Incorporating teleCBIT Into a Hospital-Based Tic Program

Sponsor
San Jose State University (Other)
Overall Status
Completed
CT.gov ID
NCT04007913
Collaborator
American Academy of Neurology (Other), Tourette Association of America (Other)
31
2
1
32.8
15.5
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: teleCBIT
N/A

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
Actual Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
True masking not possible due to single-arm design. However, independent evaluator is blind to treatment utilization and progress.
Primary Purpose:
Treatment
Official Title:
Incorporating teleCBIT Into a Hospital-Based Tic Program
Actual Study Start Date :
Sep 21, 2016
Actual Primary Completion Date :
Jun 15, 2019
Actual Study Completion Date :
Jun 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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)]

    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)

  2. Parent Tic Questionnaire (PTQ) Total Tic Severity Score [Change 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.

  3. Adult Tic Questionnaire (ATQ) Total Tic Severity Score [Change 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.

  4. Yale Global Tic Severity Scale (YGTSS) Impairment Score [Change 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 65 Years
Sexes Eligible for Study:
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Jose State University San Jose California United States 95192
2 University of Florida Health Gainesville Florida United States 32606

Sponsors and Collaborators

  • San Jose State University
  • American Academy of Neurology
  • Tourette Association of America

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matthew Capriotti, Assistant Professor, San Jose State University
ClinicalTrials.gov Identifier:
NCT04007913
Other Study ID Numbers:
  • TSCTRF2016
First Posted:
Jul 5, 2019
Last Update Posted:
Jul 5, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2019