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

Sponsor
Tourette Association of America (Other)
Overall Status
Completed
CT.gov ID
NCT00218777
Collaborator
National Institute of Mental Health (NIMH) (NIH)
120
3
28.9
40
1.4

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2004
Actual Primary Completion Date :
May 1, 2007
Actual Study Completion Date :
May 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Reduction in tic severity [10-22 weeks]

  2. Reduction in tic-related impairment and distress (measured at Week 10) [measured at week 10]

Secondary Outcome Measures

  1. Tic severity and associated impairment and distress (measured at Week 36 follow-up) [measured at week 36 follow-up]

  2. Changes in neurocognitive function (measured at Week 10) [measured at week 10]

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 17 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCLA Child OCD, Anxiety, and Tic Disorders Program Los Angeles California United States 90402
2 Johns Hopkins University Baltimore Maryland United States 21287
3 University of Wisconsin-Milwaukee Milwaukee Wisconsin United States 53211

Sponsors and Collaborators

  • Tourette Association of America
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: John Piacentini, PhD, University of California at Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
John Piacentini, Chair, TSA Behavioral Sciences Consortium; Director, UCLA Child OCD, Anxiety and Tic Disorders Program, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00218777
Other Study ID Numbers:
  • R01MH070802
  • R01MH070802
  • DSIR 84-CTS
First Posted:
Sep 22, 2005
Last Update Posted:
Dec 14, 2015
Last Verified:
Dec 1, 2015
Keywords provided by John Piacentini, Chair, TSA Behavioral Sciences Consortium; Director, UCLA Child OCD, Anxiety and Tic Disorders Program, University of California, Los Angeles
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2015