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

NCT06028945 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-11-17

No results posted yet for this study

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:

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Esther Bui · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-24
Primary Completion
2024-11-11
Completion
2024-11-11

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06028945 on ClinicalTrials.gov