title: The ONLINE-TICS Study Protocol: A Randomized Observer-Blind Clinical Trial to Demonstrate the Efficacy and Safety of Internet-Delivered Behavioral Treatment for Adults with Chronic Tic Disorders.
abstract: BACKGROUND
  In recent years, behavioral therapy with comprehensive behavioral intervention for tics (CBIT) has been recognized as an effective and safe treatment in patients with Gilles de la Tourette syndrome. 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. With this study, we want to demonstrate that iCBIT is superior to Internet-delivered psychoeducation and comparable to face-to-face CBIT.
  
  
  METHODS
  This is a multicenter, prospective, randomized, controlled, observer-blind clinical trial, which will be conducted at five sites in Germany (ONLINE-TICS). Over the course of 2 years, 160 adult patients with chronic tic disorders will be assigned to one of three treatment arms: iCBIT (n = 72), online psychoeducation (n = 72), or face-to-face CBIT (n = 16). All treatments will consist of eighty therapy sessions over a period of 10 weeks and will follow the well-established CBIT manual by Woods and colleagues. The primary outcome measure will be the change in Yale Global Tic Severity Scale (YGTSS) at 1-week posttreatment. Secondary outcome measures include YGTSS change at 3 and 6 months, video- and self-ratings of tics as well as scales for psychiatric comorbidities assessed at each visit. The primary analysis will compare iCBIT to online psychoeducation using a mixed linear model with the YGTSS change as dependent variable. Secondary analyses will look at the comparison between iCBIT and face-to-face CBIT in a non-inferiority analysis.
  
  
  CONCLUSIONS
  If iCBIT proves to be effective, it would be a considerable contribution to close the wide gap in treatment providers for tic disorders not only in Germany but also in several other countries, since this Internet-delivered therapy does not require the supervision of a therapist. In addition, iCBIT would be a cost-effective and readily available treatment alternative that guarantees high quality standard of CBIT.
  
  
  BACKGROUND
  All institutional review boards approve the protocol. All participants will provide informed consent. There are no conflicts of interest. After study completion, the results will be published.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02413216.
authors.affiliation: Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School , Hannover , Germany.
authors.forename: Ewgeni
authors.initials: E
authors.lastname: Jakubovski
authors.affiliation: Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School , Hannover , Germany.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Reichert
authors.affiliation: Institute for Biostatistics, Hannover Medical School , Hannover , Germany.
authors.forename: Annika
authors.initials: A
authors.lastname: Karch
authors.affiliation: Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School , Hannover , Germany.
authors.forename: Nadine
authors.initials: N
authors.lastname: Buddensiek
authors.affiliation: Clinical Trial Center, Hannover Medical School , Hannover , Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Breuer
authors.affiliation: Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School , Hannover , Germany.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Müller-Vahl
keywords: Internet-delivered comprehensive behavioral intervention for tics; Tourette syndrome; comprehensive behavioral intervention for tics; habit reversal training; tele-health program; tics