Pilot to Evaluate VR-Therapy on People With Epilepsy and Related Anxiety
Condition: Epilepsy; Anxiety Disorders and Symptoms
MeSH terms: Epilepsy; Anxiety Disorders
Study type: Interventional

Summary: 
      Over 28% of people with epilepsy (PwE) struggle from at least one anxiety disorder, making
      anxiety the most common psychiatric comorbidity in this population. Despite the importance of
      treating anxiety in PwE, it has not received much research attention and is often
      unrecognized and untreated. Research has suggested that including exposure therapy (ET) as a
      part of an anxiety treatment may be helpful for decreasing anxiety in PwE. Research has also
      shown that Virtual Reality (VR) is an effective and helpful tool for delivering ET in a
      number of different types of anxiety disorders, such as posttraumatic stress disorder, panic
      disorder, and social anxiety disorder.

      To the investigators' knowledge, no research has been conducted to-date on using VR to
      deliver ET (VR-ET) in PwE. People with epilepsy have commonly been excluded from VR studies
      due to the concern that it may trigger seizures in people with photosensitive epilepsy.
      Although limited research is available on the use of VR in PwE, hesitations regarding the use
      of VR in this population have not been substantiated and clinicians and researchers are
      increasingly considering VR for use in this population.

      The use of an immersive VR head-mounted display to deliver ET in this population offers
      several benefits. For example, studies suggest that VR-ET is an especially useful method for
      customized treatment when it is not safe or practical to do exposures. This is important to
      consider as it may not be practical to do exposures in-person during times of pandemic, such
      as the COVID-19 pandemic. Even outside of the pandemic, VR reduces the need for travel, which
      is difficult for PwE in normal circumstances as driver's licences are typically suspended
      after a confirmed seizure. Using VR for ET as opposed to traditional ET can also save money
      and time, and allow for more equitable access to healthcare resources for those who may not
      live in urban centers.

      The investigators designed and will be rigorously evaluating a VR-ET program administered in
      private residences specific for PwE that focuses on decreasing anxiety that is specifically
      related to their epilepsy or seizures. This study would be among the first to evaluate VR-ET
      in this population. This study will also contribute to the limited body of research that
      currently exists managing comorbid anxiety in PwE as well as the minimal existing literature
      about fears specifically related to epilepsy or seizures.

      The overall primary objective of this study is to report on the feasibility and
      appropriateness of the protocol and evaluation instruments for use in the subsequent larger
      clinical trial. The secondary objective is to evaluate whether VR-ET reduces epilepsy- or
      seizure-related anxiety in PwE. It is hypothesized that PwE will experience decreased levels
      of epilepsy-related anxiety after undergoing VR-ET. These findings will be used to inform a
      future randomized controlled trial.
    

Detailed description: 
      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.
    

Intervention name(s): Participants Receiving VR-Exposure Therapy Treatment
Intervention type(s): Device
Intervention description(s): In the baseline interview with an exposure therapy specialist and a member of the research team, participants will be presented with approximately three sets of possible exposure scenarios, each associated with approximately three different scenes that increase in severity level. Through discussion with the exposure therapy specialist, the participant will choose the exposure scenario (out of the three options) that most closely resembles their own epilepsy- or seizure-related fears. As the treatment, the participant will be exposed to the scenes that are associated with their chosen exposure set in a hierarchical manner using an immersive head-mounted display. The participant will work through the three levels of the chosen exposure scenario for approximately two weeks, ideally on each level for four days.
Intervention model: Single Group Assignment
Intervention model description: As this is a pilot study, a control will not be included. Findings from this pilot will inform methods for a subsequent larger clinical trial that will include a control group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Anxiety; Virtual Reality; Exposure Therapy; Cognitive Behavioural Therapy (CBT); Neurological Disorder; Psychiatric Disorder; Psychiatric Co-Morbidities; Interictal Anxiety; Mental Health; Panic Disorder; Phobia; Social Phobia; Agoraphobia; Generalized Anxiety; Anticipatory Anxiety; Neurological Diseases; Psychopathology; Non-Pharmacological Intervention; Biomedical Technology; Mental Disorders; Virtual Reality Exposure Therapy