Remote Delivery of a Mindfulness-Based Intervention for Tics

远程提供基于正念的抽动干预措施

• 批准号: 10713281
• 负责人: Joseph McGuire
• 金额: $ 63.13万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10713281
• 关键词: 18 year old; Adult; Adverse effects; Aftercare; Anxiety; Attention deficit hyperactivity disorder; Awareness; Behavior Therapy; Childhood; Clinical Trials; Development; Disease remission; Distress; Emotional; Esthesia; Evidence based treatment; Exhibits; FDA approved; Gilles de la Tourette syndrome; Health; Impairment; Individual; Intervention; Learning Skill; Link; Masks; Meditation; Mental Depression; Mental Health; Motor Tics; Participant; Pathway interactions; Patients; Personal Satisfaction; Pharmaceutical Preparations; Pharmacotherapy; Provider; Quality of life; Randomized; Recommendation; Relaxation Therapy; Secure; Severities; Stress; Supportive care; Symptoms; Therapeutic; Tic disorder; Training; Vocal Tics; Work; Yoga; comorbidity; comparative efficacy; efficacious treatment; efficacy evaluation; efficacy testing; electronic data capture system; emotion regulation; evidence base; experience; follow up assessment; follow-up; functional disability; group intervention; improved; mindfulness; mindfulness intervention; novel; premonitory sensory phenomena; psychoeducation; psychoeducational; randomized, clinical trials; remote delivery; remote group; response; stress reduction; telehealth; therapy outcome; tic related; treatment group; treatment trial; trial comparing

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.

项目摘要 抽动秽语综合征和持续性抽动障碍（统称TS）的特征是儿童期发作的抽搐 导致功能障碍并持续到成年期。除了抽搐，TS患者 经历先兆冲动和共病的心理健康状况（例如，焦虑症、多动症、强迫症、抑郁症） 这些都降低了生活质量。目前，只有两种基于证据的治疗方法存在与TS患者：行为 治疗和药物治疗。行为疗法被推荐为TS的一线治疗。然而，在这方面， 60%的成年TS患者对行为疗法没有反应，并且对常见的 共病的心理健康状况它也是许多人无法接近的。不到20%的成年TS患者接受 行为疗法，因为有限的访问训练有素的TS提供者。因此，大多数患有TS的成年人依赖 FDA批准的用于抽搐管理的药物，这些药物很少能缓解抽搐， 由于对健康的不利影响而停止。因此，关键是要确定新的安全，有效， 治疗，以改善治疗结果和TS成人的生活质量。作为回应，我们的团队 开发了一种基于正念的抽搐在线团体干预（MBIT）。我们的初步临床试验比较了 MBIT与团体心理教育、放松和支持疗法（PRST）在成年TS患者中的应用所有干预措施 使用安全的远程保健平台和在线电子数据采集， 系统. MBIT被认为是可行的，可接受的，有效的减少抽搐的严重程度和损害 相对于PRST。此外，MBIT改善了共病心理健康状况，并持续 最多可享受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降低抽搐严重程度的功效，（2）检查MBIT降低抽搐严重程度的机制， (3)评估MBIT对共病心理健康状况和生活质量的次要益处，以及（4） 探讨MBIT的长期效益。在这里，150名患有中度或更严重抽搐的TS的成年人将 参加成人将完成一项基线评估，以表征抽搐的严重程度，先兆冲动的严重程度， 共病心理健康状况的严重程度和生活质量。接下来，参与者将被随机分配到8个 以1：1的比例每周进行一次MBIT组或PRST组。参与者将完成治疗中期、治疗后 治疗、1个月和3个月随访评估。接受MBIT的参与者还将完成6- 随访一个月，以评估其持续效益。所有评级将由一个独立的评价者（IE）进行掩蔽 到治疗条件。研究结果将为成年TS患者建立一种新的、可获得的、循证治疗方法。 全面降低抽搐的严重程度，改善同时发生的心理健康状况和生活质量， 产生持久的治疗益处。这种干预及其远程组交付方法提供了 实用、可扩展和可持续的解决方案，以改善成年TS患者的治疗效果。