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: 10705707
• 负责人: Nina Cooperman
• 金额: $ 68.5万
• 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/10705707
• 关键词: Abstinence; Acceleration; Address; Adherence; Affect; American; Anxiety; Behavior Therapy; Brain; COVID-19; Case Study; Clinic; Clinical Trials; Communities; Data; Disparity; 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; Population; Provider; Quality of life; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recovery; Relapse; Research Design; Resources; Rewards; Supervision; System; Technology; Time; Trainers Training; Training; Translations; United States; Universities; Videoconferencing; acceptability and feasibility; addiction; arm; craving; effective intervention; effectiveness evaluation; effectiveness testing; effectiveness trial; effectiveness/implementation study; emotion dysregulation; emotional distress; evidence base; experience; health care settings; hedonic; implementation facilitators; implementation strategy; medication for opioid use disorder; methadone treatment; mindfulness; mindfulness intervention; novel; opioid epidemic; opioid overdose; opioid use; opioid use disorder; prescription opioid misuse; prevent; primary outcome; programs; remediation; remote delivery; reward processing; secondary outcome; skills; success; therapy design; timeline; 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).

项目总结 美国正在经历阿片类药物的使用和过量危机。为了解决这场危机，计划 为阿片使用障碍(MOUD)提供药物的工作正在扩大和加强。穆德是最多的 对OUD进行有效干预，美沙酮治疗(MT)是最常用的MUD处方； 然而，大约一半开始进行机器翻译的人在一年内停止，一半的人保留在 MT在6个月内使用阿片类药物。身体疼痛，情绪失调，以及奖赏处理缺陷， 影响大多数服用MT的人，可能是导致他们持续使用阿片类药物的原因。 解决身体疼痛、情绪失调、奖励处理的新型行为干预 需要在服用Moud的人中出现缺乏症和阿片类药物使用。以正念为导向的康复强化 (更多)将正念、重新评估和品味技能的训练整合到为期8周的团体治疗中 旨在补救支撑OUD的大脑奖励系统中的享乐失调。跨多个 更多的试验表明，在减少阿片类药物的使用、渴求、情绪困扰和其他方面的疼痛方面是有效的 医疗保健设置。我们的R21 Pilot随机对照试验More是第一个展示More MT临床应用的可行性和可接受性，并有初步疗效的迹象 药物使用、渴求、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，MT患者接受新干预措施的速度可能较慢 因为时间和资源往往是有限的。因此，为了最好地解决潜在的实施问题和 为了优化未来更多的实施和传播，在本研究中，我们将使用类型2，混合 实施效果研究设计。我们不仅会评估MORE的有效性，还会评估 将更多培训人员整合到MT中的障碍和促进者，并评估可持续培训培训人员的影响 关于提供者负担、干预忠诚度和参与度以及患者结果的模型。我们将随机化MT 临床医生将接受1)更高强度、更多实施战略的培训，包括培训- 培训师模型与培训在完整的更多的治疗手册加上监督和反馈或2)最低限度 强化实施策略，由简单的脚本化正念练习(SMP)组成 更多的治疗手册，只需最少的培训，没有监督，最少的反馈。 具体地说，我们的目标是：1)使用RE-AIM(覆盖范围、有效性、采用、实施和 维护)框架，检查在MT和SMP中实施MORE和SMP的障碍和促进者 评估优化培训、保真度和参与度的策略，2)优化现有的More和SMP 培训和实施工具包，包括可加速翻译的适应性资源 证据付诸实践，以及3)更高强度的疗效和治疗保真度评价 实施策略与低强度的SMP实施策略作为MT的辅助工具(N=420)。

项目成果

Mindfulness-Oriented Recovery Enhancement for Veterans and Military Personnel on Long-Term Opioid Therapy for Chronic Pain: A Randomized Clinical Trial.

退伍军人和军人长期阿片类药物治疗慢性疼痛的正念康复增强：一项随机临床试验。

• DOI: 10.1176/appi.ajp.20230272
• 发表时间: 2024
• 期刊: The American journal of psychiatry
• 作者: Garland,EricL;Nakamura,Yoshio;Bryan,CraigJ;Hanley,AdamW;Parisi,Anna;Froeliger,Brett;Marchand,WilliamR;Donaldson,GaryW
• 通讯作者: Donaldson,GaryW