Investigating Changes in Premonitory Urges During Habit Reversal Training for Tics (NCT06825520) | Clinical Trial Compass
RecruitingNot Applicable
Investigating Changes in Premonitory Urges During Habit Reversal Training for Tics
United States6 participantsStarted 2025-02-11
Plain-language summary
The primary aim of this study is to learn more about premonitory urges (PU) when using Habit Reversal Training (HRT) to treat tics.
The main focus of this study is to investigate if and when PU change during tic treatment sessions and between tic treatment sessions.
Participants will:
* Attend 5 study visits (approximately 1 to 1.5 hours each) for an intake, habit reversal training for 3 separate tics, and a post assessment
* Attend 5 practice sessions (approximately 30 minutes each) over a week for 3 weeks (total 15 practice sessions)
* Study visits and practice sessions will take place in person and online via secure videoconference
Who can participate
Age range
8 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. present with at least three motor and/or vocal tics and are interested in receiving treatment,
. 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,
. the targeted tics occur, on average, at least once per minute during a 10-minute direct observation,
. are between the ages of 8 and 17
. the patient has no planned changes in medication initiation or dosage during their study participation period.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Premonitory Urge (PU) Severity as measured by the urge thermometer
Timeframe: PU severity will be measured during a 10 minute baseline observation; approximately 15 minutes or until 5 CR initiations have occurred, whichever is longer during each of the 3 HRT sessions and 15 practice sessions; during the 15 minute post assessment
. 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),
. have previously engaged in CBIT or HRT for more than 2 sessions,
. a Yale Global Tic Severity Score of 40+ (or 20+ if they present with a primary motor or vocal tic disorder),
. suspected (based on clinical presentation) that the tics are better attributed to functional neurological symptom disorder per DSM-5-TR criteria (APA, 2022).