Developing Cognitive Training for Tourette Syndrome

NCT ID: NCT01440023

Last Updated: 2015-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-12-31

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.

Conditions

Tourette Syndrome; Chronic Tic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Comprehensive Behavioral Intervention for Tics (CBIT)

Intervention Type: BEHAVIORAL

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.

Computerized Response Inhibition Training

Intervention Type: BEHAVIORAL

Twice-weekly 45 minute computerized sessions for cognitive training focused on enhancing response inhibition capabilities.

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.

Group Type: PLACEBO_COMPARATOR

Comprehensive Behavioral Intervention for Tics (CBIT)

Intervention Type: BEHAVIORAL

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.

Computerized Placebo Cognitive Training

Intervention Type: BEHAVIORAL

Twice-weekly 45 minute computerized sessions for placebo cognitive training, which has been designed to be irrelevant for response inhibition capabilities.

Interventions

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.

Intervention Type: BEHAVIORAL

Computerized Response Inhibition Training

Twice-weekly 45 minute computerized sessions for cognitive training focused on enhancing response inhibition capabilities.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Habit Reversal for Tourette Syndrome

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tourette Association of America

OTHER

Sponsor Role: collaborator

University of Wisconsin, Milwaukee

OTHER

Sponsor Role: lead

Responsible Party

Han Joo Lee

Assistant Professor of Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Han Joo Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Milwaukee

Locations

The Psychology Clinic, University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

TSA

Identifier Type: OTHER

Identifier Source: secondary_id

TSA-2011-Lee

Identifier Type: -

Identifier Source: org_study_id