Comprehensive Behavioral Therapy for Tic Disorders

(CBIT Trial)

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Miami

Disqualifiers: Psychosis, Bipolar, Intellectual disability, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial examines how well CBIT works for children and teenagers with tics. CBIT helps them recognize and control their tics using behavioral techniques. Comprehensive Behavioral Intervention for Tics (CBIT) has been shown to be effective in reducing tics in children with chronic 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 data supports the effectiveness of the treatment Comprehensive Behavioral Intervention for Tics (CBIT) and Habit Reversal Therapy (HRT) for tic disorders?

Research shows that CBIT and HRT can significantly reduce tic symptoms in both children and adults with tic disorders, including Tourette syndrome. Studies found that these treatments led to a reduction in tic severity scores by 18.3% to 37.5%, making them effective non-drug options for managing tics. ^{1 2 3 4 5}

Is Comprehensive Behavioral Therapy for Tic Disorders safe for humans?

Comprehensive Behavioral Therapy for Tic Disorders, including CBIT and Habit Reversal Training, is considered safe and well-tolerated for managing tics in both children and adults, with no serious side effects reported in the studies. ^{1 4 5 6 7}

How is the Comprehensive Behavioral Intervention for Tics (CBIT) treatment different from other treatments for tic disorders?

CBIT, also known as Habit Reversal Therapy (HRT), is a non-drug treatment that focuses on teaching patients to recognize and manage their tics through behavioral techniques, making it a safer option compared to medications that can have serious side effects. It is particularly beneficial for children and adolescents, offering a well-tolerated and effective alternative to pharmacological approaches. ^{1 2 5 7 8}

Research Team

Jill Ehrenreich-May, Ph.D.

Principal Investigator

University of Miami

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Comprehensive Behavioral Intervention for Tics (CBIT) (Behavioral Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Habit reversal training for tic disorders in children and adolescents. [2007]

2. Italy 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. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of Group Comprehensive Behavioral Intervention for Tics in Children With Tourette's Disorder and Chronic Tic Disorder. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Pilot Testing Behavior Therapy for Chronic Tic Disorders in Neurology and Developmental Pediatrics Clinics. [2016]

5. England pubmed.ncbi.nlm.nih.gov

The therapeutic effect of habit reversal training for Tourette syndrome: a meta-analysis of randomized control trials. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Current controversies on the role of behavior therapy in Tourette syndrome. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Habit reversal training for children with tourette syndrome: update and review. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Behavioural treatment of tics: habit reversal and exposure with response prevention. [2022]