xml: <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/NCT06028945</url>
    </required_header>
    <id_info>
      <org_study_id>22-5516</org_study_id>
      <nct_id>NCT06028945</nct_id>
    </id_info>
    <brief_title>Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety</brief_title>
    <acronym>AnxEMU</acronym>
    <official_title>Randomized Controlled Trial Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety In People With Epilepsy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Health Network, Toronto</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Health Network, Toronto</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this randomized control trial is to evaluate the impact of Virtual Reality&#xD;
        (VR) Exposure Therapy (ET) on people with epilepsy who experience epilepsy/seizure-specific&#xD;
        (ES) interictal anxiety. The main questions it aims to answer are:&#xD;
  &#xD;
          1. Can virtual reality exposure therapy (VR-ET) help reduce ES-interictal anxiety in this&#xD;
             population?&#xD;
  &#xD;
          2. Are the study procedures sufficiently simple for participants to follow?&#xD;
  &#xD;
        Study Design Summary:&#xD;
  &#xD;
          -  Fourteen (14) participants will be randomized into either an Experimental arm (receiving&#xD;
             VR-ET) or Control arm&#xD;
  &#xD;
          -  Participants will be expected to have VR-ET twice a day (5 min/session) for up to 10&#xD;
             days&#xD;
  &#xD;
          -  Participants will complete self-reported questionnaires about anxiety, depression,&#xD;
             quality life, and avoidance behaviours at baseline (T0), after completing their VR&#xD;
             program (T2), and at a one-month follow-up (T3).&#xD;
  &#xD;
          -  Participants will have a short interview with a researcher after completing their VR&#xD;
             program (T2) as well as at a one-month follow-up (T3).&#xD;
  &#xD;
        Researchers will attempt to answer the study questions based on outcome measures taken at&#xD;
        various timepoints and qualitative feedback from interviews.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        BASELINE VISIT #1 (T0):&#xD;
  &#xD;
        The first study visit will take place at the participant's bedside in the EMU with a member&#xD;
        of the research team. The participant will be asked to complete several questionnaires&#xD;
        including: demographic/health history, anxiety, depression, avoidance behaviours, and quality&#xD;
        of life. The researcher will show the participant a short neutral video with the VR device&#xD;
        and check for symptoms of motion sickness that might occur using a scale from 0 to 20. Next&#xD;
        the participant will work with the researcher to identify the most appropriate exposure&#xD;
        therapy scenario. Finally the participant will be randomized into either Group 1&#xD;
        (Experimental Group) or Group 2 (Control Group) and receive training on the VR system&#xD;
        specific to their group assignment.&#xD;
  &#xD;
        INTERVENTION (T1):&#xD;
  &#xD;
        Participants will be encouraged to use the VR system throughout their EMU stay, twice per day&#xD;
        for up to 10 days. Each session will involve using VR for approximately 5 minutes. The&#xD;
        intervention may last fewer than 10 days if any participant is discharged early from the EMU,&#xD;
        or (for Group 1 participants) all levels of the exposure therapy is completed in less than 10&#xD;
        days. Before and after each exposure, participants will be asked to rate their anxiety level&#xD;
        on a scale from 0 to 100. After each exposure, participants will also be asked to rate any&#xD;
        motion sickness that might result from using VR on a scale from 0 to 20.&#xD;
  &#xD;
        POST-INTERVENTION VISIT #2 (T2)&#xD;
  &#xD;
        The second study visit will take place after the participant's last VR session. Participants&#xD;
        will be asked to repeat questionnaires from Visit #1 on anxiety, depression, avoidance&#xD;
        behaviours, and quality of life. Participants will also complete questionnaires about sense&#xD;
        of presence in VR and usability of the system. Finally participants will have a short&#xD;
        interview with the researcher to discuss their experience using VR and any thoughts about&#xD;
        whether the intervention had an impact on their anxiety.&#xD;
  &#xD;
        1-MONTH FOLLOW-UP VISIT #3 (T3)&#xD;
  &#xD;
        The third study visit will take place one (1) month after Visit #2. A researcher will&#xD;
        follow-up with a phone interview and provide a link through email for participants to repeat&#xD;
