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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Feasibility measures [Срок оценки: From baseline to 3rd month (at the end of intervention)]
• Acceptability measure [Срок оценки: From baseline to 3rd month (at the end of intervention)]

Вторичные конечные точки (4)

• The Maudsley Addiction Profile [Срок оценки: Change in problem scores from Baseline to 3rd Month and 6th month]
• The Short Warwick-Edinburgh Mental Well-being Scale [Срок оценки: Change in scores from baseline to 3rd Month and 6th month]
• EuroQol-5 [Срок оценки: Change in scores from baseline to 3rd Month and 6th month]
• Client service receipt inventory [Срок оценки: Changes from baseline to 3rd Month and 6th month]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Pakistan Recovery Oasis — Lahore

Публикации

• 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

Идентификаторы

NCT: NCT04885569 · PILL-CAMIAB-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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