Remote Delivery of a Mindfulness-Based Intervention for Tics - 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.
