<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02247206</url>
  </required_header>
  <id_info>
    <org_study_id>MIL105611</org_study_id>
    <secondary_id>F31MH096375-01</secondary_id>
    <secondary_id>5F31MH096375-02</secondary_id>
    <nct_id>NCT02247206</nct_id>
  </id_info>
  <brief_title>VoIP Delivered Behavior Therapy for Tourette Syndrome</brief_title>
  <official_title>Voice Over Internet Protocol Delivered Behavior Therapy for Tourette Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Milwaukee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Milwaukee</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to examine the preliminary efficacy, feasibility, and&#xD;
      acceptability of Voice over Internet Protocol delivered behavior therapy for Tourette&#xD;
      Syndrome through in a randomized waitlist-controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Comprehensive Behavioral Intervention for Tics (CBIT) is an emerging treatment for children&#xD;
      with Tourette Syndrome (TS) and has been shown to be efficacious in separate randomized&#xD;
      trials with children and adults; however, many families of children with TS are prevented&#xD;
      from accessing it due to limited availability of adequately trained treatment providers.&#xD;
      Recent research has shown that videoconference-delivered CBIT is as effective as face to face&#xD;
      delivery, and that both modalities are efficacious. Despite its effectiveness, traditional&#xD;
      videoconferencing has limitations including lack of portability, ease of access, the need for&#xD;
      third party clinics, and cost. A newer, more convenient alternative to increase access is the&#xD;
      use of Voice over Internet Protocol (VoIP) transmission, allowing for the direct delivery of&#xD;
      CBIT to patients' homes.&#xD;
&#xD;
      Therefore the objective of this study (the final phase of a three-phase project) is to&#xD;
      establish the preliminary efficacy of VoIP-modified CBIT for reducing tics in children with&#xD;
      TS relative to a waitlist-control. Twenty children (ages 9-17) with TS or Chronic Tic&#xD;
      Disorder as a primary diagnosis will be recruited for a randomized, observer-blind, waitlist&#xD;
      controlled trial of VoIP-delivered CBIT. Participants will be randomly assigned to 8 weekly&#xD;
      sessions of CBIT-VoIP over a 10-week acute treatment period, or waitlist control condition.&#xD;
      As an exploratory aim, the current study will investigate potential correlates of treatment&#xD;
      outcome, including home computer equipment available (i.e., web camera type, microphone type,&#xD;
      internet upload speed, and type of internet connection), prior computer experience, and&#xD;
      comfort with study computer equipment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Yale Global Tic Severity Scale (YGTSS) total tic severity scores at 10 weeks</measure>
    <time_frame>Baseline, 10-week (post-treatment)</time_frame>
    <description>The YGTSS is a clinician-rated tic severity measure, featuring a total severity score, with a rating from 0 to 50, and independent subtotals for motor and vocal tics each with ratings from 0 to 25. It also features a tic-related 0-50 point impairment scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on the Clinical Global Impressions-Severity scale at 10 weeks</measure>
    <time_frame>Baseline, 10-week (post-treatment)</time_frame>
    <description>The CGI-S is a clinician-rated measure of patient global impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response rate using the Clinical Global Impressions-Improvement scale at 10 weeks</measure>
    <time_frame>10-week (post-treatment)</time_frame>
    <description>The CGI-I is a rating of patient improvement compared to baseline. Scores of Much (2) or Very Much (1) Improved indicate positive treatment response in this study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Tourette Syndrome</condition>
  <condition>Chronic Tic Disorder</condition>
  <arm_group>
    <arm_group_label>Behavior Therapy for Tics (CBIT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The child 1) learns to become more aware of any sensations, or urges that may trigger tics, and 2) learn some other behavior (competing response) to do every time he/she feels the urge to tic. The child's parent is trained to provide prompts and praise for use of the competing response. The parent and family also receive psychoeducation about tics, and learn ways to reduce the impact of environmental stimuli on tic severity. The child learns relaxation techniques to reduce stress and make it easier for him/her to resist his or her tics. Prior to treatment sessions, the parent and child spend about 10 minutes discussing with the therapist any problematic issues he/she is having. At the end of treatment sessions the child is assigned some tasks to practice prior to the next session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist-control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the waitlist-control group, do not receive behavior therapy for tics or any other treatment during the 10-week acute treatment period. Instead they child are placed on a waitlist to receive videoconference-delivered treatment following the end of the study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavior Therapy for Tics (CBIT)</intervention_name>
