NCT04007913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

2.7 years

First QC Date

June 27, 2019

Last Update Submit

July 2, 2019

Conditions

Tic DisordersTourette Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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)

  • Parent Tic Questionnaire (PTQ) Total Tic Severity Score

    Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)

  • 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)

Study Arms (1)

teleCBIT

EXPERIMENTAL

Patient receive eight sessions of individual teleCBIT, in accordance with Woods et al's (2008) protocol, from a licensed psychologist.

Behavioral: teleCBIT

Interventions

teleCBITBEHAVIORAL

Eight sessions of individual behavior therapy

teleCBIT

Eligibility Criteria

Age5 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Jose State University

San Jose, California, 95192, United States

Location

University of Florida Health

Gainesville, Florida, 32606, United States

Location

Related Publications (1)

  • Capriotti MR, Wellen BC, Young BN, Himle MB, Conelea CA, Espil FM, Simpson H, Mathews CA. Evaluating the feasibility, acceptability, and preliminary effectiveness of tele-comprehensive behavior therapy for tics (teleCBIT) for Tourette syndrome in youth and adults. J Telemed Telecare. 2025 Apr;31(3):328-337. doi: 10.1177/1357633X231189305. Epub 2023 Aug 7.

    PMID: 37545359DERIVED

MeSH Terms

Conditions

Tic DisordersTourette Syndrome

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurodevelopmental DisordersMental DisordersBasal Ganglia DiseasesBrain DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
True masking not possible due to single-arm design. However, independent evaluator is blind to treatment utilization and progress.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 5, 2019

Study Start

September 21, 2016

Primary Completion

June 15, 2019

Study Completion

June 15, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)