NCT06408662

Remote Delivery of a Mindfulness-based Intervention for Tics

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is being done to compare a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) for individuals with Tourette's syndrome or Persistent Tic Disorders (collectively TS). It is the investigator's hope that this information cam be used to improve current treatments for individuals with TS.

Detailed description

Tourette's syndrome and other persistent tic disorders (collectively, TS) is a condition that onsets in childhood and affects \~1% of the population. Alongside motor and vocal tics, patients with TS experience distressing somatosensory sensations (i.e., premonitory urges) and co-occurring mental health conditions such as anxiety disorders, depressive disorders, obsessive-compulsive disorder (OCD), and ADHD. Tics and comorbid symptoms cause individuals with TS significant distress and impairment across life domains (e.g., physical, social, academic, occupational, emotional, and familial). Two evidence-based treatments exist for TS: behavior therapy and pharmacotherapy. Behavior therapy \[often referred to as habit reversal training (HRT) or the comprehensive behavioral intervention for tics (CBIT)\] is an evidence-based treatment that has been shown to reduce the severity of tic symptoms, and has a low risk for adverse effects. Although behavior therapy is recognized as a first-line intervention for TS, less than 40% of adults with TS respond to this evidence-based treatment. Additionally, current behavioral interventions are often inaccessible for adults with TS. While pharmacotherapy for tic management (e.g., antipsychotic medications) has been shown to be effective, these treatments can have adverse side effects with detrimental health consequences. Thus, there is a critical need for new treatments for adults with TS that are efficacious for reducing tic severity, beneficial for co-occurring conditions, and have few adverse health effects. Mindfulness-based interventions have proven beneficial for adults with a wide range of neuropsychiatric conditions. Based on the investigator's prior work, the investigators believe that a mindfulness-based intervention for tics (MBIT) is beneficial for adults with TS. This project is a randomized controlled trial (RCT) that will compare the efficacy of a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) in 150 adults with TS. All interventions and assessments will be delivered remotely using secure telehealth services platforms and online electronic data capture systems. An independent evaluator (IE) masked to treatment condition will administer all assessments during the treatment and follow-up periods. The investigators will test the mechanisms by which MBIT reduces tic severity, and examine the efficacy of MBIT relative to PRST for common co-occurring psychiatric symptoms and quality of life impairments-towards "treating the whole person". Finally, the investigators will explore the sustained therapeutic improvement from MBIT over a 6-month follow-up period focusing on tic severity, tic-related impairment, co-occurring psychiatric symptoms, and quality of life.

Conditions

• Tourette Syndrome
• Tourette's Disorder
• Chronic Motor Tic Disorder
• Chronic Vocal Tic Disorder
• Persistent Motor Tic Disorder
• Persistent Vocal Tic Disorder
• Persistent Tic Disorder
• Tic Disorders

Interventions

Type	Name	Description
OTHER	mindfulness-based intervention for tics (MBIT)	Psychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practice
OTHER	psychoeducation with relaxation and supportive therapy (PRST)	Psychological Intervention that focuses on learning more about tics, practicing a range of strategies for coping with tics (e.g., relaxation, effective communication), and discussing challenges commonly experienced by individuals with tics.

Timeline

• Start date: 2024-05-23
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2024-05-10
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States