Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders

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Brief Title

Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders

Official Title

Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders

Brief 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.
    


Study Type

Interventional


Primary Outcome

Yale Global Tic Severity Scale (YGTSS)

Secondary Outcome

 determine style of planning actions

Condition

Tic Disorder, Chronic Motor or Vocal

Intervention

Cognitive behavioural treatment for tics

Study Arms / Comparison Groups

 Comprehensive Behavioural Intervention
Description:  Participant will received psychoeducation about tic disorders, creating a tic hierarchy that will be revised during future sessions, introduce concept of function-based intervention, behavioral reward program, self-monitoring training, habit reversal training for their tics. They will received an introduction of relaxation techniques and diaphragmatic breathing exercise and an introduction of progressive muscle relaxation (PMR) exercise.
They will received booster sessions for three months and he will do hierarchy review, inconvenience review, function-based intervention and competing response review, review of relaxation techniques and relapse prevention review.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

144

Start Date

April 21, 2016

Completion Date

September 2021

Primary Completion Date

April 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  presenting a simple/complex tic for at least one year occurring daily. Those included
             in the TS group, age 8-12 or 18-65, had a diagnosis of TS as the principal presenting
             problem accompanied by vocal tics. Those included in the TD group presented a
             simple/complex tic (vocal or motor) for at least one year occurring daily.

        Exclusion Criteria:

          -  any major medical history, head injury including sensori-motor impairment, history of
             autism, Intelligence Quotient (IQ)<75; other psychiatric problem on Axis I or II
             requiring treatment (minor comorbidities were accepted), any neurological problems
             (e.g., Parkinson's, hemifacial spasms, Meige syndrome, sclerosis; Huntington's
             disease, Wilson's disease); currently receiving treatment from a psychologist,
             acupuncture, hypnotherapist, massotherapist; currently receiving psychotropic drugs
             non-relevant to TS or ADHD or abuse of alcohol or drugs.
      

Gender

All

Ages

8 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, 514-251-4015, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03225430

Organization ID

340559


Responsible Party

Principal Investigator

Study Sponsor

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Collaborators

 Canadian Institutes of Health Research (CIHR)

Study Sponsor

, , 


Verification Date

August 2019