Investigating Changes in Premonitory Urges During Habit Reversal Training for Tics

May 21, 2025 updated by: Emily Braley, University of Utah

Investigating Changes in Premonitory Urges During Habit Reversal Training

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRT
Participants will receive 3 therapist-guided sessions of habit reversal training (1 hour each) for 3 separate identified tics. Participant will also participate in 5 practice sessions per week (approximately 30 minutes sessions each; over the course of 3 weeks) in which participants will practice the skills learned in session with a study team member)
Behavioral: Habit Reversal Training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Given at baseline (first study visit)
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.
Given at post assessment (final study visit) approximately 5 weeks from study initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 13, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00183697

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie results in any publication(s) may be provided to qualified researchers. All data shared will be coded with no identifying information included. Approval of the request by the study primary investigator and execution of all applicable data sharing agreements are prerequisites to the sharing of data with the requesting party.

IPD Sharing Time Frame

Starting 6 months after publication.

IPD Sharing Access Criteria

Qualified researchers are those considered to have academic interests in tic disorders and related conditions, expertise in the scoring and interpretation of the outcome measures administered, and a reasonable and scientifically-sound justification for obtaining participant data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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