What side effects are associated with this type of intervention?

Behavioral therapies for tic disorders, such as Comprehensive Behavioral Intervention for Tics (CBIT), Habit Reversal Therapy (HRT), and Exposure with Response Prevention (ERP), are generally well-tolerated and have minimal side effects. The most common side effects include temporary increases in tic frequency or intensity during the initial stages of treatment as patients become more aware of their tics. Some individuals may also experience frustration or anxiety when trying to suppress tics or adhere to the therapeutic techniques. Overall, these therapies are considered safe and effective for managing tic disorders.

What prior FDA approvals exist?

The FDA has not specifically approved any medications solely for the treatment of Tic Disorders. However, behavioral therapies such as Comprehensive Behavioral Intervention for Tics (CBIT) have shown efficacy in managing tics. CBIT, which includes techniques like Habit Reversal Therapy (HRT) and Exposure with Response Prevention (ERP), is a non-pharmacological approach that has been supported by clinical trials. These therapies aim to help patients manage their tics through behavioral modification techniques.

What other types of research exist?

Promising, novel alternatives to CBIT for managing tic disorders in 2024 include: 1) Deep Brain Stimulation (DBS), which has shown promising results in preliminary trials for treatment-refractory cases; 2) Internet-delivered Cognitive Behavioral Therapy (ICBT), which offers accessibility and convenience; and 3) Pharmacological options such as cannabinoids, which are being explored for their potential benefits in managing tics and associated behavioral problems.

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Comprehensive Behavioral Therapy for Tic Disorders (CBIT Trial)

N/A

Recruiting

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A current diagnosis of a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Tic disorder (e.g., Tourette's Disorder/syndrome, Persistent (Chronic) Motor or Vocal Tic Disorder, or Provisional Tic Disorder) or caregiver/youth report of clinically impairing tic symptoms

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline tars scores, to 6 weeks, to 12 weeks from the start of treatment.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since CBIT is a non-drug therapy involving behavioral techniques, typical drug side effects aren't expected. However, participants may experience stress or frustration during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a tic disorder like Tourette's.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline puts scores, to 6 weeks, to 12 weeks from the start of treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline puts scores, to 6 weeks, to 12 weeks from the start of treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline puts scores, to 6 weeks, to 12 weeks from the start of treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Global Impression (CGI) - Improvement Scores

Clinical Global Impression (CGI) - Severity Scale Scores

Parent Tic Questionnaire (PTQ)

+7 more

Secondary study objectives

Revised Children's Anxiety and Depression Scale - Child and Revised Parent Short (RCADS-25/RCADS-P-25) Scores

Tic Accommodation and Reactions Scale (TARS) Scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Comprehensive Behavioral Intervention for Tics (CBIT)Experimental Treatment1 Intervention

Experimental: Comprehensive Behavioral Intervention for Tics (CBIT) Group Participants in this group will receive the CBIT intervention for up to 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Comprehensive Behavioral Intervention for Tics (CBIT)

2012

Completed Phase 1

~150

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Tic Disorders, particularly those similar to Comprehensive Behavioral Intervention for Tics (CBIT), include behavioral therapies such as Habit Reversal Training (HRT) and Exposure and Response Prevention (ERP). These therapies work by helping patients become more aware of their tics and the urges preceding them, and then teaching them alternative responses to suppress or replace the tics. Understanding these mechanisms is crucial for patients as it empowers them to actively manage their symptoms, leading to improved control over their tics and a better quality of life.

European clinical guidelines for Tourette syndrome and other tic disorders. Part II: pharmacological treatment.Habit reversal treatment of tic disorders: a methodological critique of the literature.