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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06028945

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Anxiety Disorders	Device: HMD: Virtual Reality Exposure Therapy Device: HMD: Neutral Game	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Interventional, Randomized, Pilot, Pragmatic, Open labelInterventional, Randomized, Pilot, Pragmatic, Open label

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Trial Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety In People With Epilepsy

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: VR-ET 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.	Device: HMD: Virtual Reality Exposure Therapy 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.
Active Comparator: Group 2: Neutral Game 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.	Device: HMD: Neutral Game 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

Intervention/Treatment

Experimental: Group 1: VR-ET

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.

Device: HMD: Virtual Reality Exposure Therapy

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.

Active Comparator: Group 2: Neutral Game

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.

Device: HMD: Neutral Game

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.

Outcome Measures

Primary Outcome Measures

Fast Motion Sickness (FMS) Scale [Baseline (T0)]
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.
Epilepsy Anxiety Survey Instrument (EASI) [Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)]
An 18-item questionnaire designed specifically to assess anxiety in people with epilepsy.
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) [Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)]
A 6-item screening tool for major depressive disorder (MDD) in people with epilepsy.
Liebowitz Social Anxiety Scale [Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)]
A 24-item scale used to assess fear and avoidance of a range of social interactions and performance situations
GAD-7 [Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)]
A 7-item scale used to screen for generalized anxiety disorder.
QOLIE - 31 [Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)]
A 31-item questionnaire measuring overall quality of life including emotional well-being and role limitations in people with epilepsy.
Mobility Inventory for Agoraphobia [Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)]
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.
Subjective Units of Distress/Discomfort Scale (SUDS) [Intervention Period (T1)]
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.
Fast Motion Sickness (FMS) Scale [Intervention Period (T1)]
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.
System Usability Scale (SUS) [Post-Intervention (T2)]
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.
Igroup Presence Questionnaire (IPQ) [Post-Intervention (T2)]
Measures sense of presence, the subjective experience of being present in a virtual environment while remaining physically situated in the physical environment.
Post-Intervention Interview (approx. 15 min) [Post-Intervention (T2)]
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) [1-Month Follow-Up (T3)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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