Supporting Treatment Access and Recovery for Co-Occurring Opioid Use and Mental Health Disorders (STAR-COD)

项目总结/摘要 自2000年以来，阿片类药物的使用在美国急剧增加，并对个人产生不良影响。 心理健康障碍（COD）。COD患者很容易复发， 精神健康症状恶化、阿片类药物过量、自杀、无家可归和刑事司法 参与。虽然阿片类药物使用障碍（MOUD）的药物治疗是护理的黄金标准， 率低至18%，对结果产生负面影响。此外，有各种证据表明， 增加单一行为干预以改善MOUD结局的增量治疗获益， 在临床实践指南中推荐。此外，虽然有多个组成部分的干预措施， 已知其与MOUD和标准医疗器械结合对结局的增量治疗效果 对于那些有COD的人来说。通过系统集成保持独立和清醒， 外展和网络（使命）是这样一个多组成部分，跨学科，以团队为基础的治疗 方法，结合3个循证实践沿着与MOUD：1）双重恢复疗法（DRT），这是 COD的综合团体治疗; 2）同伴支持（PS），为康复中的人提供支持， 关键时间干预（CTI），一种有时间限制的自信社区治疗形式。虽然 鉴于在大型系统中实施的困难，使命的有效性已经得到了很好的确认 由于其复杂性和需要改善那些接受MOUD的COD患者的结果， 第一步是了解使命+ MOUD的增量治疗获益，并确定最高价值 使命组件可推动最大的临床改进并提供最大的投资回报。 作为对RFA-MH-21-145的回应，拟定的采用半部分析因设计的4年研究“支持性 阿片类药物使用和精神健康障碍并存的治疗途径和恢复（STAR-COD），”将 将1,000名COD患者随机分为以下5种情况：1）单独MOUD; 2） 完整的使命协议（CTI & DRT & PS）+ MOUD; 3）CTI & DRT + MOUD; 4）PS & DRT + MOUD;或5）CTI & PS + MOUD。有四个具体目标。目标1：评价使命或其组成部分的效力 使用MOUD与单独使用MOUD相比，以及使命或捆绑部件+ MOUD的增量优势， 改善参与度、物质使用和心理健康症状。目标2：研究作用机制 使命在COD目标3：对使命或其组成部分进行全面的经济评价， MOUD。探索性目标：4.构建预测模型，以匹配使命部件的最佳组合使用 患者的需求，以改善健康状况。该提案与NIMH的战略计划目标4“保持一致， 增加服务研究的公共卫生影响，调查人员测试适应，实施和扩展的方法 以具有成本效益的方式，在多种服务环境中为不同人群提供有效的干预措施。后 完成后，它可以提供更具成本效益的，强大的，个性化的治疗。

PROJECT SUMMARY / ABSTRACT Opioid use has dramatically increased in the United States since 2000, and disproportionally affects individuals with co-occurring mental health disorders (COD). Individuals with COD are vulnerable to substance use relapses, mental health symptom exacerbations, opioid overdoses, suicide, homelessness, and criminal justice involvement. Although medication for opioid use disorder (MOUD) is the gold standard of care, engagement rates are as low as 18% which negatively impact outcomes. In addition, there is mixed evidence regarding the incremental therapeutic benefit of adding single behavioral interventions to improve MOUD outcomes, despite being recommended in clinical practice guidelines. Furthermore, while multi-component interventions exist, little is known about their incremental therapeutic effect on outcomes in conjunction with MOUD and standard medical management for those with a COD. Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION) is one such multi-component, cross-disciplinary, team-based treatment approach, combining 3 evidence-based practices along with MOUD: 1) Dual Recovery Therapy (DRT), which is integrated group therapy for COD; 2) Peer Support (PS), offering support for people in recovery by people in recovery; and 3) Critical Time Intervention (CTI), a time-limited form of assertive community treatment. Although the effectiveness of MISSION is well established, given the difficulty with implementation uptake in large systems due to its complexity and the need to improve outcomes for those with a COD who receive MOUD, a critical next step is to understand the incremental therapeutic benefit of MISSION + MOUD, and identify highest value MISSION components that drive the largest clinical improvement and offer the greatest return on investment. In response to RFA-MH-21-145, the proposed 4-year study with a half fractional factorial design, “Supporting Treatment Access and Recovery for Co-occurring Opioid Use and Mental Health Disorders (STAR-COD),” will randomize 1,000 patients with COD across 9 MOUD programs to the following 5 conditions: 1) MOUD alone; 2) full MISSION protocol (CTI & DRT & PS) + MOUD; 3) CTI & DRT + MOUD; 4) PS & DRT + MOUD; or 5) CTI & PS + MOUD. There are four specific aims. Aim 1: To evaluate the effectiveness of MISSION or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or bundled parts + MOUD to improve engagement, substance use and mental health symptoms. Aim 2: To examine mechanisms of action of MISSION in COD. Aim 3: To conduct a comprehensive economic evaluation of MISSION or its parts and MOUD. Exploratory Aim: 4. To construct a predictive model to match optimum combined use of MISSION parts with patient needs to improve health outcomes. This proposal is aligned with NIMH’s strategic plan goal 4 “to increase the public health impact of services studies, investigators test ways to adapt, implement, and scale effective interventions for varied populations across multiple service settings in a cost-effective manner.” Upon completion, it could offer more cost effective, robust, personalized treatments.