Comprehensive Behavioral Therapy for Tic Disorders

(CBIT Trial)

Overseen By Madison Bigler, B.A.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Psychosis, Bipolar, Intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on understanding how Comprehensive Behavioral Intervention for Tics (CBIT) can help young people with tic disorders, such as Tourette's, manage their symptoms. The researchers aim to evaluate CBIT's effectiveness and identify factors that contribute to its success. Children with noticeable tic symptoms that interfere with daily life, who can speak and read English, may be suitable candidates, provided they have not received this specific therapy before. Participants will undergo CBIT treatment for up to six weeks. As an unphased study, this trial offers a unique opportunity to enhance the understanding of CBIT's effectiveness in managing tic disorders.

Will I have to stop taking my current medications?

If you are taking medication for another psychiatric condition, you can continue taking it while participating in the trial. There is no required period to stop taking your current medications before starting the trial.

What prior data suggests that this protocol is safe for youth?

Research has shown that Comprehensive Behavioral Intervention for Tics (CBIT) is a well-accepted treatment for managing tic disorders. One study found that 87% of participants who improved with CBIT continued to do well even six months after treatment, demonstrating the therapy's effectiveness and lasting benefits.

CBIT helps individuals change their responses to tics, which are sudden, repetitive movements or sounds. Instead of relying on medication, it employs behavioral techniques to manage and reduce tics. Current studies indicate that this method can effectively reduce tics and related issues in children without causing significant side effects.

In summary, CBIT is considered safe, with research supporting its effectiveness and long-term benefits in managing tic disorders. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Comprehensive Behavioral Intervention for Tics (CBIT) because it offers a non-medication approach to managing tic disorders. Unlike traditional treatments that often rely on medications like antipsychotics or alpha-agonists, CBIT focuses on behavioral techniques to help individuals manage their tics. This method teaches patients to become more aware of their tics and use competing responses to reduce them. CBIT provides a promising alternative for those who prefer to avoid the side effects associated with medication.

What evidence suggests that Comprehensive Behavioral Intervention for Tics (CBIT) is effective for tic disorders?

Research has shown that Comprehensive Behavioral Intervention for Tics (CBIT), the treatment under study in this trial, can effectively reduce tic symptoms. One study found that tic symptoms became about 39% less severe, with young people experiencing a slightly higher reduction of 40.9%. Another study found that 87% of participants who improved with CBIT continued to benefit six months later. While CBIT doesn't cure tics, it helps manage them and lessen their impact on daily life. Studies also show a significant decrease in tic severity, making CBIT a strong option for both children and adults with tic disorders. ^{1 6 7 8 9}

Who Is on the Research Team?

Jill Ehrenreich-May, Ph.D.

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for young people with a Tic disorder, like Tourette's. They must speak English and have a parent to consent and help with the study. It's not for those with certain mental health conditions, who are suicidal, or already getting CBIT therapy elsewhere.

Inclusion Criteria

At least one parent/caregiver available to sign study consent forms, remain present during assessments, and fill out study questionnaires in English.

Ability for youth to speak/read English sufficiently

I have been diagnosed with a tic disorder like Tourette's.

Exclusion Criteria

Currently suicidal or who have engaged in suicidal behaviors within the past 6 months will be excluded

A current diagnosis of psychosis, bipolar disorder, intellectual disability, acute suicidality, alcohol/substance dependence, or eating disorder

I am a young person currently on medication for a mental health condition and can join without stopping my medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Comprehensive Behavioral Intervention for Tics (CBIT) for up to 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Behavioral Intervention for Tics (CBIT)

Trial Overview

The trial tests how well the Comprehensive Behavioral Intervention for Tics (CBIT) works in youth. It looks at what changes because of the treatment and tries to understand why it helps some more than others.

How Is the Trial Designed?

Group I: Comprehensive Behavioral Intervention for Tics (CBIT) Experimental Treatment 1 Intervention

Experimental: Comprehensive Behavioral Intervention for Tics (CBIT) Group Participants in this group will receive the CBIT intervention for up to 6 weeks.

Comprehensive Behavioral Intervention for Tics (CBIT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Comprehensive Behavioral Intervention for Tics for:

• Tourette Syndrome
• Persistent Motor/Vocal Tic Disorder

Approved in European Union as Comprehensive Behavioral Intervention for Tics for:

• Tourette Syndrome
• Tic Disorders

Approved in Canada as Comprehensive Behavioral Intervention for Tics for:

• Tourette Syndrome
• Tic Disorders

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

Comprehensive behavioral intervention for tics (CBIT) is a safe and effective treatment for Tourette syndrome, supported by evidence from two large multisite trials that demonstrate its efficacy and long-term benefits.

Recent guidelines recommend CBIT as a first-line treatment for tic disorders, indicating its importance in managing tics compared to traditional medications, and there is a growing effort to train more providers in the U.S. to deliver this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current controversies on the role of behavior therapy in Tourette syndrome. Scahill, L., Woods, DW., Himle, MB., et al.[2021]

In a small case series of 14 youth with Tourette disorder, an abbreviated version of the Comprehensive Behavioral Intervention for Tics (CBIT) showed a significant reduction in tic severity and tic-related impairment after treatment, indicating its efficacy in a clinical setting.

