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Developing Cognitive Training for Tourette Syndrome

Primary Purpose

Tourette Syndrome, Chronic Tic Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Behavioral Intervention for Tics (CBIT)
Computerized Response Inhibition Training
Computerized Placebo Cognitive Training
Sponsored by
University of Wisconsin, Milwaukee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring tic disorder, tourette syndrome, habit reversal, response inhibition, cognitive retraining

Eligibility Criteria

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

Inclusion Criteria:

  • age between 9 and 17
  • a diagnosis of TS or chronic tic disorder on the structured diagnostic interview
  • moderate to severe levels of tic symptoms (YGTSS total score > 13 for TS, or > 9 for CTD), and (d) IQ > 80.

Exclusion Criteria:

  • current substance abuse or dependence
  • current or past psychotic disorder, bipolar disorder, or schizophrenia
  • 4 or more previous sessions of behavioral treatments for tic
  • significant suicidal ideation and/or attempts within the past 3 months
  • any recent (in the previous month) or planned change in medication for tic symptoms.

Sites / Locations

  • The Psychology Clinic, University of Wisconsin-Milwaukee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CBIT + Response Inhibition Training

Experimental: CBIT + Placebo Computer Training

Arm Description

CBIT is an 8 session treatment protocol held over 10 weeks. In CBIT, core components are implemented across the various therapy sessions. These core components include habit reversal training (HRT), functional assessment/function-based interventions, and a behavioral reward program for the child. Each core component is briefly described below. HRT/CBIT involves three components, awareness training, competing response training, and social support training (Woods, Twohig, Roloff, & Flessner, 2003). For this condition, CBIT will be combined with adjunctive computerized response inhibition training, which will be delivered over the first 4 weeks of the CBIT treatment.

In this condition, participants receive the same package of CBIT treatment, which consists of awareness training, competing response training, and social support training (Woods, Twohig, Roloff, & Flessner, 2003). Additionally, the standard CBIT treatment is combined with computer-based placebo cognitive training that is irrelevant to the target cognitive ability (i.e., response inhibition). During the first 4 weeks of the CBIT treatment, participants will receive 8 sessions of placebo cognitive training.

Outcomes

Primary Outcome Measures

Change in scores on the Yale Global Tic Severity Scale (YGTSS) across baseline, 4-week, 8-week, and 12 week assessments. during and after the treatment from baseline
The YGTSS is a well-validated instrument that produces severity ratings for motor and vocal tics, impairment caused by the tics, and an overall severity score of tic symptoms.

Secondary Outcome Measures

Change in scores on the Clinical Global Impression Severity and Improvement (CGI-S and CGI-I) across baseline, 4-week, 8-week, and 12 week assessments.
The CGI-S and CGI-I are clinicianadministered rating scales that have been widely used in treatment outcome research for over 25 years. The current research will use the CGI scale to evaluate the overall severity and improvement in tic symptoms.

Full Information

First Posted
September 2, 2011
Last Updated
January 13, 2015
Sponsor
University of Wisconsin, Milwaukee
Collaborators
Tourette Association of America
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1. Study Identification

Unique Protocol Identification Number
NCT01440023
Brief Title
Developing Cognitive Training for Tourette Syndrome
Official Title
Developing Effective Response Inhibition Training for Symptom Relief in Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee
Collaborators
Tourette Association of America

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Many researchers suspect that individuals with Tourette Syndrome (TS) may have a poor cognitive ability (i.e., response inhibition; RI) that is essential to inhibit inappropriate response such as vocal or motor tics. The investigators aim to test whether a well-established behavior therapy for TS can be improved by increasing the individual's RI capabilities. To this end, 20 children will be randomly assigned to behavior therapy with computer-based RI training or behavior therapy with placebo computer-based cognitive training. The investigators will test the hypothesis that computer-based RI training can be a useful addition to the well-established behavior therapy to enhance its therapeutic effect.
Detailed Description
The current research seeks to examine the feasibility of using a computer-based RI training program as an adjunctive intervention for the Comprehensive Behavioral Intervention for Tics (CBIT). Our central hypothesis is that cognitive training designed to enhance RI will potentiate treatment outcomes of CBIT. To this end, the investigators will conduct a two-arm placebo-controlled double-blind trial, in which 20 children with TS will be randomly assigned to CBIT with computerized RI training (CBIT+RIT; n=10) or CBIT with placebo computer training (CBIT +PLT; n=10). CBIT consists of eight weekly sessions that present awareness training, competing response training, relaxation training and functional contingency management in a manualized format. The adjunctive computer training (RIT or PLT) will be delivered during the first 4 weeks of CBIT/HRT (i.e. 8 twice-weekly 40-min sessions). Tic symptoms and RI capabilities will be assessed at baseline, mid-treatment, post-treatment, and 1 month follow-up. This project is expected to increase our understanding about the nature of response inhibition deficits in TS and generate knowledge that will guide the development of effective cognitive interventions for TS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Chronic Tic Disorders
Keywords
tic disorder, tourette syndrome, habit reversal, response inhibition, cognitive retraining

