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Developing Cognitive Training for Tourette Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Wisconsin, Milwaukee
Sponsor:
Collaborator:
Tourette Syndrome Association
Information provided by (Responsible Party):
Han Joo Lee, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier:
NCT01440023
First received: September 2, 2011
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Tourette Syndrome
Chronic Tic Disorders
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)
Behavioral: Computerized Response Inhibition Training
Behavioral: Computerized Placebo Cognitive Training
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developing Effective Response Inhibition Training for Symptom Relief in Tourette Syndrome

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Milwaukee:

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 [ Time Frame: At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up) ] [ Designated as safety issue: No ]
    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. [ Time Frame: At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBIT + Response Inhibition Training
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.
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)
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.
Other Name: Habit Reversal for Tourette Syndrome
Behavioral: Computerized Response Inhibition Training
Twice-weekly 45 minute computerized sessions for cognitive training focused on enhancing response inhibition capabilities.
Placebo Comparator: Experimental: CBIT + Placebo Computer Training
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.
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)
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.
Other Name: Habit Reversal for Tourette Syndrome
Behavioral: Computerized Placebo Cognitive Training
Twice-weekly 45 minute computerized sessions for placebo cognitive training, which has been designed to be irrelevant for response inhibition capabilities.

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.

  Eligibility

Ages Eligible for Study:   9 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440023

Contacts
Contact: Han Joo Lee, Ph.D. 414-229-5858 leehj@uwm.edu

Locations
United States, Wisconsin
The Psychology Clinic, University of Wisconsin-Milwaukee Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Han Joo Lee, Ph.D.    414-229-5858    leehj@uwm.edu   
Principal Investigator: Han Joo Lee, Ph.D.         
Sponsors and Collaborators
University of Wisconsin, Milwaukee
Tourette Syndrome Association
Investigators
Principal Investigator: Han Joo Lee, Ph.D. University of Wisconsin, Milwaukee
  More Information

No publications provided

Responsible Party: Han Joo Lee, Assistant Professor of Clinical Psychology, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier: NCT01440023     History of Changes
Other Study ID Numbers: TSA-2011-Lee, TSA
Study First Received: September 2, 2011
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Milwaukee:
tic disorder
tourette syndrome
habit reversal
response inhibition
cognitive retraining

Additional relevant MeSH terms:
Tourette Syndrome
Syndrome
Tic Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Disease
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Mental Disorders Diagnosed in Childhood
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014