Incorporating teleCBIT Into a Hospital-Based Tic Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- San Jose State University
- Enrollment
- 31
- Locations
- 4
- Primary Endpoint
- Change in Yale Global Tic Severity Scale Tic Severity Score (YGTSS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
True masking not possible due to single-arm design. However, independent evaluator is blind to treatment utilization and progress.
Eligibility Criteria
- Ages
- 5 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
teleCBIT
Patient receive eight sessions of individual teleCBIT, in accordance with Woods et al's (2008) protocol, from a licensed psychologist.
Intervention: teleCBIT (Behavioral)
Outcomes
Primary Outcomes
Change in Yale Global Tic Severity Scale Tic Severity Score (YGTSS)
Time Frame: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
YGTSS Tic Severity Score (0-50) as rated by independent evaluator. Higher scores indicate more severe tics.
Secondary Outcomes
- Clinical Global Impression: Improvement (CGI:I) Score(CGI:I score at post-treatment (Week 10), which assesses change from pre-treatment (i.e., week 0))
- Adult Tic Questionnaire (ATQ) Total Tic Severity Score(Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week))
- Yale Global Tic Severity Scale (YGTSS) Impairment Score(Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week))
- Parent Tic Questionnaire (PTQ) Total Tic Severity Score(Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week))
Investigators
Matthew Capriotti
Assistant Professor
San Jose State University