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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iCBIT | Active Comparator | internet-delivered Comprehensive Behavioral Intervention for Tics (iCBIT) consisting of psychoeducation, habit reversal training (HRT), function-based assessment and intervention, and relaxation training |
|
| Control intervention/reference test | Placebo Comparator | internet-delivered psychoeducation and relaxation training. |
|
| face-to-face CBIT-treatment | Active Comparator | face-to-face CBIT-treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (i)Comprehensive Behavioral Intervention for Tics | Behavioral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| YGTSS-TTS | 1 week after end of treatment |
| 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. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten Mueller-Vahl, Prof., MD | Medical school Hannover, Clinic for Psychosomatics and Psychotherapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Clinic of the Ludwig-Maximilians-University | Munich | Bavaria | 80336 | Germany | ||
| Psychotherapist practice |
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| internet-delivered psychoeducation and relaxation training | Behavioral |
|
| 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. |
| Hanover |
| Lower Saxony |
| 30559 |
| Germany |
| RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics | Aachen | North Rhine-Westphalia | 52074 | Germany |
| University of Dresden, Dep. of Child and Adolescent Psychiatry | Dresden | Saxony | 01307 | Germany |
| University Medical Center Schleswig-Holstein, UK-SH Campus Lübeck, Department of Neurology | Lübeck | Schleswig-Holstein | 23538 | Germany |
| ID | Term |
|---|---|
| D020323 | Tics |
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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