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.

对于至少一半接受阿片类激动剂治疗 (OAT) 的人来说，慢性疼痛是一个严重问题 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)。 OAT 患者的药物治疗疼痛管理具有挑战性，而其他行为选择 需要控制慢性疼痛。哈他瑜伽可能是减轻疼痛的一种有用的辅助方法 相关的残疾和疼痛严重程度，以及防止 OAT 期间阿片类药物滥用。有证据支持其 对其他慢性疼痛人群的功效，瑜伽可能会针对阿片类药物的渴望和其他危险因素 复发。在 NCCIH R34 的资助下，我们对为期 12 周的哈他瑜伽课程与健康课程进行了试点随机对照试验。 接受 MMT (n=20) 或 BUP (n=20) 治疗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 在这项研究中，我们测量了手动干预措施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都达到了先验基准，但我们确实发现，与 在有关 OAT 患者行为干预的文献中，一些参与者只参加了很少的课程。因此， 作为这项研究的下一步，当前项目的目的是开发一种优化的瑜伽干预措施 套餐包括增加瑜伽剂量的关键组件，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）来做到这一点。我们将评估四个干预组成部分，所有这些组成部分都将 添加到我们的标准团体瑜伽课程中，以确定它们对所接受的瑜伽总剂量的影响。这些 组成部分包括： a) 增加两次与瑜伽老师的一对一会议； b) 提供由老师主导的学习之家 练习视频； c) 上课的金钱奖励； d) 短信旨在增加 瑜伽练习的内在动机。作为次要目标，根据 U01 计划公告， 我们还将证明，我们可以在两个彼此不同且与我们的研究不同的地点进行这项研究 上一个站点。在本研究中，在进行试点工作（第一阶段）后，我们计划进行全动力阶乘 实验将使我们能够评估 4 种干预措施中的每一种对瑜伽剂量的影响 已收到。所有参与者都将接受核心瑜伽干预，随机分配是否接受 接受上述四个干预措施中的每一个。第二阶段的结果将使我们能够做出选择 干预组件的有效组合，与标准瑜伽课程一起，最大限度地发挥瑜伽作用 剂量。我们还将能够研究假设干预成分的机制 工作。该项目将为我们的下一步研究做好准备，即全功能、多站点 RCT 测试 优化的瑜伽干预（与控制条件相比），主要结果是减少疼痛干扰。