Clinical trial NCT06825520: Investigating Changes in Premonitory Urges During Habit Reversal Training for Tics
Official title: Investigating Changes in Premonitory Urges During Habit Reversal Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tics
Tourette Disorder
Tourette Syndrome in Children
Tourette Syndrome in Adolescence
Keywords: habit reversal training
tics
tourette
tourette&#39;s disorder
Tourette syndrome
treatment for tics
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 6
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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.

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).

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Tic Change as measured by tic counts
timeFrame: Tics will be counted 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
Other outcomes:
measure: Participant scores on Treatment Expectancy and Acceptability Questionnaire at baseline
timeFrame: Given at baseline (first study visit)
measure: Patient scores on Satisfaction with Therapy and Therapist Scale- Revised (STTS-R) post treatment
timeFrame: Given at post assessment (final study visit) approximately 5 weeks from study initiation
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
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