    <description>CBIT is an 8-session 10-week behavioral treatment for chronic tic disorders, including Tourette Syndrome. The first two sessions are 90 minutes, with subsequent sessions lasting 60 minutes. The treatment consists of Habit Reversal Training (awareness training, competing response training, and social support), and function-based assessment to reduce the impact of environmental or other stimuli on tic severity. The treatment also consists of relaxation techniques to reduce tic-related stress and tension, and behavioral rewards to motivate treatment compliance.</description>
    <arm_group_label>Behavior Therapy for Tics (CBIT)</arm_group_label>
    <other_name>Comprehensive Behavioral Intervention for Tics (CBIT)</other_name>
    <other_name>Habit Reversal Training (HRT)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resides in the state of Wisconsin&#xD;
&#xD;
          -  Ages 8-17&#xD;
&#xD;
          -  Meets DSM-IV-TR diagnostic criteria for Chronic Tic Disorder (CMVT or TS)&#xD;
&#xD;
          -  Clinical global Impressions - Severity Score greater than or equal to 4 (moderately&#xD;
             ill)&#xD;
&#xD;
          -  YGTSS Total Score greater than or equal to 14 and less than 30 OR Total Score greater&#xD;
             than or equal to 10 and less than 20 if CTD with motor tics only&#xD;
&#xD;
          -  Unmedicated or on stable medication treatment for tics, OCD, ADHD, anxiety, and/or&#xD;
             depressive disorder for at least 6 weeks, with no planned changes for duration of&#xD;
             study participation&#xD;
&#xD;
          -  Fluent English speaker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  YGTSS Total Tic Score &gt; 30 (for any score exceeding 30 on the YGTSS, the research team&#xD;
             determined the appropriateness of the patient's participation in the study, taking&#xD;
             into account the patient's global functioning)&#xD;
&#xD;
          -  WASI-Vocab subtest T-Score &lt; 37&#xD;
&#xD;
          -  DSM-IV substance abuse or dependence or Conduct Disorder within the past 3 months&#xD;
&#xD;
          -  Lifetime DSM-IV diagnosis of Pervasive developmental disorder, Mania, or Psychotic&#xD;
             Disorder&#xD;
&#xD;
          -  Any serious psychiatric, psychosocial, or neurological condition requiring immediate&#xD;
             treatment other than that provided in the current&#xD;
&#xD;
          -  Previous treatment with HRT for tics (four or more sessions)&#xD;
&#xD;
          -  Lack of a functional, and accessible home computer, and high speed (i.e., cable/DSL)&#xD;
             internet connection&#xD;
&#xD;
          -  Refusal to sign a release of information form for the child's local primary care&#xD;
             physician, mental health professional, or neurologist.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily J Ricketts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Milwaukee</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Douglas W Woods, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Texas A&amp;M University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael B Himle, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin-Milwaukee Psychology Department</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Wisconsin, Milwaukee</investigator_affiliation>
    <investigator_full_name>Emily Ricketts</investigator_full_name>
    <investigator_title>Doctoral Student</investigator_title>
  </responsible_party>
  <keyword>Tourette Syndrome</keyword>
  <keyword>tic disorders</keyword>
  <keyword>behavior therapy</keyword>
  <keyword>web-based videoconferencing</keyword>
  <keyword>VoIP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tourette Syndrome</mesh_term>
    <mesh_term>Tic Disorders</mesh_term>
    <mesh_term>Tics</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02247206
org study id: MIL105611
secondary id: F31MH096375-01
secondary id: 5F31MH096375-02
nct id: NCT02247206
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this research is to examine the preliminary efficacy, feasibility, and
      acceptability of Voice over Internet Protocol delivered behavior therapy for Tourette
      Syndrome through in a randomized waitlist-controlled trial.
A Comprehensive Behavioral Intervention for Tics (CBIT) is an emerging treatment for children
      with Tourette Syndrome (TS) and has been shown to be efficacious in separate randomized
      trials with children and adults; however, many families of children with TS are prevented
      from accessing it due to limited availability of adequately trained treatment providers.
