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TicsNCT06825520

Investigating Changes in Premonitory Urges During Habit Reversal Training for Tics

A study testing Habit Reversal Training in people with Tics and Tourette Disorder, run by University of Utah at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 17 years
What is being tested?
Habit Reversal Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
11 Feb 2025to May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emily I Braley, MS contact

801-585-7114

theticlab@utah.edu

Michael Himle, PhD contact

801-581-7529

michael.himle@utah.edu

United States1 site, 1 recruiting
  • University of Utah

    Salt Lake City, Utah, 84112

    Emily I Braley, MS, 801-585-7114, theticlab@utah.edu

    Recruiting

Other trials in United States

About this study

Official title: 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
Read the 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.

Being tested
Habit Reversal Training
Keywords
habit reversal training, tics, tourette, tourette's disorder, Tourette syndrome, treatment for tics
Medical subject headings
Tics, Tourette Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Habit Reversal TrainingBehavioural

    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.

Study groups in NCT06825520
Study groupRoleWhat they receive
HRTExperimentalParticipants 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)
Receives: Behavioral: Habit Reversal Training

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 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 (1)
  1. Tic Change as measured by tic counts

    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).

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2025
  2. Study start11 Feb 2025
  3. Primary completionJul 2025 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06825520
Sponsor's protocol ID
00183697
Status last verified
May 2025
First submitted
5 Feb 2025
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Woods DW, Walther MR, Bauer CC, Kemp JJ, Conelea CA. The development of stimulus control over tics: a potential explanation for contextually-based variability in the symptoms of Tourette syndrome. Behav Res Ther. 2009 Jan;47(1):41-7. doi: 10.1016/j.brat.2008.10.013. Epub 2008 Oct 21.

    PubMed 19026406
  • Woods DW, Piacentini JC, Scahill L, Peterson AL, Wilhelm S, Chang S, Deckersbach T, McGuire J, Specht M, Conelea CA, Rozenman M, Dzuria J, Liu H, Levi-Pearl S, Walkup JT. Behavior therapy for tics in children: acute and long-term effects on psychiatric and psychosocial functioning. J Child Neurol. 2011 Jul;26(7):858-65. doi: 10.1177/0883073810397046. Epub 2011 May 9.

    PubMed 21555779
  • Wilhelm S, Deckersbach T, Coffey BJ, Bohne A, Peterson AL, Baer L. Habit reversal versus supportive psychotherapy for Tourette's disorder: a randomized controlled trial. Am J Psychiatry. 2003 Jun;160(6):1175-7. doi: 10.1176/appi.ajp.160.6.1175.

    PubMed 12777279
  • Wellen BCM, Ramanujam K, Lavelle M, Capriotti MR, Butner J, Euler MJ, Himle MB. A Test of the Behavioral Model of Tic Disorders Using a Dynamical Systems Framework. Behav Ther. 2024 May;55(3):513-527. doi: 10.1016/j.beth.2023.08.010. Epub 2023 Sep 4.

    PubMed 38670665
  • Tolin DF, Sain KS, Davis E, Gilliam C, Hannan SE, Springer KS, Stubbing J, George JR, Jean A, Goldblum R, Katz BW, Everhardt K, Darrow S, Ohr EE, Young ME, Serchuk MD. The DIAMOND-KID: Psychometric Properties of a Structured Diagnostic Interview for DSM-5 Anxiety, Mood, and Obsessive-Compulsive and Related Disorders in Children and Adolescents. Assessment. 2023 Dec;30(8):2351-2363. doi: 10.1177/10731911221143994. Epub 2023 Jan 11.

    PubMed 36632642
  • Piacentini J, Woods DW, Scahill L, Wilhelm S, Peterson AL, Chang S, Ginsburg GS, Deckersbach T, Dziura J, Levi-Pearl S, Walkup JT. Behavior therapy for children with Tourette disorder: a randomized controlled trial. JAMA. 2010 May 19;303(19):1929-37. doi: 10.1001/jama.2010.607.

    PubMed 20483969
  • McGuire JF, McBride N, Piacentini J, Johnco C, Lewin AB, Murphy TK, Storch EA. The premonitory urge revisited: An individualized premonitory urge for tics scale. J Psychiatr Res. 2016 Dec;83:176-183. doi: 10.1016/j.jpsychires.2016.09.007. Epub 2016 Sep 9.

    PubMed 27643476
  • Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015.

    PubMed 2768151
  • Houghton DC, Capriotti MR, Scahill LD, Wilhelm S, Peterson AL, Walkup JT, Piacentini J, Woods DW. Investigating Habituation to Premonitory Urges in Behavior Therapy for Tic Disorders. Behav Ther. 2017 Nov;48(6):834-846. doi: 10.1016/j.beth.2017.08.004. Epub 2017 Aug 10.

    PubMed 29029679
  • Himle MB, Woods DW, Conelea CA, Bauer CC, Rice KA. Investigating the effects of tic suppression on premonitory urge ratings in children and adolescents with Tourette's syndrome. Behav Res Ther. 2007 Dec;45(12):2964-76. doi: 10.1016/j.brat.2007.08.007. Epub 2007 Aug 10.

    PubMed 17854764
  • Himle MB, Chang S, Woods DW, Pearlman A, Buzzella B, Bunaciu L, Piacentini JC. Establishing the feasibility of direct observation in the assessment of tics in children with chronic tic disorders. J Appl Behav Anal. 2006 Winter;39(4):429-40. doi: 10.1901/jaba.2006.63-06.

    PubMed 17236340
  • Himle MB, Capriotti MR, Hayes LP, Ramanujam K, Scahill L, Sukhodolsky DG, Wilhelm S, Deckersbach T, Peterson AL, Specht MW, Walkup JT, Chang S, Piacentini J. Variables Associated With Tic Exacerbation in Children With Chronic Tic Disorders. Behav Modif. 2014 Mar;38(2):163-83. doi: 10.1177/0145445514531016. Epub 2014 Apr 28.

    PubMed 24778433
  • Kane MJ. Premonitory urges as "attentional tics" in Tourette's syndrome. J Am Acad Child Adolesc Psychiatry. 1994 Jul-Aug;33(6):805-8. doi: 10.1097/00004583-199407000-00005.

    PubMed 8083137
  • Espil FM, Woods DW, Specht MW, Bennett SM, Walkup JT, Ricketts EJ, McGuire JF, Stiede JT, Schild JS, Chang SW, Peterson AL, Scahill L, Wilhelm S, Piacentini JC. Long-term Outcomes of Behavior Therapy for Youth With Tourette Disorder. J Am Acad Child Adolesc Psychiatry. 2022 Jun;61(6):764-771. doi: 10.1016/j.jaac.2021.08.022. Epub 2021 Sep 8.

    PubMed 34508805
  • Crossley E, Seri S, Stern JS, Robertson MM, Cavanna AE. Premonitory urges for tics in adult patients with Tourette syndrome. Brain Dev. 2014 Jan;36(1):45-50. doi: 10.1016/j.braindev.2012.12.010. Epub 2013 Jan 29.

    PubMed 23369830

Questions about this trial

What is this clinical trial studying?

A study testing Habit Reversal Training in people with Tics and Tourette Disorder, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emily I Braley, MS (801-585-7114, theticlab@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06825520, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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