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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
161
Psychiatric Clinic of the Ludwig-Maximilians-University
Munich, Bavaria, Germany
Psychotherapist practice
Hanover, 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
YGTSS-TTS
Time frame: 1 week after end of treatment
YGTSS-TTS
Time frame: 1 week, 3 months and 6 months after end of treatment.
Clinical Global Impression-Improvement Score (CGI-I)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Clinical Global Impression - Severity Score (CGI-S)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Modified Rush Video-Based Tic Rating Scale (MRVS)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Adult Tic Questionnaire (ATQ) (self-report rating)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Tourette Syndrome-Quality of Life Scale (GTS-QoL)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Premonitory Urge for Tics Scale (PUTS)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Beck Depression Inventory (BDI)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Conners' Adult ADHD Rating Scale (CAARS)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Beck Anxiety Inventory (BAI)
Time frame: 1 week, 3 months and 6 months after end of treatment.
Working Alliance Inventory-Short Revised (WAI-SR)
Time frame: 1 week, 3 months and 6 months after end of treatment.
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