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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
John Piacentini, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00218777
First received: September 21, 2005
Last updated: December 10, 2015
Last verified: December 2015

September 21, 2005
December 10, 2015
December 2004
May 2007   (final data collection date for primary outcome measure)
  • Reduction in tic severity [ Time Frame: 10-22 weeks ] [ Designated as safety issue: No ]
  • Reduction in tic-related impairment and distress (measured at Week 10) [ Time Frame: measured at week 10 ] [ Designated as safety issue: No ]
  • Reduction in tic severity; measured at Week 10
  • Reduction in tic-related impairment and distress; measured at Week 10
Complete list of historical versions of study NCT00218777 on ClinicalTrials.gov Archive Site
  • Tic severity and associated impairment and distress (measured at Week 36 follow-up) [ Time Frame: measured at week 36 follow-up ] [ Designated as safety issue: No ]
  • Changes in neurocognitive function (measured at Week 10) [ Time Frame: measured at week 10 ] [ Designated as safety issue: No ]
  • Tic severity and associated impairment and distress; measured at Week 36 follow-up
  • Changes in neurocognitive function; measured at Week 10
Not Provided
Not Provided
 
Cognitive Behavior Therapy and Habit Reversal Training for the Treatment of Chronic Tic Disorders in Children
Behavior Therapy for Children With Chronic Tic Disorders
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Tourette Syndrome
  • Tic Disorders
Behavioral: Comprehensive Behavioral Intervention for Tics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
9 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00218777
R01MH070802, R01MH070802, DSIR 84-CTS
Not Provided
Not Provided
Not Provided
John Piacentini, University of California, Los Angeles
Tourette Association of America
National Institute of Mental Health (NIMH)
Principal Investigator: John Piacentini, PhD University of California at Los Angeles
Tourette Association of America
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP