Virtual Reality Therapy for People With Epilepsy and Related Anxiety (AnxEpiVR): Protocol for a Three-Phase Pilot Clinical Trial (Preprint)

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. CLINICALTRIAL ClinicalTrials.gov NCT05296057

Describing epilepsy-related anxiety to inform the design of a virtual reality exposure therapy: Results from Phase 1 of the AnxEpiVR clinical trial

“…This paper reports on the results of Phase 1 of the three-phase “AnxEpiVR” pilot study; to our knowledge this study will be the first to use VR to deliver ET to PwE. 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 full protocol). Phase 1 involved engaging individuals affected by epilepsy, either directly or through someone they know, to learn more about the scenarios and triggers that cause anxiety related to epilepsy/seizures.…”