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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a therapy called Comprehensive Behavioral Intervention for Tics (CBIT) to help manage chronic tics, which are sudden, repetitive movements or sounds. The goal is to understand CBIT's effectiveness and identify factors that might predict its success. Participants will learn techniques to control their tics over eight sessions. Children aged 10-17 with chronic motor or vocal tics present for at least a year, and who are not currently receiving similar therapy, might be a good fit. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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 prior data suggests that this behavioral therapy is safe for treating tic disorders?

Research has shown that Comprehensive Behavioral Intervention for Tics (CBIT) is well-received by people with tic disorders. In one study, 87% of participants who benefited from CBIT continued to see positive results six months after completing the treatment. CBIT is a type of therapy that helps manage tics by teaching people to perform different actions instead of the tic.

The treatment is considered safe, with no major side effects reported in the research. Since this study is in Phase 2, earlier trials have already tested CBIT for safety, indicating it is generally safe for people with chronic tics. These findings provide reassuring evidence of CBIT’s safety for those considering participation in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Comprehensive Behavioral Intervention for Tics (CBIT) is unique because it focuses on behavioral strategies rather than medication to manage tic disorders. Unlike standard treatments that often rely on medications like antipsychotics or alpha agonists to reduce tic severity, CBIT empowers individuals with tic disorders to gain control through techniques such as habit reversal training and relaxation. Researchers are excited about CBIT because it offers a non-drug approach, minimizing the risk of medication side effects and potentially providing a long-term, sustainable way to manage tics by addressing the underlying behaviors.

What evidence suggests that Comprehensive Behavioral Intervention for Tics (CBIT) might be an effective treatment for chronic tics?

Research has shown that Comprehensive Behavioral Intervention for Tics (CBIT), which participants in this trial will receive, can greatly help manage tic symptoms. One study found that group-CBIT improved tic symptoms by reducing their interference with daily life. Another study showed that 87% of participants who benefited from CBIT continued to do well six months after treatment. Behavioral treatments like CBIT have proven very effective in reducing tic symptoms. Initial results also suggest an average 39% reduction in tic severity, with improvements lasting over time. Overall, CBIT is a promising method for managing tic disorders. ^{1 6 7 8 9}

Who Is on the Research Team?

Christine Conelea, PhD, LP

Principal Investigator

University of Minnesota

Sonya Wang, MD

Principal Investigator

University of Minnesota

Deanna Greene, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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.

Full scale IQ greater than 70

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

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 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 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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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. 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 ...

3. kosinmedj.org kosinmedj.org/journal/view.php?number=1332

a structured review of HRT, ERP, and CBIT Behavioral interventions have demonstrated significant efficacy in managing tic symptoms. This review examines three principal evidence-based ...

4. medrxiv.org 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 ...

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2022.851250/full

The Efficacy of Cognitive Behavioral Therapy for Tic Disorder The results showed that the effect of CBT was better than that of the control group. The pooled standardized mean difference (SMD) was −0.34 (95 ...

6. 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7683326/

Internet-based guided self-help comprehensive behavioral ... This study evaluated the feasibility and potential effectiveness of an Internet-based, self-help CBIT program (ICBIT) guided by parents with minimal therapist ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00218777

NCT00218777 | Cognitive Behavior Therapy and Habit ... This study will determine the effectiveness of cognitive behavior therapy (CBT) with habit reversal training (HRT) in treating chronic tic disorders (CTDs) in ...

9. 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.