Tics, Tourette Syndrome, Tourette Syndrome in Adolescence
Conditions
Keywords
CoPs, Biofeedback, cognitive-psychophysiological therapy, Tourette, Young adults, Tics, 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. \*
Interventions
BEHAVIORALCognitive psychophysiological
Focus on the processes influencing thoughts and behaviors underlying tics.
BEHAVIORALCognitive psychophysiological and Biofeedback
Biofeedback refers to visual exercises that help improve movement control.
Sponsors
Ciusss de L'Est de l'Île de Montréal
Université du Québec a Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Randomization ensures that participants will not immediately know their treatment modality. However, since we do not have a drug under study and the interventions are therapies, the participant may end up knowing their group by themselves. To avoid biases, the evaluators will have no idea which group the participant belongs to. Only the therapists will know the participants' modality, as they are the ones who will administer it.
Eligibility
Sex/Gender
ALL
Age
14 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of TS or to experience bothersome tics; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Invetory | 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. |
| Perdue Pegboard Test | 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. |
| Perceived Stress Scale (PSS-14) | 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. |
| Finger-Tapping Test | 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. |
| DKEFS CWIT | 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. |
| Brief Cannabis Consumption Questionnaire | Only in T1 (pre-test) , up to 4 weeks ( first interview). | To attest the consumption of cannabis. |
| Conners | 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) |
| CY-BOCS | 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) |
| STAI | 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). |
| Perfectionism Scale | 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 |
| STOP | 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) |
| Self-Esteem Inventory | 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. |
| TS-Quality of Life Scale | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bem Sex Role | 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. |
| Wechsler | 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). |
| BRIEF | 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). |
| SCID-5-RV130 | 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. |
| BASC-3-SRP131 | 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. |
Countries
Canada
Contacts
Primary ContactJulie Leclerc, Psychology
Backup ContactAudrey-Ann Lachance
Outcome results
None listed