Investigating Changes in Premonitory Urges During Habit Reversal Training for Tics

NCT06825520 | Recruiting

• 1 other identifier: 00183697
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Tics; Tourette Disorder; Tourette Syndrome in Children; Tourette Syndrome in Adolescence

Keywords

habit reversal training; tics; tourette; tourette's disorder; Tourette syndrome; treatment for tics

Outcome Measures

Primary Outcomes (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.

  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)

• Tic Change as measured by tic counts

  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 (2)

• Participant scores on Treatment Expectancy and Acceptability Questionnaire at baseline

  Given at baseline (first study visit)

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

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

Study Arms (1)

HRT

EXPERIMENTAL

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

Interventions

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.

HRT

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (19)

• 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.

  PMID: 19026406 BACKGROUND

• 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.

  PMID: 21555779 BACKGROUND

• 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.

  PMID: 12777279 BACKGROUND

• 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.

  PMID: 38670665 BACKGROUND

• 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.

  PMID: 36632642 BACKGROUND

• 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.

  PMID: 20483969 BACKGROUND

• 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.

  PMID: 27643476 BACKGROUND

• 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.

  PMID: 2768151 BACKGROUND

• 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.

  PMID: 29029679 BACKGROUND

• 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.

  PMID: 17854764 BACKGROUND

• 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.

  PMID: 17236340 BACKGROUND

• 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.

  PMID: 24778433 BACKGROUND

• 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.

  PMID: 8083137 BACKGROUND

• 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.

  PMID: 34508805 BACKGROUND

• 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.

  PMID: 23369830 BACKGROUND

• Capriotti MR, Piacentini JC, Himle MB, Ricketts EJ, Espil FM, Lee HJ, Turkel JE, Woods DW. Assessing Environmental Consequences of Ticcing in Youth with Chronic Tic Disorders: The Tic Accommodation and Reactions Scale. Child Health Care. 2015;44(3):205-220. doi: 10.1080/02739615.2014.948164. Epub 2014 Dec 9.

  PMID: 27076696 BACKGROUND

• Capriotti MR, Brandt BC, Turkel JE, Lee HJ, Woods DW. Negative Reinforcement and Premonitory Urges in Youth With Tourette Syndrome: An Experimental Evaluation. Behav Modif. 2014 Mar;38(2):276-96. doi: 10.1177/0145445514531015. Epub 2014 Apr 21.

  PMID: 24752420 BACKGROUND

• Capriotti MR, Brandt BC, Ricketts EJ, Espil FM, Woods DW. Comparing the effects of differential reinforcement of other behavior and response-cost contingencies on tics in youth with Tourette syndrome. J Appl Behav Anal. 2012 Summer;45(2):251-63. doi: 10.1901/jaba.2012.45-251.

  PMID: 22844135 BACKGROUND

• American Psychiatric Association. (2022). Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revision (DSM-5-TR). American Psychiatric Association Publishing. https://doi.org/10.1176/appi.books.9780890425787

  BACKGROUND

MeSH Terms

Conditions

Tics; Tourette Syndrome

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Emily I Braley, MS

CONTACT

801-585-7114; theticlab@utah.edu

Michael Himle, PhD

CONTACT

801-581-7529; michael.himle@utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of Utah

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 13, 2025
• Study Start: February 11, 2025
• Primary Completion: July 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication.
• 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.

Locations

US (1)