        baseline questionnaires about anxiety, depression, avoidance behaviours, and quality of life.&#xD;
        However if participants prefer, they may request the researcher to record their responses to&#xD;
        the questionnaires over the phone rather than completing the web-based questionnaires.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</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>Interventional, Randomized, Pilot, Pragmatic, Open label</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fast Motion Sickness (FMS) Scale</measure>
      <time_frame>Baseline (T0)</time_frame>
      <description>A single assessment question where motion sickness (nausea and general discomfort) is rated on a visual analog scale ranging from 0 to 20. This scale will be used as a measure of simulator sickness during baseline training.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Epilepsy Anxiety Survey Instrument (EASI)</measure>
      <time_frame>Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)</time_frame>
      <description>An 18-item questionnaire designed specifically to assess anxiety in people with epilepsy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)</measure>
      <time_frame>Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)</time_frame>
      <description>A 6-item screening tool for major depressive disorder (MDD) in people with epilepsy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Liebowitz Social Anxiety Scale</measure>
      <time_frame>Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)</time_frame>
      <description>A 24-item scale used to assess fear and avoidance of a range of social interactions and performance situations</description>
    </primary_outcome>
    <primary_outcome>
      <measure>GAD-7</measure>
      <time_frame>Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)</time_frame>
      <description>A 7-item scale used to screen for generalized anxiety disorder.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>QOLIE - 31</measure>
      <time_frame>Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)</time_frame>
      <description>A 31-item questionnaire measuring overall quality of life including emotional well-being and role limitations in people with epilepsy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mobility Inventory for Agoraphobia</measure>
      <time_frame>Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)</time_frame>
      <description>On this instrument, 26 situations and locations (including shopping malls, public transit, and social gatherings) are rated for avoidance both when accompanied by a trusted companion and when alone. The instrument also collects information on panic symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Subjective Units of Distress/Discomfort Scale (SUDS)</measure>
      <time_frame>Intervention Period (T1)</time_frame>
      <description>A single assessment question where level of anxiety is rated on a visual analog scale ranging from 0 to 100. This scale will be used to measure anxiety immediately before and after VR exposures.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fast Motion Sickness (FMS) Scale</measure>
      <time_frame>Intervention Period (T1)</time_frame>
      <description>A single assessment question where motion sickness (nausea and general discomfort) is rated on a visual analog scale ranging from 0 to 20. This scale will be used as a measure of simulator sickness immediately after using VR.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>System Usability Scale (SUS)</measure>
      <time_frame>Post-Intervention (T2)</time_frame>
      <description>A 10-item survey that provides a quick assessment of the usability of various products and services, including hardware, software, mobile devices, websites and applications.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Igroup Presence Questionnaire (IPQ)</measure>
      <time_frame>Post-Intervention (T2)</time_frame>
      <description>Measures sense of presence, the subjective experience of being present in a virtual environment while remaining physically situated in the physical environment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Post-Intervention Interview (approx. 15 min)</measure>
      <time_frame>Post-Intervention (T2)</time_frame>
      <description>The semi-structured exit interview will be conducted by a researcher the day after the participant has completed their final VR session. The purpose of this interview is to collect feedback on the VR-system usability and training, treatment delivery, overall experience, and (experimental arm only) effectiveness of VR exposure scenes. Participants will also be asked about the intervention's perceived change on their anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Follow-Up Interview (approx. 15 min)</measure>
