Online Mindfulness-based Tic Reduction (Phase Two)

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 or find them unacceptable. Thus, it is essential that researchers continue to develop and test novel treatment approaches. In this randomized controlled trial the investigators will compare two different online group-based interventions for tics: a mindfulness-based program (Mindfulness-based Intervention for Tics (MBIT), and a psychoeducational and supportive therapy program (Tic Information and Coping Strategies (TICS)). The purpose of this study is to determine which intervention is more helpful for adults with a tic disorder.

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

Conditions
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Tourette Syndrome, Persistent Tic Disorder

Intervention / Treatment
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* Behavioral: Mindfulness-based Intervention for Tics
* Behavioral: Tic Information and Coping Strategies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be 18 years of age or older, possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder, be fluent in English reside 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 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based Intervention for Tics<br>8-week group-based mindfulness-based program | Behavioral: Mindfulness-based Intervention for Tics<br>* Psychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practices.<br>|
| Active Comparator: Tic Information and Coping Strategies<br>8-week group-based educational and supportive therapy program | Behavioral: Tic Information and Coping Strategies<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score | Clinician-rated measure of tic severity | Screening, Week 0, Week 9, Week 13, Week 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions Scale |  | Weeks 0, 9, 13, 35 | 
| Adult Tic Questionnaire |  | Weeks 0, 9, 13, 35 | 
| Yale-Brown Obsessive Compulsive Scale |  | Weeks 0, 9, 13, 35 | 
| Attention-Deficit Hyperactivity Rating Scale |  | Weeks 0, 9, 13, 35 | 
| Depression Anxiety Stress Scale |  | Weeks 0, 9, 13, 35 | 
| Premonitory Urge to Tic Scale |  | Weeks 0, 9, 13, 35 | 
| Tic Rating Form |  | Weeks 1-8 | 
| Problem Rating Form |  | Weeks 1-8 | 
| Patient Health Questionnaire-9 |  | Weeks 0, 9, 13, 35 | 
| Work and Social Adjustment Survey |  | Weeks 0, 9, 13, 35 | 
| Five Facet Mindfulness Questionnaire |  | Weeks 0, 4, 8, 9, 13, 35 | 
| Credibility and Expectancy Questionnaire |  | Week 3 | 
| Patient Satisfaction Questionnaire |  | Week 9 | 
| Self Compassion Scale |  | Weeks 0, 9, 13, 35 | 
| Affective Reactivity Index |  | Weeks 0, 9, 13, 35 | 
| Brief Irritability Test |  | Weeks 0, 9, 13, 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tourette Syndrome, Tic Disorder, Online, Adults, Mindfulness, Therapy