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Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety (AnxEMU)

Primary Purpose

Epilepsy, Anxiety Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HMD: Virtual Reality Exposure Therapy
HMD: Neutral Game
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Anxiety, Virtual Reality, Exposure Therapy, Cognitive Behavioural Therapy, Seizure, Interictal Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals who are at least 18 years old Individuals admitted to the EMU Individuals who have self-reported anxiety related to having epilepsy or seizures Individuals who score <15 on the Fast Motion Sickness (FMS) after the VR neutral demo Exclusion Criteria: Individuals with an unconfirmed epilepsy diagnosis Individuals with stereotaxic EEG monitoring Individuals with photosensitive epilepsy Individuals with open wounds on the face or cervical conditions or injuries that would make it unsafe for use the VR headset Individuals who have started an antidepressant, antianxiety drug, or medical marijuana in the last twelve weeks Individuals who cannot speak or understand English

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: VR-ET

Group 2: Neutral Game

Arm 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.

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.

Outcomes

Primary Outcome Measures

Fast Motion Sickness (FMS) Scale
A single assessment question where motion sickness (nausea and general discomfort) is rated on a visual analog scale ranging from 0 (no sickness at all) to 20 (severe sickness). This scale will be used as a measure of simulator sickness during baseline training.
Epilepsy Anxiety Survey Instrument (EASI)
An 18-item questionnaire designed specifically to assess anxiety in people with epilepsy. Scores can range from 0 to 54, where higher scores indicate more severe anxiety.
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
A 6-item screening tool for major depressive disorder (MDD) in people with epilepsy. Scores can range from 6 to 24, where higher scores indicate more severe depression.
Liebowitz Social Anxiety Scale
A 24-item scale used to assess fear and avoidance of a range of social interactions and performance situations. Scores range from 0 to 144, where higher scores indicate more severe social anxiety.
GAD-7
A 7-item scale used to screen for generalized anxiety disorder. Scores range from 0 to 21, where higher scores indicate more severe anxiety.
QOLIE - 31
A 31-item questionnaire measuring overall quality of life including emotional well-being and role limitations in people with epilepsy. Scores range from 0 to 100, where higher scores reflect higher quality of life.
Mobility Inventory for Agoraphobia
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. Average scores for each subscale (accompanied vs alone) range from 1 (never avoid) to 5 (always avoid). The instrument also collects information on panic attacks, with a score ranging from 1 (very mild) to 5 (extremely severe).
Subjective Units of Distress/Discomfort Scale (SUDS)
A single assessment question where level of anxiety is rated on a visual analog scale ranging from 0 (no distress; totally relaxed) to 100 (highest anxiety/distress that you have ever felt). This scale will be used to measure anxiety immediately before and after VR exposures.
Fast Motion Sickness (FMS) Scale
A single assessment question where motion sickness (nausea and general discomfort) is rated on a visual analog scale ranging from 0 (no sickness at all) to 20 (severe sickness). This scale will be used as a measure of simulator sickness immediately after using VR.
System Usability Scale (SUS)
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. Scores range from 0 to 100, with higher scores indicating higher level of usability.
Igroup Presence Questionnaire (IPQ)
Several subscales to measure sense of presence, spatial presence, involvement, and experienced realism while in the virtual environment. Average scores for the different subscales range from 0 to 6, with higher scores indicating higher sense of presence/realism.
Post-Intervention Interview (approx. 15 min)
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.
Follow-Up Interview (approx. 15 min)
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.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2023
Last Updated
October 18, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT06028945
Brief Title
Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety
Acronym
AnxEMU
Official Title
Randomized Controlled Trial Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety In People With Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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: Can virtual reality exposure therapy (VR-ET) help reduce ES-interictal anxiety in this population? 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Anxiety Disorders
Keywords
Epilepsy, Anxiety, Virtual Reality, Exposure Therapy, Cognitive Behavioural Therapy, Seizure, Interictal Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional, Randomized, Pilot, Pragmatic, Open label
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: VR-ET
Arm Type
Experimental
Arm 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 Title
Group 2: Neutral Game
Arm Type
Active Comparator
Arm 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(s)
HMD: Virtual Reality Exposure Therapy
Intervention 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.
Intervention Type
Device
Intervention Name(s)
HMD: Neutral Game
Intervention 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.
Primary Outcome Measure Information:
Title
Fast Motion Sickness (FMS) Scale
Description
A single assessment question where motion sickness (nausea and general discomfort) is rated on a visual analog scale ranging from 0 (no sickness at all) to 20 (severe sickness). This scale will be used as a measure of simulator sickness during baseline training.