      <time_frame>1-Month Follow-Up (T3)</time_frame>
      <description>The follow-up phone interview will take place one month post-intervention. The researcher will call the participant and inquire about their general and ES-interictal anxiety levels, as well as their current levels of, and any perceived changes in, fear/comfort and avoidance of feared scenarios.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Epilepsy</condition>
    <condition>Anxiety Disorders</condition>
    <arm_group>
      <arm_group_label>Group 1: VR-ET</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 1 will receive the VR-ET for up to 10 days while in the EMU and complete a set of questionnaires at the first visit and after the last day of VR. A researcher will conduct a short exit interview with participants about their experience during their second visit. There will be a one-month follow-up phone interview with a researcher and participants will complete a final set of questionnaires.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2: Neutral Game</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group 2 will have access to a VR device with a &quot;neutral&quot; game for up to 10 days while in the EMU and complete a set of questionnaires at the first visit and after the last day of VR. A researcher will conduct a short exit interview with participants about their experience during their second visit. There will be a one-month follow-up phone interview with a researcher and participants will complete a final set of questionnaires.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>HMD: Virtual Reality Exposure Therapy</intervention_name>
      <description>The virtual reality exposure therapy uses 360-degree videos delivered through a head mounted display (HMD). Participants will be matched with one of three available exposure hierarchies: Social Party Scenario, Subway Scenario, or Shopping Mall Scenario. Each hierarchy comprises seven 5-min scenes ordered in increasing intensity (from low to high anxiety). Participants are gradually exposed to scenes, viewed twice per day for up to 10 days, while rating their anxiety immediately before and after the exposures. Anxiety ratings will inform when participants may advance to the next level intensity in the exposure hierarchy.</description>
      <arm_group_label>Group 1: VR-ET</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>HMD: Neutral Game</intervention_name>
      <description>The neutral game is a virtual-reality based game that is not designed to provoke anxiety. Participants assigned to the neutral game will play for 5 minutes twice per day for up to 10 days.</description>
      <arm_group_label>Group 2: Neutral Game</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals who are at least 18 years old&#xD;
  &#xD;
            -  Individuals admitted to the EMU&#xD;
  &#xD;
            -  Individuals who have self-reported anxiety related to having epilepsy or seizures&#xD;
  &#xD;
            -  Individuals who score &lt;15 on the Fast Motion Sickness (FMS) after the VR neutral demo&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with an unconfirmed epilepsy diagnosis&#xD;
  &#xD;
            -  Individuals with stereotaxic EEG monitoring&#xD;
  &#xD;
            -  Individuals with photosensitive epilepsy&#xD;
  &#xD;
            -  Individuals with open wounds on the face or cervical conditions or injuries that would&#xD;
               make it unsafe for use the VR headset&#xD;
  &#xD;
            -  Individuals who have started an antidepressant, antianxiety drug, or medical marijuana&#xD;
               in the last twelve weeks&#xD;
  &#xD;
            -  Individuals who cannot speak or understand English&#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>Esther Bui</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Health Network, Toronto</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Danielle Tchao</last_name>
      <phone>647-408-9638</phone>
      <email>danielle.tchao@uhn.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lora Appel, PhD</last_name>
      <email>lora.appel@uhn.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Toronto Western Hospital</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5T 2S8</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Danielle Tchao</last_name>
        <phone>647-408-9638</phone>
        <email>danielle.tchao@uhn.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <link>
      <url>https://www.ilae.org/files/dmfile/EASI-18.pdf</url>
      <description>EASI-18</description>
    </link>
    <link>
      <url>https://www.rand.org/health-care/surveys_tools/qolie.html</url>
      <description>QOLIE-31</description>
    </link>
    <link>
      <url>https://psychology-tools.com/test/liebowitz-social-anxiety-scale</url>
