Recruiting
Phase 2

Behavioral Intervention

Sponsor:

University of Minnesota

Code:

NCT06194305

Conditions

Tourette Syndrome

Persistent Tic Disorder

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

CBIT

Study Details

Brief summary:

Tourette Syndrome and Persistent Motor/Vocal Tic Disorder affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom. Comprehensive Behavioral Intervention for Tics (CBIT) is a manualized treatment focused on tic management skills. During the core CBIT procedure, competing response training, patients learn to inhibit tics by engaging in a competing motor action. The overall objective of this study is to identify bio-behavioral predictors and correlates of response and the most potent aspects of CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Neural, behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded. CBIT process will be measured with a video-based behavioral coding scheme that will be refined and validated during years 1-2 using archival CBIT videos

Conditions

Tourette Syndrome

Persistent Tic Disorder

Study ID

NCT06194305

Start date

Apr 25, 2024

Status verified date

Jul, 2026

Completion date

Feb 19, 2029

Anticipated

Primary completion date

Feb 19, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 10-17 years at time of enrollment.
  • Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance.
  • At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only).
  • Full scale IQ greater than 70.
  • Child participant required to have English fluency to ensure comprehension of study measures and instructions.
  • To increase external validity of findings, we will include participants taking psychotropic medications that have been stable for 4 weeks and expect to remain stable for the study period. Individuals receiving non-tic related psychotherapy involving procedures that overlap with CBIT can be eligible to participate if they refrain from receiving treatment once enrolled through the post-treatment assessment. All concurrent treatments will be monitored.

Exclusion Criteria:

  • Inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG.
  • Active suicidality Previous diagnosis of psychosis, cognitive disability, or structural brain disease that in the investigator opinion would impede participation.
  • History of seizure disorder
  • Active substance abuse or dependence.
  • Presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for comorbidities that commonly occur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met, as only 10-15% of patients with TS have no comorbidities.
  • Concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
  • Psychotropic medication changes in the past 4 weeks and/or plans to change medication during the study period through post-treatment assessment.
  • ≥ 4 previous sessions of CBIT.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: CBIT group

Participants with chronic TICs

Interventions

CBIT

Participants will receive 8 sessions delivered weekly over 10 weeks. All sessions will be video recorded. CBIT components are: 1) Psychoeducation about tics, 2) Functional interventions, 3) Competing response (CR) training, 4) Social support: supportive people (e.g., parent, teacher) , 5) Motivational enhancements, 6) Homework: is assigned each session and typically involves self-monitoring and CR practice. Participants will complete a brief daily homework tracking log in REDCap.

Primary outcome measure

  • Change in the Total Tic Score on the Yale Global Tic Severity Scale (YGTSS). [ Time Frame: 27 weeks ]

Central Contacts and Locations

Central contacts

Sonya Wang, MD

612-301-1454ticlab@umn.edu

Locations

University of California

Recruiting

San Diego, California, United States, 92093

Contacts

Deanna Greene, PhD

deannagreene@ucsd.edu

Principal Investigator:

Deanna Greene, PhD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Sonya Wang

ticlab@umn.edu

Principal Investigator:

Christine Conelea, PhD, LP

More Information

Sponsor

University of Minnesota

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-07-22.