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: 9982464
• 负责人: Zev David Schuman Olivier
• 金额: $ 82万
• 依托单位: CAMBRIDGE HEALTH ALLIANCE
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-20 至 2021-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9982464
• 关键词: Abstinence; Accidental Injury; Address; Alcohol or Other Drugs use; Anxiety; Attention; Behavior Therapy; Behavioral; Benzodiazepines; Buprenorphine; Cellular Phone; Clinical; Cocaine; Comorbidity; Compassion; Continuity of Patient Care; Contracts; County; Dangerousness; Dose; Drops; Drug usage; Emotions; Feedback; Funding; Generations; HIV risk; Health; Health Personnel; Health behavior change; Hour; Individual; Informal Social Control; Insurance; Lead; Link; Maintenance; Manuals; Mediating; Mental Depression; Mindfulness Training; Motivation; Opioid; Outcome; Overdose; Patient Care; Patient Self-Report; Patients; Phase; Post-Traumatic Stress Disorders; Preparation; Primary Health Care; Provider; Psychosocial Stress; Publishing; Randomized; Recovery; Regulation; Relapse; Reporting; Research; Risk Behaviors; Sampling; Science; Self Efficacy; Site; Stress; Suboxone; Support Groups; Time; Toxicology; Training; Trauma; United States National Institutes of Health; United States Substance Abuse and Mental Health Services Administration; Urine; addiction; anxiety reduction; anxiety symptoms; base; behavior change; buprenorphine treatment; care providers; chronic pain; cognitive control; comparative effectiveness; compare effectiveness; design; disorder later incidence prevention; distress tolerance; effectiveness trial; emotion dysregulation; emotion regulation; emotional distress; evidence base; flexibility; improved; innovation; medication-assisted treatment; mindfulness; mindfulness intervention; mobile application; opioid mortality; opioid overdose; opioid use; opioid use disorder; overdose death; patient oriented; prevent; primary outcome; programs; psychiatric symptom; skills; stress disorder; stress reduction; stress symptom; therapy design; treatment group; treatment site; waiver

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, non- pharmacologic 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 proposes to adapt, refine and compare the effectiveness of the 6-month Mindful Recovery OUD Care Continuum (M-ROCC) delivered within Group-Based Opioid Treatment (GBOT) versus standard GBOT alone. M-ROCC is derived a three phase program 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 4-week Low Dose Mindfulness Entry Group, Mindfulness Maintenance Check-in Support Group, and an 8-week 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 of lower anxiety, stress, and depression, while increasing self-efficacy and capacity for behavioral change by engaging self-regulation mechanisms. During the R21 phase, we will prepare for a multi-site RCT by 1) adapting the M-ROCC manual; 2) training providers at 5 MA primary care sites to lead M-ROCC; 3) piloting M-ROCC assessing qualitative feedback for iterative refinement; 4) manualizing GBOT and offering training to MA OBOT sites; and 5) preparing for the R33 phase by obtaining necessary approvals and site contracts. In the R33 phase, we will conduct a five-site RCT comparing M-ROCC plus GBOT with GBOT alone for 200 primary care patients prescribed B/N for OUD, primarily evaluating its impact on opioid use and anxiety, but also on cocaine and BZD use, as well as aspects of self-regulation needed for sustained addiction recovery.

阿片类药物使用障碍（OUD）是一种全国性的健康危机。阿片类药物治疗（OBOT）， 丁丙诺啡/纳洛酮（B/N）可预防过量死亡。心理社会压力与精神病 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），以解决焦虑和情绪困扰的危险后果，非 在小学阶段，需要对焦虑、压力和情绪失调进行药物治疗。 Care OBOT是美国大多数县OUD治疗的主要接入点。正念- 基于干预措施（MBI）安全可靠地减少压力，焦虑，抑郁和 慢性疼痛，这可能会增加OBOT保留，同时降低复发率和过量 死亡然而，目前的8周标准MBIs似乎没有强大的，持续的影响， 物质使用的结果，这表明在OUD治疗环境中需要更长或增强的MBI。 本项目建议调整、改进和比较6个月正念恢复的有效性 OUD连续护理（M-ROCC）在基于组的阿片类药物治疗（GBOT）中提供， 标准GBOT M-ROCC是一个基于循证医学的三阶段计划， 建立了初级保健正念培训（MTPC）计划，该计划已被改编为 阿片类药物使用障碍。M-ROCC包括灵活的、以患者为中心的、激励响应的设计， 包括为期4周的低剂量正念入门组，正念维持签到支持 组，和一个为期8周的强化正念训练初级保健（MTPC-OUD）组。M-ROCC 建立在之前展示的提升正念练习剂量阶梯方法的基础上，该方法 帮助OUD患者培养动力，解决正念练习的矛盾心理。 MTPC已被证明具有较低的焦虑，压力和抑郁，同时增加自我效能感， 通过自我调节机制改变行为的能力。在R21阶段，我们将 通过1）修改M-ROCC手册; 2）在5个MA初级阶段培训提供者，为多中心RCT做准备 3）试行M-ROCC评估定性反馈以进行迭代改进; 4)GBOT手册化，并为MA OBOT站点提供培训;以及5）通过以下方式为R33阶段做准备： 获得必要的批准和现场合同。在R33阶段，我们将进行一项5中心RCT 比较了200例接受B/N处方的初级保健患者的M-ROCC + GBOT与GBOT单药治疗， OUD，主要评估其对阿片类药物使用和焦虑的影响，但也评估其对可卡因和BZD使用的影响， 以及持续成瘾康复所需的自我调节方面。