Modeling Tic Change During Behavior Therapy for Tics

NCT06270251 | Recruiting

• 1 other identifier: PSYCH-2023-32292
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics 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 of Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders. CBIT is a manualized treatment focused on increasing tic controllability. Its core procedure is competing response training (CRT), in which patients learn to inhibit tics by learning and applying a competing motor action to one tic at a time. CBIT is recommended as a first-line treatment relative to medications and other therapies. However, only 52% of children and 38% of adults show clinically meaningful tic improvement. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients, and meta-analysis shows comparable effect sizes for CBIT and medication. Although increasing tic controllability is the primary goal of CBIT, tic controllability nor its correlates have been examined longitudinally during the intervention. The overall objective of this study is to use fine-grained data collection strategies to identify patterns in tic controllability and other relevant related variables that are associated with treatment response to CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded.

Conditions

Chronic Tic Disorder

Outcome Measures

Primary Outcomes (9)

• Tic Severity

  Yale Global Tic Severity Scale (YGTSS) will be used, which is Gold-standard, clinician administered tic severity scale. It includes symptom checklist of specific tic types YGTSS ranges from 0-50, higher scores are more severe tic symptoms

  Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)

• Sheehan Disability scale

  Self and parent measure of functional impairment

  Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)

• Behavior Rating Inventory of Executive Function

  Self and parent-rated measure of impairment of executive function

  Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)

• Ask Suicide-Screening Questions (ASQ)

  Clinician-administered screen of suicidality

  Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)

• Child Attitudes Toward Illness Scale (CATIS)

  Self-report measure of favorably or unfavorably adolescent feels about having a chronic illness

  Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)

• Rosenberg Self-Esteem Scale

  Self-report measure of adolescent feelings of self-esteem and self-worth

  Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)

• Caregiver Strain Questionnaire

  Measure of strain experienced by caregivers and family of youth with health/emotional challenges

  Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)

• Clinical Global Impressions (CGI)

  Clinician, patient, parent-rated global measure of illness severity and improvement

  Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)

• Parent/Adult Tic Questionnaire

  Adult-self or parent-report measure of tic symptoms and severity

  Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)

Secondary Outcomes (3)

• Premonitory Urge for Tics Scale

  Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)

• Tic Suppression Task

  Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)

• Stop signal task

  Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)

Study Arms (1)

Study group

EXPERIMENTAL

Youth ages 12-21 years with chronic tics will complete a course of 10 outpatient, weekly CBIT sessions with pre-, post-, 1-month and 3-month follow up assessments.

Behavioral: CBIT

Interventions

CBIT BEHAVIORAL

8sessions of CBIT following a published treatment manual delivered over 10 weeks (the last two sessions are biweekly) CBIT is a well-established behavioral treatment that is considered by the American Academy of Neurology to be the first-line intervention for tics.

Study group

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 12-21 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
• English fluency to ensure comprehension of study measures and instructions.

You may not qualify if:

• Active suicidality.
• Previous diagnosis of psychosis or cognitive disability.
• Substance abuse or dependence within the past year.
• Concurrent psychotherapy focused on tics.
• Neuroleptic/antipsychotic medications.
• Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Tic Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Christine Conelea, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brianna Wellen, PhD

CONTACT

6126265472

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 21, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)