<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/NCT03001154</url>
  </required_header>
  <id_info>
    <org_study_id>VRetorik</org_study_id>
    <nct_id>NCT03001154</nct_id>
  </id_info>
  <brief_title>Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software</brief_title>
  <acronym>VRETORIK</acronym>
  <official_title>Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stockholm University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stockholm University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Virtual Reality Exposure Therapy (VRET) is an efficacious treatment of fear and anxiety, but&#xD;
      because of the high financial costs and technical complexity of the past generation of VR&#xD;
      hardware, there has been no large-scale implementation of this promising treatment. The&#xD;
      present study will investigate whether off-the-shelf, commercial VR hardware and software can&#xD;
      be used as stimuli material to conduct in-session exposure therapy for speech anxiety. The&#xD;
      study will recruit n=25+25 participants from the general public suffering from substantial&#xD;
      speech anxiety, who will be randomized to either a waiting-list, or one-session VRET with a&#xD;
      therapist, followed by four weeks of a progressive maintenance program encouraging in-vivo&#xD;
      exposure. The waiting-list group will then receive an Internet-delivered VRET treatment&#xD;
      program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">May 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Public Speaking Anxiety Scale</measure>
    <time_frame>Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21</time_frame>
    <description>Self-rating of public speaking anxiety</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Liebowitz Social Anxiety Scale Self-Report</measure>
    <time_frame>Change from baseline: Week 0, 5 and 21</time_frame>
    <description>Self-rating of general social anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Fear of Negative Evaluation Scale</measure>
    <time_frame>Change from baseline: Week 0, 5 and 21</time_frame>
    <description>Self-rating of fear of negative evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire 9-item</measure>
    <time_frame>Change from baseline: Week 0, 5 and 21</time_frame>
    <description>Self-rating of depressive symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder 7-item</measure>
    <time_frame>Change from baseline: Week 0, 5 and 21</time_frame>
    <description>Self-rating of general anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brunnsviken Brief Quality of life scale</measure>
    <time_frame>Change from baseline: Week 0, 5 and 21</time_frame>
    <description>Self-rating of quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Social Phobia</condition>
  <condition>Anxiety</condition>
  <condition>Behavior Therapy</condition>
  <arm_group>
    <arm_group_label>One-session VRET face-to-face</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One-session Virtual Reality Exposure Therapy led by therapist (face-to-face), followed by a 4-week therapist-guided Internet-administered progressive maintenance program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting-list, then Internet-administered VRET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4-week waiting list, followed by therapist-guided, Internet-administered VRET with a 4-week progressive maintenance program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Face-to-face Virtual Reality Exposure Therapy</intervention_name>
    <description>In session, systematic, hierarchical exposure to feared stimuli with therapist.</description>
    <arm_group_label>One-session VRET face-to-face</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet-administered Virtual Reality Exposure Therapy</intervention_name>
    <description>Therapist-guided, Internet-administered Virtual Reality Exposure Therapy self-help program</description>
    <arm_group_label>Waiting-list, then Internet-administered VRET</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Waiting-list</intervention_name>
    <description>Weekly assessments of public speaking</description>
    <arm_group_label>Waiting-list, then Internet-administered VRET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Substantial public speaking anxiety&#xD;
&#xD;
          -  Have access to VR-compatible smartphone (including Internet)&#xD;
&#xD;
          -  Can travel to Stockholm University for treatment on one occasion&#xD;
&#xD;
          -  Can speak and understand sufficient Swedish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Deficits in sight or balance impacting the VR-experience&#xD;
&#xD;
          -  A severe psychiatric disorder better treated elsewhere, including current major&#xD;
             depression, alcohol or drug abuse, bipolarity, psychosis or similar&#xD;
&#xD;
          -  Active psychopharmacological treatment, unless stable for last 3 months&#xD;
&#xD;
          -  Other ongoing psychological treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Psychology</name>
      <address>
        <city>Stockholm</city>
        <zip>10691</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>March 6, 2019</last_update_submitted>
  <last_update_submitted_qc>March 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stockholm University</investigator_affiliation>
    <investigator_full_name>Per Carlbring</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Phobia, Social</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/NCT03001154
org study id: VRetorik
nct id: NCT03001154
lead sponsor: 
has dmc: No
Virtual Reality Exposure Therapy (VRET) is an efficacious treatment of fear and anxiety, but
      because of the high financial costs and technical complexity of the past generation of VR
      hardware, there has been no large-scale implementation of this promising treatment. The
      present study will investigate whether off-the-shelf, commercial VR hardware and software can
      be used as stimuli material to conduct in-session exposure therapy for speech anxiety. The
      study will recruit n=25+25 participants from the general public suffering from substantial
      speech anxiety, who will be randomized to either a waiting-list, or one-session VRET with a
      therapist, followed by four weeks of a progressive maintenance program encouraging in-vivo
      exposure. The waiting-list group will then receive an Internet-delivered VRET treatment
      program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Public Speaking Anxiety Scale
time frame: Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21
description: Self-rating of public speaking anxiety
measure: Liebowitz Social Anxiety Scale Self-Report
time frame: Change from baseline: Week 0, 5 and 21
description: Self-rating of general social anxiety
measure: Brief Fear of Negative Evaluation Scale
time frame: Change from baseline: Week 0, 5 and 21
description: Self-rating of fear of negative evaluation
measure: Patient Health Questionnaire 9-item
time frame: Change from baseline: Week 0, 5 and 21
description: Self-rating of depressive symptoms
measure: Generalized Anxiety Disorder 7-item
time frame: Change from baseline: Week 0, 5 and 21
description: Self-rating of general anxiety symptoms
measure: Brunnsviken Brief Quality of life scale
time frame: Change from baseline: Week 0, 5 and 21
description: Self-rating of quality of life
arm group label: One-session VRET face-to-face
arm group type: Experimental
description: One-session Virtual Reality Exposure Therapy led by therapist (face-to-face), followed by a 4-week therapist-guided Internet-administered progressive maintenance program.
arm group label: Waiting-list, then Internet-administered VRET
arm group type: Experimental
description: 4-week waiting list, followed by therapist-guided, Internet-administered VRET with a 4-week progressive maintenance program.
intervention type: Behavioral
intervention name: Face-to-face Virtual Reality Exposure Therapy
description: In session, systematic, hierarchical exposure to feared stimuli with therapist.
arm group label: One-session VRET face-to-face
intervention type: Behavioral
intervention name: Internet-administered Virtual Reality Exposure Therapy
description: Therapist-guided, Internet-administered Virtual Reality Exposure Therapy self-help program
arm group label: Waiting-list, then Internet-administered VRET
intervention type: Other
intervention name: Waiting-list
description: Weekly assessments of public speaking
arm group label: Waiting-list, then Internet-administered VRET
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Stockholm University
investigator full name: Per Carlbring
investigator title: Professor
mesh term: Anxiety Disorders
mesh term: Phobia, Social
sharing ipd: Undecided