Tic Disorder, Chronic Motor or VocalNCT03225430
Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders
A study testing Cognitive behavioural treatment for tics and Cognitive psychophysiological in people with Tic Disorder, Chronic Motor or Vocal and Tourette Syndrome in Children, run by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 8 to 65 years
- Conditions the study is for
- Tic Disorder, Chronic Motor or Vocal, Tourette Syndrome in Children, Tourette Syndrome
- What is being tested?
- Cognitive behavioural treatment for tics and Cognitive psychophysiological
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteCanada
- Study dates
- 21 Apr 2016to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche de l'Institut universitaire en santé mentale de Montréal
Montreal East, Quebec, H1N 3V2
About this study
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.
Read the 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.
- Being tested
- Cognitive behavioural treatment for tics, Cognitive psychophysiological
- Medical subject headings
- Tic Disorders, Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioural treatment for ticsBehavioural
Also called CBIT
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 psychophysiologicalBehavioural
Also called CoPs
Focus on the processes influencing thoughts and behaviors underlying tics.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Behavioural Intervention | Active comparator | 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. Receives: Behavioral: Cognitive behavioural treatment for tics |
| Cognitive psychophysiological (CoPs) | Experimental | The participant will received a rational about the treatment and awareness training about tics and creating list of tics. He will identifying high and low risk situations provoking tics, do video record and make a list of inconveniences of tic. He will do a screening session of the video and muscle discrimination exercises. Worked on a situational profile with a Kelly's grill and beginning relaxation and breathing exercises. He will identifying style of planning and work on it to do an advantages and inconveniences list to adopt this style. Some behavioral and cognitive re structuration about style of planning and how to modifying. At the end, he will received a relapse prevention informations and how to generalize the learnings and a record of the therapy. Finally, he will have to practice all this techniques at home for four week and do a last session to discuss home practice and received strategies for the future. Receives: Behavioral: Cognitive psychophysiological |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (36)
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.
Measured: baseline
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.
Measured: change from baseline
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.
Measured: change from baseline at 6 months
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.
Measured: baseline
change in dimensions of perfectionism
The Frost Multidimensional Perfectionism Scale is a self-administered questionnaire of 35 items covering six dimensions of perfectionism.
Measured: change from baseline
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.
Measured: change from baseline at 6 months
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.
Measured: baseline
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.
Measured: change from baseline
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.
Measured: change from baseline at 6 months
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 (α = .91), assesses cognitive, emotional and somatic depressive symptoms.
Measured: baseline
measure the effect of therapy on symptom of depression
The Beck Depression Inventory consists of a 21-item relative to depression (α = .91), assesses cognitive, emotional and somatic depressive symptoms.
Measured: change from baseline
measure the long term effect of therapy on symptom of depression
The Beck Depression Inventory consists of a 21-item relative to depression (α = .91), assesses cognitive, emotional and somatic depressive symptoms.
Measured: change from baseline at 6 months
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.
Measured: baseline
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.
Measured: change from baseline
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.
Measured: change from baseline at 6 months
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
Measured: baseline
measure the effect of the therapy on Self-Esteem
The Self-Esteem Inventory measure individual self-esteem
Measured: change from baseline
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
Measured: change from baseline at 6 months
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
Measured: baseline
measure the effect of the therapy on motor and attentional impulsivity
Barrat Impulsivity Scale measure motor and attentional impulsivity.
Measured: change from baseline
measure the long term effect of the therapy on motor and attentional impulsivity
Barrat Impulsivity Scale measure motor and attentional impulsivity.
Measured: change from baseline at 6 months
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
Measured: baseline
measuring effect of therapy on quality of life
measure change in quality of life linked with symptoms of Tourette syndrome
Measured: change from baseline
measuring long term effect of therapy on quality of life
measure change in quality of life linked with symptoms of Tourette syndrome
Measured: change from baseline at 6 months
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.
Measured: baseline
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.
Measured: change from baseline
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.
Measured: change from baseline at 6 months
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).
Measured: baseline
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).
Measured: change from baseline
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).
Measured: change from baseline at 6 months
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.
Measured: baseline
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.
Measured: change from baseline
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.
Measured: change from baseline at 6 months
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.
Measured: baseline
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.
Measured: change from baseline
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.
