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: 10586124
• 负责人: Michael D Stein
• 金额: $ 76.39万
• 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/10586124
• 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; National Center for Complementary and Integrative Health; 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; 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; pain-related disability; 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.

慢性疼痛对于接受阿片样物质激动剂治疗（OAT）的所有人中的至少一半来说是一个重大问题， 阿片类药物使用障碍-即，丁丙诺啡/纳洛酮（BUP）或美沙酮维持治疗（MMT）。 药物疼痛管理在OAT患者中具有挑战性， 需要管理慢性疼痛。哈他瑜伽可能是一种有效的减少疼痛的方法- 相关的残疾和疼痛严重程度，并防止OAT期间阿片类药物滥用。有证据表明， 在其他慢性疼痛人群中的疗效，瑜伽可能针对阿片类药物的渴望和其他风险因素 复发在NCCIH R34的资助下，我们进行了一项为期12周的哈达瑜伽课程与健康课程的试点RCT。 接受MMT（n=20）或BUP（n=20）的慢性疼痛患者的教育课程（HE;对照条件）， 阿片类药物使用障碍瑜伽干预的主要目标是减少疼痛对生活的干扰。在 在本研究中，我们测量了手动干预的可行性和可接受性的多个指标。 尽管我们在许多可行性指标上达到了先验基准，但我们确实发现， 关于OAT患者行为干预的文献，一些参与者只参加了很少的课程。因此，在本发明中， 作为这项研究的下一步，目前项目的目的是开发一种优化的瑜伽干预方法。 包括增加瑜伽剂量的关键成分的包，定义为上课时间（a 参加的课程数量的函数）加上家庭瑜伽练习时间。我们计划使用多相 优化策略（MOST）可以做到这一点。我们将评估四个干预组成部分，所有这些都将是 添加到我们的标准组瑜伽课程，以确定它们对瑜伽总剂量的影响。这些 组成部分是：a）增加两次与瑜伽教师的1：1会议; B）提供学习教师主导的家庭 练习视频; c）上课出勤的金钱奖励;以及d）旨在增加 瑜伽练习的内在动机。作为第二个目标，与U 01计划的宣布保持一致， 我们还将证明，我们可以在两个不同的地点进行这项研究， 以前的网站。在本研究中，在进行试点工作（第1阶段）后，我们计划进行一个完全功效的析因分析， 实验，将使我们能够评估的影响，每4个干预组成部分对瑜伽剂量 收到。所有参与者将接受核心瑜伽干预，随机分配接受或不接受 接受上述四个干预部分中的每一个。第二阶段的结果将使我们能够选择 一个有效的组合干预组件，与标准瑜伽课程一起，最大限度地提高瑜伽 剂量.我们还将能够检查干预成分被假设为 工作这个项目将为我们的下一步研究做好准备，即，一项全功能、多中心RCT测试 优化的瑜伽干预（与对照条件相比），主要结果是疼痛干扰减少。