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Behavioural Intervention

Virtual Reality Exposure Therapy for Epilepsy-related Anxiety (AnxEMU Trial)

N/A

Waitlist Available

Led By Esther Bui

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals who are at least 18 years old

Be older than 18 years old

Must not have

Individuals with an unconfirmed epilepsy diagnosis

Individuals with open wounds on the face or cervical conditions or injuries that would make it unsafe for use the VR headset

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (t0), post-intervention (t2), 1-month follow-up (t3)

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate the impact of Virtual Reality (VR) Exposure Therapy (ET) on people with epilepsy who experience anxiety to help reduce it and assess if the study procedures are easy to follow.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from wearing the VR headset, temporary dizziness or nausea especially if prone to motion sickness, and possible emotional distress due to exposure therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My epilepsy diagnosis is not confirmed.

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

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I cannot speak or understand English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (t0), post-intervention (t2), 1-month follow-up (t3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (t0), post-intervention (t2), 1-month follow-up (t3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (t0), post-intervention (t2), 1-month follow-up (t3) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Epilepsy Anxiety Survey Instrument (EASI)

Fast Motion Sickness (FMS) Scale

Follow-Up Interview (approx. 15 min)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1: VR-ETExperimental Treatment1 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 GameActive Control1 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.

0 / 4Eligibility criteria met