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBIT + Response Inhibition Training
Arm Type
Experimental
Arm Description
CBIT is an 8 session treatment protocol held over 10 weeks. In CBIT, core components are implemented across the various therapy sessions. These core components include habit reversal training (HRT), functional assessment/function-based interventions, and a behavioral reward program for the child. Each core component is briefly described below. HRT/CBIT involves three components, awareness training, competing response training, and social support training (Woods, Twohig, Roloff, & Flessner, 2003). For this condition, CBIT will be combined with adjunctive computerized response inhibition training, which will be delivered over the first 4 weeks of the CBIT treatment.
Arm Title
Experimental: CBIT + Placebo Computer Training
Arm Type
Placebo Comparator
Arm Description
In this condition, participants receive the same package of CBIT treatment, which consists of awareness training, competing response training, and social support training (Woods, Twohig, Roloff, & Flessner, 2003). Additionally, the standard CBIT treatment is combined with computer-based placebo cognitive training that is irrelevant to the target cognitive ability (i.e., response inhibition). During the first 4 weeks of the CBIT treatment, participants will receive 8 sessions of placebo cognitive training.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Behavioral Intervention for Tics (CBIT)
Other Intervention Name(s)
Habit Reversal for Tourette Syndrome
Intervention Description
CBIT is an 8 session treatment protocol held over 10 weeks. Its core components are implemented across the various therapy sessions. These core components include habit reversal training (HRT), functional assessment/function-based interventions, and a behavioral reward program for the child.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Response Inhibition Training
Intervention Description
Twice-weekly 45 minute computerized sessions for cognitive training focused on enhancing response inhibition capabilities.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Placebo Cognitive Training
Intervention Description
Twice-weekly 45 minute computerized sessions for placebo cognitive training, which has been designed to be irrelevant for response inhibition capabilities.
Primary Outcome Measure Information:
Title
Change in scores on the Yale Global Tic Severity Scale (YGTSS) across baseline, 4-week, 8-week, and 12 week assessments. during and after the treatment from baseline
Description
The YGTSS is a well-validated instrument that produces severity ratings for motor and vocal tics, impairment caused by the tics, and an overall severity score of tic symptoms.
Time Frame
At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)
Secondary Outcome Measure Information:
Title
Change in scores on the Clinical Global Impression Severity and Improvement (CGI-S and CGI-I) across baseline, 4-week, 8-week, and 12 week assessments.
Description
The CGI-S and CGI-I are clinicianadministered rating scales that have been widely used in treatment outcome research for over 25 years. The current research will use the CGI scale to evaluate the overall severity and improvement in tic symptoms.
Time Frame
At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)

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: age between 9 and 17 a diagnosis of TS or chronic tic disorder on the structured diagnostic interview moderate to severe levels of tic symptoms (YGTSS total score > 13 for TS, or > 9 for CTD), and (d) IQ > 80. Exclusion Criteria: current substance abuse or dependence current or past psychotic disorder, bipolar disorder, or schizophrenia 4 or more previous sessions of behavioral treatments for tic significant suicidal ideation and/or attempts within the past 3 months any recent (in the previous month) or planned change in medication for tic symptoms.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Joo Lee, Ph.D.
Organizational Affiliation
University of Wisconsin, Milwaukee
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Psychology Clinic, University of Wisconsin-Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States

12. IPD Sharing Statement

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Developing Cognitive Training for Tourette Syndrome

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