Virtual Reality Exposure Therapy for Epilepsy-related Anxiety

(AnxEMU Trial)

Overseen By Lora Appel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Antidepressants, Antianxiety, Medical marijuana

Disqualifiers: Unconfirmed epilepsy, Photosensitive epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

14 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Esther Bui

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for adults with epilepsy admitted to the EMU who experience anxiety related to their condition. They must not have photosensitive epilepsy, recent changes in certain medications, or conditions that prevent safe VR headset use.

Inclusion Criteria

People who are in the emergency medical unit.

You feel very sick when you experience virtual reality.

I am 18 years old or older.

Exclusion Criteria

My epilepsy diagnosis is not confirmed.

I do not have open wounds on my face or neck conditions that make using a VR headset unsafe.

I cannot speak or understand English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants complete baseline questionnaires on anxiety, depression, avoidance behaviours, and quality of life. They are also shown a neutral video with the VR device to check for motion sickness.

1 day

1 visit (in-person)

Intervention

Participants use the VR system twice a day for up to 10 days, with each session lasting approximately 5 minutes. Anxiety and motion sickness are assessed before and after each session.

10 days

Daily sessions (in-person)

Post-Intervention Assessment

Participants repeat baseline questionnaires and complete additional questionnaires on VR usability and sense of presence. A short interview is conducted to discuss their experience.

1 day

1 visit (in-person)

1-Month Follow-up

A follow-up phone interview is conducted, and participants repeat baseline questionnaires about anxiety, depression, avoidance behaviours, and quality of life.

1 day

1 visit (phone)

Treatment Details

Interventions

• Virtual Reality Exposure Therapy

Trial Overview The study tests if Virtual Reality Exposure Therapy (VR-ET) can reduce seizure-specific anxiety in epileptic patients. Participants are randomly assigned to either a VR-ET group or a control group and complete sessions twice daily for 10 days.

Participant Groups

Group I: Group 1: VR-ET Experimental Treatment 1 Intervention

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 II: Group 2: Neutral Game Active Control 1 Intervention

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.

Virtual Reality Exposure Therapy is already approved in United States for the following indications:

Approved in United States as Virtual Reality Exposure Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+