NCT Number: NCT06873841
The goal of this clinical trial is to compare the effectiveness of CoPs therapy with or without the therapeutic component of biofeedback in treating tics in Tourette Syndrome with emerging young adults.
Hypotheses:
1. The CoPs+Biofeedback treatment will improve the severity of tics (YGTSS) and the Clinical Global Impression, surpassing the clinical significance threshold of CoPs treatment alone. 2. We expect that the identified variables (psychosocial, neurocognitive, biological) will predict the improvement of tics.
Researchers will compare if the biofeedback treatment will improve the severity of tics.
* In the pre-test, participants will undergo two interviews, each lasting 3 hours. These interviews will assess (through a battery of tests) the severity of tics as well as the psychosocial, biological, and neurocognitive aspects of functioning. A general assessment of intelligence and executive functions will also be conducted. * They will next attend 10 to 12 therapy sessions, with or without biofeedback. (The biofeedback component is explained in more detail in the ''Study Design'' section). * The post-test follow-ups consist of two evaluations: one 3 months after the end of the treatment and the other 6 months after. The evaluation will be done using the same battery of tests as during the pre-test interview.
Interested in participating?
Request Info14 year–21 year
All sexes
Interventional
Not applicable
Montreal, Quebec, H1E 1A4, Canada
Location status: Recruiting
Audrey-Ann Lachance
CONTACT
5143237260 ext. 2381
Julie Leclerc
CONTACT
514-323-7260 ext. 2190
Julie Leclerc
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Focus on the processes influencing thoughts and behaviors underlying tics.
Biofeedback refers to visual exercises that help improve movement control.
Time frame: The YGTSS is administered trough the study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months))
The Yale Global Tic Severity Scale (YGTSS) provides an assessment of motor and vocal tics based on 5 dimensions: number, frequency, intensity, complexity, and interference. A subtotal of 50 is used to determine the severity of the tics. A separate scale assesses impairment, or the overall effect of tic disorders on daily functioning, with another subtotal of 50. In this study, only the tic severity score out of 50 will be used (comparable to other studies focusing on tics).
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
Psychosocial measures For ADHD symptoms, the Conners 3 (8-18 years) or Conners' Adult ADHD Rating Scales (CAARS)
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
For OCD symptoms, the Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
For anxiety symptoms, the State-Trait Anxiety Inventory (STAI).
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
The adapted/inadapted Perfectionism Scale
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
For mood-related symptoms, the Beck Depression Inventory will be used.
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
The Style of Planning Action (STOP)
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
The short version of the Self-Esteem Inventory.
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
TS-Quality of Life Scale will also be used.
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
The evaluation of fine motor dexterity using the Purdue Pegboard will determine the baseline equivalence between groups and test functional differences after treatment. The Finger-Tapping Test will be administered to assess speed and motor control.
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
We will collect a hair sample to measure the cortisol levels of the participants: a 14-item Perceived Stress Scale (PSS-14) will be administered at the 4 time points of measurement.
Time frame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
The Finger-Tapping Test will be administered to assess speed and motor control.
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
Participants will be assessed with the 4 sections of the DKEFS CWIT: color naming, word reading, inhibition.
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
To attest the consumption of cannabis.
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
The Structured Clinical Interview for DSM-5 - Research (SCID-5-RV130) will allow for clinical screening of disorders that may present a differential or comorbid diagnosis with PTSD, which could impact treatment engagement or outcomes.
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
The Behavioral Assessment System, 3rd Edition - Self-Report of Personality (BASC-3-SRP131) will be administered to provide an overall profile of affect and behavior, complementing the SCID-5-RV.
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
Sex assigned at birth and gender identity will be assessed using the Bem Sex Role Inventory.
Time frame: Only in T1 (pre-test) , up to 4 weeks (first interview).
General intelligence will be evaluated through subscales of the Wechsler Intelligence Scale for Children/Adults, depending on the participant's age (WAIS-IV, WISC-V: Vocabulary, Matrices).
Time frame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
Executive functions will also be screened using the Brief Inventory of Executive Function (BRIEF), (version for ages 14-18 years or adults).
Contact information is provided by the study sponsor or research team.
Audrey-Ann Lachance
CONTACT
1-514-323-7260 ext. 2381
Julie Leclerc, Psychology
CONTACT
1-514-987-3000 ext. 5267
Université du Québec a Montréal
Other
Can the Cognitive-Psychophysiological Treatment of Tics be Optimized Through Biofeedback in Adolescents and Emerging Adults With Tourette Syndrome? - A Randomized Clinical Trial
Acronym: CoBRa
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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