Clinical trial NCT02605902: Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders
Official title: Randomized Observer Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tics
Tourette Syndrome
Keywords: Chronic tic disorders
Tourette syndrome
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: YGTSS-TTS
timeFrame: 1 week after end of treatment
Secondary outcomes:
measure: YGTSS-TTS
timeFrame: 1 week, 3 months and 6 months after end of treatment.
measure: Clinical Global Impression-Improvement Score (CGI-I)
timeFrame: 1 week, 3 months and 6 months after end of treatment.
measure: Clinical Global Impression - Severity Score (CGI-S)
timeFrame: 1 week, 3 months and 6 months after end of treatment.
measure: Modified Rush Video-Based Tic Rating Scale (MRVS)
timeFrame: 1 week, 3 months and 6 months after end of treatment.
measure: Adult Tic Questionnaire (ATQ) (self-report rating)
timeFrame: 1 week, 3 months and 6 months after end of treatment.
measure: Tourette Syndrome-Quality of Life Scale (GTS-QoL)
timeFrame: 1 week, 3 months and 6 months after end of treatment.
measure: Premonitory Urge for Tics Scale (PUTS)
timeFrame: 1 week, 3 months and 6 months after end of treatment.
measure: Beck Depression Inventory (BDI)
timeFrame: 1 week, 3 months and 6 months after end of treatment.
measure: Conners' Adult ADHD Rating Scale (CAARS)
timeFrame: 1 week, 3 months and 6 months after end of treatment.
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: 1 week, 3 months and 6 months after end of treatment.
measure: Beck Anxiety Inventory (BAI)
timeFrame: 1 week, 3 months and 6 months after end of treatment.
measure: Working Alliance Inventory-Short Revised (WAI-SR)
timeFrame: 1 week, 3 months and 6 months after end of treatment.
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Psychiatric Clinic of the Ludwig-Maximilians-University
state: Bavaria
city: Hannover
country: Germany
facility: Psychotherapist practice
state: Lower Saxony
city: Aachen
country: Germany
facility: RWTH Aachen, Department of Psychiatry, Psychotherapy and Psychosomatics
state: North Rhine-Westphalia
city: Dresden
country: Germany
facility: University of Dresden, Dep. of Child and Adolescent Psychiatry
state: Saxony
city: Lübeck
country: Germany
facility: University Medical Center Schleswig-Holstein, UK-SH Campus Lübeck, Department of Neurology
state: Schleswig-Holstein
Study officials:
affiliation: Medical school Hannover, Clinic for Psychosomatics and Psychotherapy
name: Kirsten Mueller-Vahl, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: