Pilot to Evaluate VR-Therapy on People With Epilepsy and Related Anxiety

This pilot trial will be a mixed-methods, single-arm study with a target total recruitment of 5 participants. Each participant will take part in: a baseline interview, 12 to 14 days of the intervention, and then a final interview seven days after the last day of the VR-ET. After obtaining informed consent and before the baseline interview, participants will receive a document that includes a mindfulness strategy, a self-compassion strategy, and a guided imagery technique. Participants will be encouraged to practice these mechanisms before the baseline interview as they will review them with the exposure therapy specialist at that time. Baseline (T0): The research coordinator will set up a time convenient to both parties to conduct a semi-structured interview at baseline (T0) with an exposure therapy specialist and a member of the research team over tele- or video-conferencing software. The baseline interview will involve a questionnaire that collects the participant's demographic information as well as information about their history with health and anxiety. In this interview, participants will also verbally respond to the diagnostic protocol for epilepsy-specific anxiety disorders proposed by Hingray et al. (2019). During the baseline interview, the exposure therapy specialist will also present the participant with three sets of possible exposure scenarios. Each of the three possible sets of exposures will consist of a distinct overarching epilepsy-related fear that is commonly experienced within this population, as determined in previous findings. The same three exposure scenarios will be presented to each participant in their respective baseline interviews and through discussion, the exposure therapy specialist and participant will determine which exposure set fits most aligns with their individual epilepsy-related fears. As ET is typically delivered in a hierarchical manner, each exposure set will include three levels of scenes. Therefore, after choosing the appropriate exposure set, the exposure therapy specialist and participant will also discuss the most appropriate order in which the three scenes associated with the chosen set should be delivered during the intervention. Participants during the VR-ET intervention will be exposed to the scenes in order of what is least anxiety-provoking for them to most anxiety-provoking. In preparation to run the study, a total of nine 360-degree videos (3 exposure sets x 3 levels) will be included in the AnxiEpi-VR minimal viable product. After the baseline interview, participants will also provide their baseline scores for two questionnaires over a secure online platform (the Epilepsy Anxiety Survey Instrument (EASI) and the Perceived Stress Scale (PSS)). The only in-person aspect of T0 will be when a member of the research team visits the participant's residence to set up the VR equipment and teaches them how to use and store the device. In teaching participants how to use the VR head-mounted display (HMD), participants will practice using the device set to a neutral scene that is not expected to provoke anxiety in PwE. After using the VR HMD, participants will complete the VR Induced Symptoms and Effects (VRISE) questionnaire to record their baseline motion sickness tendencies. The VRISE assessment is one of the four domains included in the Virtual Reality Neuroscience Questionnaire (VRNQ) and evaluates the intensity of motion sickness. The three other domains included in the VRNQ (user experience, game mechanics, and in-game assistance) are not relevant to this study and thus, will not be asked. As a lower score on the VRISE assessment suggests greater motion sickness, anyone who scores below 25 on VRISE after using VR with a neutral scene will not be allowed to continue with the study. Intervention (T1): The VR-ET intervention will consist of a five-minute exposure session every day for up to 14 days over a one-on-one video-call with a member of the research team. During each session, PwE will be seated in a chair of their choice at their home. Before each exposure, the researcher will remind participants that if they "feel too overwhelmed" during the exposure, they should remove the HMD (therefore ending the exposure, even if they have not performed the exposure for the full 5 minutes yet) and use coping mechanisms that they prepared with the exposure therapy specialist during the baseline interview. Prior to putting on the HMD, the participant will also fill out a Subjective Units of Distress Survey (SUDS) describing their anxiety levels prior to doing the exposure (in other words, their anticipatory anxiety levels). \[If a participant's pre-exposure SUDS score is above 70, they will complete an easier exposure instead.\] After completing the pre-exposure SUDS, the participant will then put on the HMD and do the exposure for a maximum of five minutes. After performing each exposure for a maximum of five minutes, the participant will immediately repeat the SUDS so that their anxiety in anticipation of performing the exposure can be compared with the anxiety that they feel immediately after performing the exposure. After completing the first post-exposure SUDS, the participant will then complete the Fast Motion Sickness Scale (FMS). The purpose of collecting FMS scores will be to quantitatively measure motion sickness, specifically the general discomfort and nausea components, that participants may have experienced during the VR exposure session. Participants will then provide another SUDS score 10 minutes after completing the exposure so that it can be assessed whether or not their anxiety decreased over time after completing an exposure session (i.e., immediately after the exposure vs 10 minutes after the exposure). The intent is that each exposure level will be completed everyday for four days, after which the participant will move onto the next level. However, if it is decided based on the predetermined cut-off points of SUDS scores that the participant is not yet ready to move onto the next level, the previous level will be repeated until they are ready. Specifically, the participant must continue to stay at that exposure level until they score 70 or below. The goal of the study is for participants to habituate to their fears and ultimately experience decreased levels of anxiety. The expectation is that participants' SUDS scores recorded immediately after the exposure will be lower than their SUDS scores recorded prior to starting the exposure. This alone will provide encouragement to participants to continue performing the exposures. It may also decrease unnecessary safety-seeking behaviours. Even if participants' SUDS scores remain high on the first post-exposure SUDS test, the study may still be considered successful if the scores are lower on the 10-minute post-exposure SUDS test and/or participants' follow-up at T2 suggests that they are engaging in less safety-seeking behaviours compared to before they began the VR-ET. Post-intervention (T2) One week (seven days) after completing the last exposure session, the participant will have another semi-structured interview with the exposure therapy specialist and/or a member of the research team over tele- or video-conferencing software. The interview will aim at gathering additional feedback about participants' experiences, including their experience with the various devices,the subjective impact of the VR-ET program, and what may be improved about the program. With participants' consent, this interview will be audio-recorded. \[Note: the T2 interview is the only aspect of the entire study that may be audio-recorded.\] Over an online secure platform, participants will repeat the EASI and PSS. They will also respond to the Igroup Presence Questionnaire (IPQ), which assesses an individual's subjective experience of being in a virtual environment when they are physically situated in another. Additionally, participants will respond to the System Usability Scale (SUS), which assesses usability of the hardware and software. The only in-person part of T2 will be when a member of the research team goes to the participant's house to collect the VR equipment.