Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders
Condition: Tic Disorder, Chronic Motor or Vocal; Tourette Syndrome in Children; Tourette Syndrome
MeSH terms: Tourette Syndrome; Tics; Tic Disorders; Syndrome
Study type: Interventional

Summary: 
      It is a randomized controlled trial to compare two behavioural treatments, namely CBIT and
      CoPs. This study would be the first head-to-head randomized trial between two established
      treatments rather than supportive counseling or wait-list control. Thirty-six adults and 36
      children with TS/TD will be recruited into each of the two (CBIT, CoPs) modalities requiring
      a total recruitment of 72 adults and 72 children over 5 years, which permits, even for a
      small-medium effect size, a robust power calculation. Motor performance measures will give
      concurrent validity to changes pre-post in TS/TD motor processes. Recruitment of both males
      and females will permit sex comparisons. The participants meeting inclusion/exclusion
      criteria will be assessed at pre-post 1 month and 6 months following treatment on
      standardized tic scales and global assessment of functioning. Participants will be treated
      individually on a weekly basis by therapists with an allegiance to each modality and outcome
      assessed by masked evaluation. The treatments are manualized and will last 10 weeks with 4
      weeks of home practice at post-treatment with 6-month follow-up assessment on all outcome
      measures, plus motor performance measures post-treatment. All treatment sessions will be
      audio-recorded and assessed with implementation of treatment integrity procedures scales. The
      hypotheses are that: (1) the CoPs group will show superiority in clinically significant
      improvement on standard tic scale score, global functioning and quality of life than the CBIT
      group; and (2) changes in recognized parameters on selected motor tests scored according to
      published norms will change towards normalization post CoPs but not post CBIT. The outcome
      data from the two treatments will be analyzed by a mixed linear model adaptation of repeated
      measures MANOVA and daily diary measures will allow for an additive time series design over
      the 10 weeks treatment session. This design will allow computation of the size of treatment
      effects at different stages of therapy. The study results will impact on the treatment of
      choice and access to treatment for tic disorders and on the conceptualization of tic
      disorders.
    

Detailed description: 
      Tics are defined as repetitive non-voluntary contractions of functionally related groups of
      skeletal muscles in one or more parts of the body. Gilles de la Tourette's syndrome (TS)
      forms a separate diagnostic category with multiple tics including vocal (phonic) tics
      occurring several times per day, for at least 1 year with onset before age 18. Persistent
      (chronic) tic disorder (TD) may involve a single motor or vocal tic. Tics peak around age 11
      but can persist into adulthood with a prevalence of 1% and if untreated cause significant
      impairment. The current treatment guidelines for managing the tics recommend a Behavioural
      treatment, "habit reversal", which focuses on reversing the tic habit, now developed as a
      Comprehensive Behavioural Intervention for Tics (CBIT). CBIT involves multiple stages
      including awareness, relaxation, contingency training, positive reinforcement for not do the
      tic and the practice of a competing response antagonistic to the tic. A recent large scale
      multisite study compared CBIT with supportive therapy and found a significantly greater
      decrease in adults and children tics treated with CBIT. However, in both adult and child
      studies, 48-62% of samples were classified as non-responders. Effect sizes were medium
      (Cohen's d´= 0.55 - 0.68) compared to supportive therapy with mean tic decrease of 25-30% and
      samples remained symptomatic at follow-up. Research over the last 10 years (funded by the
      CIHR) have led to elaboration of a cognitive behavioural psychophysiological model of
      treatment (CoPs) of tic disorders. The CoPs is multi-modal and targets cognitive, behavioural
      and physiological processes characteristic of tic disorders rather than focusing on reversing
      the actual tic at onset. In the last funding period 2009-2013 the investigators have
      successfully applied the program to all subtypes and severity of adults with TS/TD both with
      and without comorbidity and compared outcome with a natural waitlist control. Results showed
      a clinically significant reduction of tic frequency following CoPs (Cohen's d- 1.43-2.34),
      maintained at 6-month follow-up. Validity of the CoPs model was supported by a change in
      behavioural and psychosocial as well as tic symptom measures post-treatment and at 6-month
      follow-up, and a post-treatment normalization of participants' performance on
      neuropsychological and electrophysiological measures.
    

Intervention name(s): Cognitive behavioural treatment for tics; Cognitive psychophysiological
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mainly based on the habit reversal treatment (HRT) and in addition to HRT components, they learn awareness training, relaxation, competing response, contingency management, and generalization training.; Focus on the processes influencing thoughts and behaviors underlying tics.
Other intervention name(s): CBIT; CoPs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment