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

Tourette Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225430
• Other study ID #: 340559
• Status: Completed
• Phase: N/A
• Start date: April 21, 2016
• Est. completion date: September 1, 2021

Study information

• Verified date: July 2022
• Source: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Syndrome
• Tic Disorder, Chronic Motor or Vocal
• Tic Disorders
• Tics
• Tourette Syndrome
• Tourette Syndrome in Children

Intervention

Behavioral:
• Cognitive behavioural treatment for tics
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.
• Cognitive psychophysiological
Focus on the processes influencing thoughts and behaviors underlying tics.

Locations

Country	Name	City	State
Canada	Centre de recherche de l'Institut universitaire en santé mentale de Montréal	Montréal-Est	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intelligence and executive functioning screening assessment	General intelligence evaluation with subscales of the Wechsler Adult Intelligence Scale or the Wechsler Intelligence Scale for Children, (WAIS-III or WISC-V - Vocabulary, block and similitude).	baseline
Other	Intelligence and executive functioning screening assessment	General intelligence evaluation with subscales of the Wechsler Adult Intelligence Scale or the Wechsler Intelligence Scale for Children, (WAIS-III or WISC-V - Vocabulary, block and similitude).	change from baseline
Other	The Brief Inventory of Executive Function (BRIEF-A)	Is a standardized 75-item questionnaire designed to assess adult's and children's views of their everyday environment.	baseline
Other	The Brief Inventory of Executive Function (BRIEF-A)	Is a standardized 75-item questionnaire designed to assess adult's and children's views of their everyday environment.	change from baseline
Other	Motor function	The assessment of fine motor dexterity by the Purdue pegboard test and for the evaluation of motor speed and control, the finger tapping task will be administered.	baseline
Other	Motor function	The assessment of fine motor dexterity by the Purdue pegboard test and for the evaluation of motor speed and control, the finger tapping task will be administered.	change from baseline
Primary	Yale Global Tic Severity Scale (YGTSS)	The YGTSS is a clinician-rated scale used to assess change in tic severity and impairment due to tics.	baseline
Secondary	determine style of planning actions	The style of planning (STOP) questionnaire was developed to assess everyday style of planning actions. The aim of the STOP was to capture the behavioural and cognitive aspects involved in adequate planning of action in a variety of everyday situations involving routing, complex tasks and both anticipation and enactment.	baseline
Secondary	measure effect of therapy in style of planning score	The style of planning (STOP) questionnaire was developed to assess everyday style of planning actions. The aim of the STOP was to capture the behavioural and cognitive aspects involved in adequate planning of action in a variety of everyday situations involving routing, complex tasks and both anticipation and enactment.	change from baseline
Secondary	measure long term effect of therapy in style of planning score	The style of planning (STOP) questionnaire was developed to assess everyday style of planning actions. The aim of the STOP was to capture the behavioural and cognitive aspects involved in adequate planning of action in a variety of everyday situations involving routing, complex tasks and both anticipation and enactment.	change from baseline at 6 months
Secondary	change in dimensions of perfectionism and use as a predictive variable of treatment issues	The Frost Multidimensional Perfectionism Scale is a self-administered questionnaire of 35 items covering six dimensions of perfectionism.	baseline
Secondary	change in dimensions of perfectionism	The Frost Multidimensional Perfectionism Scale is a self-administered questionnaire of 35 items covering six dimensions of perfectionism.	change from baseline
Secondary	measure the long term effect on dimensions of perfectionism	The Frost Multidimensional Perfectionism Scale is a self-administered questionnaire of 35 items covering six dimensions of perfectionism.	change from baseline at 6 months
Secondary	determine the initial score of symptom of anxiety use as a predictive variable of treatment issues	The Beck Anxiety Inventory consists of a 21-item anxiety symptom checklist rating symptom intensity for the last week on a 0-3 scale.	baseline
Secondary	measure the effect of therapy on symptom of anxiety	The Beck Anxiety Inventory consists of a 21-item anxiety symptom checklist rating symptom intensity for the last week on a 0-3 scale.	change from baseline
Secondary	measure the long term effect of therapy on symptom of anxiety	The Beck Anxiety Inventory consists of a 21-item anxiety symptom checklist rating symptom intensity for the last week on a 0-3 scale.	change from baseline at 6 months
Secondary	determine an initial score of symptom of depression and use as a predictive variable of treatment issues	The Beck Depression Inventory consists of a 21-item relative to depression (a = .91), assesses cognitive, emotional and somatic depressive symptoms.	baseline
Secondary	measure the effect of therapy on symptom of depression	The Beck Depression Inventory consists of a 21-item relative to depression (a = .91), assesses cognitive, emotional and somatic depressive symptoms.	change from baseline
Secondary	measure the long term effect of therapy on symptom of depression	The Beck Depression Inventory consists of a 21-item relative to depression (a = .91), assesses cognitive, emotional and somatic depressive symptoms.	change from baseline at 6 months
Secondary	measure the presence and the impact on treatment issues of major life events	Life Events Survey determine which life events have occurred in the participant life over the past two years.	baseline
Secondary	measure the presence and the impact on treatment issues of major life events	Life Events Survey determine which life events have occurred in the participant life over the past two years.	change from baseline
