Cognitive-psychophysiological Treatment for Tics in Young People With Tourette's Syndrome With or Without Biofeedback

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-21
SponsorUniversité du Québec a Montréal

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Cognitive psychophysiological

    Behavioral

    Focus on the processes influencing thoughts and behaviors underlying tics.

  • Cognitive psychophysiological and Biofeedback

    Behavioral

    Biofeedback refers to visual exercises that help improve movement control.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Cognitive-psychophysiological therapy (CoPs).Active comparator 1 intervention
Group B: Cognitive-psychophysiological therapy (CoPs) combined with biofeedback exercises.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

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))

Secondary outcomes

1

Conners

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)).
2

CY-BOCS

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)).
3

STAI

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)).
4

Perfectionism Scale

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)).

Other outcomes

1

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.

Time frame
Only in T1 (pre-test) , up to 4 weeks ( first interview).
2

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.

Time frame
Only in T1 (pre-test) , up to 4 weeks ( first interview).
3

Bem Sex Role

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).
4

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).

Time frame
Only in T1 (pre-test) , up to 4 weeks (first interview).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Université du Québec a Montréal

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Collaborator