Time Frame
Baseline (T0)
Title
Epilepsy Anxiety Survey Instrument (EASI)
Description
An 18-item questionnaire designed specifically to assess anxiety in people with epilepsy. Scores can range from 0 to 54, where higher scores indicate more severe anxiety.
Time Frame
Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
Title
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
Description
A 6-item screening tool for major depressive disorder (MDD) in people with epilepsy. Scores can range from 6 to 24, where higher scores indicate more severe depression.
Time Frame
Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
Title
Liebowitz Social Anxiety Scale
Description
A 24-item scale used to assess fear and avoidance of a range of social interactions and performance situations. Scores range from 0 to 144, where higher scores indicate more severe social anxiety.
Time Frame
Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
Title
GAD-7
Description
A 7-item scale used to screen for generalized anxiety disorder. Scores range from 0 to 21, where higher scores indicate more severe anxiety.
Time Frame
Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
Title
QOLIE - 31
Description
A 31-item questionnaire measuring overall quality of life including emotional well-being and role limitations in people with epilepsy. Scores range from 0 to 100, where higher scores reflect higher quality of life.
Time Frame
Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
Title
Mobility Inventory for Agoraphobia
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. Average scores for each subscale (accompanied vs alone) range from 1 (never avoid) to 5 (always avoid). The instrument also collects information on panic attacks, with a score ranging from 1 (very mild) to 5 (extremely severe).
Time Frame
Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
Title
Subjective Units of Distress/Discomfort Scale (SUDS)
Description
A single assessment question where level of anxiety is rated on a visual analog scale ranging from 0 (no distress; totally relaxed) to 100 (highest anxiety/distress that you have ever felt). This scale will be used to measure anxiety immediately before and after VR exposures.
Time Frame
Intervention Period (T1)
Title
Fast Motion Sickness (FMS) Scale
Description
A single assessment question where motion sickness (nausea and general discomfort) is rated on a visual analog scale ranging from 0 (no sickness at all) to 20 (severe sickness). This scale will be used as a measure of simulator sickness immediately after using VR.
Time Frame
Intervention Period (T1)
Title
System Usability Scale (SUS)
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. Scores range from 0 to 100, with higher scores indicating higher level of usability.
Time Frame
Post-Intervention (T2)
Title
Igroup Presence Questionnaire (IPQ)
Description
Several subscales to measure sense of presence, spatial presence, involvement, and experienced realism while in the virtual environment. Average scores for the different subscales range from 0 to 6, with higher scores indicating higher sense of presence/realism.
Time Frame
Post-Intervention (T2)
Title
Post-Intervention Interview (approx. 15 min)
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.
Time Frame
Post-Intervention (T2)
Title
Follow-Up Interview (approx. 15 min)
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.
Time Frame
1-Month Follow-Up (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals who are at least 18 years old Individuals admitted to the EMU Individuals who have self-reported anxiety related to having epilepsy or seizures Individuals who score <15 on the Fast Motion Sickness (FMS) after the VR neutral demo Exclusion Criteria: Individuals with an unconfirmed epilepsy diagnosis Individuals with stereotaxic EEG monitoring Individuals with photosensitive epilepsy Individuals with open wounds on the face or cervical conditions or injuries that would make it unsafe for use the VR headset Individuals who have started an antidepressant, antianxiety drug, or medical marijuana in the last twelve weeks Individuals who cannot speak or understand English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Tchao
Phone
647-408-9638
Email
danielle.tchao@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lora Appel, PhD
Email
lora.appel@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Bui
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Tchao
Phone
647-408-9638
Email
danielle.tchao@uhn.ca

12. IPD Sharing Statement

Citations:
PubMed Identifier
31037466
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.
Results Reference
result
PubMed Identifier
24652453
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.
Results Reference
result
PubMed Identifier
36701931
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.
Results Reference
result
PubMed Identifier
31382122
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.
Results Reference
result
PubMed Identifier
32104130
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.
Results Reference
result
PubMed Identifier
1382122
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.
Results Reference
result
PubMed Identifier
2300295
Citation
McConnell EA. Assessing a quadriplegic's severe headache. Nursing. 1990 Jan;20(1):84-7. No abstract available.
Results Reference
result
PubMed Identifier
36692939
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.
Results Reference
result
PubMed Identifier
36794093
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.
Results Reference
result
Links:
URL
https://www.ilae.org/files/dmfile/EASI-18.pdf
Description
EASI-18
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

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Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety

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