Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders
- Conditions
- TicsTourette Syndrome
- Registration Number
- NCT02605902
- Lead Sponsor
- Hannover Medical School
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method YGTSS-TTS 1 week after end of treatment
- Secondary Outcome Measures
Name Time Method Conners' Adult ADHD Rating Scale (CAARS) 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. 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. Beck Depression Inventory (BDI) 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. YGTSS-TTS 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.
Trial Locations
- Locations (5)
Psychiatric Clinic of the Ludwig-Maximilians-University
🇩🇪Munich, Bavaria, Germany
Psychotherapist practice
🇩🇪Hannover, Lower Saxony, Germany
RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
🇩🇪Aachen, North Rhine-Westphalia, Germany
University of Dresden, Dep. of Child and Adolescent Psychiatry
🇩🇪Dresden, Saxony, Germany
University Medical Center Schleswig-Holstein, UK-SH Campus Lübeck, Department of Neurology
🇩🇪Lübeck, Schleswig-Holstein, Germany
Psychiatric Clinic of the Ludwig-Maximilians-University🇩🇪Munich, Bavaria, Germany