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出境医 / 临床实验 / Incorporating teleCBIT Into a Hospital-Based Tic Program

Incorporating teleCBIT Into a Hospital-Based Tic Program

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
Tic Disorders Tourette Syndrome Behavioral: teleCBIT Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : September 21, 2016
Actual Primary Completion Date : June 15, 2019
Actual Study Completion Date : June 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) [ 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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Layout table for location information
United States, California
San Jose State University
San Jose, California, United States, 95192
United States, Florida
University of Florida Health
Gainesville, Florida, United States, 32606
Sponsors and Collaborators
San Jose State University
American Academy of Neurology
Tourette Association of America
Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE September 21, 2016
Actual Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019) 		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
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • 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)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • Clinical Global Impression: Improvement (CGI:I) Score [ Time Frame: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week) ]
    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 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Incorporating teleCBIT Into a Hospital-Based Tic Program
Official Title  ICMJE Incorporating teleCBIT Into a Hospital-Based Tic Program
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Tic Disorders
  • Tourette Syndrome
Intervention  ICMJE Behavioral: teleCBIT
Eight sessions of individual behavior therapy
Study Arms  ICMJE Experimental: teleCBIT
Patient receive eight sessions of individual teleCBIT, in accordance with Woods et al's (2008) protocol, from a licensed psychologist.
Intervention: Behavioral: teleCBIT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2019) 		31
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 15, 2019
Actual Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04007913
Other Study ID Numbers  ICMJE TSCTRF2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Matthew Capriotti, San Jose State University
Study Sponsor  ICMJE San Jose State University
Collaborators  ICMJE
  • American Academy of Neurology
  • Tourette Association of America
Investigators  ICMJE Not Provided
PRS Account San Jose State University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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