About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a diagnosis of TS or to experience bothersome tics;
Be aged 14 to 21 years inclusive at the start of therapy.
Disqualifiers
Present a sensorimotor impairment;
Have a diagnosis of intellectual disability (intelligence quotient below 75);
Alcohol or drug abuse;
A neurological issue (e.g., hemifacial spasms, Huntington's disease);
Trial design
Parallel
Treatments tested in this trial
Cognitive psychophysiological
BehavioralFocus on the processes influencing thoughts and behaviors underlying tics.
Cognitive psychophysiological and Biofeedback
BehavioralBiofeedback refers to visual exercises that help improve movement control.
Treatment groups
Trial outcomes
Primary outcomes
Primary outcome
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).
Secondary outcomes
Conners
Psychosocial measures For ADHD symptoms, the Conners 3 (8-18 years) or Conners' Adult ADHD Rating Scales (CAARS)
CY-BOCS
For OCD symptoms, the Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
STAI
For anxiety symptoms, the State-Trait Anxiety Inventory (STAI).
Perfectionism Scale
The adapted/inadapted Perfectionism Scale
Other outcomes
SCID-5-RV130
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.
BASC-3-SRP131
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.
Bem Sex Role
Sex assigned at birth and gender identity will be assessed using the Bem Sex Role Inventory.
Wechsler
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).
Sponsors and contacts
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Université du Québec a Montréal
Lead sponsor
Ciusss de L'Est de l'Île de Montréal
Collaborator