Mindfulness-Based Ecological Momentary Intervention for Co-Occurring Opioid Use Disorder and Chronic Pain: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 5
- 主要终点
- Completion rates for the lessons on the Mindful Journey
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a smartphone app-based ecological momentary intervention called Mindful Journey, which teaches mindfulness skills, can support adults in recovery from both opioid use disorder and chronic pain. The primary objective of this pilot study is to assess the feasibility and acceptability of Mindful Journey in this population.
详细描述
There is a paucity of interventions for co-occurring opioid use disorder and chronic pain. Difficulty with emotion regulation is a key shared vulnerability factor underlying both conditions. Mindfulness-Based Interventions (MBIs) are a promising intervention approach, as they target core skills that can improve emotion regulation. However, research on MBIs for co-morbid opioid use disorder and chronic pain is limited. Existing MBIs are also limited by not providing adequate support "in the moment" when individuals are in high-risk situations. A responsive, momentary MBI for co-occurring opioid use disorder and chronic pain may be highly promising, but has yet to be established. In the present study, we will be evaluating a smartphone app-based ecological momentary intervention, called Mindful Journey, for individuals with opioid use disorder and chronic pain. The core feature of the app is training in mindful acceptance and savoring skills via momentary "just-in-time" delivery of brief video-based exercises based upon ecological momentary assessments.
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 of age or older
- •fluent in English
- •enrollment in medication-assisted treatment for opioid use disorder
- •report at least bothersome chronic pain, as indicated by Graded Chronic Pain Scale-Revised
- •has a smartphone.
排除标准
- •self-reporting of chronic malignant pain (e.g., cancer) or systemic inflammatory disease (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus, and sarcoidosis)
- •self-reporting of psychotic disorder symptoms
- •participated in the previous phase of the study in which participants provided feedback to inform the development of the Mindful Journey app.
研究组 & 干预措施
Evaluating the Feasibility and Acceptability of Mindful Journey Prototype
In this single arm trial, participants will complete surveys and interviews about experiences with opioid and other substance use, chronic pain, and treatments, and a brief timeline follow-back assessment for substance use. Participants will also be completing a training session to learn about the study procedure, and the mobile app platform. Participants will enter the intervention period (8-weeks) and complete 14 foundational modules throughout the intervention period using the Mindful Journey app. Daily brief check-in surveys will be completed via the app. Based on these survey responses, participants will receive brief, tailored momentary mindfulness coaching. Study staff will also conduct weekly phone check-ins to support engagement. The final visit will occur following the intervention period and the participant will complete a series of self-report batteries and participate in a brief exit interview to gather feedback and suggestions for improving the app.
干预措施: Mindfulness based smartphone app (Behavioral)
结局指标
主要结局
Completion rates for the lessons on the Mindful Journey
时间窗: 8-week treatment period
Percent of lessons completed
Dimensions of acceptability of the Mindful Journey lessons
时间窗: Assessed at the end of the 8-week treatment period
Single-items measuring ratings of acceptability dimensions for the lessons, including usability, understandability, engage-ability, visual appeal, helpfulness, skill acquisition, and confidence implementing skills. Scores for each item range from 1 to 5, with higher scores indicating better acceptability.
Dimensions of acceptability of the ecological momentary intervention (momentary coaching)
时间窗: Assessed at the end of the 8-week treatment period
Single-items measuring ratings of acceptability dimensions for ecological momentary intervention (momentary coaching), including usability, understandability, engage-ability, visual appeal, helpfulness, skill acquisition, and confidence implementing skills. Scores for each item range from 1 to 5, with higher scores indicating better acceptability.
Momentary ratings of acceptability of the ecological momentary intervention (momentary coaching)
时间窗: Administered immediately after participants receive each ecological momentary intervention (momentary coaching)
Single item of perceived helpfulness
Completion rates for ecological momentary intervention (momentary coaching)
时间窗: 8-week treatment period
Percent of ecological momentary interventions (momentary coaching) completed
Completion rates for momentary check-in surveys
时间窗: 8-week treatment period
Percent of momentary check-in surveys completed
次要结局
未报告次要终点
研究者
Chung Jung Mun
Associate Professor
Arizona State University