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

BackgroundIn 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.Method and analysisThis 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.DiscussionIf 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.Ethics and disseminationAll 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.Study registration Identifier: NCT02413216.

Tourette syndrome research highlights from 2016

“…Müller-Vahl and colleagues are beginning a large RCT that will test the efficacy of CBIT delivered by internet 64 . A commercial CBIT delivery system has been described, but (as of mid-2017) is not yet active.…”

Treating Tourette Together: An Agenda for Patient-Centered Research Focused on Comprehensive Behavior Therapy for Tics

“…CBIT-JR places greater emphasis on family-focused functional assessment and intervention treatment components, and presents direct tic inhibition skills from habit reversal in a game-like fashion thought to be more easily acquired for children of these ages. As noted above, other CBIT variants leverage technology for treatment delivery, including CBIT delivered over teleconferencing (Himle et al, 2012;Ricketts, Goetz, et al, 2016) and internet-based, selfguided CBIT delivered by automated computer programs that teach the patient core CBIT skills (e.g., tichelper.com ( (Conelea & Wellen, 2017;Jakubovski et al, 2016;PsycTech Ltd, n.d.). These programs generally include interactive exercises, informational videos, and self-report ratings to track symptoms over time.…”

Tics and Tourette syndrome

“…CBIT has been shown to be superior to supportive psychotherapy for children aged 9–17 years with TS, including those with comorbid OCD and ADHD . Patients who are not taking tic‐suppressing medications may experience greater benefit from CBIT than those on medication . As it is difficult to access trained CBIT therapists, online delivery of CBIT study is being investigated .…”

“…42 As it is difficult to access trained CBIT therapists, online delivery of CBIT study is being investigated. 42 Children younger than around 10 years of age may not have awareness of the premonitory urge or be able to understand and apply the strategies and so may not be suitable for CBIT. 43 Furthermore, the success of a behavioural management programme for TS depends on the active involvement and commitment of the parents.…”