Cognitive Behavior Therapy and Habit Reversal Training for the Treatment of Chronic Tic Disorders in Children

Tourette Syndrome Clinical Trial

— CBIT  

Official title:

Behavior Therapy for Children With Chronic Tic Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218777
• Other study ID #: R01MH070802
• Secondary ID: R01MH070802DSIR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 21, 2005
• Last updated: December 10, 2015
• Start date: December 2004
• Est. completion date: May 2007

Study information

• Verified date: December 2015
• Source: Tourette Association of America
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will determine the effectiveness of cognitive behavior therapy (CBT) with habit reversal training (HRT) in treating chronic tic disorders (CTDs) in children and adolescents.

Description:

CTDs and Tourette syndrome are neurobehavioral disorders that are characterized by a persistent pattern of motor and vocal tics. Tics are intermittent movements or sounds that occur repeatedly. They can be either brief, rapid, and darting movements or more purposeful movements, such as repetitively locking and unlocking a door. Vocal tics can be simple, as in sniffing or grunting, or more complex, such as complete words or phrases. Tic disorders can cause considerable distress in affected children, and can lead to social and academic impairment. If left untreated, CTDs can last into adulthood. The standard treatment for suppressing CTDs is medication; dopamine-blocking drugs are used most commonly. These medications, however, are associated with a range of adverse effects that can result in poor treatment compliance and premature treatment termination. Recent research suggests that HRT may be an effective, lower risk treatment for CTDs. HRT is a behavioral treatment based on increasing awareness of one's behaviors and replacing unwanted behaviors with less bothersome ones. This study will determine the effectiveness of CBT with HRT in treating CTDs in children and adolescents.

Participants in this double blind study will be randomly assigned to receive either CBT plus HRT or standard care, which will consist of psychoeducation and supportive therapy. All participants will partake in 8 sessions of their assigned therapy over the course of 10 weeks. After the initial 10 weeks, those who responded to treatment will report back to the study site for 3 monthly booster sessions. Changes in tic severity, effects of the therapies on overall functioning and quality of life, and possible predictors of treatment outcome will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 17 Years

Eligibility

Inclusion Criteria:

• Meets DSM-IV diagnostic criteria for chronic tic disorder (chronic motor or vocal tic disorder or Tourette syndrome)

• Score of at least 3 on the Clinical Global Impressions Severity Scale

• Score of at least 14 on the Yale Global Tic Severity Scale (YGTSS) or at least 10 for individuals with motor tics only

• Unmedicated or currently on a stable medication treatment for tics, obsessive compulsive disorder (OCD), ADHD, anxiety, and/or depressive disorder for at least 6 weeks, with no planned changes for the duration of study participation

• Child speaks English

Exclusion Criteria:

• Score greater than 30 on the YGTSS

• IQ less than 80 on the Wechsler Abbreviated Scale of Intelligence (WASI)

• Meets DSM-IV criteria for substance abuse or dependence within the 3 months prior to study entry

• Meets DSM-IV criteria for conduct disorder within the 3 months prior to study entry

• Lifetime DSM-IV diagnosis of pervasive developmental disorder, mania, or psychotic disorder

• Any serious psychiatric, psychosocial, or neurological condition (i.e., OCD, ADHD, major depressive disorder, anxiety, severe aggression, or family discord) requiring immediate treatment other than what is provided in the current study (i.e., medication, school intervention, or family therapy)

• Previous treatment with four or more sessions of HRT for tics

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

Behavioral:
• Comprehensive Behavioral Intervention for Tics

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	UCLA Child OCD, Anxiety, and Tic Disorders Program	Los Angeles	California
United States	University of Wisconsin-Milwaukee	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Tourette Association of America	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in tic severity		10-22 weeks	No
Primary	Reduction in tic-related impairment and distress (measured at Week 10)		measured at week 10	No
Secondary	Tic severity and associated impairment and distress (measured at Week 36 follow-up)		measured at week 36 follow-up	No
Secondary	Changes in neurocognitive function (measured at Week 10)		measured at week 10	No

External Links

•   Click here for the Tourette Syndrome Association, Inc. website
•   Click here for the UCLA Child OCD, Anxiety, and Tic Disorders Program website