MINDFUL-OBOT Pilot: Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment -- Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Likelihood of recommending program to a friend
研究概览
简要总结
The goal of this pilot study is to test the Mindful Recovery OBOT Care Continuum (M-ROCC) model in primary care office-based opioid treatment (OBOT). M-ROCC features integration of evidence-based mindfulness training with weekly group-based opioid treatment. Primary outcomes include (1) Feasibility measured by implementation of the curriculum into two CHA primary care sites and attendance at weekly sessions; (2) Acceptance via self-report and qualitative interviews. Secondary outcomes include anxiety reduction.
详细描述
The primary objective of this study is to conduct a single-arm pilot study in order to refine a Mindfulness-Based Intervention for the Opioid Use Disorder (OUD) treatment in primary care, called the Mindful Recovery OUD Care Continuum (M-ROCC). Study investigators will conduct qualitative interviews, assess opioid use, preliminary pre/post measures for participants participating in the pilot study. Additional aims of the pilot study is manual refinement and pilot testing assessment batteries to prepare for a multi-site RCT.
The study will focus on demonstrating feasibility and acceptability of the M-ROCC continuum.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Current CHA patient with a CHA primary care provider
- •Diagnosis of opioid use disorder prescribed buprenorphine/naloxone
- •Sufficient English fluency to understand procedures and questionnaires
- •<90 days of complete abstinence from illicit opioids, cocaine, benzodiazepines, AND alcohol (excluding cannabis/nicotine)
- •Ability to provide informed consent.
排除标准
- •Thought disorder
- •Schizophrenia or Schizoaffective disorder
- •Acute suicidality with plan
- •Cognitive inability as demonstrated by Montreal Cognitive Assessment (MOCA) <24 OR the inability to complete consent quiz and baseline assessments.
- •Current participation in another CHA research study
- •Expected hospitalization in next 6 months, including second and third trimester pregnancy at screening.
结局指标
主要结局
Likelihood of recommending program to a friend
时间窗: Week 24
Percentage of participants who would recommend the program to a friend (score of 4 or 5 on a Likert scale (1-5))
次要结局
- Anxiety PROMIS-SF 8a(Week 24)
- Number of biochemically-confirmed illicit opioid abstinent weeks(Week 24)
- PROMIS-SF 8a (PROMIS-ASF) Pain Interference(Week 24)
- Number of weekly sessions attended(Week 24)