Measured: change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start21 Apr 2016
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tic Disorder, Chronic Motor or VocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Frederick Aardema, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225430
- Sponsor's protocol ID
- 340559
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2017
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders
- ClinicalTrials.gov ID
- NCT03225430
- Acronym / sponsor ID
- 340559
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire en santé Mentale de MontréalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 21 Apr 2016 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Behavioural Intervention | Active comparator | Behavioral: Cognitive behavioural treatment for ticsParticipant 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. |
| Cognitive psychophysiological (CoPs) | Experimental | Behavioral: Cognitive psychophysiologicalThe participant will received a rational about the treatment and awareness training about tics and creating list of tics. He will identifying high and low risk situations provoking tics, do video record and make a list of inconveniences of tic. He will do a screening session of the video and muscle discrimination exercises. Worked on a situational profile with a Kelly's grill and beginning relaxation and breathing exercises. He will identifying style of planning and work on it to do an advantages and inconveniences list to adopt this style. Some behavioral and cognitive re structuration about style of planning and how to modifying. At the end, he will received a relapse prevention informations and how to generalize the learnings and a record of the therapy. Finally, he will have to practice all this techniques at home for four week and do a last session to discuss home practice and received strategies for the future. |
Who may qualify
- Ages
- 8 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioural treatment for ticsAlso: CBITMainly 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. | Behavioural | Comprehensive Behavioural Intervention |
| Cognitive psychophysiologicalAlso: CoPsFocus on the processes influencing thoughts and behaviors underlying tics. | Behavioural | Cognitive psychophysiological (CoPs) |
Primary outcome
Yale Global Tic Severity Scale (YGTSS)
Time frame: baseline
The YGTSS is a clinician-rated scale used to assess change in tic severity and impairment due to tics.
36 secondary outcomes
determine style of planning actions
Time frame: baseline
measure effect of therapy in style of planning score
Time frame: change from baseline
measure long term effect of therapy in style of planning score
Time frame: change from baseline at 6 months
change in dimensions of perfectionism and use as a predictive variable of treatment issues
Time frame: baseline
change in dimensions of perfectionism
Time frame: change from baseline
measure the long term effect on dimensions of perfectionism
Time frame: change from baseline at 6 months
determine the initial score of symptom of anxiety use as a predictive variable of treatment issues
Time frame: baseline
measure the effect of therapy on symptom of anxiety
Time frame: change from baseline
measure the long term effect of therapy on symptom of anxiety
Time frame: change from baseline at 6 months
determine an initial score of symptom of depression and use as a predictive variable of treatment issues
Time frame: baseline
measure the effect of therapy on symptom of depression
Time frame: change from baseline
measure the long term effect of therapy on symptom of depression
Time frame: change from baseline at 6 months
measure the presence and the impact on treatment issues of major life events
Time frame: baseline
measure the presence and the impact on treatment issues of major life events
Time frame: change from baseline
measure the presence and the impact of major life events
Time frame: change from baseline at 6 months
determine an initial score of individual self-esteem and use as a predictive variable of treatment issues
Time frame: baseline
measure the effect of the therapy on Self-Esteem
Time frame: change from baseline
measure the long term effect of the therapy on Self-Esteem and use as a predictor of issues of treatment
Time frame: change from baseline at 6 months
determine an initial score of individual motor and attentional impulsivity and use as a predictive variable of treatment issues
Time frame: baseline
measure the effect of the therapy on motor and attentional impulsivity
Time frame: change from baseline
measure the long term effect of the therapy on motor and attentional impulsivity
Time frame: change from baseline at 6 months
determine a baseline score of quality of life linked with Tourette syndrome
Time frame: baseline
measuring effect of therapy on quality of life
Time frame: change from baseline
measuring long term effect of therapy on quality of life
Time frame: change from baseline at 6 months
measuring initial symptoms of ADHD and use as a predictive variable of treatment issues
Time frame: baseline
measuring effect of therapy on symptoms of ADHD
Time frame: change from baseline
measuring long term effect of therapy on symptoms of ADHD
Time frame: change from baseline at 6 months
assessing symptom severity of obsessive-compulsive disorder (OCD) and use as a predictive variable of treatment issues
Time frame: baseline
assessing change of symptom severity of obsessive-compulsive disorder (OCD)
Time frame: change from baseline
assessing long term change of symptom severity of obsessive-compulsive disorder (OCD)
Time frame: change from baseline at 6 months
determine an initial score of level of self-esteem use as a predictive variable of treatment issues
Time frame: baseline
evaluate post-therapy effects on level of self-esteem
Time frame: change from baseline
evaluate long term post-therapy effects on level of self-esteem
Time frame: change from baseline at 6 months
change in the global measure of level of functionning in children, adolescents and adults
Time frame: baseline
change in the global measure of level of functionning in children, adolescents and adults
Time frame: change from baseline
change in the global measure of level of functionning in children, adolescents and adults
Time frame: change from baseline at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioural treatment for tics and Cognitive psychophysiological in people with Tic Disorder, Chronic Motor or Vocal and Tourette Syndrome in Children, run by Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Global Tic Severity Scale (YGTSS) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.