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NCT Number: NCT06270251

Modeling Tic Change During Behavior Therapy for Tics

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.

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Key information

Conditions

Chronic Tic Disorder Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodevelopmental Disorders Tic Disorders

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Brianna Wellen

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Tic Severity

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

    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

  2. Sheehan Disability scale

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

    Self and parent measure of functional impairment

  3. Behavior Rating Inventory of Executive Function

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

    Self and parent-rated measure of impairment of executive function

  4. Ask Suicide-Screening Questions (ASQ)

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

    Clinician-administered screen of suicidality

  5. Child Attitudes Toward Illness Scale (CATIS)

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

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

  6. Rosenberg Self-Esteem Scale

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

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

  7. Caregiver Strain Questionnaire

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

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

  8. Clinical Global Impressions (CGI)

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

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

  9. Parent/Adult Tic Questionnaire

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

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

Secondary outcomes

  1. Premonitory Urge for Tics Scale

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

    Self-report measure of intensity of urges to tic

  2. Tic Suppression Task

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

    Direct observation measure of tic suppression ability

  3. Stop signal task

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

    Computerized task measuring ability to inhibit prepotent motor responses. This task is optional.

Study contacts

Contact information is provided by the study sponsor or research team.

Brianna Wellen, PhD

CONTACT

6126265472

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 21, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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