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| Name | Class |
|---|---|
| Ciusss de L'Est de l'Île de Montréal | OTHER |
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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:
Researchers will compare if the biofeedback treatment will improve the severity of tics.
* The project explanations are in English for everyone's ease of understanding, but our study is conducted in French. *
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-psychophysiological therapy (CoPs). | Active Comparator | Six therapeutic steps: 1) Awareness training; 2) Profile of high/low-risk situations for tics; 3) Muscular discrimination; 4) Reduction of sensorimotor activation and modification of action planning style; 5) Cognitive, metacognitive, and behavioral restructuring in high-risk tic situations; 6) Generalization and relapse prevention. The individual sessions last 80 minutes: 55 minutes of therapy, 20 minutes of active listening and 5 minutes for a computer activity. The active listening and activity are unrelated to the analyses but ensure that treatment modalities are equivalent in duration and use of a computer. Participants will be informed about the duration of the therapy (10 to 12 sessions weekly) and that its completion requires continuous attendance at the sessions. The program has been adapted for youth with a treatment guide containing examples and exercises tailored for better understanding. Adolescents aged 14 to 17 will receive this manual to support their comprehension. |
|
| Cognitive-psychophysiological therapy (CoPs) combined with biofeedback exercises. | Experimental | After each 55-minute CoPs session (same protocol as arm 1), 25 minutes will be dedicated to biofeedback exercises (80 minutes total). This 25-minute period includes 2 minutes to record the baseline resting level, 15 minutes for the active biofeedback session, and 2 minutes for the second resting measurement. Active electromyographic (EMG) biofeedback will take the form of computer-generated graphs displayed on a screen at 2 meters (horizontal angle). Changes in muscle activity will cause the movement of a balance with a silvered ball; the graphical feedback of this stimulus is particularly effective in capturing the participant's attention and interactive engagement. The goal is to contract the arm muscle to keep the ball balanced for 5 minutes for each arm, then 5 minutes with both arms (15 minutes). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive psychophysiological | Behavioral | Focus on the processes influencing thoughts and behaviors underlying tics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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)) |
| Measure | Description | Time Frame |
|---|---|---|
| Conners | Psychosocial measures For ADHD symptoms, the Conners 3 (8-18 years) or Conners' Adult ADHD Rating Scales (CAARS) | Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)). |
| CY-BOCS |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Only in T1 (pre-test) , up to 4 weeks ( first interview). |
| BASC-3-SRP131 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Leclerc, Psychology | Contact | 1-514-987-3000 | 5267 | leclerc.julie@uqam.ca |
| Audrey-Ann Lachance | Contact | 1-514-323-7260 | 2381 | audrey-ann.lachance.cnmtl@ssss.gouv.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Julie Leclerc, Psychology | Université du Québec à Montréal- UQAM | Principal Investigator |
| Marc Lavoie, Psychology | Université TÉLUQ | Study Chair |
| Marie-France Marin, Psychology |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal, Hôpital Rivières-des-Prairies | Recruiting | Montreal | Quebec | H1E 1A4 | Canada |
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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.
| Cognitive psychophysiological and Biofeedback | Behavioral | Biofeedback refers to visual exercises that help improve movement control. |
|
For OCD symptoms, the Yale-Brown Obsessive-Compulsive Scale (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)). |
| STAI | For anxiety symptoms, the State-Trait Anxiety Inventory (STAI). | Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)). |
| Perfectionism Scale | The adapted/inadapted 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)). |
| Beck Depression Invetory | For mood-related symptoms, the Beck Depression Inventory will be used. | Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)). |
| STOP | The Style of Planning Action (STOP) | Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)). |
| Self-Esteem Inventory | The short version of the 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)). |
| TS-Quality of Life Scale | TS-Quality of Life Scale will also be used. | Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)). |
| Perdue Pegboard Test | 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. | Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)). |
| Perceived Stress Scale (PSS-14) | 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. | Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)). |
| Finger-Tapping Test | The Finger-Tapping Test will be administered to assess speed and motor control. | Administered trough study completion, an average of 1 year (T1 pre, T2 post, T3 follow up (3 months), T4 follow up (6 months)). |
| DKEFS CWIT | Participants will be assessed with the 4 sections of the DKEFS CWIT: color naming, word reading, inhibition. | Only in T1 (pre-test) , up to 4 weeks ( first interview). |
| Brief Cannabis Consumption Questionnaire | To attest the consumption of cannabis. | 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. |
| Only in T1 (pre-test) , up to 4 weeks ( first interview). |
| Bem Sex Role | Sex assigned at birth and gender identity will be assessed using the Bem Sex Role Inventory. | Only in T1 (pre-test) , up to 4 weeks ( first interview). |
| 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). | Only in T1 (pre-test) , up to 4 weeks (first interview). |
| BRIEF | Executive functions will also be screened using the Brief Inventory of Executive Function (BRIEF), (version for ages 14-18 years or adults). | Only in T1 (pre-test) , up to 4 weeks ( first interview). |
| Université du Québec à Montréal-UQAM |
| Study Chair |
| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| D020323 | Tics |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
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