An interventional study of mindfulness-based intervention for tics (MBIT) and psychoeducation with relaxation and supportive therapy (PRST) in Tourette Syndrome, Tourette's Disorder and Chronic Motor Tic Disorder, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
This study's planned enrollment of 150 is above the median of 36 across 183 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This is an 8-week mindfulness-based group intervention delivered via telehealth. It consists of mindfulness and meditative practice, didactics, inquiry, discussion and weekly therapeutic exercises and assignments (i.e., homework).
Other: mindfulness-based intervention for tics (MBIT)
This is an 8-week educational and supportive therapy group intervention delivered via telehealth. It consists of psychoeducation, relaxation, discussion, and weekly therapeutic exercises and assignments (i.e., homework).
Other: psychoeducation with relaxation and supportive therapy (PRST)
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
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.
Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
The YGTSS is a clinician-administered measure of tic symptom severity (0-50) and impairment (0-50). Greater scores are reflective of greater severity and/or impairment.
Time frame: Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Clinical Global Impressions Scales of Severity and Improvement (CGI-S & CGI-I)
In order for a participant to be considered a treatment responder, he or she must receive a score of 1 (not ill or very much improved) or 2 (borderline mentally ill or much improved).
Time frame: Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Adult Tic Questionnaire (ATQ)
Higher ATQ scores reflect a worse outcome. For each tic present in the past week, its severity score is the sum of its frequency score (0-4, 4 worst, occurring "almost all the time during the day") and its intensity score (0-4, 4 worst). The ATQ severity score is the sum of the severity score for each of up to 27 tics present in the past week. The minimum possible severity score on the ATQ is 0, indicating that no tics were present in the past week. The maximum possible severity score on the ATQ indicates is 216, indicating that a tic of each of the 27 types listed was present in the past week, each with an item severity score of 8 = 4 + 4.
Time frame: Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Yale-Brown Obsessive Compulsive Scale-II
A clinician-administered measure of OCD severity that has shown good psychometric properties. The total score ranges from 0 to 50, with greater total score reflective of greater severity.
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Attention-Deficit Hyperactivity Rating Scale (ADHD-RS)
A self-report measure of ADHD severity that has shown good psychometric properties in TS studies. The total score ranges from 0 to 72, with greater scores indicating greater ADHD severity.
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Patient Health Questionnaire-9 (PHQ-9)
A self-report measure of depressive symptom severity (range: 0-27), with greater total score reflecting greater depressive severity.
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Premonitory Urge to Tic Scale (PUTS)
A self-report measure of premonitory urges (range: 0-36), with a greater total score reflective of greater premonitory urges.
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Five Facet Mindfulness Questionnaire (FFMQ)
Each item is rated on a 1 to 5 scale with 1=never or very rarely true and 5=very often or always true; responses are summed and then divided by 39 (the number of items). Higher scores on the FFMQ reflects a higher level of mindfulness (a better outcome).
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Client Satisfaction Questionnaire
An 8-item self-report measure assessing client's satisfaction with treatment services. The total score ranges from 8 to 32. Greater total score corresponds with greater satisfaction with services
Time frame: Post-treatment (Week 9)
Self Compassion Scale
Measure ranges from 26 to 130, with higher scores indicating higher levels of self-compassion
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Affective Reactivity Index
A 6-item scale of affective reactivity that ranges from 0-12, with higher scores reflective of greater affective reactivity.
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Brief Irritability Test
A five-item self-report measure of irritability that ranges from 5 to 30, with greater scores reflective of greater irritability.
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Individualized Premonitory Urge to Tic Scale (I-PUTS)
The I-PUTS is a clinician-administered scale that parallels the YGTSS symptom checklist. The clinician assesses each tic that is present in the past week for premonitory urges. The urges are rated on the dimensions of frequency (1-4) and intensity (1-4), with the frequency and intensity summed to create a total premonitory urge severity score
Time frame: Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Depression Anxiety and Stress Scale (DASS)
The Depression Anxiety and Stress Scale (DASS) is a self-report measure of depression, anxiety, and stress. The 21-items are rated on a scale from 0 to 2, with a total score ranging from 0 to 42. Greater scores are reflective of worse symptom severity.
Time frame: Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
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Started May 2024 (actual). Primary completion is estimated for Jun 2028, 49 months after the start.
Of 65 non-industry interventional studies with no phase under Tourette Syndrome, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's planned 49 months is above that.
Counting every sponsor, half of 65 studies reached it within 33 months; a quarter within 22 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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