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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03225430
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Frederick Aardema, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

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.

Condition or disease Intervention/treatment Phase
Tic Disorder, Chronic Motor or Vocal Tourette Syndrome in Children Tourette Syndrome Behavioral: Cognitive behavioural treatment for tics Behavioral: Cognitive psychophysiological Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Assessors will receive no information on participant history and psychopathology. All evaluation sessions will be audio-recorded for reliability and to ensure that treatment status is not divulged. The Assessors will be separated from the therapists by geographical location site and will sign agreements not to discuss cases in the study with any other team member. Child and adult participants will agree not to discuss treatment or therapy during evaluation. Management of assessors will be delegated to a separate clinical coordinator who will assume overall responsibility for evaluations and preempting any direct contact between the principal investigator and Co-investigators and the assessors.
Primary Purpose: Treatment
Official Title: Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders
Actual Study Start Date : April 21, 2016
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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.

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.
Other Name: CBIT

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.
Behavioral: Cognitive psychophysiological
Focus on the processes influencing thoughts and behaviors underlying tics.
Other Name: CoPs




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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

  17. measure the effect of the therapy on Self-Esteem [ Time Frame: change from baseline ]
    The Self-Esteem Inventory measure individual self-esteem

  18. 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

  19. 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

  20. measure the effect of the therapy on motor and attentional impulsivity [ Time Frame: change from baseline ]
    Barrat Impulsivity Scale measure motor and attentional impulsivity.

  21. 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.

  22. 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

  23. 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

  24. 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

  25. 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.

  26. 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.

  27. 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.

  28. 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).

  29. 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).

  30. 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).

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.


Other Outcome Measures:
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225430


Contacts
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Contact: Kieron O'Connor, Ph. D. 514-251-4015 ext 2343 kieron.oconnor@umontreal.ca
Contact: Leclerc Julie, Ph. D. 514-251-4015 ext 2340 leclerc.julie@uqam.ca

Locations
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Canada, Quebec
Centre de recherche de l'Institut universitaire en santé mentale de Montréal Recruiting
Montréal-Est, Quebec, Canada, H1N 3V2
Contact: Philippe Valois, bachelor    514-251-4015 ext 3585    pvalois.iusmm@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Canadian Institutes of Health Research (CIHR)

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Responsible Party: Frederick Aardema, Professeur titulaire, Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
ClinicalTrials.gov Identifier: NCT03225430    
Other Study ID Numbers: 340559
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tourette Syndrome
Tics
Tic Disorders
Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms