Modeling Tic Change During Behavior Therapy for Tics

NCT ID: NCT06270251

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2028-09-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

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.

Group Type: EXPERIMENTAL

CBIT

Intervention Type: 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.

Interventions

CBIT

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Conelea, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brianna Wellen, PhD

Role: CONTACT

6126265472

Facility Contacts

Brianna Wellen

Role: primary

Other Identifiers

PSYCH-2023-32292

Identifier Type: -

Identifier Source: org_study_id