<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/NCT04450303</url>
  </required_header>
  <id_info>
    <org_study_id>56697</org_study_id>
    <nct_id>NCT04450303</nct_id>
  </id_info>
  <brief_title>Social Anxiety Telehealth Therapy Study</brief_title>
  <official_title>Social Anxiety Telehealth Therapy Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</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>
      The COVID-19 pandemic has substantially increased the risk of adverse mental health outcomes;&#xD;
      while physical distancing is required to reduce infection risk, it also increases loneliness&#xD;
      and isolation and prevents access to traditional in-person therapy, which further contribute&#xD;
      to risk of adverse mental health outcomes. These problems may be especially acute for&#xD;
      individuals with social anxiety disorder (as many as 12% of Americans), however there is a&#xD;
      limited evidence-base for telehealth options to directly address social anxiety. This project&#xD;
      aims to adapt exposure therapy for social anxiety to a telehealth and physical&#xD;
      distancing-compatible intervention, and test whether this effectively decreases loneliness in&#xD;
      adults with elevated social anxiety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2020</start_date>
  <completion_date type="Actual">June 2, 2021</completion_date>
  <primary_completion_date type="Actual">June 2, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Liebowitz Social Anxiety Scale (LSAS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with Therapy and Therapists Scale (STTS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Therapy satisfaction subscale, higher scores are better (indicating greater satisfaction). Minimum score is 6, maximum score is 30.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>UCLA Loneliness Scale version 3</measure>
    <time_frame>12 weeks</time_frame>
    <description>Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Liebowitz Social Anxiety Scale (LSAS)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UCLA Loneliness Scale version 3</measure>
    <time_frame>24 weeks</time_frame>
    <description>Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Social Anxiety</condition>
  <arm_group>
    <arm_group_label>Telehealth Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telehealth CBT</intervention_name>
    <description>The Coordinated Anxiety Learning and Management (CALM) program is an evidence-based, computer-assisted protocol for cognitive behavioral therapy (CBT) for anxiety, depression, and/or post-traumatic stress. CALM will be implemented via secure and HIPAA compliant video-conferencing software (enterprise Zoom), following modifications to address obstacles associated with physical distancing and the tele-health medium.</description>
    <arm_group_label>Telehealth Therapy</arm_group_label>
    <other_name>CALM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18+,&#xD;
&#xD;
          -  Liebowitz Social Anxiety Scale (LSAS) total score &gt; 50&#xD;
&#xD;
          -  Fluent spoken and written English&#xD;
&#xD;
          -  Access to the internet via a smartphone or computer with a camera&#xD;
&#xD;
          -  Ability to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of mania or psychosis&#xD;
&#xD;
          -  Moderate or severe substance use disorder within the past year&#xD;
&#xD;
          -  Current psychiatric diagnosis of greater impairment than that arising from social&#xD;
             anxiety&#xD;
&#xD;
          -  High risk for suicide (&gt;8 on the Mini International Neuropsychiatric Interview&#xD;
             suicidality section)&#xD;
&#xD;
          -  Prior exposure therapy (more than 2 sessions)&#xD;
&#xD;
          -  Current psychotropic medication use&#xD;
&#xD;
          -  Current psychotherapy other than couples counseling.&#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>Tali Ball, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Tali Manber Ball, PhD</investigator_full_name>
    <investigator_title>Instructor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04450303
org study id: 56697
nct id: NCT04450303
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The COVID-19 pandemic has substantially increased the risk of adverse mental health outcomes;
      while physical distancing is required to reduce infection risk, it also increases loneliness
      and isolation and prevents access to traditional in-person therapy, which further contribute
      to risk of adverse mental health outcomes. These problems may be especially acute for
      individuals with social anxiety disorder (as many as 12% of Americans), however there is a
      limited evidence-base for telehealth options to directly address social anxiety. This project
      aims to adapt exposure therapy for social anxiety to a telehealth and physical
      distancing-compatible intervention, and test whether this effectively decreases loneliness in
      adults with elevated social anxiety.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Liebowitz Social Anxiety Scale (LSAS)
time frame: 12 weeks
description: Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.
measure: Satisfaction with Therapy and Therapists Scale (STTS)
time frame: 12 weeks
description: Therapy satisfaction subscale, higher scores are better (indicating greater satisfaction). Minimum score is 6, maximum score is 30.
measure: UCLA Loneliness Scale version 3
time frame: 12 weeks
description: Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.
measure: Liebowitz Social Anxiety Scale (LSAS)
time frame: 24 weeks
description: Social anxiety severity, lower scores are better (indicating less anxiety). Minimum score is 0, maximum score is 144.
measure: UCLA Loneliness Scale version 3
time frame: 24 weeks
description: Loneliness, lower scores are better (indicating less loneliness). Minimum score is 20, maximum score is 80.
arm group label: Telehealth Therapy
arm group type: Experimental
intervention type: Behavioral
intervention name: Telehealth CBT
description: The Coordinated Anxiety Learning and Management (CALM) program is an evidence-based, computer-assisted protocol for cognitive behavioral therapy (CBT) for anxiety, depression, and/or post-traumatic stress. CALM will be implemented via secure and HIPAA compliant video-conferencing software (enterprise Zoom), following modifications to address obstacles associated with physical distancing and the tele-health medium.
arm group label: Telehealth Therapy
other name: CALM
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tali Ball, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Tali Manber Ball, PhD
investigator title: Instructor
mesh term: Anxiety Disorders
sharing ipd: Undecided