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NCT Number: NCT04885569

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Recovery Oasis

Lahore, Pakistan

Location status: Recruiting

Location contact

Junaid Ahmad

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

CAMIAB

Behavioral

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

Primary outcomes

  1. 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%.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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".

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Bashir Chaudhry, Prof.

CONTACT

[email protected]

02135871845

Muqaddas Asif, Ms.

CONTACT

[email protected]

04235775483

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 13, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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