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

Primary Purpose

Tourette Syndrome, Tic Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Behavioral Intervention for Tics
Sponsored by
Tourette Association of America
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Chronic tic disorder, Motor tics, Vocal tics

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Child OCD, Anxiety, and Tic Disorders Program
  • Johns Hopkins University
  • University of Wisconsin-Milwaukee

Outcomes

Primary Outcome Measures

Reduction in tic severity
Reduction in tic-related impairment and distress (measured at Week 10)

Secondary Outcome Measures

Tic severity and associated impairment and distress (measured at Week 36 follow-up)
Changes in neurocognitive function (measured at Week 10)

Full Information

First Posted
September 21, 2005
Last Updated
December 10, 2015
Sponsor
Tourette Association of America
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00218777
Brief Title
Cognitive Behavior Therapy and Habit Reversal Training for the Treatment of Chronic Tic Disorders in Children
Acronym
CBIT
Official Title
Behavior Therapy for Children With Chronic Tic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tourette Association of America
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Tic Disorders
Keywords
Chronic tic disorder, Motor tics, Vocal tics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Behavioral Intervention for Tics
Primary Outcome Measure Information:
Title
Reduction in tic severity
Time Frame
10-22 weeks
Title
Reduction in tic-related impairment and distress (measured at Week 10)
Time Frame
measured at week 10
Secondary Outcome Measure Information:
Title
Tic severity and associated impairment and distress (measured at Week 36 follow-up)
Time Frame
measured at week 36 follow-up
Title
Changes in neurocognitive function (measured at Week 10)
Time Frame
measured at week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Piacentini, PhD
Organizational Affiliation
University of California at Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Child OCD, Anxiety, and Tic Disorders Program
City
Los Angeles
State/Province
California
ZIP/Postal Code
90402
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Wisconsin-Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29029679
Citation
Houghton DC, Capriotti MR, Scahill LD, Wilhelm S, Peterson AL, Walkup JT, Piacentini J, Woods DW. Investigating Habituation to Premonitory Urges in Behavior Therapy for Tic Disorders. Behav Ther. 2017 Nov;48(6):834-846. doi: 10.1016/j.beth.2017.08.004. Epub 2017 Aug 10.
Results Reference
derived
PubMed Identifier
28202705
Citation
Sukhodolsky DG, Woods DW, Piacentini J, Wilhelm S, Peterson AL, Katsovich L, Dziura J, Walkup JT, Scahill L. Moderators and predictors of response to behavior therapy for tics in Tourette syndrome. Neurology. 2017 Mar 14;88(11):1029-1036. doi: 10.1212/WNL.0000000000003710. Epub 2017 Feb 15.
Results Reference
derived
PubMed Identifier
26763495
Citation
Peterson AL, McGuire JF, Wilhelm S, Piacentini J, Woods DW, Walkup JT, Hatch JP, Villarreal R, Scahill L. An Empirical Examination of Symptom Substitution Associated With Behavior Therapy for Tourette's Disorder. Behav Ther. 2016 Jan;47(1):29-41. doi: 10.1016/j.beth.2015.09.001. Epub 2015 Sep 11.
Results Reference
derived
PubMed Identifier
25988365
Citation
McGuire JF, Piacentini J, Scahill L, Woods DW, Villarreal R, Wilhelm S, Walkup JT, Peterson AL. Bothersome tics in patients with chronic tic disorders: Characteristics and individualized treatment response to behavior therapy. Behav Res Ther. 2015 Jul;70:56-63. doi: 10.1016/j.brat.2015.05.006. Epub 2015 May 12.
Results Reference
derived
PubMed Identifier
24144615
Citation
McGuire JF, Nyirabahizi E, Kircanski K, Piacentini J, Peterson AL, Woods DW, Wilhelm S, Walkup JT, Scahill L. A cluster analysis of tic symptoms in children and adults with Tourette syndrome: clinical correlates and treatment outcome. Psychiatry Res. 2013 Dec 30;210(3):1198-204. doi: 10.1016/j.psychres.2013.09.021. Epub 2013 Sep 27.
Results Reference
derived
PubMed Identifier
24001701
Citation
Jeon S, Walkup JT, Woods DW, Peterson A, Piacentini J, Wilhelm S, Katsovich L, McGuire JF, Dziura J, Scahill L. Detecting a clinically meaningful change in tic severity in Tourette syndrome: a comparison of three methods. Contemp Clin Trials. 2013 Nov;36(2):414-20. doi: 10.1016/j.cct.2013.08.012. Epub 2013 Aug 31.
Results Reference
derived
PubMed Identifier
21555779
Citation
Woods DW, Piacentini JC, Scahill L, Peterson AL, Wilhelm S, Chang S, Deckersbach T, McGuire J, Specht M, Conelea CA, Rozenman M, Dzuria J, Liu H, Levi-Pearl S, Walkup JT. Behavior therapy for tics in children: acute and long-term effects on psychiatric and psychosocial functioning. J Child Neurol. 2011 Jul;26(7):858-65. doi: 10.1177/0883073810397046. Epub 2011 May 9.
Results Reference
derived
PubMed Identifier
20483969
Citation
Piacentini J, Woods DW, Scahill L, Wilhelm S, Peterson AL, Chang S, Ginsburg GS, Deckersbach T, Dziura J, Levi-Pearl S, Walkup JT. Behavior therapy for children with Tourette disorder: a randomized controlled trial. JAMA. 2010 May 19;303(19):1929-37. doi: 10.1001/jama.2010.607.
Results Reference
derived
Links:
URL
http://www.tsa-usa.org/
Description
Click here for the Tourette Syndrome Association, Inc. website

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

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