Tics, Tourette Syndrome
Conditions
Keywords
Chronic tic disorders, Tourette syndrome
Brief summary
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.
Interventions
BEHAVIORAL(i)Comprehensive Behavioral Intervention for Tics
BEHAVIORALinternet-delivered psychoeducation and relaxation training
Sponsors
Hannover Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| YGTSS-TTS | 1 week after end of treatment |
Secondary
| Measure | 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. |
| Working Alliance Inventory-Short Revised (WAI-SR) | 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. |
| Tourette Syndrome-Quality of Life Scale (GTS-QoL) | 1 week, 3 months and 6 months after end of treatment. |
Countries
Germany
Outcome results
None listed