Behavioral Therapy for Tic Disorders
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Minnesota
Disqualifiers: MRI issues, Suicidality, Psychosis, Seizure, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
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.
12345Is 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.
13567How 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.
12458Eligibility 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
+2 more
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.
+6 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: CBIT groupExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
University of CaliforniaSan Diego, CA
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
The therapeutic effect of habit reversal training for Tourette syndrome: a meta-analysis of randomized control trials. [2021]Comprehensive behavioral intervention for tics (CBIT) and habit reversal training (HRT) are forms of cognitive behavioral therapy that can effectively reduce tic symptoms in patients with tic disorders, but their efficacies and potential moderators were needed to be clarified.
The effectiveness of habit reversal therapy in the treatment of Tourette syndrome and other chronic tic disorders: a systematic review. [2022]Tourette syndrome (TS) is a neurodevelopmental disorder characterized by multiple tics, which can require active intervention. It is recognized that behavioral techniques, especially habit reversal therapy (HRT), can offer an effective alternative or complement to pharmacotherapy in this setting. We conducted a systematic literature review to evaluate the efficacy of HRT in TS and other chronic tic disorders (CTDs). Our search was restricted to randomized controlled trials that used standardized diagnostic and outcome measures to compare the efficacy of HRT against a control treatment. We identified five relevant studies, which included 353 patients. Significant post-treatment reductions in tic severity scores (range: 18.3%-37.5%) were seen in the HRT groups across all studies. Current evidence suggests that HRT can significantly reduce tic severity in both adults and children with TS and other CTDs. Further head-to-head studies are needed to compare the efficacy of HRT with other behavioral interventions for tic management.
Current controversies on the role of behavior therapy in Tourette syndrome. [2021]Comprehensive behavioral intervention for tics (CBIT) is a safe and effective treatment for managing the tics of Tourette syndrome (TS). In contrast to most current medications used for the treatment of tics, the efficacy of CBIT has been demonstrated in 2 relatively large, multisite trials. It also shows durability of benefit over time. Similar to psychopharmacological intervention, skilled practitioners are required to implement the intervention. Despite concerns about the effort required to participate in CBIT, patients with TS and parents of children with TS appear willing to meet the requirements of the CBIT program. Efforts are under way to increase the number of trained CBIT providers in the United States. Based on available evidence, recent published guidelines suggest that CBIT can be considered a first-line treatment for persons with tic disorders. © 2013 Movement Disorder Society.
Behavioural treatment of tics: habit reversal and exposure with response prevention. [2022]Behaviour therapy has been shown to be an effective strategy in treating tics; both habit reversal (HR) and exposure and response prevention (ER) are recommended as first-line interventions. This review provides an overview of the history, theoretical concepts and evidence at present for HR and ER. In addition, treatment manuals for HR and ER are described. Despite the evidence and availability of treatment manuals, many patients do not receive a first-line psychological intervention for tics. Barriers to the acceptance and dissemination of behaviour therapy are discussed as are ways to overcome these barriers, such as the use of E-health and E-learning.
Habit reversal training for tic disorders in children and adolescents. [2007]Chronic tic disorders, including Tourette's syndrome (TS), affect approximately .5% of children and adolescents. Although strong evidence exists supporting a neurobiological etiology, operant factors may play a role in the maintenance of tic behaviors. Pharmacological approaches remain the most commonly used intervention for chronic tic disorder in children and adults. Nevertheless, the unpredictable efficacy and serious side effects associated with medication along with parental concerns about long-term medication use in children underlie the need for nonpharmacological interventions for tics in this age group. This article reviews the rationale and evidence base for the use of habit reversal training (HRT), a multicomponent behavioral treatment package, as a treatment for childhood tics. Each of the primary treatment components of HRT is described and implementation is illustrated in case report format. A growing body of data suggests that HRT is a well-tolerated and efficacious intervention for tic disorders in this age group.
Pilot Testing Behavior Therapy for Chronic Tic Disorders in Neurology and Developmental Pediatrics Clinics. [2016]Comprehensive Behavioral Intervention for Tics (CBIT) is an efficacious treatment with limited regional availability. As neurology and pediatric clinics are often the first point of therapeutic contact for individuals with tics, the present study assessed preliminary treatment response, acceptability, and feasibility of an abbreviated version, modified for child neurology and developmental pediatrics clinics. Fourteen youth (9-17) with Tourette disorder across 2 child neurology clinics and one developmental pediatrics clinic participated in a small case series. Clinician-rated tic severity (Yale Global Tic Severity Scale) decreased from pre- to posttreatment, z = -2.0, P
Group behavioral interventions for tics and comorbid symptoms in children with chronic tic disorders. [2022]Exposure and Response Prevention (ERP), Habit Reversal Training (HRT) and Comprehensive Behavioral Intervention for Tics (CBIT) are effective in reducing tic severity. ERP and HRT have recently gained primary support in a group setting, while CBIT has not been examined similarly. We compared the efficacy of group-CBIT to group-Educational Intervention for Tics (group-EIT) for tics and comorbid symptoms. Children with Tourette Syndrome (TS) or Chronic Tic Disorder (CTD) were randomized to group-CBIT or group-EIT. Tics and comorbid symptoms were assessed in forty-six children pre- and postintervention, and 3-month later. Yale Global Tic Severity Scale (YGTSS) Motor tic severity decreased following both interventions, and was maintained at follow-up for group-CBIT only. The Parent Tic Questionnaire (PTQ) showed significant decrease in total and motor tic severity following group-CBIT only, a gain maintained three months later. YGTSS impairment score decreased following both interventions and was maintained at follow-up. YGTSS vocal tic severity score increased following both interventions, and then decreased significantly at follow up. Co-morbid symptoms including anxiety, behavioral problems, and aggressive behavior decreased following both interventions. Children with behavioral problems benefitted less while children with higher intellectual ability benefit more from intervention. Both group interventions showed efficacy in reducing tic impairment and comorbid symptoms. Group-CBIT was superior to group-EIT in reducing motor tic severity at 3-month follow-up, showing an advantage for tic-focused treatment. Based on the PTQ, group-CBIT was superior to group-EIT in reducing motor, vocal, and total tic scores, a gain maintained three months later. Clinical trial registry information-Group Intervention for Children with Chronic Tics Syndrome: CBIT vs Psychoeducational Intervention URL: http://clinicaltrials.gov , Identifier: NCT02407951, http://www.controlled-trials.com ).
Behavior Therapy for Tic Disorders: An Evidenced-based Review and New Directions for Treatment Research. [2022]Behavior therapy is an evidenced-based intervention with moderate-to-large treatment effects in reducing tic symptom severity among individuals with Persistent Tic Disorders (PTDs) and Tourette's Disorder (TD). This review describes the behavioral treatment model for tics, delineates components of evidence-based behavior therapy for tics, and reviews the empirical support among randomized controlled trials for individuals with PTDs or TD. Additionally, this review discusses several challenges confronting the behavioral management of tics, highlights emerging solutions for these challenges, and outlines new directions for treatment research.