      <description>Liebowitz Social Anxiety Scale</description>
    </link>
    <link>
      <url>https://cpb-us-w2.wpmucdn.com/web.sas.upenn.edu/dist/6/184/files/2017/03/Mobility-Inventory-1zjichf.pdf</url>
      <description>Mobility Inventory for Agoraphobia</description>
    </link>
    <link>
      <url>https://www.disordersofmood.com/pdf/SUDS.pdf</url>
      <description>Subjective Units of Distress/Discomfort Scale (SUDS)</description>
    </link>
    <link>
      <url>https://www.usability.gov/how-to-and-tools/methods/system-usability-scale.html</url>
      <description>System Usability Scale (SUS)</description>
    </link>
    <link>
      <url>http://www.igroup.org/pq/ipq/items.php</url>
      <description>Igroup Presence Questionnaire (IPQ)</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/21901938/</url>
      <description>Fast Motion Sickness Scale (FMS)</description>
    </link>
    <link>
      <url>https://adaa.org/sites/default/files/GAD-7_Anxiety-updated_0.pdf</url>
      <description>GAD-7</description>
    </link>
    <results_reference>
      <citation>Hingray C, McGonigal A, Kotwas I, Micoulaud-Franchi JA. The Relationship Between Epilepsy and Anxiety Disorders. Curr Psychiatry Rep. 2019 Apr 29;21(6):40. doi: 10.1007/s11920-019-1029-9.</citation>
      <PMID>31037466</PMID>
    </results_reference>
    <results_reference>
      <citation>Munger Clary HM. Anxiety and epilepsy: what neurologists and epileptologists should know. Curr Neurol Neurosci Rep. 2014 May;14(5):445. doi: 10.1007/s11910-014-0445-9.</citation>
      <PMID>24652453</PMID>
    </results_reference>
    <results_reference>
      <citation>Munger Clary HM, Giambarberi L, Floyd WN, Hamberger MJ. Afraid to go out: Poor quality of life with phobic anxiety in a large cross-sectional adult epilepsy center sample. Epilepsy Res. 2023 Feb;190:107092. doi: 10.1016/j.eplepsyres.2023.107092. Epub 2023 Jan 16.</citation>
      <PMID>36701931</PMID>
    </results_reference>
    <results_reference>
      <citation>Deng W, Hu D, Xu S, Liu X, Zhao J, Chen Q, Liu J, Zhang Z, Jiang W, Ma L, Hong X, Cheng S, Liu B, Li X. The efficacy of virtual reality exposure therapy for PTSD symptoms: A systematic review and meta-analysis. J Affect Disord. 2019 Oct 1;257:698-709. doi: 10.1016/j.jad.2019.07.086. Epub 2019 Jul 30.</citation>
      <PMID>31382122</PMID>
    </results_reference>
    <results_reference>
      <citation>Tychsen L, Thio LL. Concern of Photosensitive Seizures Evoked by 3D Video Displays or Virtual Reality Headsets in Children: Current Perspective. Eye Brain. 2020 Feb 11;12:45-48. doi: 10.2147/EB.S233195. eCollection 2020.</citation>
      <PMID>32104130</PMID>
    </results_reference>
    <results_reference>
      <citation>Gribkoff VK, Lum-Ragan JT. Evidence for nitric oxide synthase inhibitor-sensitive and insensitive hippocampal synaptic potentiation. J Neurophysiol. 1992 Aug;68(2):639-42. doi: 10.1152/jn.1992.68.2.639.</citation>
      <PMID>1382122</PMID>
    </results_reference>
    <results_reference>
      <citation>McConnell EA. Assessing a quadriplegic's severe headache. Nursing. 1990 Jan;20(1):84-7. No abstract available.</citation>
      <PMID>2300295</PMID>
    </results_reference>
    <results_reference>
      <citation>Gray HG, Tchao D, Lewis-Fung S, Pardini S, Harris LR, Appel L. Virtual Reality Therapy for People With Epilepsy and Related Anxiety: Protocol for a 3-Phase Pilot Clinical Trial. JMIR Res Protoc. 2023 Jan 24;12:e41523. doi: 10.2196/41523.</citation>
      <PMID>36692939</PMID>
    </results_reference>
    <results_reference>
      <citation>Tchao D, Lewis-Fung S, Gray H, Pardini S, Harris LR, Appel L. Describing epilepsy-related anxiety to inform the design of a virtual reality exposure therapy: Results from Phase 1 of the AnxEpiVR clinical trial. Epilepsy Behav Rep. 2023 Jan 16;21:100588. doi: 10.1016/j.ebr.2023.100588. eCollection 2023.</citation>
      <PMID>36794093</PMID>
    </results_reference>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Epilepsy</keyword>
    <keyword>Anxiety</keyword>
    <keyword>Virtual Reality</keyword>
    <keyword>Exposure Therapy</keyword>
    <keyword>Cognitive Behavioural Therapy</keyword>
    <keyword>Seizure</keyword>
    <keyword>Interictal Anxiety</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Epilepsy</mesh_term>
      <mesh_term>Seizures</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028945
  org study id: 22-5516
  nct id: NCT06028945
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this randomized control trial is to evaluate the impact of Virtual Reality
        (VR) Exposure Therapy (ET) on people with epilepsy who experience epilepsy/seizure-specific
        (ES) interictal anxiety. The main questions it aims to answer are:
  
