Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder

正念导向康复增强作为美沙酮治疗阿片类药物使用障碍的辅助疗法的实施和有效性

• 批准号: 10501361
• 负责人: Nina Cooperman
• 金额: $ 71.3万
• 依托单位: RUTGERS BIOMEDICAL AND HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10501361
• 关键词: Abstinence; Address; Adherence; Affect; American; Anxiety; Behavior Therapy; Brain; COVID-19; Case Study; Clinic; Clinical Trials; Communities; Data; Dissemination and Implementation; Dropout; Drug Prescriptions; Drug usage; Educational Materials; Effectiveness; Feedback; Future; Group Therapy; Heroin; Internet; Intervention; Manuals; Measures; Mental Depression; Methods; Modeling; Opioid; Pain; Patient-Focused Outcomes; Patients; Personal Satisfaction; Persons; Pharmaceutical Preparations; Population; Provider; Quality of life; Randomized; Randomized Controlled Trials; Reach Effectiveness Adoption Implementation and Maintenance; Recovery; Relapse; Research Design; Resources; Rewards; Source; Supervision; System; Technology; Time; TimeLine; Trainers Training; Training; Translations; United States; Universities; Videoconferencing; acceptability and feasibility; addiction; arm; base; craving; effective intervention; effectiveness evaluation; effectiveness implementation study; effectiveness testing; effectiveness trial; emotion dysregulation; emotional distress; evidence base; experience; health care settings; hedonic; implementation facilitators; implementation strategy; methadone treatment; mindfulness; mindfulness intervention; novel; opioid epidemic; opioid overdose; opioid use; opioid use disorder; prescription opioid misuse; prevent; primary outcome; programs; remote delivery; reward processing; secondary outcome; skills; success; therapy design; treatment as usual; uptake

PROJECT SUMMARY The United States is experiencing an opioid use and overdose crisis. To address this crisis, programs that provide medication for opioid use disorder (MOUD) are being expanded and enhanced. MOUD is the most effective intervention for an OUD, and methadone treatment (MT) is the most commonly prescribed MOUD; however, approximately half of people who begin MT discontinue within a year, and half of people retained in MT use opioids within six months. Physical pain, emotion dysregulation, and reward processing deficits, affecting most people on MT, could be contributing to their ongoing opioid use. Novel behavioral interventions that address physical pain, emotion dysregulation, reward processing deficits and opioid use among people on MOUD are needed. Mindfulness-Oriented Recovery Enhancement (MORE) integrates training in mindfulness, reappraisal, and savoring skills into an 8-week group therapy designed to remediate hedonic dysregulation in brain reward systems underpinning OUD. Across multiple trials, MORE has demonstrated efficacy for reducing opioid use, craving, emotional distress, and pain in other healthcare settings. Our R21 pilot randomized controlled trial of MORE was the first to demonstrate MORE’s feasibility and acceptability as delivered in MT clinics, with indications of preliminary efficacy for decreasing drug use, craving, depression, anxiety, and pain for people with OUD. Further, expedited implementation and dissemination of effective interventions is needed. However, uptake of novel interventions may be slow in MT because time and resources are often limited. Therefore, to best address potential implementation issues and to optimize future MORE implementation and dissemination, in this study, we will utilize a Type 2, Hybrid Implementation-Effectiveness study design. We will not only evaluate MORE’s effectiveness but also assess barriers and facilitators to integrating MORE into MT and evaluate the impact of a sustainable train-the-trainer model on provider burden, intervention fidelity and engagement, and patient outcomes. We will randomize MT clinicians to receive training in 1) a higher intensity MORE implementation strategy consisting of a train-the- trainer model with training in the full MORE treatment manual plus supervision and feedback or 2) a minimal intensity implementation strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from the MORE treatment manual with minimal training, no supervision, and minimal feedback. Specifically, we aim to: 1) using a RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework, examine barriers and facilitators to implementation of MORE and SMP in MT and evaluate strategies for optimizing training, fidelity, and engagement, 2) optimize existing MORE and SMP training and implementation toolkits, including adaptable resources that can accelerate the translation of evidence into practice, and 3) evaluate effectiveness and treatment fidelity of a higher intensity MORE implementation strategy versus a lower intensity SMP implementation strategy as an adjunct to MT (N=420).

项目摘要 美国正在经历阿片类药物使用和过量危机。为了解决这一危机， 为阿片类药物使用障碍（MOUD）提供药物的工作正在扩大和加强。MOUD是最 有效干预OUD，美沙酮治疗（MT）是最常用的MOUD处方; 然而，大约一半开始MT的人在一年内停止， MT在六个月内使用阿片类药物。身体疼痛，情绪失调，奖励处理缺陷， 影响大多数MT患者，可能导致他们持续使用阿片类药物。 新的行为干预，解决身体疼痛，情绪失调，奖励处理 需要在MOUD人群中使用阿片类药物。以正念为导向的恢复增强 （更多）将正念，重新评估和品味技能的培训整合到为期8周的团体治疗中 旨在修复支撑OUD的大脑奖励系统中的享乐失调。跨多个 在临床试验中，MORE已经证明了减少阿片类药物使用，渴望，情绪困扰和其他疼痛的有效性。 医疗保健设置。我们的R21试点随机对照试验是第一个证明MORE的 在MT诊所提供的可行性和可接受性，以及降低 吸毒、渴望、抑郁、焦虑和疼痛。此外，加快执行和 需要传播有效的干预措施。然而，新的干预措施的吸收可能是缓慢的MT 因为时间和资源往往有限。因此，为了最好地解决潜在的执行问题， 为了优化未来MORE的实施和传播，在本研究中，我们将使用第2类混合型 实施效果研究设计。我们不仅会评估MORE的有效性， 将MORE纳入MT的障碍和促进因素，并评估可持续的培训员培训的影响 提供者负担、干预忠诚度和参与度以及患者结局的模型。我们将MT随机化 临床医生接受以下培训：1）更高强度的MORE实施策略，包括培训 培训师模型，在完整的MORE治疗手册中进行培训，加上监督和反馈，或2）最低限度 强度实施策略，包括一个简单的，脚本正念练习（SMP）提取自 更多的治疗手册，最少的培训，没有监督，最少的反馈。 具体来说，我们的目标是：1）使用RE-AIM（覆盖范围，有效性，采用，实施， 维护）框架，审查在MT中实施MORE和SMP的障碍和促进因素， 评估优化培训、忠诚度和参与度的策略，2）优化现有的MORE和SMP 培训和实施工具包，包括可加快翻译 将证据付诸实践，3）评估更高强度的有效性和治疗保真度更多 实施策略与较低强度SMP实施策略作为MT的辅助（N=420）。