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临床试验/NCT04885569
NCT04885569招募中不适用

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

Pakistan Institute of Living and Learning1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
260
试验地点
1
主要终点
Feasibility measures

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Motivational Interviewing with CBT (MICBT)

Experimental

Participants in this arm will receive a total of 12 weekly sessions of CBT based Motivational Interviewing over a period of 12 weeks.

干预措施: Motivational interviewing with CBT (MICBT) (Behavioral)

Mindfulness based Relapse Prevention Group (MBRP)

Experimental

Participants in this arm will receive a total of 12 weekly sessions of mindfulness intervention over a period of 12 weeks.

干预措施: Mindfulness based Relapse Prevention (MBRP) (Behavioral)

Integrated MICBT and MBRP Group (CAMIAB)

Experimental

This will be integrated MICBT plus MBRP intervention. Participants will receive a total of 12 weekly sessions of this integrated CAMIAB intervention.

干预措施: CAMIAB (Behavioral)

Treatment as usual (TAU)

No Intervention

This will be routine care psychological treatment that they will be receiving.

结局指标

主要结局

Feasibility measures

时间窗: 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

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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