Online Mindfulness-based Tic Reduction

Study Overview
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Brief Summary
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Tourette Syndrome (TS) and Persistent Tic Disorder (PTD) are chronic and potentially disabling neurobiological conditions. Although a range of pharmacological and psychosocial treatments exists, a significant number of individuals either do not respond to the current treatments, find them unacceptable, or cannot access them. Thus, it is essential that researchers continue to pursue novel treatment approaches that can also be easily disseminated to those in need. Initial pilot data suggest that a mindfulness-based intervention may be beneficial for adults with tic disorders. In the present study, the researchers aim to further develop this mindfulness-based intervention, adapt it to be delivered online and pilot test the intervention with a small group of participants. The data from this pilot test will inform a subsequent randomized controlled trial comparing online mindfulness-based tic reduction to online psychoeducation, relaxation, and supportive therapy. The specific aim is to determine the feasibility and acceptability of Online Mindfulness-based Tic Reduction in 6 adults with TS or PTD. The researchers hypothesize that Online Mindfulness-based Tic Reduction will be feasible and acceptable to adults with tic disorders as measured by participant satisfaction, qualitative participant feedback, home practice compliance, dropout, and adverse events.

Official Title
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Online Mindfulness-based Tic Reduction: Development and Testing (Phase One)

Conditions
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Tourette Syndrome, Tic Disorders

Intervention / Treatment
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* Behavioral: Online Mindfulness-based Tic Reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older, possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder, fluent in English residing in the United States, either not be taking any tic suppressant medication or other psychotropic medication or be at a stable dose for 8 weeks prior to the baseline assessment and throughout the study Exclusion Criteria: be receiving concurrent psychotherapy for the duration of the study have prior extensive experience with mindfulness and/or meditation and cannot have another medical or psychological condition that would prevent the individual from fully engaging in the study or require a higher level of care (e.g., suicidality).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online Mindfulness-based Tic Reduction<br> | Behavioral: Online Mindfulness-based Tic Reduction<br>* 8-week online group mindfulness-based intervention for tics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Questionnaire |  | week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homework Compliance Questionnaire |  | Weeks 1-8 | 
| Attrition Form |  | Weeks 1-8 | 
| Adverse Events Monitoring Form |  | Weeks 1-9 | 
| Yale Global Tic Severity Scale (YGTSS) |  | Week 0, Week 9 | 
| Adult Tic Questionnaire |  | Weeks 0-9 | 
| Clinical Global Impressions Scale-Severity |  | Week 0, Week 9 | 
| Clinical Global Impressions Scale-Improvement |  | Week 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tic Disorders, Mindfulness, Meditation, Online, Internet-based, Treatment