          1. Can virtual reality exposure therapy (VR-ET) help reduce ES-interictal anxiety in this
             population?
  
          2. Are the study procedures sufficiently simple for participants to follow?
  
        Study Design Summary:
  
          -  Fourteen (14) participants will be randomized into either an Experimental arm (receiving
             VR-ET) or Control arm
  
          -  Participants will be expected to have VR-ET twice a day (5 min/session) for up to 10
             days
  
          -  Participants will complete self-reported questionnaires about anxiety, depression,
             quality life, and avoidance behaviours at baseline (T0), after completing their VR
             program (T2), and at a one-month follow-up (T3).
  
          -  Participants will have a short interview with a researcher after completing their VR
             program (T2) as well as at a one-month follow-up (T3).
  
        Researchers will attempt to answer the study questions based on outcome measures taken at
        various timepoints and qualitative feedback from interviews.
  BASELINE VISIT #1 (T0):
  
        The first study visit will take place at the participant's bedside in the EMU with a member
        of the research team. The participant will be asked to complete several questionnaires
        including: demographic/health history, anxiety, depression, avoidance behaviours, and quality
        of life. The researcher will show the participant a short neutral video with the VR device
        and check for symptoms of motion sickness that might occur using a scale from 0 to 20. Next
        the participant will work with the researcher to identify the most appropriate exposure
        therapy scenario. Finally the participant will be randomized into either Group 1
        (Experimental Group) or Group 2 (Control Group) and receive training on the VR system
        specific to their group assignment.
  
        INTERVENTION (T1):
  
        Participants will be encouraged to use the VR system throughout their EMU stay, twice per day
        for up to 10 days. Each session will involve using VR for approximately 5 minutes. The
        intervention may last fewer than 10 days if any participant is discharged early from the EMU,
        or (for Group 1 participants) all levels of the exposure therapy is completed in less than 10
        days. Before and after each exposure, participants will be asked to rate their anxiety level
        on a scale from 0 to 100. After each exposure, participants will also be asked to rate any
        motion sickness that might result from using VR on a scale from 0 to 20.
  
        POST-INTERVENTION VISIT #2 (T2)
  
        The second study visit will take place after the participant's last VR session. Participants
        will be asked to repeat questionnaires from Visit #1 on anxiety, depression, avoidance
        behaviours, and quality of life. Participants will also complete questionnaires about sense
        of presence in VR and usability of the system. Finally participants will have a short
        interview with the researcher to discuss their experience using VR and any thoughts about
        whether the intervention had an impact on their anxiety.
  
        1-MONTH FOLLOW-UP VISIT #3 (T3)
  