The study found that 56% of participants were classified as treatment responders, and both satisfaction and therapeutic alliance ratings were high, suggesting that the modified CBIT protocol is acceptable and feasible for use in child neurology and developmental pediatrics clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Testing Behavior Therapy for Chronic Tic Disorders in Neurology and Developmental Pediatrics Clinics. Ricketts, EJ., Gilbert, DL., Zinner, SH., et al.[2016]

Habit reversal training (HRT) is an effective behavioral intervention for reducing tic severity in children and adolescents with chronic tic disorders, based on a review of studies since 2000.

Recent multisite trials indicate that adding functional analysis to traditional HRT may further improve its effectiveness in treating tic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Habit reversal training for children with tourette syndrome: update and review. Hwang, GC., Tillberg, CS., Scahill, L.[2018]

Habit reversal training (HRT) is a promising nonpharmacological intervention for chronic tic disorders, including Tourette's syndrome, particularly in children and adolescents, as it is well-tolerated and shows efficacy based on a growing body of evidence.

Given the concerns about the side effects and unpredictable efficacy of pharmacological treatments, HRT offers a valuable alternative approach to managing tic behaviors without the risks associated with long-term medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Habit reversal training for tic disorders in children and adolescents. Piacentini, J., Chang, S.[2007]

A meta-analysis of 10 randomized controlled trials involving 586 patients found that habit reversal training (HRT) is effective in reducing tic symptoms, with a small to medium effect size (SMD of -0.43).

The efficacy of HRT was influenced by the type of behavioral therapy used in the control group, indicating that different comparison conditions can affect treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The therapeutic effect of habit reversal training for Tourette syndrome: a meta-analysis of randomized control trials. Yu, L., Li, Y., Zhang, J., et al.[2021]

Behavior therapy, specifically habit reversal (HR) and exposure and response prevention (ER), is effective in treating tics and is recommended as a first-line intervention.

Despite the proven efficacy of these therapies and the availability of treatment manuals, many patients do not receive these psychological interventions due to various barriers, which could potentially be addressed through E-health and E-learning solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural treatment of tics: habit reversal and exposure with response prevention. van de Griendt, JM., Verdellen, CW., van Dijk, MK., et al.[2022]

Habit reversal therapy (HRT) has been shown to significantly reduce tic severity in individuals with Tourette syndrome and chronic tic disorders, with reductions ranging from 18.3% to 37.5% across five studies involving 353 patients.

The evidence supports HRT as an effective alternative or complement to medication for managing tics, but more research is needed to compare its efficacy against other behavioral interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of habit reversal therapy in the treatment of Tourette syndrome and other chronic tic disorders: a systematic review. Dutta, N., Cavanna, AE.[2022]

In a study involving 30 children with chronic tic disorders, group-based Comprehensive Behavioral Intervention for Tics (group-CBIT) significantly reduced tic severity and associated impairment compared to a control group.

The intervention led to notable improvements in motor tic interference and overall severity scores, demonstrating its efficacy as a treatment for tic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Group Comprehensive Behavioral Intervention for Tics in Children With Tourette's Disorder and Chronic Tic Disorder. Kang, NR., Kim, HJ., Moon, DS., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9513408/

Effects of Group Comprehensive Behavioral Intervention ...

The group-CBIT showed an improvement in tic symptoms, especially in reducing the level of interference and impairment of tics.

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tourette.org

tourette.org/research-medical/cbit-overview/

Comprehensive Behavioral Intervention for Tics (CBIT)

A recent study showed that 87% of participants who thrived with CBIT continued to do well six months after treatment. Remember CBIT is not a cure; it is a ...

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medrxiv.org/content/10.1101/2025.09.11.25335505v1.full-text

Habit Reversal Training for Tic Disorders

At session 14, tic symptoms showed a median 39.0% severity reduction (youth: 40.9%; adults: 38.1%). Improvements were maintained through the ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S258997912400009X

Comparison of cognitive-behavioral treatments for tics and ...

CBIT aims to reverse the onset of tics using behavioral principles, making it an effective treatment option for both children (d = 0.68) and adults (d = 0.55– ...

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epublications.marquette.edu

epublications.marquette.edu/cgi/viewcontent.cgi?article=1805&context=theses_open

Comprehensive Behavioral Intervention for Tics Specialty ...

The results indicate a significant decrease in tic severity over the course of the treatment, underscoring the effectiveness of CBIT when applied to individuals ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5669407/

Behavioral therapy for Tourette syndrome and chronic tic ...

Currently recommended behavioral interventions view tics as habitual responses that may be further strengthened through negative reinforcement.

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practicalneurology.com

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Comprehensive Behavioral Intervention for Tics

This review provides an introduction to the epidemiology, common comorbidities, suspected etiologies, and therapies of tic disorders including Tourette ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT00218777

Cognitive Behavior Therapy and Habit Reversal Training ...

This study will determine the effectiveness of cognitive behavior therapy (CBT) with habit reversal training (HRT) in treating chronic tic disorders (CTDs) in ...

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Behavior Therapy for Children With Tourette Disorder

A comprehensive behavioral intervention based on habit reversal training was effective in reducing tics and tic-related impairment in children ...