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Completed

NCT Number: NCT04007913

Incorporating teleCBIT Into a Hospital-Based Tic Program

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.

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Key information

Conditions

Tic Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Tourette Syndrome

Age range

5 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Jose State University, San Jose, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

teleCBIT

Behavioral

Eight sessions of individual behavior therapy

Primary outcomes

  1. 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

  1. Clinical Global Impression: Improvement (CGI:I) Score

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

San Jose State University

Other

Collaborators

  • American Academy of Neurology
  • Tourette Association of America

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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