Remote Delivery of a Mindfulness-Based Intervention for Tics

项目总结 抽动症和持续性抽动障碍(统称为抽动障碍)以儿童期抽动发作为特征 在大多数情况下会导致功能障碍并持续到成年。除了抽搐，患有TS的患者 体验先兆冲动和共病的心理健康状况(例如，焦虑、ADHD、强迫症、抑郁症) 所有这些都降低了生活质量。目前，对TS患者只有两种循证治疗：行为 治疗和药物治疗。行为疗法被推荐为TS的一线治疗方法。然而， 60%患有TS的成年人对行为疗法没有反应，而且它不会为普通患者带来任何好处 精神健康状况并存。对于许多人来说，它也是无法到达的。不到20%的患有TS的成年人收到 行为疗法，因为训练有素的TS提供者的可及性有限。因此，大多数患有TS的成年人依赖于 FDA批准的治疗抽搐的药物，这种药物很少产生抽搐缓解，通常是 由于对健康的不利影响而停产。因此，确定新的安全、有效和可获得的新方法至关重要 改善成人TS患者治疗结果和生活质量的治疗。作为回应，我们团队已经 开发了一种基于正念的抽搐在线团体干预(MBIT)。我们的先导临床试验对照组 MBIT对患有TS的成人进行心理教育、放松和支持治疗(PRST)。所有干预措施 使用安全的远程医疗平台和在线电子数据捕获远程提供评估 系统。MBIT在减少抽动严重程度和损害方面是可行的、可接受的和有效的。 相对于PRST。此外，MBIT还改善了共病的精神健康状况，并持续 最长6个月的福利。在这项工作的基础上，我们将进行一项随机临床试验(RCT)：(1)测试 MBIT用于降低抽动严重程度的有效性，(2)检查MBIT降低抽动严重程度的机制， (3)评估MBIT对共病心理健康状况和生活质量的次要益处；(4) 探索Mbit的长期利益。在这里，150名患有中度或更严重抽搐的成人TS患者将 参与进来。成人将完成一项基线评估，以表征抽搐的严重程度，先兆冲动严重程度， 共病心理健康状况和生活质量的严重程度。接下来，参与者将被随机分配到8人 Mbit组或PRST组以1：1的比例每周开会。参与者将完成中期治疗、治疗后 治疗，1个月和3个月的随访评估。获得Mbit的参与者还将完成6- 随访1个月，评估其持续受益情况。所有评级将由蒙面的独立评估者(IE)进行 恢复到治疗状态。研究结果将为成人TS建立一种新的、可获得的、循证的治疗方法 这全面降低了抽搐的严重性，改善了共同发生的精神健康状况和生活质量，以及 产生持久的治疗效果。这种干预及其远程团体交付方法提供了一种 实用、可扩展和可持续的解决方案，以改善成人TS的治疗结果。

PROJECT SUMMARY Tourette Syndrome and persistent tic disorders (collectively TS) are characterized by the childhood onset of tics that cause functional impairment and persist into adulthood in most cases. Alongside tics, patients with TS experience premonitory urges and comorbid mental health conditions (e.g., anxiety, ADHD, OCD, depression) that all diminish quality of life. Presently, only two evidence-based treatments exist for patients with TS: behavior therapy and pharmacotherapy. Behavior therapy is recommended as the first-line treatment for TS. However, 60% of adults with TS do not respond to behavior therapy and it does not confer any benefit for common comorbid mental health conditions. It is also inaccessible for many. Less than 20% of adults with TS receive behavior therapy because of limited accessibility to trained TS providers. Consequently, most adults with TS rely on FDA-approved medications for tic management, which infrequently produce tic remission and are often discontinued due to adverse health effects. Thus, it is critical to identify new safe, efficacious, and accessible treatments to improve therapeutic outcomes and quality of life for adults with TS. In response, our team has developed an online mindfulness-based group intervention for tics (MBIT). Our pilot clinical trial compared group MBIT to group psychoeducation, relaxation, and supportive therapy (PRST) in adults with TS. All interventions and assessments were delivered remotely using secure telehealth platforms and online electronic data capture systems. MBIT was found to be feasible, acceptable, and efficacious for reducing tic severity and impairment relative to PRST. Additionally, MBIT produced improvement in comorbid mental health conditions, and sustained benefit for up to 6-months. Building on this work, we will conduct a randomized clinical trial (RCT) that: (1) tests the efficacy of MBIT for reducing tic severity, (2) examines the mechanism by which MBIT reduces tic severity, (3) evaluates the secondary benefit of MBIT for comorbid mental health conditions and quality of life, and (4) explores the long-term benefit of MBIT. Here, 150 adults with TS with moderate or greater tic severity will participate. Adults will complete a baseline assessment to characterize tic severity, premonitory urge severity, the severity of comorbid mental health conditions, and quality of life. Next, participants will be randomized to 8 weekly sessions of group MBIT or group PRST in a 1:1 ratio. Participants will complete mid-treatment, post- treatment, 1-month and 3-month follow-up assessments. Participants receiving MBIT will also complete a 6- month follow-up to assess its sustained benefit. All ratings will be made by an independent evaluator (IE) masked to treatment condition. Findings will establish a new, accessible, evidence-based treatment for adults with TS that comprehensively reduces tic severity, improves co-occurring mental health conditions and quality of life, and produces lasting therapeutic benefit. This intervention and its remote group delivery approach provides a practical, scalable, and sustainable solution to improve therapeutic outcomes for adults with TS.