Clinical trial NCT04007913: Incorporating teleCBIT Into a Hospital-Based Tic Program
Official title: Incorporating teleCBIT Into a Hospital-Based Tic Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tic Disorders
Tourette Syndrome
Lead sponsor: San Jose State University
Sponsor class: OTHER
Collaborators: name: American Academy of Neurology
name: Tourette Association of America
First posted: 2019-07-05
Enrollment: 31
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Yale Global Tic Severity Scale Tic Severity Score (YGTSS)
timeFrame: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
Secondary outcomes:
measure: Clinical Global Impression: Improvement (CGI:I) Score
timeFrame: CGI:I score at post-treatment (Week 10), which assesses change from pre-treatment (i.e., week 0)
measure: Parent Tic Questionnaire (PTQ) Total Tic Severity Score
timeFrame: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
measure: Adult Tic Questionnaire (ATQ) Total Tic Severity Score
timeFrame: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
measure: Yale Global Tic Severity Scale (YGTSS) Impairment Score
timeFrame: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
Other outcomes:
Locations:
city: San Jose
country: United States
facility: San Jose State University
state: California
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
Study officials:
References: