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

University Health Network, Toronto

Status: Not yet enrolling

Conditions: Epilepsy; Anxiety Disorders

Treatments: Device: HMD: Virtual Reality Exposure Therapy; Device: HMD: Neutral Game

Study type: Interventional

Funder types: Other

Identifiers

NCT06028945

23-5516

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Group 1: VR-ET

Experimental group

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.

Treatment:

Device: HMD: Virtual Reality Exposure Therapy

Group 2: Neutral Game

Active Comparator group

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.

Treatment:

Device: HMD: Neutral Game