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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00218777
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 14, 2015
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
John Piacentini, University of California, Los Angeles

Brief 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.

Condition or disease Intervention/treatment Phase
Tourette Syndrome Tic Disorders Behavioral: Comprehensive Behavioral Intervention for Tics Phase 2 Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Behavior Therapy for Children With Chronic Tic Disorders
Study Start Date : December 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Reduction in tic severity [ Time Frame: 10-22 weeks ]
  2. Reduction in tic-related impairment and distress (measured at Week 10) [ Time Frame: measured at week 10 ]

Secondary Outcome Measures :
  1. Tic severity and associated impairment and distress (measured at Week 36 follow-up) [ Time Frame: measured at week 36 follow-up ]
  2. Changes in neurocognitive function (measured at Week 10) [ Time Frame: measured at week 10 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00218777

United States, California
UCLA Child OCD, Anxiety, and Tic Disorders Program
Los Angeles, California, United States, 90402
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Wisconsin
University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
Tourette Association of America
National Institute of Mental Health (NIMH)
Principal Investigator: John Piacentini, PhD University of California at Los Angeles

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: John Piacentini, Chair, TSA Behavioral Sciences Consortium; Director, UCLA Child OCD, Anxiety and Tic Disorders Program, University of California, Los Angeles Identifier: NCT00218777     History of Changes
Other Study ID Numbers: R01MH070802 ( U.S. NIH Grant/Contract )
R01MH070802 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by John Piacentini, University of California, Los Angeles:
Chronic tic disorder
Motor tics
Vocal tics

Additional relevant MeSH terms:
Tourette Syndrome
Tic Disorders
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms