<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/NCT03771235</url>
  </required_header>
  <id_info>
    <org_study_id>2018-30</org_study_id>
    <nct_id>NCT03771235</nct_id>
  </id_info>
  <brief_title>Online Mindfulness-based Tic Reduction (Phase Two)</brief_title>
  <official_title>Online Mindfulness-based Tic Reduction: Development and Testing (Phase Two)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bowdoin College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bowdoin College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tourette Syndrome (TS) and Persistent Tic Disorder (PTD) are chronic and potentially&#xD;
      disabling neurobiological conditions. Although a range of pharmacological and psychosocial&#xD;
      treatments exists, a significant number of individuals either do not respond to the current&#xD;
      treatments or find them unacceptable. Thus, it is essential that researchers continue to&#xD;
      develop and test novel treatment approaches.&#xD;
&#xD;
      In this randomized controlled trial the investigators will compare two different online&#xD;
      group-based interventions for tics: a mindfulness-based program (Mindfulness-based&#xD;
      Intervention for Tics (MBIT), and a psychoeducational and supportive therapy program (Tic&#xD;
      Information and Coping Strategies (TICS)). The purpose of this study is to determine which&#xD;
      intervention is more helpful for adults with a tic disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2018</start_date>
  <completion_date type="Actual">December 2, 2020</completion_date>
  <primary_completion_date type="Actual">December 2, 2020</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score</measure>
    <time_frame>Screening, Week 0, Week 9, Week 13, Week 35</time_frame>
    <description>Clinician-rated measure of tic severity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions Scale</measure>
    <time_frame>Weeks 0, 9, 13, 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adult Tic Questionnaire</measure>
    <time_frame>Weeks 0, 9, 13, 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Yale-Brown Obsessive Compulsive Scale</measure>
    <time_frame>Weeks 0, 9, 13, 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention-Deficit Hyperactivity Rating Scale</measure>
    <time_frame>Weeks 0, 9, 13, 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Anxiety Stress Scale</measure>
    <time_frame>Weeks 0, 9, 13, 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Premonitory Urge to Tic Scale</measure>
    <time_frame>Weeks 0, 9, 13, 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tic Rating Form</measure>
    <time_frame>Weeks 1-8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Problem Rating Form</measure>
    <time_frame>Weeks 1-8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9</measure>
    <time_frame>Weeks 0, 9, 13, 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work and Social Adjustment Survey</measure>
    <time_frame>Weeks 0, 9, 13, 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Facet Mindfulness Questionnaire</measure>
    <time_frame>Weeks 0, 4, 8, 9, 13, 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Credibility and Expectancy Questionnaire</measure>
    <time_frame>Week 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction Questionnaire</measure>
    <time_frame>Week 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Compassion Scale</measure>
    <time_frame>Weeks 0, 9, 13, 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Affective Reactivity Index</measure>
    <time_frame>Weeks 0, 9, 13, 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Irritability Test</measure>
    <time_frame>Weeks 0, 9, 13, 35</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Tourette Syndrome</condition>
  <condition>Persistent Tic Disorder</condition>
  <arm_group>
    <arm_group_label>Mindfulness-based Intervention for Tics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8-week group-based mindfulness-based program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tic Information and Coping Strategies</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>8-week group-based educational and supportive therapy program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-based Intervention for Tics</intervention_name>
    <description>Psychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practices.</description>
    <arm_group_label>Mindfulness-based Intervention for Tics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tic Information and Coping Strategies</intervention_name>
    <description>Psychological Intervention that focuses on learning more about tics, practicing a range of strategies for coping with tics (e.g., relaxation, effective communication), and discussing challenges commonly experienced by individuals with tics.</description>
    <arm_group_label>Tic Information and Coping Strategies</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. be 18 years of age or older,&#xD;
&#xD;
          2. possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,&#xD;
&#xD;
          3. be fluent in English&#xD;
&#xD;
          4. reside in the United States,&#xD;
&#xD;
          5. either not be taking any tic suppressant medication or other psychotropic medication&#xD;
             or be at a stable dose for 8 weeks prior to the baseline assessment and throughout the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. be receiving concurrent psychotherapy for the duration of the study&#xD;
&#xD;
          2. have prior extensive experience with mindfulness and/or meditation and&#xD;
&#xD;
          3. have another medical or psychological condition that would prevent the individual from&#xD;
             fully engaging in the study or require a higher level of care (e.g., suicidality).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hannah Reese, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bowdoin College</name>
      <address>
        <city>Brunswick</city>
        <state>Maine</state>
        <zip>04011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bowdoin College</investigator_affiliation>
    <investigator_full_name>Hannah Reese</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Tourette Syndrome</keyword>
  <keyword>Tic Disorder</keyword>
  <keyword>Online</keyword>
  <keyword>Adults</keyword>
  <keyword>Mindfulness</keyword>
  <keyword>Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tourette Syndrome</mesh_term>
    <mesh_term>Tics</mesh_term>
    <mesh_term>Tic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03771235
org study id: 2018-30
nct id: NCT03771235
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Tourette Syndrome (TS) and Persistent Tic Disorder (PTD) are chronic and potentially
      disabling neurobiological conditions. Although a range of pharmacological and psychosocial
      treatments exists, a significant number of individuals either do not respond to the current
      treatments or find them unacceptable. Thus, it is essential that researchers continue to
      develop and test novel treatment approaches.

      In this randomized controlled trial the investigators will compare two different online
      group-based interventions for tics: a mindfulness-based program (Mindfulness-based
      Intervention for Tics (MBIT), and a psychoeducational and supportive therapy program (Tic
      Information and Coping Strategies (TICS)). The purpose of this study is to determine which
      intervention is more helpful for adults with a tic disorder.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Controlled Trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
time frame: Screening, Week 0, Week 9, Week 13, Week 35
description: Clinician-rated measure of tic severity
measure: Clinical Global Impressions Scale
time frame: Weeks 0, 9, 13, 35
measure: Adult Tic Questionnaire
time frame: Weeks 0, 9, 13, 35
measure: Yale-Brown Obsessive Compulsive Scale
time frame: Weeks 0, 9, 13, 35
measure: Attention-Deficit Hyperactivity Rating Scale
time frame: Weeks 0, 9, 13, 35
measure: Depression Anxiety Stress Scale
time frame: Weeks 0, 9, 13, 35
measure: Premonitory Urge to Tic Scale
time frame: Weeks 0, 9, 13, 35
measure: Tic Rating Form
time frame: Weeks 1-8
measure: Problem Rating Form
time frame: Weeks 1-8
measure: Patient Health Questionnaire-9
time frame: Weeks 0, 9, 13, 35
measure: Work and Social Adjustment Survey
time frame: Weeks 0, 9, 13, 35
measure: Five Facet Mindfulness Questionnaire
time frame: Weeks 0, 4, 8, 9, 13, 35
measure: Credibility and Expectancy Questionnaire
time frame: Week 3
measure: Patient Satisfaction Questionnaire
time frame: Week 9
measure: Self Compassion Scale
time frame: Weeks 0, 9, 13, 35
measure: Affective Reactivity Index
time frame: Weeks 0, 9, 13, 35
measure: Brief Irritability Test
time frame: Weeks 0, 9, 13, 35
arm group label: Mindfulness-based Intervention for Tics
arm group type: Experimental
description: 8-week group-based mindfulness-based program
arm group label: Tic Information and Coping Strategies
arm group type: Active Comparator
description: 8-week group-based educational and supportive therapy program
intervention type: Behavioral
intervention name: Mindfulness-based Intervention for Tics
description: Psychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practices.
arm group label: Mindfulness-based Intervention for Tics
intervention type: Behavioral
intervention name: Tic Information and Coping Strategies
description: Psychological Intervention that focuses on learning more about tics, practicing a range of strategies for coping with tics (e.g., relaxation, effective communication), and discussing challenges commonly experienced by individuals with tics.
arm group label: Tic Information and Coping Strategies
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hannah Reese, Ph.D.
role: Principal Investigator
affiliation: Assistant Professor
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Bowdoin College
investigator full name: Hannah Reese
investigator title: Assistant Professor
mesh term: Tourette Syndrome
mesh term: Tics
mesh term: Tic Disorders
sharing ipd: No