Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 31, 2022
Open Peer Review Period: Jul 31, 2022 - Sep 25, 2022
Date Accepted: Nov 24, 2022
(closed for review but you can still tweet)
Virtual Reality Therapy for People With Epilepsy and Related Anxiety (AnxEpiVR): Protocol for a Three-Phase Pilot Clinical Trial
ABSTRACT
Background:
Anxiety is one of the most common psychiatric comorbidities in people with epilepsy (PwE) and often involves fears specifically related to the condition, such as anxiety related to the fear of having another seizure. Although research has suggested that exposure therapy (ET) is helpful in decreasing anxiety in PwE, no research to our knowledge has been conducted on ET in PwE using Virtual Reality (VR). The use of an immersive VR head-mounted display for ET in this population offers several benefits. In the present research protocol, we describe the design of an innovative Virtual Reality for exposure therapy (VR-ET) program administered in the home that focuses on decreasing anxiety in PwE.
Objective:
Our primary objective is to examine the feasibility of the study protocol, determine effect sizes and identify suggestions for improvement when designing a subsequent larger clinical trial. The secondary objective is to evaluate whether VR-ET is effective in decreasing epilepsy-related anxiety. We hypothesize that levels of epilepsy-related anxiety will decrease from using VR-ET.
Methods:
This mixed-methods study comprises three phases: 1) engaging with those with lived experiences to validate assumptions about anxiety and ET; 2) filming videos for the VR-ET intervention (likely consisting of three sets of scenes, each with three intensity levels); and 3) evaluating the VR-ET intervention and study methods.
Results:
This pilot study was funded in November, 2021. Data collection for Phase 1 began in June 2022 with 14 participants recruited as of July 31, 2022.
Conclusions:
We anticipate that the insights from this study will establish a new application of VR and add to the limited body of research that currently exists on the use of VR in the epilepsy population. Findings will inform the methods for a subsequent larger randomized controlled trial. Clinical Trial: ClinicalTrials.gov NCT05296057
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.