      Recent research has shown that videoconference-delivered CBIT is as effective as face to face
      delivery, and that both modalities are efficacious. Despite its effectiveness, traditional
      videoconferencing has limitations including lack of portability, ease of access, the need for
      third party clinics, and cost. A newer, more convenient alternative to increase access is the
      use of Voice over Internet Protocol (VoIP) transmission, allowing for the direct delivery of
      CBIT to patients' homes.

      Therefore the objective of this study (the final phase of a three-phase project) is to
      establish the preliminary efficacy of VoIP-modified CBIT for reducing tics in children with
      TS relative to a waitlist-control. Twenty children (ages 9-17) with TS or Chronic Tic
      Disorder as a primary diagnosis will be recruited for a randomized, observer-blind, waitlist
      controlled trial of VoIP-delivered CBIT. Participants will be randomly assigned to 8 weekly
      sessions of CBIT-VoIP over a 10-week acute treatment period, or waitlist control condition.
      As an exploratory aim, the current study will investigate potential correlates of treatment
      outcome, including home computer equipment available (i.e., web camera type, microphone type,
      internet upload speed, and type of internet connection), prior computer experience, and
      comfort with study computer equipment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline in Yale Global Tic Severity Scale (YGTSS) total tic severity scores at 10 weeks
time frame: Baseline, 10-week (post-treatment)
description: The YGTSS is a clinician-rated tic severity measure, featuring a total severity score, with a rating from 0 to 50, and independent subtotals for motor and vocal tics each with ratings from 0 to 25. It also features a tic-related 0-50 point impairment scale.
measure: Change from baseline on the Clinical Global Impressions-Severity scale at 10 weeks
time frame: Baseline, 10-week (post-treatment)
description: The CGI-S is a clinician-rated measure of patient global impairment.
measure: Treatment response rate using the Clinical Global Impressions-Improvement scale at 10 weeks
time frame: 10-week (post-treatment)
description: The CGI-I is a rating of patient improvement compared to baseline. Scores of Much (2) or Very Much (1) Improved indicate positive treatment response in this study.
arm group label: Behavior Therapy for Tics (CBIT)
arm group type: Experimental
description: The child 1) learns to become more aware of any sensations, or urges that may trigger tics, and 2) learn some other behavior (competing response) to do every time he/she feels the urge to tic. The child's parent is trained to provide prompts and praise for use of the competing response. The parent and family also receive psychoeducation about tics, and learn ways to reduce the impact of environmental stimuli on tic severity. The child learns relaxation techniques to reduce stress and make it easier for him/her to resist his or her tics. Prior to treatment sessions, the parent and child spend about 10 minutes discussing with the therapist any problematic issues he/she is having. At the end of treatment sessions the child is assigned some tasks to practice prior to the next session.
arm group label: Waitlist-control Group
arm group type: No Intervention
description: Participants in the waitlist-control group, do not receive behavior therapy for tics or any other treatment during the 10-week acute treatment period. Instead they child are placed on a waitlist to receive videoconference-delivered treatment following the end of the study period.
intervention type: Behavioral
intervention name: Behavior Therapy for Tics (CBIT)
description: CBIT is an 8-session 10-week behavioral treatment for chronic tic disorders, including Tourette Syndrome. The first two sessions are 90 minutes, with subsequent sessions lasting 60 minutes. The treatment consists of Habit Reversal Training (awareness training, competing response training, and social support), and function-based assessment to reduce the impact of environmental or other stimuli on tic severity. The treatment also consists of relaxation techniques to reduce tic-related stress and tension, and behavioral rewards to motivate treatment compliance.
arm group label: Behavior Therapy for Tics (CBIT)
other name: Comprehensive Behavioral Intervention for Tics (CBIT)
other name: Habit Reversal Training (HRT)
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Emily J Ricketts, PhD
role: Principal Investigator
affiliation: University of Wisconsin, Milwaukee
last name: Douglas W Woods, PhD
role: Study Director
affiliation: Texas A&M University
last name: Michael B Himle, PhD
role: Study Chair
affiliation: University of Utah
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Wisconsin, Milwaukee
investigator full name: Emily Ricketts
investigator title: Doctoral Student
mesh term: Tourette Syndrome
mesh term: Tic Disorders
mesh term: Tics
mesh term: Syndrome