Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-25 @ 4:20 AM
NCT ID:
NCT06825520
Eligibility Criteria:
Inclusion Criteria:
Participants who meet criteria for a DSM-5-TR diagnosis of a TD will be recruited to participate in this study. Participants will be eligible for the study if they
1. present with at least three motor and/or vocal tics and are interested in receiving treatment,
2. report experiencing a PU for each of their target tics with a minimum rating of a 4/8 on a subjective rating (i.e., the Urge Thermometer; Silverman \& Albano, 1996) for each tic,
3. the targeted tics occur, on average, at least once per minute during a 10-minute direct observation,
4. are between the ages of 8 and 17
5. the patient has no planned changes in medication initiation or dosage during their study participation period.
Exclusion Criteria:
1. the presence of any comorbid conditions that are considered a primary treatment concern and/or could interfere with study participation or treatment (i.e., unmanaged ADHD, OCD, anxiety),
2. have previously engaged in CBIT or HRT for more than 2 sessions,
3. a Yale Global Tic Severity Score of 40+ (or 20+ if they present with a primary motor or vocal tic disorder),
4. suspected (based on clinical presentation) that the tics are better attributed to functional neurological symptom disorder per DSM-5-TR criteria (APA, 2022).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT06825520
Study Brief:
Protocol Section:
NCT06825520