Virtual Reality Exposure Therapy for Epilepsy-related Anxiety

(AnxEMU Trial)

DT
LA
Overseen ByLora Appel, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality exposure therapy (VR-ET) can reduce anxiety in people with epilepsy who experience anxiety between seizures. Researchers aim to determine if VR therapy makes a difference and if participants find the process easy to follow. Participants will either receive VR-ET or play a neutral VR game for up to 10 days. Those admitted to an epilepsy monitoring unit and reporting anxiety related to epilepsy or seizures might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new anxiety management strategies for epilepsy.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have started an antidepressant, antianxiety drug, or medical marijuana in the last twelve weeks, you cannot participate.

What prior data suggests that Virtual Reality Exposure Therapy is safe for people with epilepsy-related anxiety?

Research has shown that Virtual Reality Exposure Therapy (VR-ET) is generally safe for treating anxiety disorders such as phobias and post-traumatic stress disorder. Other studies found that people with epilepsy also tolerated VR-ET well, with no severe side effects reported. This therapy uses a VR headset to create a controlled setting, reducing anxiety through repeated exposure. As VR-ET involves no physical procedures and has been safely tested in similar contexts, it appears to be a safe option.12345

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality Exposure Therapy (VR-ET) for epilepsy-related anxiety because it offers a unique, immersive approach that differs from traditional methods like medication or cognitive behavioral therapy. Unlike standard treatments, VR-ET provides a controlled, virtual environment where individuals can safely confront and manage their anxiety triggers in real-time. This method not only makes therapy more engaging and interactive but also has the potential to deliver quicker results by allowing patients to experience and practice coping strategies in a realistic yet controlled setting. Additionally, the neutral game used in the comparison group helps understand how different types of virtual experiences might affect anxiety, potentially leading to more personalized treatment options.

What evidence suggests that Virtual Reality Exposure Therapy is effective for epilepsy-related anxiety?

Research has shown that Virtual Reality Exposure Therapy (VR-ET), which participants in this trial may receive, can help lower anxiety in people with epilepsy. One study found that 71% of participants felt the VR scenarios resembled their real-life anxiety triggers, indicating that the therapy effectively targets anxiety. VR-ET has also successfully treated other anxiety issues, such as phobias and PTSD (post-traumatic stress disorder). These early results suggest that VR-ET might effectively reduce anxiety related to epilepsy. Meanwhile, another group in this trial will use a VR device with a "neutral" game, serving as an active comparator.12346

Who Is on the Research Team?

EB

Esther Bui

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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 feel anxious because of my epilepsy or seizures.

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.
See 3 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: VR-ETExperimental Treatment1 Intervention
Group II: Group 2: Neutral GameActive Control1 Intervention

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

🇺🇸
Approved in United States as Virtual Reality Exposure Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Citations

Virtual Reality Therapy for People With Epilepsy and ...We describe the design of an innovative VR-ET program administered in the home that focuses on decreasing anxiety in people with epilepsy.
Describing epilepsy-related anxiety to inform the design of ...The study is aimed at assessing the feasibility and efficacy of a pilot VR-ET intervention targeted at decreasing ES-interictal anxiety in PwE (see [19] for the ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36692939/
Virtual Reality Therapy for People With Epilepsy and ...We describe the design of an innovative VR-ET program administered in the home that focuses on decreasing anxiety in people with epilepsy.
Designing virtual reality exposure scenarios to treat anxiety ...VR-ET has been successfully used to treat anxiety disorders including specific phobias and post-traumatic stress disorder, typically relying on ...
P.086 Randomized controlled trial evaluating virtual reality ...Of the exposure participants, 71% felt the scenarios simulated their real-world anxiety triggers. Conclusions: VR-ET was well-tolerated in PwE.
NCT05302518 | Virtual Reality for AnxIety DisordersDuring exposure, participants' anxiety level is estimated in real time based on heart rate and electrodermal activity. Estimated anxiety level can guide the ...
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