Secondary	measure the presence and the impact of major life events	Life Events Survey determine which life events have occurred in the participant life over the past two years.	change from baseline at 6 months
Secondary	determine an initial score of individual self-esteem and use as a predictive variable of treatment issues	The Self-Esteem Inventory measure individual self-esteem	baseline
Secondary	measure the effect of the therapy on Self-Esteem	The Self-Esteem Inventory measure individual self-esteem	change from baseline
Secondary	measure the long term effect of the therapy on Self-Esteem and use as a predictor of issues of treatment	The Self-Esteem Inventory measure individual self-esteem	change from baseline at 6 months
Secondary	determine an initial score of individual motor and attentional impulsivity and use as a predictive variable of treatment issues	Barrat Impulsivity Scale measure motor and attentional impulsivity	baseline
Secondary	measure the effect of the therapy on motor and attentional impulsivity	Barrat Impulsivity Scale measure motor and attentional impulsivity.	change from baseline
Secondary	measure the long term effect of the therapy on motor and attentional impulsivity	Barrat Impulsivity Scale measure motor and attentional impulsivity.	change from baseline at 6 months
Secondary	determine a baseline score of quality of life linked with Tourette syndrome	Tourette syndrome quality of life questionnaire measure change in quality of life linked with symptoms of Tourette syndrome	baseline
Secondary	measuring effect of therapy on quality of life	measure change in quality of life linked with symptoms of Tourette syndrome	change from baseline
Secondary	measuring long term effect of therapy on quality of life	measure change in quality of life linked with symptoms of Tourette syndrome	change from baseline at 6 months
Secondary	measuring initial symptoms of ADHD and use as a predictive variable of treatment issues	The Conners Adult and child ADHD Rating Scale - Short: Self-administered is a self-reported questionnaire which measures attention deficit hyperactivity disorder (ADHD) symptoms.	baseline
Secondary	measuring effect of therapy on symptoms of ADHD	The Conners Adult ADHD Rating Scale - Short: Self-administered is a self-reported questionnaire which measures ADHD symptoms.	change from baseline
Secondary	measuring long term effect of therapy on symptoms of ADHD	The Conners Adult ADHD Rating Scale - Short: Self-administered is a self-reported questionnaire which measures ADHD symptoms.	change from baseline at 6 months
Secondary	assessing symptom severity of obsessive-compulsive disorder (OCD) and use as a predictive variable of treatment issues	The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) is assessing symptom severity in older children (i.e., 8-18 years) diagnosed with obsessive-compulsive disorder (OCD).	baseline
Secondary	assessing change of symptom severity of obsessive-compulsive disorder (OCD)	The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) is assessing symptom severity in older children (i.e., 8-18 years) diagnosed with obsessive-compulsive disorder (OCD).	change from baseline
Secondary	assessing long term change of symptom severity of obsessive-compulsive disorder (OCD)	The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) is assessing symptom severity in older children (i.e., 8-18 years) diagnosed with obsessive-compulsive disorder (OCD).	change from baseline at 6 months
Secondary	determine an initial score of level of self-esteem use as a predictive variable of treatment issues	The Culture Free Self-Esteem inventory is a self-report inventories used to determine the level of self-esteem in students ages 6-18 years and adults. It can be used to identify children and adolescents or adults in need of psychological assistance due to self-esteem problems, assess therapeutic progress, and evaluate post-therapy effects.	baseline
Secondary	evaluate post-therapy effects on level of self-esteem	The Culture Free Self-Esteem inventory is a self-report inventories used to determine the level of self-esteem in students ages 6-18 years and adults. It can be used to identify children and adolescents or adults in need of psychological assistance due to self-esteem problems, assess therapeutic progress, and evaluate post-therapy effects.	change from baseline
Secondary	evaluate long term post-therapy effects on level of self-esteem	The Culture Free Self-Esteem inventory is a self-report inventories used to determine the level of self-esteem in students ages 6-18 years and adults. It can be used to identify children and adolescents or adults in need of psychological assistance due to self-esteem problems, assess therapeutic progress, and evaluate post-therapy effects.	change from baseline at 6 months
Secondary	change in the global measure of level of functionning in children, adolescents and adults	The Childrens Global Assessment Scale (CGAS) and the global assessment scale (GAS) they are global measures of level of functioning in children and adolescents and adult. This measures provides a single global rating only, on scale of 0-100. In making their rating, the clinician makes use of the glossary details to determine the meaning of the points on the scale.	baseline
Secondary	change in the global measure of level of functionning in children, adolescents and adults	The Childrens Global Assessment Scale (CGAS) and the global assessment scale (GAS) they are global measures of level of functioning in children and adolescents and adult. This measures provides a single global rating only, on scale of 0-100. In making their rating, the clinician makes use of the glossary details to determine the meaning of the points on the scale.	change from baseline
Secondary	change in the global measure of level of functionning in children, adolescents and adults	The Childrens Global Assessment Scale (CGAS) and the clinical global assessment of functionning scale (GAF) are global measures of level of functioning in children and adolescents and adult. This measures provides a single global rating only, on scale of 0-100. In making their rating, the clinician makes use of the glossary details to determine the meaning of the points on the scale.	change from baseline at 6 months