AnxEpiVR: Intervention Design and Pilot to Evaluate VR-Therapy on People With Epilepsy and Related Anxiety Disorders

Sponsor

University Health Network, Toronto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05296057

Collaborator

York University (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief 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 suggests that exposure therapy (ET) is helpful in decreasing anxiety in PwE and that Virtual Reality (VR) is an effective and helpful tool for delivering ET in a number of different types of anxiety disorders, such as generalized anxiety disorder, panic disorders, and phobias. To our knowledge, no research has been conducted to-date on VR-ET in PwE.

People with epilepsy have previously been excluded from many VR studies because of the hesitancy around possible adverse events (e.g. seizures) due to photosensitivity in the population. As these initial warnings have not been substantiated, researchers and clinicians are increasingly considering VR a potential tool for use with PwE. The use of an immersive VR head-mounted display to deliver ET in this population offers several benefits: 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 COVID-19, and even outside of the pandemic VR reduces the need for travel, which is difficult for PwE in normal circumstances as driver's licenses are typically suspended after a confirmed seizure. Indeed using VR for ET as opposed to traditional ET can save money and time, and allow for more equitable access to healthcare resources for those who may not live in urban centers.

We are designing and rigorously evaluating a VR-ET program administered in private residences that focuses on decreasing anxiety in PwE. This study would be among the first to evaluate VR-ET in this population, also contributing to the limited body of research that currently exists on managing comorbid anxiety in PwE.

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-related anxiety in PwE. We hypothesize 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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Anxiety Disorders and Symptoms	Device: Participants Receiving VR-Exposure Therapy Treatment	N/A

Detailed Description

This pilot trial will be a mixed-methods, single-arm study with a target total recruitment of 10 participants. Each participant will participate in the study for 12 to 14 days.

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 deep breathing technique. Participants will be encouraged to practice these mechanisms before the baseline one-on-one interview as they will review them with the exposure therapy specialist during the baseline interview.

The research coordinator will set up a time convenient to both parties to conduct a one-on-one semi-structured interview at baseline (T0) with an exposure therapy specialist over tele- or video-conferencing software. The baseline interview will involve collecting demographics, including the participant's history with epilepsy and anxiety. This interview will also involve several questionnaires for self-reported anxiety.

During the baseline interview, the exposure therapy specialist will also present the participant with three possible exposure scenarios. The same three exposure scenarios will be presented to each participant in their respective baseline interviews. Each of the three possible scenarios will consist of a distinct overarching epilepsy-related fear that is commonly experienced within this population, as determined in previous findings. Each scenario will involve three different levels that increase in how anxiety-provoking they are expected to be. Each participant will only work on one exposure scenario and the corresponding three levels that is deemed most appropriate for them through their discussion with the exposure therapy specialist. In preparation to run the study, a total of nine 360-degree videos (3 scenarios x 3 levels) will be included in the AnxiEpi-VR minimal viable product.

The intervention will consist of an exposure-therapy session of five-minute duration everyday for a total of 12 to 14 days. During each session, PwE should 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 VR head-mounted display (therefore ending the exposure, even if they have not done the exposure for the full 5 minutes yet) and use coping mechanism that they prepared with the exposure therapy specialist during their baseline one-on-one 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). [If their pre-exposure SUDS score is at or above a predetermined value of 80, they will complete an easier exposure level 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 each exposure, the participant will repeat the SUDS at the following time points: one minute, 10 minutes, and 20 minutes after each 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 below 80. Each exposure session will be conducted over a one-on-one tele- or video-call between a member of the research team and the participant at a time that is convenient to both parties.

The goal of our study is for participants to habituate to their fears and ultimately experience decreased levels of anxiety. Our hope is that participants' SUDS scores that are recorded one minute after the exposure will be lower than their anticipatory anxiety SUDS scores. This alone will provide encouragement to the participant to conduct the next exposure. It might also decrease unnecessary safety-seeking behaviours. We will also consider our study to be successful even if participants' SUDS scores remain high in the first post-exposure SUDS test and decrease over the 10-minute and/or 20-minute post-exposure SUDS tests.

After the 12 to 14 days (T1), the participant will have another one-on-one semi-structured interview with the exposure therapy specialist over tele- or video-conferencing software. The participant will repeat the questionnaires that were given in the baseline interview. Participants will also be asked to give additional feedback about their experience, including their experiences with the various devices and the subjective impact of the therapy.

The only parts of the study that will take place in-person are: when a member of the research team goes to the participant's house to set up the VR equipment and teaches the participant how to use it at T0; and when a member of the research team goes to the participant's house to collect the VR equipment at T1. There will be no audio or video recording at any point in this study. If the participant provides explicit consent, a transcript will be saved from the one-on-one semi-structured interviews at T0 and T1.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

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.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

Official Title:

Intervention Design and Pilot Study to Evaluate Virtual Reality Exposure Therapy on People With Epilepsy and Related Anxiety Disorders

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants Receiving VR-Exposure Therapy Treatment All participants will be receiving the experimental VR-exposure therapy treatment.	Device: Participants Receiving VR-Exposure Therapy Treatment In the one-on-one baseline interview with an exposure therapy specialist, participants will be presented with three possible exposure scenarios, each containing three different levels that increase in severity. Through discussion with the exposure therapy specialist, the participant will select the exposure scenario (out of the three options) that is the most closely related to their own epilepsy-related fears. As the treatment, the participant will be exposed to this scenario (and the three accompanying levels) through an immersive Head-Mounted Display. The participant will work through three levels of the chosen exposure scenario for 12 to 14 days, ideally working on each level for 4 days.

Arm

Intervention/Treatment

Experimental: Participants Receiving VR-Exposure Therapy Treatment

All participants will be receiving the experimental VR-exposure therapy treatment.

Device: Participants Receiving VR-Exposure Therapy Treatment

In the one-on-one baseline interview with an exposure therapy specialist, participants will be presented with three possible exposure scenarios, each containing three different levels that increase in severity. Through discussion with the exposure therapy specialist, the participant will select the exposure scenario (out of the three options) that is the most closely related to their own epilepsy-related fears. As the treatment, the participant will be exposed to this scenario (and the three accompanying levels) through an immersive Head-Mounted Display. The participant will work through three levels of the chosen exposure scenario for 12 to 14 days, ideally working on each level for 4 days.

Outcome Measures

Primary Outcome Measures

Change in baseline scores using the Generalized Anxiety Disorder-7 (GAD-7) Scale [Days 0 (i.e., at T0) and 14 (i.e., at T1) of participation]
The GAD-7 scale is validated for detecting generalized anxiety disorder (GAD) in people with epilepsy. The GAD-7 is a 7-item questionnaire and it evaluates self-reported anxiety levels experienced over the previous two weeks. It employs a 4-point scale ranging from 0 to 3. Scores range from 0 to 21. According to the original scoring, score ranges from: 0-4 represent minimal levels of anxiety severity; 5-9 represent mild levels of anxiety severity; 10-14 represent moderate levels of anxiety severity; 15-21 represent severe levels of anxiety severity.
Change in baseline scores using the Brief Epilepsy Anxiety Survey Instrument (brEASI) [Days 0 (i.e., at T0) and 14 (i.e., at T1) of participation]
The brEASI is validated for detecting anxiety disorders specifically in people with epilepsy. The brEASI is an 8-item questionnaire and employs a 4-point scale ranging from 0 to 3. Scores range from 0 to 24. A score greater than or equal to 7 suggests that the participant likely has an anxiety disorder.
Change in baseline scores using the Hospital Anxiety and Depression scale (HADS), specifically HADS-Anxiety (HADS-A) [Days 0 (i.e., at T0) and 14 (i.e., at T1) of participation]
The HADS-A evaluates self-reported anxiety in people with physical health issues. The HADS-A is a 7-item questionnaire and employs a 4-point Likert scale ranging from 0 to 3. Scores range from 0 to 21. According to the original scoring, score ranges from: 0-7 represent no signs of anxiety; 8-10 represent borderline anxiety; and 11-21 represent anxiety.
Change in baseline scores using the diagnostic protocol proposed by Hingray et al. Curr Psychiatry Rep 2019;40 [Days 0 (i.e., at T0) and 14 (i.e., at T1) of participation]
Hingray et al. (2019) proposes a diagnostic enquiry and an accompanying suggested evaluation for the severity of symptoms. The questions are meant to detect distinct interictal anxiety disorders suggested by Hingray et al. (2019), namely: anticipatory seizure anxiety, seizure phobia, epileptic social phobia and epileptic panic disorder. They also include questions that relate to avoidance behaviour that may accompany these anxiety disorders. Some of the questions are yes/no, some are on a scale ranging from 1-10, and some ask for specific answers.
Change in baseline scores using the Perceived Stress Scale (PSS) [Days 0 (i.e., at T0) and 14 (i.e., at T1) of participation]
The PSS assesses how one perceives their own stress levels. The PSS is a 14-item questionnaire and employs a 5-point scale with a range of 0 to 4. Scores range from 0 to 56. Higher scores indicate greater perceived stress levels.

Secondary Outcome Measures

Feasibility and appropriateness of the study procedures and evaluation instruments. [Day 14 of participation]
Questions during the one-on-one semi-structured interview at T1 will assess opinions on the device and VR-therapy program experience including: (1) Ease of using the device; (2) Strengths of the program; (3) Areas for program improvement; (4) Subjective remark on whether or not the participant experiences less epilepsy- or seizure-related anxiety after completing the VR-exposure therapy program; (5) If this VR-ET program was more, less, or equally helpful to other exposure therapy programs previously undergone, if any; (6) Experience completing the exposure over a video- or tele-call with a member of the research team; (7) Open-ended question to capture opinions on doing the program at private residences as opposed to in-person in a laboratory setting.

Other Outcome Measures

Epilepsy-related anxiety levels after each VR-exposure therapy session [Days 1-14 of participation]
Participants will fill out the "Subjective Units of Distress Survey" (SUDS) at the following time points each day in the program that an exposure is completed: Immediately before the exposure One minute after completing the exposure Ten minutes after completing the exposure Twenty minutes after completing the exposure The SUDS assesses the participant's anxiety levels on a scale of 0-100. We will be assessing if: the SUDS scores (i.e., levels of anxiety) that are recorded immediately before completing the exposure are lower compared to the SUDS scores that are recorded one minute after completing the exposure. We will also assess if the SUDS scores decrease over the 10-minute and 20-minute post-exposure SUDS.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Individuals with self-reported epilepsy aged 18-65.
Mild, moderate, or severe epilepsy-related anxiety.

Exclusion criteria:

PwE with known photosensitive epilepsy or paroxysmal responses.
PwE that experience pre-ictal, ictal, and post-ictal anxiety.
Individuals with open wounds on face.
Individuals with cervical conditions or injuries that would make it unsafe for them to use the VR headset.
Individuals who cannot speak and understand English.
PwE that started an antidepressant or antianxiety drug in the last twelve weeks.
PwE that started using marijuana in the last twelve weeks.
PwE that have tonic-clonic seizures more than once a month.
PwE that believe or have ever been told that stress has provoked their seizure(s) in the past.