Incorporating teleCBIT Into a Hospital-Based Tic Program

Tourette Syndrome Clinical Trial

Official title:

Incorporating teleCBIT Into a Hospital-Based Tic Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007913
• Other study ID #: TSCTRF2016
• Status: Completed
• Phase: N/A
• Start date: September 21, 2016
• Est. completion date: June 15, 2019

Study information

• Verified date: July 2019
• Source: San Jose State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

Behavioral:
• teleCBIT
Eight sessions of individual behavior therapy

Locations

Country	Name	City	State
United States	University of Florida Health	Gainesville	Florida
United States	San Jose State University	San Jose	California

Sponsors (3)

Lead Sponsor	Collaborator
San Jose State University	American Academy of Neurology, Tourette Association of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
Secondary	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)	CGI:I score at post-treatment (Week 10), which assesses change from pre-treatment (i.e., week 0)
Secondary	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.	Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
Secondary	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.	Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
Secondary	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	Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)