        The third study visit will take place one (1) month after Visit #2. A researcher will
        follow-up with a phone interview and provide a link through email for participants to repeat
        baseline questionnaires about anxiety, depression, avoidance behaviours, and quality of life.
        However if participants prefer, they may request the researcher to record their responses to
        the questionnaires over the phone rather than completing the web-based questionnaires.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Interventional, Randomized, Pilot, Pragmatic, Open label
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Fast Motion Sickness (FMS) Scale
  time frame: Baseline (T0)
  description: A single assessment question where motion sickness (nausea and general discomfort) is rated on a visual analog scale ranging from 0 to 20. This scale will be used as a measure of simulator sickness during baseline training.
  measure: Epilepsy Anxiety Survey Instrument (EASI)
  time frame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
  description: An 18-item questionnaire designed specifically to assess anxiety in people with epilepsy.
  measure: Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
  time frame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
  description: A 6-item screening tool for major depressive disorder (MDD) in people with epilepsy.
  measure: Liebowitz Social Anxiety Scale
  time frame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
  description: A 24-item scale used to assess fear and avoidance of a range of social interactions and performance situations
  measure: GAD-7
  time frame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
  description: A 7-item scale used to screen for generalized anxiety disorder.
  measure: QOLIE - 31
  time frame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
  description: A 31-item questionnaire measuring overall quality of life including emotional well-being and role limitations in people with epilepsy.
  measure: Mobility Inventory for Agoraphobia
  time frame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
  description: On this instrument, 26 situations and locations (including shopping malls, public transit, and social gatherings) are rated for avoidance both when accompanied by a trusted companion and when alone. The instrument also collects information on panic symptoms.
  measure: Subjective Units of Distress/Discomfort Scale (SUDS)
  time frame: Intervention Period (T1)
  description: A single assessment question where level of anxiety is rated on a visual analog scale ranging from 0 to 100. This scale will be used to measure anxiety immediately before and after VR exposures.
  measure: Fast Motion Sickness (FMS) Scale
  time frame: Intervention Period (T1)
  description: A single assessment question where motion sickness (nausea and general discomfort) is rated on a visual analog scale ranging from 0 to 20. This scale will be used as a measure of simulator sickness immediately after using VR.
  measure: System Usability Scale (SUS)
  time frame: Post-Intervention (T2)
  description: A 10-item survey that provides a quick assessment of the usability of various products and services, including hardware, software, mobile devices, websites and applications.
  measure: Igroup Presence Questionnaire (IPQ)
  time frame: Post-Intervention (T2)
  description: Measures sense of presence, the subjective experience of being present in a virtual environment while remaining physically situated in the physical environment.
  measure: Post-Intervention Interview (approx. 15 min)
  time frame: Post-Intervention (T2)
  description: The semi-structured exit interview will be conducted by a researcher the day after the participant has completed their final VR session. The purpose of this interview is to collect feedback on the VR-system usability and training, treatment delivery, overall experience, and (experimental arm only) effectiveness of VR exposure scenes. Participants will also be asked about the intervention's perceived change on their anxiety.
  measure: Follow-Up Interview (approx. 15 min)
  time frame: 1-Month Follow-Up (T3)
  description: The follow-up phone interview will take place one month post-intervention. The researcher will call the participant and inquire about their general and ES-interictal anxiety levels, as well as their current levels of, and any perceived changes in, fear/comfort and avoidance of feared scenarios.
  arm group label: Group 1: VR-ET
  arm group type: Experimental
  description: Group 1 will receive the VR-ET for up to 10 days while in the EMU and complete a set of questionnaires at the first visit and after the last day of VR. A researcher will conduct a short exit interview with participants about their experience during their second visit. There will be a one-month follow-up phone interview with a researcher and participants will complete a final set of questionnaires.
  arm group label: Group 2: Neutral Game
  arm group type: Active Comparator
  description: Group 2 will have access to a VR device with a "neutral" game for up to 10 days while in the EMU and complete a set of questionnaires at the first visit and after the last day of VR. A researcher will conduct a short exit interview with participants about their experience during their second visit. There will be a one-month follow-up phone interview with a researcher and participants will complete a final set of questionnaires.
  intervention type: Device
  intervention name: HMD: Virtual Reality Exposure Therapy
  description: The virtual reality exposure therapy uses 360-degree videos delivered through a head mounted display (HMD). Participants will be matched with one of three available exposure hierarchies: Social Party Scenario, Subway Scenario, or Shopping Mall Scenario. Each hierarchy comprises seven 5-min scenes ordered in increasing intensity (from low to high anxiety). Participants are gradually exposed to scenes, viewed twice per day for up to 10 days, while rating their anxiety immediately before and after the exposures. Anxiety ratings will inform when participants may advance to the next level intensity in the exposure hierarchy.
  arm group label: Group 1: VR-ET
  intervention type: Device
  intervention name: HMD: Neutral Game
  description: The neutral game is a virtual-reality based game that is not designed to provoke anxiety. Participants assigned to the neutral game will play for 5 minutes twice per day for up to 10 days.
  arm group label: Group 2: Neutral Game
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Esther Bui
  role: Principal Investigator
  affiliation: University Health Network, Toronto
  last name: Danielle Tchao
  phone: 647-408-9638
  email: danielle.tchao@uhn.ca
  last name: Lora Appel, PhD
  email: lora.appel@uhn.ca
  facility: 
  contact: 
  country: Canada
  url: https://www.ilae.org/files/dmfile/EASI-18.pdf
  description: EASI-18
  url: https://www.rand.org/health-care/surveys_tools/qolie.html
  description: QOLIE-31
  url: https://psychology-tools.com/test/liebowitz-social-anxiety-scale
  description: Liebowitz Social Anxiety Scale
  url: https://cpb-us-w2.wpmucdn.com/web.sas.upenn.edu/dist/6/184/files/2017/03/Mobility-Inventory-1zjichf.pdf
  description: Mobility Inventory for Agoraphobia
  url: https://www.disordersofmood.com/pdf/SUDS.pdf
  description: Subjective Units of Distress/Discomfort Scale (SUDS)
  url: https://www.usability.gov/how-to-and-tools/methods/system-usability-scale.html
  description: System Usability Scale (SUS)
  url: http://www.igroup.org/pq/ipq/items.php
  description: Igroup Presence Questionnaire (IPQ)
  url: https://pubmed.ncbi.nlm.nih.gov/21901938/
  description: Fast Motion Sickness Scale (FMS)
  url: https://adaa.org/sites/default/files/GAD-7_Anxiety-updated_0.pdf
  description: GAD-7
  citation: Hingray C, McGonigal A, Kotwas I, Micoulaud-Franchi JA. The Relationship Between Epilepsy and Anxiety Disorders. Curr Psychiatry Rep. 2019 Apr 29;21(6):40. doi: 10.1007/s11920-019-1029-9.
  PMID: 31037466
  citation: Munger Clary HM. Anxiety and epilepsy: what neurologists and epileptologists should know. Curr Neurol Neurosci Rep. 2014 May;14(5):445. doi: 10.1007/s11910-014-0445-9.
  PMID: 24652453
  citation: Munger Clary HM, Giambarberi L, Floyd WN, Hamberger MJ. Afraid to go out: Poor quality of life with phobic anxiety in a large cross-sectional adult epilepsy center sample. Epilepsy Res. 2023 Feb;190:107092. doi: 10.1016/j.eplepsyres.2023.107092. Epub 2023 Jan 16.
  PMID: 36701931
  citation: Deng W, Hu D, Xu S, Liu X, Zhao J, Chen Q, Liu J, Zhang Z, Jiang W, Ma L, Hong X, Cheng S, Liu B, Li X. The efficacy of virtual reality exposure therapy for PTSD symptoms: A systematic review and meta-analysis. J Affect Disord. 2019 Oct 1;257:698-709. doi: 10.1016/j.jad.2019.07.086. Epub 2019 Jul 30.
  PMID: 31382122
  citation: Tychsen L, Thio LL. Concern of Photosensitive Seizures Evoked by 3D Video Displays or Virtual Reality Headsets in Children: Current Perspective. Eye Brain. 2020 Feb 11;12:45-48. doi: 10.2147/EB.S233195. eCollection 2020.
  PMID: 32104130
  citation: Gribkoff VK, Lum-Ragan JT. Evidence for nitric oxide synthase inhibitor-sensitive and insensitive hippocampal synaptic potentiation. J Neurophysiol. 1992 Aug;68(2):639-42. doi: 10.1152/jn.1992.68.2.639.
  PMID: 1382122
  citation: McConnell EA. Assessing a quadriplegic's severe headache. Nursing. 1990 Jan;20(1):84-7. No abstract available.
  PMID: 2300295
  citation: Gray HG, Tchao D, Lewis-Fung S, Pardini S, Harris LR, Appel L. Virtual Reality Therapy for People With Epilepsy and Related Anxiety: Protocol for a 3-Phase Pilot Clinical Trial. JMIR Res Protoc. 2023 Jan 24;12:e41523. doi: 10.2196/41523.
  PMID: 36692939
  citation: Tchao D, Lewis-Fung S, Gray H, Pardini S, Harris LR, Appel L. Describing epilepsy-related anxiety to inform the design of a virtual reality exposure therapy: Results from Phase 1 of the AnxEpiVR clinical trial. Epilepsy Behav Rep. 2023 Jan 16;21:100588. doi: 10.1016/j.ebr.2023.100588. eCollection 2023.
  PMID: 36794093
  responsible party type: Sponsor
  mesh term: Epilepsy
  mesh term: Seizures
  mesh term: Anxiety Disorders