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.

在接受阿片类激动剂治疗(OAT)的所有患者中，至少有一半的人面临慢性疼痛的严重问题 阿片使用障碍--即丁丙诺啡/纳洛酮(BUP)或美沙酮维持治疗(MMT)。 药物治疗疼痛管理在燕麦片患者中是具有挑战性的，以及其他行为选择 管理慢性疼痛是必要的。哈达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，以及防止在燕麦片治疗期间滥用阿片类药物。有证据支持它的 对其他慢性疼痛人群的疗效，瑜伽可能针对阿片类药物的渴望和其他风险因素 旧病复发。在NCCIH R34的资助下，我们进行了一项为期12周的哈他瑜伽课与健康课的试点RCT 慢性疼痛患者接受MMT(n=20)或BUP(n=20)的教育课程(HE；控制性条件) 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……里面 在本研究中，我们测量了多个指标的可行性和可接受性的人工干预。 尽管我们在许多这些可行性指数上都达到了先验基准，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 包括增加瑜伽剂量的关键成分的套餐，定义为上课时间(a 上课次数的函数)加上在家练习瑜伽的时间。我们计划使用多阶段 优化策略(MOST)做到了这一点。我们将评估四个干预组成部分，所有这些都将是 添加到我们的标准团体瑜伽课中，以确定它们对瑜伽总剂量的影响。这些 内容包括：a)增加两次与瑜伽老师的1：1会议；b)提供学习老师指导的家庭 练习视频；c)上课出勤率的金钱奖励；d)旨在增加 练习瑜伽的内在动机。作为次要目标，为了与U01计划的宣布保持一致， 我们还将证明，我们可以在两个彼此不同的地点和我们的 以前的站点。在这项研究中，在进行了试点工作(阶段1)之后，我们计划进行完全强大的因素分析 这个实验将允许我们评估四个干预成分中的每一个对瑜伽剂量的影响 收到了。所有参与者将接受核心瑜伽干预，并随机分配接受或不接受 接受上述四项干预措施中的每一项。第二阶段的结果将允许我们选择 干预组件的有效组合，与标准瑜伽课一起，最大限度地提高瑜伽 剂量。我们还将能够检查干预组件被假设为 工作。该项目将为我们下一步的研究做好准备，即全功率、多站点RCT测试 优化的瑜伽干预(与对照条件相比)，主要结果是减少疼痛干预。