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
- 1
- 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.
研究组 & 干预措施
M-ROCC
Mindful Recovery OUD Care Continuum (M-ROCC) builds on other mindfulness interventions for addictive disorders, but is specifically designed with the clinical needs of OUD patients on buprenorphine and logistic needs of primary care OBOT clinicians in mind. It focuses on integration of mindfulness practice for living well through stress, anxiety, depression, pain and addiction recovery. M-ROCC curriculum has three primary components, including a low-dose mindfulness phase, an intensive mindfulness training phase and then ongoing mindful recovery support.
干预措施: M-ROCC (Behavioral)
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)