ONLINE-TICS: Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: iCBIT 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
Other Names:
|
| Placebo Comparator: Control intervention/reference test internet-delivered psychoeducation and relaxation training. |
Behavioral: internet-delivered psychoeducation and relaxation training
|
| Active Comparator: face-to-face CBIT-treatment face-to-face CBIT-treatment |
Behavioral: (i)Comprehensive Behavioral Intervention for Tics
Other Names:
|
Outcome Measures
Primary Outcome Measures
- YGTSS-TTS [1 week after end of treatment]
Secondary Outcome Measures
- 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.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Chronic tic disorder or Tourette syndrome according to DSM-5
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Age ≥18 years; Yale Global Tic Severity Scale (YGTSS) total tic score (TTS) > 14 or > 10 (for patients only with motor or vocal tics)
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Clinical Global Impression-Severity Score (CGI-S) > 4
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Medication for tics and comorbidities must be on a stable dose for at least 6 weeks before entering the study
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Fluent German in speaking and writing
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Ability to give informed consent and signed informed consent
Exclusion Criteria:
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History of schizophrenia or pervasive developmental disorder
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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
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History of behavioral treatment for tics
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Current illicit substance abuse or addiction (clinically diagnosed)
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Secondary tic disorder or other significant neurological and psychiatric disease
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No internet access or ability to use the internet
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Participation in a study with medicinal products or devices is not allowed within 6 weeks before inclusion or concurrent to this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Psychiatric Clinic of the Ludwig-Maximilians-University | Munich | Bavaria | Germany | 80336 |
| 2 | Psychotherapist practice | Hannover | Lower Saxony | Germany | 30559 |
| 3 | RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics | Aachen | North Rhine-Westphalia | Germany | 52074 |
| 4 | University of Dresden, Dep. of Child and Adolescent Psychiatry | Dresden | Saxony | Germany | 01307 |
| 5 | University Medical Center Schleswig-Holstein, UK-SH Campus Lübeck, Department of Neurology | Lübeck | Schleswig-Holstein | Germany | 23538 |
Sponsors and Collaborators
- Hannover Medical School
Investigators
- Principal Investigator: Kirsten Mueller-Vahl, Prof., MD, Medical school Hannover, Clinic for Psychosomatics and Psychotherapy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- online-tics iCBIT