Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT06825520
Status:
RECRUITING
Last Update Posted:
2025-05-28
First Post:
2025-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating Changes in Premonitory Urges During Habit Reversal Training for Tics
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
Investigating Changes in Premonitory Urges During Habit Reversal Training
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Current research has shown that although tics can be effectively reduced with short-term suppression strategies or habit reversal training (HRT), it remains unclear whether improvement in tic symptoms is accompanied by a reduction in premonitory urges (PUs). Premonitory urges are uncomfortable premonitory sensations that signal a tic is about to occur. Most individuals describe these premonitory sensations as an itch, pressure, energy, or other uncomfortable or "not just right" sensation that is usually localized to the area of the body in which the tic occurs. Furthermore, most individuals report that their PUs increase when tics are suppressed and are reduced or eliminated, albeit temporarily, after the tic is executed. Because the execution of tics reduces aversive PUs, it has been hypothesized that they are strengthened, shaped, and maintained, at least in part, by automatic negative reinforcement. Further investigation into the PU-tic association during treatment is needed. A better understanding of how PUs fluctuate during HRT (both within and between sessions) will potentially provide further insight into its underlying mechanism(s). A better understanding of how PUs fluctuate during HRT (both within and between sessions) will potentially provide further insight into its underlying mechanism(s). Specifically, if tics reduce but PU do not reduce when within and between HRT sessions, such findings would cast doubt on the role of habituation and spur the investigation of alternative hypotheses. The primary aim of this study is to contribute to the current literature on the model of tic maintenance and reduction and the PU-tic association by investigating individual PU severity fluctuations within and between sessions when using HRT to treat tics. Specifically, the study will examine whether subjective ratings of PUs decrease within and between sessions following HRT, as would be expected from the habituation hypothesis.
The primary aim of this study is to contribute to the current literature on the model of tic maintenance and reduction and the PU-tic association by investigating individual PU severity fluctuations within and between sessions when using HRT to treat tics.
The primary aim of this study is to contribute to the current literature on the model of tic maintenance and reduction and the PU-tic association by investigating individual PU severity fluctuations within and between sessions when using HRT to treat tics.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: