Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders

Study Overview
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Brief Summary
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Gilles da la Tourette syndrome (TS)* is a common chronic neuropsychiatric disorder characterized by motor and vocal tics. In most adult patients, quality of life is significantly impaired. TS, therefore, is a cost-intensive disease (in Germany: mean total costs=€3404/year). Despite significant adverse effects, dopamine receptor antagonists were recommended as first choice treatment for many years. Although efficacy could be demonstrated only recently, today, behavioral therapy with face-to-face Comprehensive Behavioral Intervention for Tics (CBIT) (including psychoeducation, habit reversal training, function-based assessment and intervention, and relaxation training) is recommended as first line treatment for tics. In Germany, however, dissemination of CBIT is restricted due to a considerable lack of well-trained therapists. The aim of this study is to overcome this deficiency by creating a new and sophisticated internet-delivered CBIT (iCBIT) program. In addition, internet-delivered CBIT will shorten waiting time, will reach additional groups of patients and will be - once developed and established - highly cost-effective (about € 100 vs. € 1450 for face-to-face CBIT). Investigators want to perform a multicenter, randomized, controlled, observer-blind trial including 160 adult patients in order to demonstrate that 8 sessions (10 weeks) of iCBIT are superior to internet-delivered psychoeducation/relaxation in adult patients with TS. Both immediate (1 week after end of treatment) and long-term effects (after 3 and 6 months) will be evaluated.

Official Title
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Randomized Observer Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders

Conditions
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Tics, Tourette Syndrome

Intervention / Treatment
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* Behavioral: (i)Comprehensive Behavioral Intervention for Tics
* Behavioral: internet-delivered psychoeducation and relaxation training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic tic disorder or Tourette syndrome according to DSM-5 Age ≥18 years; Yale Global Tic Severity Scale (YGTSS) total tic score (TTS) > 14 or > 10 (for patients only with motor or vocal tics) Clinical Global Impression-Severity Score (CGI-S) > 4 Medication for tics and comorbidities must be on a stable dose for at least 6 weeks before entering the study Fluent German in speaking and writing Ability to give informed consent and signed informed consent Exclusion Criteria: History of schizophrenia or pervasive developmental disorder Comorbid obsessive-compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), depression, anxiety disorder when unstable and/or in need of an initial adjustment for a therapy History of behavioral treatment for tics Current illicit substance abuse or addiction (clinically diagnosed) Secondary tic disorder or other significant neurological and psychiatric disease No internet access or ability to use the internet Participation in a study with medicinal products or devices is not allowed within 6 weeks before inclusion or concurrent to this study

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iCBIT<br>internet-delivered Comprehensive Behavioral Intervention for Tics (iCBIT) consisting of psychoeducation, habit reversal training (HRT), function-based assessment and intervention, and relaxation training | Behavioral: (i)Comprehensive Behavioral Intervention for Tics<br> <br> * Other names: (i)CBIT;|
| Placebo Comparator: Control intervention/reference test<br>internet-delivered psychoeducation and relaxation training. | Behavioral: internet-delivered psychoeducation and relaxation training<br> <br> |
| Active Comparator: face-to-face CBIT-treatment<br>face-to-face CBIT-treatment | Behavioral: (i)Comprehensive Behavioral Intervention for Tics<br> <br> * Other names: (i)CBIT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| YGTSS-TTS |  | 1 week after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| YGTSS-TTS |  | 1 week, 3 months and 6 months after end of treatment. | 
| Clinical Global Impression-Improvement Score (CGI-I) |  | 1 week, 3 months and 6 months after end of treatment. | 
| Clinical Global Impression - Severity Score (CGI-S) |  | 1 week, 3 months and 6 months after end of treatment. | 
| Modified Rush Video-Based Tic Rating Scale (MRVS) |  | 1 week, 3 months and 6 months after end of treatment. | 
| Adult Tic Questionnaire (ATQ) (self-report rating) |  | 1 week, 3 months and 6 months after end of treatment. | 
| Tourette Syndrome-Quality of Life Scale (GTS-QoL) |  | 1 week, 3 months and 6 months after end of treatment. | 
| Premonitory Urge for Tics Scale (PUTS) |  | 1 week, 3 months and 6 months after end of treatment. | 
| Beck Depression Inventory (BDI) |  | 1 week, 3 months and 6 months after end of treatment. | 
| Conners' Adult ADHD Rating Scale (CAARS) |  | 1 week, 3 months and 6 months after end of treatment. | 
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) |  | 1 week, 3 months and 6 months after end of treatment. | 
| Beck Anxiety Inventory (BAI) |  | 1 week, 3 months and 6 months after end of treatment. | 
| Working Alliance Inventory-Short Revised (WAI-SR) |  | 1 week, 3 months and 6 months after end of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic tic disorders, Tourette syndrome