Behavior Therapy for Tic Disorders

Overseen By Brianna Wellen, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Neuroleptics, Antipsychotics

Disqualifiers: Active suicidality, Psychosis, Substance abuse, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 10 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how Comprehensive Behavioral Intervention for Tics (CBIT) can help people with chronic tics, which are sudden, repetitive movements or sounds. CBIT teaches individuals to control their tics by using a different, deliberate action instead. The trial seeks participants aged 12-21 who have experienced motor or vocal tics for at least a year. By video recording sessions and tracking changes over time, researchers hope to better understand the factors that enhance CBIT's effectiveness. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could improve treatment strategies for chronic tics.

Will I have to stop taking my current medications?

The trial requires that participants not be on neuroleptic or antipsychotic medications. If you are taking other medications, they must be stable (same medication and dose) for at least 6 weeks with no planned changes during the study.

What prior data suggests that CBIT is safe for treating tic disorders?

Research has shown that CBIT (Comprehensive Behavioral Intervention for Tics) is a well-accepted treatment for tic disorders. It avoids medication, thereby sidestepping drug-related side effects. CBIT teaches patients to control their tics by learning a new action to prevent a tic.

Studies have found that CBIT effectively reduces tic severity in both children and adults. The Tourette Association of America recommends it, and large studies have shown it to be as effective as medication. As a type of behavioral therapy, CBIT has no serious reported side effects, making it a safe choice for managing tic disorders without medication risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment options for tic disorders, which often include medications like antipsychotics and alpha agonists, CBIT (Comprehensive Behavioral Intervention for Tics) offers a drug-free approach. CBIT is unique because it focuses on teaching individuals to become more aware of their tics and use competing responses to reduce them. This method empowers patients to manage their symptoms through behavior modification, potentially avoiding medication side effects. Researchers are excited about CBIT because it provides a non-invasive, empowering option that could improve quality of life for those with chronic tics.

What evidence suggests that CBIT is effective for treating chronic tics?

Research has shown that Comprehensive Behavioral Intervention for Tics (CBIT), which participants in this trial will receive, reduces the severity of tics in both children and adults. Studies have found that CBIT is more effective than supportive therapy for managing tics. In one study, 87% of participants continued to see improvements six months after finishing treatment. Reviews of multiple studies also show that CBIT is as effective as medications used for tics. While CBIT is not a cure, it helps control tics, greatly improving quality of life. ^{6 7 8 9 10}

Who Is on the Research Team?

Christine Conelea, PhD, LP

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for young people aged 12-21 with chronic motor and/or vocal tics, which have lasted at least a year without a break of more than three months. Participants should have moderate tic severity as measured by the Yale scale, an IQ over 70, and must understand English well.

Inclusion Criteria

I am between 12 and 21 years old.

Full scale IQ greater than 70

English fluency to ensure comprehension of study measures and instructions

Exclusion Criteria

Previous diagnosis of psychosis or cognitive disability

Active suicidality

I am currently receiving therapy specifically for tics.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a manualized course of 10 outpatient, weekly CBIT sessions

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

2 follow-up assessments (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CBIT

Trial Overview The study tests CBIT (Comprehensive Behavioral Intervention for Tics), focusing on increasing control over tics through competing response training. The treatment's effectiveness will be monitored across eight sessions using video recordings and assessments of behavior and overall functioning.

How Is the Trial Designed?

Group I: Study group Experimental Treatment 1 Intervention

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.

CBIT is already approved in United States, European Union for the following indications:

Approved in United States as CBIT for:

• Chronic tics associated with Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders

Approved in European Union as CBIT for:

• Chronic tics associated with Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

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]

Comprehensive Behavioral Intervention for Tics (CBIT) is likely effective in reducing tic severity in Chinese children with chronic tic disorders and Tourette syndrome, as shown in a 10-week trial with 37 participants.

CBIT alone resulted in greater improvements in quality of life compared to combined treatment with pharmacotherapy, suggesting that CBIT may be a suitable standalone treatment option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary study of comprehensive behavioral intervention for tics in Chinese children with chronic tic disorder or Tourette syndrome. Xu, W., Ding, Q., Zhao, Y., et al.[2022]

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]

The comprehensive behavioral intervention for tics (CBIT) significantly reduced tic severity and the number of tics in 30 children with tic disorder after completing an eight-session program.

