based Relapse Prevention (MBRP)
  • Experimental: 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.
    Intervention: Behavioral: CAMIAB
  • No Intervention: Treatment as usual (TAU)
    This will be routine care psychological treatment that they will be receiving.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2021)		 260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2025
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Imran Bashir Chaudhry, Prof. 02135871845 imran.chaudhry@pill.org.pk
Contact: Muqaddas Asif, Ms. 04235775483 muqaddas.asif@pill.org.pk
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04885569
Other Study ID Numbers  ICMJE PILL-CAMIAB-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Pakistan Institute of Living and Learning
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pakistan Institute of Living and Learning
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Imran Bashir Chaudhry, Prof. Pakistan Institute of Living and Learning
PRS Account Pakistan Institute of Living and Learning
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP