Effect of Mindfulness Training on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment

正念训练对初级保健丁丙诺啡治疗期间阿片类药物使用和焦虑的影响

• 批准号: 10636734
• 负责人: Zev David Schuman Olivier
• 金额: $ 70万
• 依托单位: CAMBRIDGE HEALTH ALLIANCE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10636734
• 关键词: Abstinence; Address; Advertising; Alcohols; Anxiety; Behavioral; Benzodiazepines; COVID-19 pandemic; Cannabis; Characteristics; Clinical Trials; Cocaine; Code; Continuity of Patient Care; Contracts; County; Dangerousness; Databases; Dose; Drops; Enrollment; Facebook; Generations; Geography; Health; Hearing; Illicit Drugs; Individual; Informal Social Control; Information Systems; Maintenance; Measurement; Measures; Mental Depression; Mindfulness Training; Motivation; Opioid; Outcome; Pain interference; Participant; Patient Outcomes Assessments; Patient Self-Report; Patients; Phase; Primary Health Care; Provider; Psychosocial Stress; Recovery; Recovery Support; Relapse; Rural; Rural Community; Sampling; Self Efficacy; Site; Stress; Suboxone; Support Groups; Telemedicine; Training; acceptability and feasibility; addiction; base; buprenorphine treatment; chronic pain; clinically relevant; cocaine use; comparative effectiveness trial; compare effectiveness; design; emotion dysregulation; emotional distress; evidence base; flexibility; illicit opioid; mindfulness; mindfulness intervention; opioid mortality; opioid use; opioid use disorder; outreach; overdose death; patient oriented; prevent; programs; recruit; social media; substance use; virtual

Opioid Use Disorder (OUD) is a national health crisis. Office-Based Opioid Treatment (OBOT) with buprenorphine/naloxone (B/N) prevents overdose deaths. Psychosocial stress and psychiatric problems (e.g., Anxiety) are major reasons for OBOT drop out and relapse. Many patients turn to benzodiazepines (BZD) to address anxiety and emotional distress with dangerous consequences. Nonpharmacologic approaches to anxiety, stress, and emotion dysregulation are needed during primary care OBOT, which is the primary access point for OUD treatment in most US counties. Mindfulness-Based Interventions (MBI) safely and reliably reduce the impact of stress, anxiety, depression, and chronic pain, which could increase OBOT retention, while reducing rates of relapse and overdose deaths. However, current 8-week standard MBIs do not appear to have strong, sustained impact on substance use outcomes, suggesting longer or enhanced MBIs are needed in the OUD treatment setting. This project originally proposed to adapt, refine, and compare the effectiveness of the 6-month live-online Mindful Recovery OUD Care Continuum (M-ROCC) versus a standard recovery group in primary care. M-ROCC is derived from the evidence-based, established Mindfulness Training for Primary Care (MTPC) program, which has been adapted for Opioid Use Disorder. M-ROCC includes a flexible, patient-centered, motivationally responsive design, including a Low Dose Mindfulness Entry Group, Mindfulness Maintenance Check-in Support Group, and an intensive Mindfulness Training for Primary Care (MTPC-OUD) Group. M-ROCC builds on the previously demonstrated ascending mindfulness practice dose ladder approach, which helps individuals with OUD nurture motivation and resolve ambivalence for mindfulness practice. MTPC has been shown to lower anxiety, stress, and depression, while increasing self-efficacy and capacity for behavioral change by engaging self-regulation mechanisms. During the R21 phase, we established the feasibility and acceptability of the M-ROCC program and prepared for the R33 phase by training providers and obtaining necessary approvals and site contracts. In the R33 phase, we planned to conduct a five-site RCT comparing M-ROCC versus Group-Based Opioid Treatment (GBOT). Due to the COVID-19 pandemic, we modified all aspects of the R33 phase to be conducted with a national sample in a remote, live-online, virtual format, comparing M-ROCC versus a standard online recovery group for 196 patients prescribed B/N for OUD, primarily evaluating its impact on opioid use and anxiety. We all evaluate effects on cocaine and BZD use, as well as aspects of self-regulation needed for sustained addiction recovery. Participants in the online clinical trial are recruited from multiple U.S. states through provider outreach and social media advertising.

阿片类药物使用障碍 (OUD) 是一场全国性的健康危机。办公室阿片类药物治疗 (OBOT) 丁丙诺啡/纳洛酮 (B/N) 可预防过量死亡。社会心理压力和精神科 问题（例如焦虑）是 OBOT 退出和复发的主要原因。许多患者转向 苯二氮卓类药物（BZD）可解决焦虑和情绪困扰，并带来危险的后果。 在治疗过程中，需要采用非药物方法来治疗焦虑、压力和情绪失调。 初级保健 OBOT，是美国大多数县 OUD 治疗的主要接入点。 基于正念的干预措施 (MBI) 安全可靠地减少压力、焦虑、 抑郁症和慢性疼痛，这可以增加 OBOT 保留率，同时降低复发率 和过量死亡。然而，目前的 8 周标准 MBI 似乎没有很强的、 对物质使用结果产生持续影响，表明需要更长或加强的 MBI OUD 治疗设置。该项目最初提议调整、完善和比较 为期 6 个月的在线正念恢复 OUD 护理连续体 (M-ROCC) 与 初级保健中的标准恢复组。 M-ROCC 源自基于证据的、已建立的 初级保健正念培训 (MTPC) 计划，已针对阿片类药物使用进行了调整 紊乱。 M-ROCC 包括灵活的、以患者为中心、积极响应的设计，包括 低剂量正念入门小组、正念维持登记支持小组和 初级保健强化正念培训 (MTPC-OUD) 小组。 M-ROCC 建立在 先前展示的上升正念练习剂量阶梯方法，这有助于 具有 OUD 的个人可以培养正念练习的动力并解决矛盾心理。 MTPC 有 已被证明可以降低焦虑、压力和抑郁，同时提高自我效能和能力 通过自我调节机制来改变行为。在R21阶段，我们建立了 M-ROCC方案的可行性和可接受性，并通过培训为R33阶段做好准备 供应商并获得必要的批准和现场合同。在R33阶段，我们计划 进行一项五中心随机对照试验，比较 M-ROCC 与基于群体的阿片类药物治疗 (GBOT)。由于 在 COVID-19 大流行期间，我们修改了 R33 阶段的所有方面，以便与国家 以远程实时在线虚拟格式进行示例，将 M-ROCC 与标准在线恢复进行比较 一项针对 196 名患者开出 B/N OUD 处方的研究小组，主要评估其对阿片类药物使用的影响，以及 焦虑。我们都评估对可卡因和 BZD 使用的影响，以及所需的自我监管方面 持续的成瘾康复。在线临床试验的参与者是从多个美国招募的。 通过提供商外展和社交媒体广告来说明情况。

项目成果

Building a Group-Based Opioid Treatment (GBOT) blueprint: a qualitative study delineating GBOT implementation.

建立基于群体的阿片类药物治疗 (GBOT) 蓝图：一项描述 GBOT 实施的定性研究。

• 发表时间: 2019-12-27
• 影响因子: 3.7
• 作者: Sokol, Randi;Albanese, Mark;Chew, Aaronson;Early, Jessica;Grossman, Ellie;Roll, David;Sawin, Greg;Wu, Dominic J;Schuman
• 通讯作者: Schuman

Effects of live-online, group mindfulness training on opioid use and anxiety during buprenorphine treatment: A comparative effectiveness RCT.

在线直播、团体正念训练对丁丙诺啡治疗期间阿片类药物使用和焦虑的影响：比较有效性随机对照试验。

• 发表时间: 2024-02
• 影响因子: 2.2
• 作者: Rosansky, Joseph A;Howard, Leah;Goodman, Hannah;Okst, Kayley;Fatkin, Thomas;Fredericksen, A Kiera;Sokol, Randi;Gardiner, Paula;Parry, Gareth;Cook, Benjamin L;Weiss, Roger D;Schuman
• 通讯作者: Schuman

Implementing group visits for opioid use disorder: A case series.

对阿片类药物使用障碍实施小组访问：案例系列。

• 发表时间: 2020
• 影响因子: 3.5
• 作者: Sokol, Randi;Albanese, Mark;Albanese, Chiara;Coste, Gerard;Grossman, Ellie;Morrill, Diana;Roll, David;Sobieszczyk, Amy;Schuman
• 通讯作者: Schuman