Participants also reported lower distress levels and improved self-perception regarding their ability to perform everyday activities, indicating enhanced occupational performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive behavioral intervention to improve occupational performance in children with Tourette disorder. Rowe, J., Yuen, HK., Dure, LS.[2013]

The internet-delivered Comprehensive Behavioral Intervention for Tics (iCBIT) showed a significant reduction in tic severity compared to placebo, with effects increasing over time, indicating its potential efficacy as a treatment for chronic tic disorders in a study of 161 adult patients.

iCBIT was found to be non-inferior to face-to-face CBIT, suggesting that it can be an effective alternative therapy without the need for qualified therapists, and no safety concerns were reported during the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ONLINE-TICS: Internet-Delivered Behavioral Treatment for Patients with Chronic Tic Disorders. Haas, M., Jakubovski, E., Kunert, K., et al.[2022]

A modified four-session Comprehensive Behavioral Intervention for Tics significantly reduced tic severity in children and adolescents with Tourette's syndrome compared to routine care, as shown by a randomized controlled study with 46 participants.

The positive effects of the intervention were maintained for at least 3 months after treatment, indicating its potential long-term benefits for managing tics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a modified comprehensive behavioral intervention for tics for children and adolescents with tourette's syndrome: A randomized controlled trial. Chen, CW., Wang, HS., Chang, HJ., et al.[2020]

A family-based adaptation of the Comprehensive Behavioral Intervention for Tic Disorders (CBIT) was successfully implemented for children aged 5-8 years, showing high treatment satisfaction and a 100% retention rate among participants.

The adapted CBIT led to a 54% treatment response rate and a significant reduction in tic severity, with effects maintained at follow-ups, suggesting it is an effective intervention for young children with chronic tic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Open Trial of a Psychosocial Intervention for Young Children With Chronic Tics: The CBIT-JR Study. Bennett, SM., Capriotti, M., Bauer, C., et al.[2020]

Current guidelines recommend behavioral interventions like habit reversal training and comprehensive behavioral intervention as first-line treatments for primary tic disorders, emphasizing the importance of patient selection based on age and comorbidities.

Emerging nonpharmacologic treatments, including Internet-based and telehealth approaches, show potential for improving accessibility and effectiveness in treating tics, while novel methods like autonomic modulation may offer new therapeutic options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral therapy for Tourette syndrome and chronic tic disorders. Fründt, O., Woods, D., Ganos, C.[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

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4198411/

Intensive outpatient comprehensive behavioral intervention ... Recent randomized clinical trials have established the efficacy of Comprehensive Behavioral Intervention for Tics (CBIT) in treating children and adults ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05547854

Evaluation of an Online Comprehensive Behavioral ... Secondary therapist outcomes that will be assessed include changes in knowledge of tic disorders and CBIT; changes in comfort and self-efficacy in delivering ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S258997912400009X

Comparison of cognitive-behavioral treatments for tics and ... In conclusion, CoPs and CBIT effectively reduce tic severity and improve global functioning in children and adults with tic disorders and Tourette syndrome.

5. 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 ...

6. nm.org nm.org/conditions-and-care-areas/treatments/comprehensive-behavioral-intervention-for-tics-cbit

Comprehensive Behavioral Intervention for Tics (CBIT) CBIT is a treatment option for tic disorders, including Tourette syndrome. It is endorsed by The Tourette Association of America.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02413216

Study Details | NCT02413216 | TicHelper: A Computerized ... Effective non-pharmacological treatment options such as comprehensive behavioral intervention for tics (CBIT) have been shown to be effective for reducing tics ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9691679/

A preliminary study of comprehensive behavioral ... CBIT is probably effective in reducing tic severity in Chinese children with tic disorders. CBIT + PT may not be superior to CBIT alone in reducing tic ...

9. cdc.gov cdc.gov/tourette-syndrome/articles/behavioral-treatment-for-tics-that-works.html

Behavioral Treatment for Tics That Works CBIT is a type of behavioral therapy that is very systematic and carefully planned according to a person's specific needs and symptoms.

10. practicalneurology.com practicalneurology.com/diseases-diagnoses/movement-disorders/comprehensive-behavioral-intervention-for-tics/31642/

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