Incorporating teleCBIT Into a Hospital-Based Tic Program

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.

Study Overview

• Status: Completed
• Conditions: Tourette Syndrome; Tic Disorders
• Intervention / Treatment: Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95192
      • San Jose State University
  • Florida
    • Gainesville, Florida, United States, 32606
      • University of Florida Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 63 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: teleCBIT; Patient receive eight sessions of individual teleCBIT, in accordance with Woods et al's (2008) protocol, from a licensed psychologist.	Behavioral: teleCBIT; Eight sessions of individual behavior therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: San Jose State University
• Collaborators: Tourette Association of America; American Academy of Neurology

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2016
• Primary Completion (Actual): June 15, 2019
• Study Completion (Actual): June 15, 2019

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tourette Syndrome; Tic Disorders
• Other Study ID Numbers: TSCTRF2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No