Clinical trial NCT03225430: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tic Disorder, Chronic Motor or Vocal
Tourette Syndrome in Children
Tourette Syndrome
Lead sponsor: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-07-21
Enrollment: 144
Sex: ALL
Minimum age (years): 8
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: baseline
Secondary outcomes:
measure: determine style of planning actions
timeFrame: baseline
measure: measure effect of therapy in style of planning score
timeFrame: change from baseline
measure: measure long term effect of therapy in style of planning score
timeFrame: change from baseline at 6 months
measure: change in dimensions of perfectionism and use as a predictive variable of treatment issues
timeFrame: baseline
measure: change in dimensions of perfectionism
timeFrame: change from baseline
measure: measure the long term effect on dimensions of perfectionism
timeFrame: change from baseline at 6 months
measure: determine the initial score of symptom of anxiety use as a predictive variable of treatment issues
timeFrame: baseline
measure: measure the effect of therapy on symptom of anxiety
timeFrame: change from baseline
measure: measure the long term effect of therapy on symptom of anxiety
timeFrame: change from baseline at 6 months
measure: determine an initial score of symptom of depression and use as a predictive variable of treatment issues
timeFrame: baseline
measure: measure the effect of therapy on symptom of depression
timeFrame: change from baseline
measure: measure the long term effect of therapy on symptom of depression
timeFrame: change from baseline at 6 months
measure: measure the presence and the impact on treatment issues of major life events
timeFrame: baseline
measure: measure the presence and the impact on treatment issues of major life events
timeFrame: change from baseline
measure: measure the presence and the impact of major life events
timeFrame: change from baseline at 6 months
measure: determine an initial score of individual self-esteem and use as a predictive variable of treatment issues
timeFrame: baseline
measure: measure the effect of the therapy on Self-Esteem
timeFrame: change from baseline
measure: measure the long term effect of the therapy on Self-Esteem and use as a predictor of issues of treatment
timeFrame: change from baseline at 6 months
measure: determine an initial score of individual motor and attentional impulsivity and use as a predictive variable of treatment issues
timeFrame: baseline
measure: measure the effect of the therapy on motor and attentional impulsivity
timeFrame: change from baseline
measure: measure the long term effect of the therapy on motor and attentional impulsivity
timeFrame: change from baseline at 6 months
measure: determine a baseline score of quality of life linked with Tourette syndrome
timeFrame: baseline
measure: measuring effect of therapy on quality of life
timeFrame: change from baseline
measure: measuring long term effect of therapy on quality of life
timeFrame: change from baseline at 6 months
measure: measuring initial symptoms of ADHD and use as a predictive variable of treatment issues
timeFrame: baseline
measure: measuring effect of therapy on symptoms of ADHD
timeFrame: change from baseline
measure: measuring long term effect of therapy on symptoms of ADHD
timeFrame: change from baseline at 6 months
measure: assessing symptom severity of obsessive-compulsive disorder (OCD) and use as a predictive variable of treatment issues
timeFrame: baseline
measure: assessing change of symptom severity of obsessive-compulsive disorder (OCD)
timeFrame: change from baseline
measure: assessing long term change of symptom severity of obsessive-compulsive disorder (OCD)
timeFrame: change from baseline at 6 months
measure: determine an initial score of level of self-esteem use as a predictive variable of treatment issues
timeFrame: baseline
measure: evaluate post-therapy effects on level of self-esteem
timeFrame: change from baseline
measure: evaluate long term post-therapy effects on level of self-esteem
timeFrame: change from baseline at 6 months
measure: change in the global measure of level of functionning in children, adolescents and adults
timeFrame: baseline
measure: change in the global measure of level of functionning in children, adolescents and adults
timeFrame: change from baseline
measure: change in the global measure of level of functionning in children, adolescents and adults
timeFrame: change from baseline at 6 months
Other outcomes:
measure: Intelligence and executive functioning screening assessment
timeFrame: baseline
measure: Intelligence and executive functioning screening assessment
timeFrame: change from baseline
measure: The Brief Inventory of Executive Function (BRIEF-A)
timeFrame: baseline
measure: The Brief Inventory of Executive Function (BRIEF-A)
timeFrame: change from baseline
measure: Motor function
timeFrame: baseline
measure: Motor function
timeFrame: change from baseline
Locations:
city: Montréal-Est
country: Canada
facility: Centre de recherche de l'Institut universitaire en santé mentale de Montréal
state: Quebec
Study officials:
References: