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Incorporating teleCBIT Into a Hospital-Based Tic Program

Primary Purpose

Tic Disorders, Tourette Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

teleCBIT

About this trial

This is an interventional treatment trial for Tic Disorders

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age 5-65, diagnosis of Tourette Syndrome or other persistent tic disorder (per diagnostic interview and self-report of prior physician diagnosis)
Clinical Global Impressions - Severity Score > 3 (i.e., "moderately ill" or worse),
unmedicated or on stable medication treatment for tics and psychiatric problems,
fluency in English
a functional accessible home computer and high speed (i.e., cable/DSL) internet connection
willingness to sign a release of information to contact a local, licensed medical or mental health provider, of whom they are currently a patient (in case of emergent safety concerns).
Minor participants must have a parent or guardian who is fluent in English available to attend treatment and assessment sessions.

Exclusion Criteria:

significant suicidality, (i.e., a score of > 12 on the MINI or MINI-Kid suicidality module);
prior diagnoses of intellectual disability; pervasive developmental disorder, mania, schizophrenia, psychotic disorder, substance abuse, substance dependence, or conduct disorder; currently experiencing a psychosocial, psychiatric, or neurological problem that requires immediate care
lack of a functional home computer with high speed (i.e., cable or DSL) internet connection;
or, prior receipt of >3 previous sessions of behavior therapy for tics within the past year (per self/parent report)

Sites / Locations

San Jose State University
University of Florida Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

teleCBIT

Arm Description

Patient receive eight sessions of individual teleCBIT, in accordance with Woods et al's (2008) protocol, from a licensed psychologist.

Outcomes

Primary Outcome Measures

Change in Yale Global Tic Severity Scale Tic Severity Score (YGTSS)

YGTSS Tic Severity Score (0-50) as rated by independent evaluator. Higher scores indicate more severe tics.

Secondary Outcome Measures

Clinical Global Impression: Improvement (CGI:I) Score

CGI:I scores (range: 1-7) describe the global level of change in clinical severity of a disorder. Lower scores indicate more favorable change over time. Following common practice, we will also dichotomize CGI:I scores to evaluate Clinical Responder Status according to CGI:I score (i.e., responder: CGI:I=1 or 2; non-responder=CGI:I>2)

Parent Tic Questionnaire (PTQ) Total Tic Severity Score

Child Tic Severity as measured by parent-report on the PTQ (range: 0-224). Higher scores indicate more severe tics.

Adult Tic Questionnaire (ATQ) Total Tic Severity Score

Adult Tic Severity as measured by self-report on the ATQ (range: 0-224). Higher scores indicate more severe tics.

Yale Global Tic Severity Scale (YGTSS) Impairment Score

YGTSS Impairment Score (0-50) as rated by independent evaluator. Higher scores indicate greater tic-related impairment

Full Information

NCT ID

NCT04007913

First Posted

June 27, 2019

Last Updated

July 2, 2019

Sponsor

San Jose State University

Collaborators

American Academy of Neurology, Tourette Association of America

1. Study Identification

Unique Protocol Identification Number

NCT04007913

Brief Title

Incorporating teleCBIT Into a Hospital-Based Tic Program

Official Title

Incorporating teleCBIT Into a Hospital-Based Tic Program

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

September 21, 2016 (Actual)

Primary Completion Date

June 15, 2019 (Actual)

Study Completion Date

June 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

San Jose State University

Collaborators

American Academy of Neurology, Tourette Association of America

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a single-arm open trial of Comprehensive Behavioral Intervention for Tics (CBIT) delivered to pediatric and adult patients with persistent tic disorders in their homes via videoconferencing (i.e., teleCBIT). All participants who enroll will receive teleCBIT.

Detailed Description

Comprehensive Behavioral Intervention for Tics (CBIT) is a behavioral therapy with proven efficacy for treating persistent tic disorders (e.g., Tourette Syndrome) in youth and adults. Lack of access to a local CBIT provider prevents treatment access for many patients who could benefit from CBIT. Providing CBIT to patients in their homes via videoconferencing technology (i.e., teleCBIT) is a promising approach to increasing CBIT access. This study investigates treatment uptake, acceptability, feasibility, and clinical effectiveness of teleCBIT among pediatric and adult patients enrolled as patients in a state-of-the-art medical tic program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tic Disorders, Tourette Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

True masking not possible due to single-arm design. However, independent evaluator is blind to treatment utilization and progress.

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

teleCBIT

Arm Type

Experimental

Arm Description

Patient receive eight sessions of individual teleCBIT, in accordance with Woods et al's (2008) protocol, from a licensed psychologist.

Intervention Type

Behavioral

Intervention Name(s)

teleCBIT

Intervention Description

Eight sessions of individual behavior therapy

Primary Outcome Measure Information:

Title

Change in Yale Global Tic Severity Scale Tic Severity Score (YGTSS)

Description

YGTSS Tic Severity Score (0-50) as rated by independent evaluator. Higher scores indicate more severe tics.

Time Frame

Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)

Secondary Outcome Measure Information:

Title

Clinical Global Impression: Improvement (CGI:I) Score

Description

Time Frame

CGI:I score at post-treatment (Week 10), which assesses change from pre-treatment (i.e., week 0)

Title

Parent Tic Questionnaire (PTQ) Total Tic Severity Score

Description

Child Tic Severity as measured by parent-report on the PTQ (range: 0-224). Higher scores indicate more severe tics.

Time Frame

Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)

Title

Adult Tic Questionnaire (ATQ) Total Tic Severity Score

Description

Adult Tic Severity as measured by self-report on the ATQ (range: 0-224). Higher scores indicate more severe tics.

Time Frame

Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)

Title

Yale Global Tic Severity Scale (YGTSS) Impairment Score

Description

YGTSS Impairment Score (0-50) as rated by independent evaluator. Higher scores indicate greater tic-related impairment

Time Frame

Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 5-65, diagnosis of Tourette Syndrome or other persistent tic disorder (per diagnostic interview and self-report of prior physician diagnosis) Clinical Global Impressions - Severity Score > 3 (i.e., "moderately ill" or worse), unmedicated or on stable medication treatment for tics and psychiatric problems, fluency in English a functional accessible home computer and high speed (i.e., cable/DSL) internet connection willingness to sign a release of information to contact a local, licensed medical or mental health provider, of whom they are currently a patient (in case of emergent safety concerns). Minor participants must have a parent or guardian who is fluent in English available to attend treatment and assessment sessions. Exclusion Criteria: significant suicidality, (i.e., a score of > 12 on the MINI or MINI-Kid suicidality module); prior diagnoses of intellectual disability; pervasive developmental disorder, mania, schizophrenia, psychotic disorder, substance abuse, substance dependence, or conduct disorder; currently experiencing a psychosocial, psychiatric, or neurological problem that requires immediate care lack of a functional home computer with high speed (i.e., cable or DSL) internet connection; or, prior receipt of >3 previous sessions of behavior therapy for tics within the past year (per self/parent report)

Facility Information:

Facility Name

San Jose State University

City

San Jose

State/Province

California

ZIP/Postal Code

95192

Country

United States

Facility Name

University of Florida Health

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32606

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Incorporating teleCBIT Into a Hospital-Based Tic Program

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