Abstract
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. 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. 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. 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. ClinicalTrials.gov Identifier: NCT02413216.
Highlights
Gilles de la Tourette syndrome (TS) is a chronic neuropsychiatric disorder of childhood onset characterized by multiple motor and vocal tics
Quality of life is significantly impaired in a substantial number of patients due to tics and comorbidities and because of ignorance and a lack of information, leading to bullying and stigmatization
We will carry out a large multicenter, randomized controlled trials (RCT) in five different German TS centers to compare the efficacy of Internet-delivered CBIT (iCBIT) [an online therapy, which follows closely the comprehensive behavioral intervention for tics (CBIT) manual by Woods [20]] to [1] an online placebo – containing only psychoeducation – and to [2] a conventional and well-established face-to-face CBIT treatment
Summary
Gilles de la Tourette syndrome (TS) is a chronic neuropsychiatric disorder of childhood onset characterized by multiple motor and vocal tics. Quality of life is significantly impaired in a substantial number of patients due to tics and comorbidities and because of ignorance and a lack of information, leading to bullying and stigmatization. Even today, it takes on average more than 5 years to make the correct diagnosis [3]. 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. The aim of this study is to overcome this deficiency by creating a new and sophisticated Internet-delivered CBIT (iCBIT) program. We want to demonstrate that iCBIT is superior to Internet-delivered psychoeducation and comparable to face-to-face CBIT
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