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临床试验/NCT03882125
NCT03882125已完成不适用

Mindfulness-Based Relapse Prevention for Methadone Maintenance: A Feasibility Trial

Pacific University0 个研究点目标入组 14 人开始时间: 2015年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
14
主要终点
Acceptability - Satisfaction with the Course

研究概览

简要总结

The current study was designed to inform protocol adaptation, and to evaluate the feasibility, acceptability, and preliminary efficacy of a mindfulness-based intervention for methadone maintenance clients. Adults (N=15) were recruited from a methadone clinic to participate in a 6-week mindfulness course. Indices of feasibility, including recruitment, retention, data from focus groups and course satisfaction surveys, supported feasibility of the intervention. Outcome measures were self-report, and included depression, craving, PTSD symptoms, and experiential avoidance, and were assessed at baseline, postcourse, and 1-month follow-up. Data were analyzed using qualitative and quantitative approaches. Mean scores on all primary outcomes changed in the expected direction at both postcourse and 1-month follow-up assessment, although only depression and experiential avoidance reached significance. Results support feasibility and acceptability, and provide preliminary data on outcomes for future trials of mindfulness-based approaches within this client population.

详细描述

As rates of opiate misuse rise in the United States, there areso do significant associated health, and financial consequences to afflicted individuals, their families, and society at large. Methadone Maintenance Therapy (MMT) is one evidence-based approach to treating individuals with opiate addiction, yet supplemental psychosocial treatment to support this approach is lacking. Mindfulness-Based Relapse Prevention (MBRP) has shown to be efficacious in various substance use populations, but has yet to be assessed with MMT clients. The current study was designed to inform protocol adaptation for to MMT clients, and to evaluate the feasibility, acceptability, and preliminary efficacy of a MBRP for this population. The sample consisted of adults (N=15) recruited from a methadone clinic to participate in a 6-week MBRP course. Indices of feasibility, including recruitment, retention, data from focus groups and course satisfaction surveys, supported feasibility of the intervention. Outcome measures were self-report, and included self-compassion, depression, craving, PTSD symptoms, and experiential avoidance, and were assessed at baseline, postcourse, and 1-month follow-up. Data were analyzed using qualitative and quantitative approaches. Mean scores on all primary outcomes changed in the expected direction at both postcourse and 1-month follow-up assessment, although only depression and experiential avoidance reached significance. Results from this initial pilot support feasibility and acceptability, and provide preliminary data on outcomes for future trials of mindfulness-based approaches within the MMT community.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clearance from clinic staff
  • Currently enrolled in a methadone maintenance program
  • Agree to complete assessment questionnaires and attend treatment sessions
  • Fluent in English

排除标准

  • Indication of active psychosis
  • Participation in past mindfulness-based relapse prevention group

研究组 & 干预措施

Mindfulness

Experimental

Assigned to a 6-week mindfulness-based relapse prevention course

干预措施: Mindfulness-based relapse prevention (Behavioral)

结局指标

主要结局

Acceptability - Satisfaction with the Course

时间窗: post course (6 weeks)

Satisfaction with the course will be assessed using the Overall Course Satisfaction Survey, items #1-4 (Bowen, Chawla, \& Marlatt, 2010). This is a self-report questionnaire, the first 4 items of which are open-ended questions assessing satisfaction with the course, barriers to learning, and perceived helpfulness.

Acceptability - Enactment of Learned Skills

时间窗: post course (6 weeks)

Enactment will be assessed using the Overall Course Satisfaction Survey, items #5-7 (Bowen, Chawla, \& Marlatt, 2010). This is a self-report questionnaire, the last 3 questions of which are 10-point Likert-type items, and assess importance of skills and likelihood of implementing them into daily life after the course ends. Higher scores indicate higher perceived importance and likelihood.

次要结局

  • Depression(1 month)
  • Anxiety(1 month)
  • Craving(1 month)
  • Trauma symptoms(1 month)
  • Experiential avoidance(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Bowen

Assistant Professor

Pacific University

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