- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03225430
Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Quebec
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Montréal-Est, Quebec, Canada, H1N 3V2
- Centre de recherche de l'Institut universitaire en santé mentale de Montréal
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Comprehensive Behavioural Intervention
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. |
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.
Other Names:
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Experimental: Cognitive psychophysiological (CoPs)
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.
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Focus on the processes influencing thoughts and behaviors underlying tics.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
determine style of planning actions
Time Frame: baseline
|
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
|
measure effect of therapy in style of planning score
Time Frame: change from baseline
|
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
|
measure long term effect of therapy in style of planning score
Time Frame: change from baseline at 6 months
|
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
|
change in dimensions of perfectionism and use as a predictive variable of treatment issues
Time Frame: baseline
|
The Frost Multidimensional Perfectionism Scale is a self-administered questionnaire of 35 items covering six dimensions of perfectionism.
|
baseline
|
change in dimensions of perfectionism
Time Frame: change from baseline
|
The Frost Multidimensional Perfectionism Scale is a self-administered questionnaire of 35 items covering six dimensions of perfectionism.
|
change from baseline
|
measure the long term effect on dimensions of perfectionism
Time Frame: change from baseline at 6 months
|
The Frost Multidimensional Perfectionism Scale is a self-administered questionnaire of 35 items covering six dimensions of perfectionism.
|
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
|
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
|
measure the effect of therapy on symptom of anxiety
Time Frame: change from baseline
|
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
|
measure the long term effect of therapy on symptom of anxiety
Time Frame: change from baseline at 6 months
|
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
|
determine an initial score of symptom of depression and use as a predictive variable of treatment issues
Time Frame: baseline
|
The Beck Depression Inventory consists of a 21-item relative to depression (α = .91),
assesses cognitive, emotional and somatic depressive symptoms.
|
baseline
|
measure the effect of therapy on symptom of depression
Time Frame: change from baseline
|
The Beck Depression Inventory consists of a 21-item relative to depression (α = .91),
assesses cognitive, emotional and somatic depressive symptoms.
|
change from baseline
|
measure the long term effect of therapy on symptom of depression
Time Frame: change from baseline at 6 months
|
The Beck Depression Inventory consists of a 21-item relative to depression (α = .91),
assesses cognitive, emotional and somatic depressive symptoms.
|
change from baseline at 6 months
|
measure the presence and the impact on treatment issues of major life events
Time Frame: baseline
|
Life Events Survey determine which life events have occurred in the participant life over the past two years.
|
baseline
|
measure the presence and the impact on treatment issues of major life events
Time Frame: change from baseline
|
Life Events Survey determine which life events have occurred in the participant life over the past two years.
|
change from baseline
|
measure the presence and the impact of major life events
Time Frame: change from baseline at 6 months
|
Life Events Survey determine which life events have occurred in the participant life over the past two years.
|
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
|
The Self-Esteem Inventory measure individual self-esteem
|
baseline
|
measure the effect of the therapy on Self-Esteem
Time Frame: change from baseline
|
The Self-Esteem Inventory measure individual self-esteem
|
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
|
The Self-Esteem Inventory measure individual self-esteem
|
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
|
Barrat Impulsivity Scale measure motor and attentional impulsivity
|
baseline
|
measure the effect of the therapy on motor and attentional impulsivity
Time Frame: change from baseline
|
Barrat Impulsivity Scale measure motor and attentional impulsivity.
|
change from baseline
|
measure the long term effect of the therapy on motor and attentional impulsivity
Time Frame: change from baseline at 6 months
|
Barrat Impulsivity Scale measure motor and attentional impulsivity.
|
change from baseline at 6 months
|
determine a baseline score of quality of life linked with Tourette syndrome
Time Frame: baseline
|
Tourette syndrome quality of life questionnaire measure change in quality of life linked with symptoms of Tourette syndrome
|
baseline
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measuring effect of therapy on quality of life
Time Frame: change from baseline
|
measure change in quality of life linked with symptoms of Tourette syndrome
|
change from baseline
|
measuring long term effect of therapy on quality of life
Time Frame: change from baseline at 6 months
|
measure change in quality of life linked with symptoms of Tourette syndrome
|
change from baseline at 6 months
|
measuring initial symptoms of ADHD and use as a predictive variable of treatment issues
Time Frame: baseline
|
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
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measuring effect of therapy on symptoms of ADHD
Time Frame: change from baseline
|
The Conners Adult ADHD Rating Scale - Short: Self-administered is a self-reported questionnaire which measures ADHD symptoms.
|
change from baseline
|
measuring long term effect of therapy on symptoms of ADHD
Time Frame: change from baseline at 6 months
|
The Conners Adult ADHD Rating Scale - Short: Self-administered is a self-reported questionnaire which measures ADHD symptoms.
|
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
|
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
|
assessing change of symptom severity of obsessive-compulsive disorder (OCD)
Time Frame: change from baseline
|
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
|
assessing long term change of symptom severity of obsessive-compulsive disorder (OCD)
Time Frame: change from baseline at 6 months
|
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
|
determine an initial score of level of self-esteem use as a predictive variable of treatment issues
Time Frame: baseline
|
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
|
evaluate post-therapy effects on level of self-esteem
Time Frame: change from baseline
|
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
|
evaluate long term post-therapy effects on level of self-esteem
Time Frame: change from baseline at 6 months
|
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
|
change in the global measure of level of functionning in children, adolescents and adults
Time Frame: baseline
|
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
|
change in the global measure of level of functionning in children, adolescents and adults
Time Frame: change from baseline
|
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
|
change in the global measure of level of functionning in children, adolescents and adults
Time Frame: change from baseline at 6 months
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intelligence and executive functioning screening assessment
Time Frame: baseline
|
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
|
Intelligence and executive functioning screening assessment
Time Frame: change from baseline
|
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
|
The Brief Inventory of Executive Function (BRIEF-A)
Time Frame: baseline
|
Is a standardized 75-item questionnaire designed to assess adult's and children's views of their everyday environment.
|
baseline
|
The Brief Inventory of Executive Function (BRIEF-A)
Time Frame: change from baseline
|
Is a standardized 75-item questionnaire designed to assess adult's and children's views of their everyday environment.
|
change from baseline
|
Motor function
Time Frame: baseline
|
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
|
Motor function
Time Frame: change from baseline
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Disease
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Syndrome
- Tourette Syndrome
- Tic Disorders
- Tics
Other Study ID Numbers
- 340559
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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