Chronic Tic DisorderNCT06270251
Modeling Tic Change During Behavior Therapy for Tics
A study testing CBIT in people with Chronic Tic Disorder, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Chronic Tic Disorder
- What is being tested?
- CBIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brianna Wellen, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Brianna Wellen
About this study
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
- Being tested
- CBIT
- Medical subject headings
- Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBITBehavioural
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CBIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Self-report measure of intensity of urges to tic
Measured: 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
Direct observation measure of tic suppression ability
Measured: 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
Computerized task measuring ability to inhibit prepotent motor responses. This task is optional.
Measured: Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Tic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Conelea, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270251
- Sponsor's protocol ID
- PSYCH-2023-32292
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Tic Change During Behavior Therapy for Tics
- ClinicalTrials.gov ID
- NCT06270251
- Acronym / sponsor ID
- PSYCH-2023-32292
- Conditions
- Chronic Tic Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: CBITYouth 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. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBIT8sessions 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. | Behavioural | Study group |
Primary outcome
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
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
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
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
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
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
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
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
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
3 secondary outcomes
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brianna Wellen, PhD contact
Christine Conelea, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBIT in people with Chronic Tic Disorder, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brianna Wellen, PhD (6126265472), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.