Optimization and multi-site feasibility of yoga for chronic pain in people in treatment for opioid use disorder

瑜伽治疗阿片类药物使用障碍患者慢性疼痛的优化和多部位可行性

• 批准号: 10451048
• 负责人: Michael D Stein
• 金额: $ 12.29万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10451048
• 关键词: Behavior Therapy; Behavioral; Benchmarking; Clinic; Clinical Trials; Data; Decision Making; Dose; Enrollment; Evaluation; Funding; Future; Goals; Health behavior change; Health education; Home; Human; Illicit Drugs; Intervention; Life; Literature; Manuals; Measures; Mental disorders; Modeling; NIH Program Announcements; Opioid; Outcome; Pain; Pain interference; Pain management; Participant; Patient Recruitments; Patients; Persons; Pharmacological Treatment; Phase; Population; Preparation; Procedures; Quality of life; Randomized; Relapse; Reporting; Research; Research Design; Research Personnel; Risk Factors; Running; Schedule; Serious Adverse Event; Severities; Site; Suboxone; Testing; Text Messaging; Theory of Change; Time; Training; Work; Yoga; acceptability and feasibility; base; chronic pain; chronic pain management; craving; design; disability; dosage; efficacy evaluation; efficacy trial; experimental study; financial incentive; follow up assessment; improved; indexing; instructor; intrinsic motivation; meetings; methadone treatment; mindfulness intervention; multiphase optimization strategy; opioid agonist therapy; opioid misuse; opioid use disorder; pain reduction; pilot trial; prevent; primary outcome; recruit; relapse risk; substance misuse; substance use; teacher; treatment adherence

Chronic pain is a significant problem for at least half of all persons receiving opioid agonist therapy (OAT) for opioid use disorder – i.e., buprenorphine/ naloxone (BUP) or methadone maintenance treatment (MMT). Pharmacotherapeutic pain management is challenging in OAT patients, and other behavioral options for managing chronic pain are needed. Hatha yoga may be a useful adjunctive approach for decreasing pain- related disability and pain severity, and preventing opioid misuse during OAT. There is evidence supporting its efficacy in other chronic pain populations, and yoga may target cravings and other risk factors for opioid relapse. With NCCIH R34 funding, we conducted a pilot RCT of a 12-week hatha yoga class vs. a health education class (HE; a control condition) for people with chronic pain receiving MMT (n=20) or BUP (n=20) for opioid use disorder. The primary target of the yoga intervention was decreased life interference due to pain. In this study, we measured multiple indices of feasibility and acceptability of the manualized interventions. Although we met a priori benchmarks on many of these feasibility indices, we did find that, consistent with literature on behavioral interventions in OAT patients, some participants attended only very few classes. Thus, as a next step in this research, the purpose of the current project is to develop an optimized yoga intervention package that includes key components that increase yoga dosage received, defined as time in class (a function of number of classes attended) plus home yoga practice time. We plan to use the Multiphase Optimization STrategy (MOST) to do this. We will evaluate four intervention components, all of which will be added to our standard group yoga classes, to determine their impact on total yoga dosage received. These components are: a) two added 1:1 meetings with the yoga teachers; b) provision of study teacher-led home practice videos; c) monetary incentives for class attendance; and d) text messages designed to increase intrinsic motivation for yoga practice. As a secondary goal, in keeping with the U01 program announcement, we will also demonstrate that we can conduct this research in two sites distinct from each other and from our previous site. In this study, after conducting pilot work (Phase 1), we plan to conduct a fully-powered factorial experiment that will allow us to evaluate the impact of each of the 4 intervention components on yoga dosage received. All participants will receive the core yoga intervention, with random assignment to receive or not receive each of the four intervention components outlined above. Results from Phase 2 will allow us to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage. We will also be able to examine mechanisms by which intervention components are hypothesized to work. This project will prepare us for the next step in this research, i.e., a fully-powered, multi-site RCT testing the optimized yoga intervention (vs. a control condition), with a primary outcome of reduced pain interference.

对于所有接受阿片类药物激动剂治疗（OAT）的人中，慢性疼痛是一个重大问题 OOPIOED使用障碍 - 即丁丙诺啡/纳洛酮（BUP）或Meadadone维护处理（MMT）。 药物治疗疼痛管理在燕麦患者中具有挑战性，其他行为选择 需要管理慢性疼痛。 Hatha瑜伽可能是减轻疼痛的有用辅助方法 相关的残疾和疼痛严重程度，并防止燕麦中阿片类药物的失误。有证据支持其 其他慢性疼痛群体的功效和瑜伽可能针对卵子的渴望和其他风险因素 借助NCCIH R34资金，我们进行了12周的Hatha Yoga班级飞行员RCT与健康 慢性疼痛患者接受MMT（n = 20）或BUP（n = 20）的教育课（HE；一个控制状况） OOPIOED使用障碍。瑜伽干预的主要目标是由于疼痛而减少了生命干扰。在 这项研究，我们测量了手动干预措施的可行性和可接受性的多个指数。 尽管我们在许多此类可行性指标上均遇到了先验基准，但我们确实发现，与 关于燕麦患者行为干预的文献，一些参与者仅参加了很少的课程。那， 作为这项研究的下一步，当前项目的目的是开发优化的瑜伽干预 包含关键组件的软件包，以增加收到的瑜伽剂量，定义为课堂时间（a 参加课程数量的功能）加上家庭瑜伽练习时间。我们计划使用多相 这样做的优化策略（大多数）。我们将评估四个干预组件，所有这些都将是 加入我们的标准组瑜伽课，以确定它们对收到的瑜伽总剂量的影响。这些 组件是：a）两个与瑜伽老师的会议增加了1：1； b）提供学习教师主导的家 练习视频； c）上课的货币激励措施； d）旨在增加的短信 瑜伽练习的内在动机。作为次要目标，与U01计划公告保持一致 我们还将证明我们可以在彼此之间和与我们的两个站点进行这项研究 上一个网站。在这项研究中，在进行了试点工作（第1阶段）之后，我们计划进行完全动力的阶乘 实验将使我们能够评估4种干预组件中每一个的影响对瑜伽剂量的影响 已收到。所有参与者将接受核心瑜伽干预，并随机分配接受或不接收 接收上面概述的四个干预组件中的每一个。第2阶段的结果将使我们可以选择 干预成分的有效组合，与标准瑜伽类别一起，最大化瑜伽 剂量。我们还将能够检查通过假设干预组件的机制 工作。该项目将使我们为这项研究的下一步做好准备，即全位置的RCT测试 优化的瑜伽干预（与对照条件），疼痛干扰减少的主要结果。