Behavioral Therapy for Tic Disorders

Recruiting at 1 trial location

Overseen By Sonya Wang, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Minnesota

Disqualifiers: MRI issues, Suicidality, Psychosis, Seizure, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Tourette Syndrome and Persistent Motor/Vocal Tic Disorder 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. Comprehensive Behavioral Intervention for Tics (CBIT) is a manualized treatment focused on tic management skills. During the core CBIT procedure, competing response training, patients learn to inhibit tics by engaging in a competing motor action. The overall objective of this study is to identify bio-behavioral predictors and correlates of response and the most potent aspects of CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Neural, behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded. CBIT process will be measured with a video-based behavioral coding scheme that will be refined and validated during years 1-2 using archival CBIT videos

Will I have to stop taking my current medications?

If you are taking psychotropic medications, you can continue them as long as they have been stable for at least 6 weeks and remain stable during the study. All treatments will be monitored, but the protocol does not specify stopping current medications.

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, which are types of behavioral therapy, can significantly reduce tic symptoms in people with tic disorders, including Tourette syndrome. Studies found that these therapies can decrease tic severity by 18.3% to 37.5%, making them effective alternatives to medication. ^{1 2 3 4 5}

Is behavioral therapy for tic disorders safe for humans?

Comprehensive Behavioral Intervention for Tics (CBIT) and Habit Reversal Training (HRT) are considered safe treatments for managing tics in conditions like Tourette syndrome, with studies showing they are well-tolerated and effective without the serious side effects often associated with medications. ^{1 3 5 6 7}

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

CBIT, also known as Habit Reversal Therapy (HRT), is unique because it is a non-drug treatment that uses behavioral techniques to help reduce tic symptoms, offering an effective alternative or complement to medication, which can have unpredictable effects and serious side effects. ^{1 2 4 5 8}

Research Team

Deanna Greene, PhD

Principal Investigator

University of California, San Diego

Sonya Wang, MD

Principal Investigator

University of Minnesota

Christine Conelea, PhD, LP

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for young people with tic disorders, including Tourette Syndrome and Chronic Tic Disorder. Participants should be experiencing chronic tics that impact their daily life. The study aims to help them manage their symptoms through a treatment called CBIT.

Inclusion Criteria

I am between 10 and 17 years old.

I have had motor or vocal tics for over a year without a break longer than 3 months.

Full scale IQ greater than 70

Exclusion Criteria

I haven't changed my mental health medication in the last 6 weeks and don't plan to change it during the study.

I have a history of seizures.

I have attended at least 4 CBIT sessions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a manualized course of 8-session Comprehensive Behavioral Intervention for Tics (CBIT)

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

19 weeks

Treatment Details

Interventions

• Comprehensive Behavioral Intervention for Tics (CBIT)

Trial Overview The trial tests Comprehensive Behavioral Intervention for Tics (CBIT), which teaches patients how to control tics using competing motor actions. It involves an 8-session course where the effectiveness of CBIT will be evaluated through various assessments and video recordings.

Participant Groups

Group I: CBIT group Experimental Treatment 1 Intervention

Participants with chronic TICs

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 Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

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]

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]

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]

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 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]

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]

In a study involving 46 children with Tourette Syndrome or Chronic Tic Disorder, group Comprehensive Behavioral Intervention for Tics (CBIT) was found to be more effective than group Educational Intervention for Tics (EIT) in reducing motor tic severity, with improvements maintained at a 3-month follow-up.

Both interventions effectively reduced tic impairment and comorbid symptoms, but only group-CBIT showed significant and lasting reductions in total and motor tic severity, highlighting the benefits of a tic-focused treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group behavioral interventions for tics and comorbid symptoms in children with chronic tic disorders. Zimmerman-Brenner, S., Pilowsky-Peleg, T., Rachamim, L., et al.[2022]

Behavior therapy has been shown to effectively reduce tic severity in individuals with Persistent Tic Disorders and Tourette's Disorder, demonstrating moderate-to-large treatment effects based on randomized controlled trials.

The review highlights the need for continued research into behavioral management of tics, addressing challenges in treatment and exploring new solutions to improve outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior Therapy for Tic Disorders: An Evidenced-based Review and New Directions for Treatment Research. McGuire, JF., Ricketts, EJ., Piacentini, J., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

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

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

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

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

7. Germany pubmed.ncbi.nlm.nih.gov

Group behavioral interventions for tics and comorbid symptoms in children with chronic tic disorders. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Behavior Therapy for Tic Disorders: An Evidenced-based Review and New Directions for Treatment Research. [2022]