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NCT Number: NCT06825520

Investigating Changes in Premonitory Urges During Habit Reversal Training for Tics

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

  • 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).

Treatment and study plan

Habit Reversal Training

Behavioral

Participants learn to identify when their tics occur and then learn a competing response to engage in instead of the 3 identified tics and then practice competing responses learned in session during the practice sessions throughout the week.

Primary outcomes

  1. Premonitory Urge (PU) Severity as measured by the urge thermometer

    Time frame: 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

    Premonitory urge (PU) severity is an subjective measure of PU ratings while participants are implementing their competing response during study treatment sessions or practice sessions. The Urge Thermometer is an adapted version of the "feelings thermometer" from the Anxiety Disorders Interview Schedule for DSM-IV. It is a 9-point rating scale, ranging from 0 to 8 with higher scores indicating stronger urge experiences, designed to efficiently collect the patients' subjective rating of the severity/intensity of their urge.

Secondary outcomes

  1. Tic Change as measured by tic counts

    Time frame: 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

    Coding for tics will utilize 10-second partial interval coding in which the presence or absence of each target tic is recorded as present or absent in each 10-s interval. Tic rate will be calculated by dividing the number of intervals in which each target tic is present by the total number of intervals and multiplying this number by 100%. Ten-second partial interval coding has been shown to provide a reliable and valid measure of tics over observation periods of 5 minutes or longer (Himle et al., 2006).

Other outcomes

  1. Participant scores on Treatment Expectancy and Acceptability Questionnaire at baseline

    Time frame: Given at baseline (first study visit)

    At the baseline assessment, participants will be asked to rate how much they believe in the treatment on a 5-point scale, and how much they think their tics will improve on a 5-point scale with additional questions from the Credibility/Expectancy Questionnaire (Devilly & Borkovec, 2000). Scores can range from 3 to 15. Participants will also be asked to rate treatment acceptability at pre-treatment (including questions about the acceptability, ethicality, effectiveness, and potential negative side effects of the treatment). Questions are rated on a 1 to 7 scale, with lower scores representing more negative impressions and reactions to the proposed treatment. Scores can be totaled ranging from 6 to 42.

  2. Patient scores on Satisfaction with Therapy and Therapist Scale- Revised (STTS-R) post treatment

    Time frame: Given at post assessment (final study visit) approximately 5 weeks from study initiation

    The STTS is a commonly used 13-item self-report measure that assesses patients' satisfaction with their therapist and the treatment that they received. Each item is rated on a 5-point Likert-type scale with higher scores indicating greater overall satisfaction with treatment and the therapist. Scores range from 15 to 65.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily I Braley, MS

CONTACT

[email protected]

801-585-7114

Michael Himle, PhD

CONTACT

[email protected]

801-581-7529

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Investigating Changes in Premonitory Urges During Habit Reversal Training

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 13, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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