CBIT Therapist Training for Tourette Syndrome

(CBIT-Trainer Trial)

Recruiting at 1 trial location

Overseen By Michael Himle, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Serious psychiatric, neurological conditions, others

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

Compensation: Varies

Number of Visits: 7

Duration: 10 weeks

234 Participants Needed

Trial Summary

What is the purpose of this trial?

Tic disorders are a class of childhood-onset neuropsychiatric disorders that occur in 1-3% of the population. Studies have shown that a non-drug treatment known as Comprehensive Behavioral Intervention for Tics (CBIT) is more effective than supportive therapy for reducing tics in children and adults. Although CBIT is now recommended as a first-line intervention for tic disorders, many patients do not have access to CBIT, in part due to a lack of trained therapists. Currently, the only option available for training therapists in CBIT is an intensive, two day, in-person behavior therapy training institute (BTTI). This study will compare the traditional in-person training approach to a recently developed online, self-paced CBIT therapist training program called CBIT-Trainer with regard to (1) therapists' ability to accurately administer CBIT and (2) change in the severity of patients' tic symptoms after being treated by a CBIT-trained therapist.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a behavioral therapy for tics, so it's best to discuss your medications with the study team or your doctor.

What data supports the effectiveness of this treatment for Tourette Syndrome?

Research shows that Comprehensive Behavioral Intervention for Tics (CBIT) is effective in reducing tic symptoms in people with Tourette Syndrome. Studies have demonstrated that CBIT can significantly decrease tic severity and improve daily functioning, making it a recommended first-line treatment for tic disorders. ^{1 2 3 4 5}

Is CBIT safe for treating Tourette Syndrome?

CBIT is considered a safe treatment for managing tics in Tourette Syndrome, with evidence from multiple studies supporting its safety and effectiveness compared to medications. ^{1 2 3 5 6}

How is the CBIT treatment different from other treatments for Tourette Syndrome?

CBIT (Comprehensive Behavioral Intervention for Tics) is unique because it is a non-drug therapy that focuses on behavioral techniques to manage tics, unlike most treatments that rely on medication. It has been shown to be effective in reducing tic severity and maintaining benefits over time, making it a first-line treatment option for Tourette Syndrome. ^{1 2 5 6 7}

Research Team

Suzanne Mouton-Odum, PhD

Principal Investigator

PsycTech, LLC

Doug Woods, PhD

Principal Investigator

Marquette University

Michael Himle, PhD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for licensed therapists with a Master's degree or higher in mental/behavioral health, medical, or related fields. They must be able to travel for training and find at least one patient with tic disorders to participate. Patients should have a diagnosed tic disorder, be 7 years old or older, speak English fluently, and have internet access.

Inclusion Criteria

Speaks fluent English

Access to a private computer with high-speed internet access

I am at least 7 years old. If under 18, I have a consenting adult.

Exclusion Criteria

Patient is a first, second, or third degree biological relative of the study-matched therapist or if the study-matched therapist is the patient's legal guardian

I cannot participate if a suitable therapist for me is not found.

You have a serious mental or neurological condition that needs urgent treatment or would make it hard for you to take part in the study, according to your doctor or the study team.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Training

Therapists undergo either in-person or online training to deliver CBIT

2 weeks

1 visit (in-person) or self-paced online

Treatment

Therapists administer CBIT to patients, and outcomes are assessed

10 weeks

Regular sessions with patients

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

Assessments at 6-month follow-up

Treatment Details

Interventions

• Behavior Therapy Training Institute
• CBIT-Trainer

Trial Overview The study compares traditional in-person CBIT therapist training to an online self-paced program called CBIT-Trainer. It evaluates the effectiveness of each method by assessing therapists' ability to administer CBIT and the resulting change in patients' tic severity.

Participant Groups

Group I: Online Therapist Training Experimental Treatment 1 Intervention

Group II: In-Person Therapist Training Active Control 1 Intervention

Behavior Therapy Training Institute is already approved in United States, European Union for the following indications:

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

• Tic disorders
• Tourette syndrome

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

• Tic disorders
• Tourette syndrome

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

PsycTech, LLC

Collaborator

Trials

1

Recruited

230+

Marquette University

Collaborator

Trials

68

Recruited

202,000+

Findings from Research

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]

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]

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]

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]

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 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]

References

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

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

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

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

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

Comprehensive behavioral intervention to improve occupational performance in children with Tourette disorder. [2013]

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. Germany pubmed.ncbi.nlm.nih.gov

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

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

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