Remote Delivery of a Mindfulness-Based Intervention for Tics

远程提供基于正念的抽动干预措施

基本信息

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
项目类别：
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

项目摘要

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.

项目概要抽动秽语综合症和持续性抽动障碍（统称为 TS）的特点是抽动在儿童时期发作在大多数情况下，除了抽动之外，TS 患者还会导致功能障碍并持续到成年。经历预兆性冲动和共存心理健康状况（例如焦虑、注意力缺陷多动症、强迫症、抑郁症）目前，对于 TS 患者来说，只有两种基于证据的治疗方法：行为。行为疗法被推荐作为 TS 的一线治疗方法。 60% 患有 TS 的成年人对行为疗法没有反应，并且它不会给常见疾病带来任何益处对于许多患有 TS 的成年人来说，也无法接受这种治疗。由于受过训练的 TS 提供者接受检查的机会有限，大多数患有 TS 的成年人依赖行为疗法。 FDA 批准的用于抽动控制的药物，这些药物很少能缓解抽动，并且经常由于对健康的不利影响而停止使用，因此，寻找新的安全、有效和可利用的药物至关重要。为了改善 TS 成人的治疗结果和生活质量，我们的团队采取了应对措施。我们开发了一种基于在线正念的抽动症团体干预（MBIT）我们的试点临床试验比较组。 MBIT 对成人 TS 进行团体心理教育、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采集远程进行评估 MBIT 系统被发现对于降低抽动严重程度和损伤是可行的、可接受的且有效的。此外，相对于 PRST，MBIT 改善了共病心理健康状况，并且持续有效。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 降低抽动严重程度的功效，(2) 检查 MBIT 降低抽动严重程度的机制， (3) 评估 MBIT 对共存心理健康状况和生活质量的次要益处，以及 (4) 在此，150 名患有中度或以上抽动严重程度的 TS 成人将探讨 MBIT 的长期益处。成人将完成基线评估，以表征抽动的严重程度、先兆性冲动的严重程度、接下来，参与者将被随机分为 8 名。每周一次的 MBIT 组或 PRST 组以 1:1 的比例进行，参与者将在治疗中期、治疗后完成。接受 MBIT 的参与者还将完成 6 个月的治疗、1 个月和 3 个月的随访评估。一个月的后续行动以评估其持续效益。所有评级将由独立评估员 (IE) 进行。研究结果将为患有 TS 的成人建立一种新的、可行的、基于证据的治疗方法。全面降低抽动的严重程度，改善同时发生的心理健康状况和生活质量，以及这种干预及其远程团体交付方法提供了持久的治疗效益。实用、可扩展且可持续的解决方案，可改善成人 TS 的治疗结果。