Clinical trial NCT06873841: Cognitive-psychophysiological Treatment for Tics in Young People With Tourette's Syndrome With or Without Biofeedback
Official title: Can the Cognitive-Psychophysiological Treatment of Tics be Optimized Through Biofeedback in Adolescents and Emerging Adults With Tourette Syndrome? - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tourette Syndrome
Tics
Tourette Syndrome in Adolescence
Keywords: CoPs
Biofeedback
cognitive-psychophysiological therapy
Tourette
Young adults
Tics
Treatment
Lead sponsor: Université du Québec a Montréal
Sponsor class: OTHER
Collaborators: name: Ciusss de L'Est de l'Île de Montréal
First posted: 2025-03-13
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: \* The project explanations are in English for everyone's ease of understanding, but our study is conducted in French. \*

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of TS as the main issue, as reported by the participant;
* Be aged 14 to 21 years inclusive at the start of therapy.

Exclusion Criteria:

* 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);
* Change medication one month or less before step 1 and up to step 4 (last measurement time) without informing a member of the research team;
* Simultaneously receive another intervention for tics (e.g., psychologist, massage therapist) without informing a research team member.

Primary outcomes:
measure: Primary outcome
timeFrame: 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:
measure: Conners
timeFrame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
measure: CY-BOCS
timeFrame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
measure: STAI
timeFrame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
measure: Perfectionism Scale
timeFrame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
measure: Beck Depression Invetory
timeFrame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
measure: STOP
timeFrame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
measure: Self-Esteem Inventory
timeFrame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
measure: TS-Quality of Life Scale
timeFrame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
measure: Perdue Pegboard Test
timeFrame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
measure: Perceived Stress Scale (PSS-14)
timeFrame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
measure: Finger-Tapping Test
timeFrame: Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)).
measure: DKEFS CWIT
timeFrame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
measure: Brief Cannabis Consumption Questionnaire
timeFrame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
Other outcomes:
measure: SCID-5-RV130
timeFrame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
measure: BASC-3-SRP131
timeFrame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
measure: Bem Sex Role
timeFrame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
measure: Wechsler
timeFrame: Only in T1 (pre-test) , up to 4 weeks (first interview).
measure: BRIEF
timeFrame: Only in T1 (pre-test) , up to 4 weeks ( first interview).
Locations:
city: Montreal
country: Canada
facility: Hôpital en santé mentale Rivière-des-Prairies
state: Quebec
Study officials:
affiliation: Université du Québec à Montréal- UQAM
name: Julie Leclerc, Psychology
role: PRINCIPAL_INVESTIGATOR
affiliation: Université TÉLUQ
name: Marc Lavoie, Psychology
role: STUDY_CHAIR
affiliation: Université du Québec à Montréal-UQAM
name: Marie-France Marin, Psychology
role: STUDY_CHAIR
References: