Abstract
Comprehensive Behavioral Intervention for Tics (CBIT) is considered a first-line therapy for tics. However, availability of CBIT is extremely limited due to a lack of qualified therapists. This study is a multicenter (n = 5), randomized, controlled, observer-blind trial including 161 adult patients with chronic tic disorders (CTD) to provide data on efficacy and safety of an internet-delivered, completely therapist-independent CBIT intervention (iCBIT Minddistrict®) in the treatment of tics compared to placebo and face-to-face (f2f) CBIT. Using a linear mixed model with the change to baseline of Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) as a dependent variable, we found a clear trend towards significance for superiority of iCBIT (n = 67) over placebo (n = 70) (−1.28 (−2.58; 0.01); p = 0.053). In addition, the difference in tic reduction between iCBIT and placebo increased, resulting in a significant difference 3 (−2.25 (−3.75; −0.75), p = 0.003) and 6 months (−2.71 (−4.27; −1.16), p < 0.001) after the end of treatment. Key secondary analysis indicated non-inferiority of iCBIT in comparison to f2f CBIT (n = 24). No safety signals were detected. Although the primary endpoint was narrowly missed, it is strongly suggested that iCBIT is superior compared to placebo. Remarkably, treatment effects of iCBIT even increased over time.
Highlights
Chronic tic disorders (CTD) are neuropsychiatric disorders with childhood onset characterized by sudden, rapid, recurrent, non-rhythmic movements or vocalizations persisting for more than one year [1]
67 participants were allocated to InternetDelivered Comprehensive Behavioral Intervention for Tics (iCBIT), 70 to placebo, and 24 to f2f Comprehensive Behavioral Intervention for Tics (CBIT)
Non-compliance could be inferred from missing clinic visits until V3 (n = 42) and non-participation in a sufficient number of iCBIT, placebo, or f2f CBIT treatment sessions (n = 11)
Summary
Chronic tic disorders (CTD) are neuropsychiatric disorders with childhood onset characterized by sudden, rapid, recurrent, non-rhythmic movements or vocalizations persisting for more than one year [1]. Cognitive behavioral therapy with habit reversal training (HRT) or Comprehensive Behavioral Intervention for Tics (CBIT) has been shown to be an effective and safe treatment for tics in children and adults [6,7]. HRT/CBIT is considered a first-line intervention for tics in patients with CTD/TS [9,10,11]. Despite this clear recommendation, in most countries, HRT/CBIT cannot be provided to patients because of a considerable lack of psychotherapists trained in and offering HRT/CBIT [10,12]. An unacceptably large number of patients never get the chance to be treated with HRT/CBIT, or at best have to accept very long waiting periods
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