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Incorporating teleCBIT Into a Hospital-Based Tic Program

Incorporating teleCBIT Into a Hospital-Based Tic Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04007913
Enrollment
31
Registered
2019-07-05
Start date
2016-09-21
Completion date
2019-06-15
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tic Disorders, Tourette Syndrome

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.

Interventions

BEHAVIORALteleCBIT

Eight sessions of individual behavior therapy

Sponsors

American Academy of Neurology
CollaboratorOTHER
Tourette Association of America
CollaboratorOTHER
San Jose State University
Lead SponsorOTHER

Study design

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

Sex/Gender
ALL
Age
5 Years to 65 Years
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)

Design outcomes

Primary

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

MeasureTime frameDescription
Clinical Global Impression: Improvement (CGI:I) ScoreCGI:I score at post-treatment (Week 10), which assesses change from pre-treatment (i.e., week 0)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 ScoreChange from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)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 ScoreChange from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)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 ScoreChange from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)YGTSS Impairment Score (0-50) as rated by independent evaluator. Higher scores indicate greater tic-related impairment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026