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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05296057
Recruitment Status : Completed
First Posted : March 25, 2022
Last Update Posted : October 23, 2023
Sponsor:
Collaborator:
York University
Information provided by (Responsible Party):
Lora Appel, University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE March 15, 2022
First Posted Date  ICMJE March 25, 2022
Last Update Posted Date October 23, 2023
Actual Study Start Date  ICMJE March 24, 2023
Actual Primary Completion Date September 20, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2022)
  • Change in baseline scores using the Epilepsy Anxiety Survey Instrument (EASI) [ Time Frame: Baseline and post-intervention (i.e., one week after completing the VR-ET intervention) ]
    The EASI is validated for assessing epilepsy-related anxiety features and severity. The EASI is an 18-item questionnaire and employs a 4-point scale ranging from 0 to 3. Scores range from 0 to 54, where higher scores suggest more severe anxiety. Note that by using the EASI, the investigators are simultaneously using the brEASI (brief Epilepsy Anxiety Survey Instrument), which is a validated screening tool for anxiety disorders in PwE. The brEASI is made up of eight items that are already asked in the EASI, also employing a 4-point scale ranging from 0 to 3. Scores range from 0 to 24, where a score greater than or equal to 7 suggests that the participant likely has an anxiety disorder.
  • Change in baseline scores using the Perceived Stress Scale (PSS) [ Time Frame: Baseline and post-intervention (i.e., one week after completing the VR-ET intervention) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2022)
  • Change in baseline scores using the Generalized Anxiety Disorder-7 (GAD-7) Scale [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2022)
Feasibility and appropriateness of the study procedures and evaluation instruments [ Time Frame: One week after completing the VR-ET intervention ]
Questions during a semi-structured interview at T2 will assess opinions on the device and VR-therapy program experience including: (1) Ease of using the device; (2) Participants' experience with learning how to use the device; (3) Realism of the 360-degree videos; (4) Subjective remarks on whether or not they experience less fear about the scenario that they were exposed to and their avoidance behaviours in relation to that scenario over the past week in the real world; (5) Subjective remarks on how their epilepsy- or seizure- related anxiety in general compares to before they started the VR-exposure therapy program; (5) Aspects of the program that they thought were particularly helpful or unhelpful; and (6) Experience completing the exposure over a video-call with a member of the research team from their home.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2022)
Feasibility and appropriateness of the study procedures and evaluation instruments. [ Time Frame: 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.
Current Other Pre-specified Outcome Measures
 (submitted: August 29, 2022)
  • Anxiety levels after each VR-exposure therapy session [ Time Frame: Each day of the VR-ET intervention (approximately two weeks) ]
    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:
    1. Before the exposure
    2. Immediately after completing the exposure
    3. Ten minutes after completing the exposure
    The SUDS assesses the participant's anxiety levels on a scale of 0-100. The purpose of using the SUDS will be to assess if: the SUDS scores (i.e., levels of anxiety) that are recorded before completing the exposure are lower compared to the SUDS scores that are recorded immediately after completing the exposure; the SUDS scores decrease over the 10-minute post-exposure SUDS; and if participants' overall anxiety progressively decreases over the course of each exposure level.
  • Changes in safety-seeking behaviours after completing the VR-ET intervention [ Time Frame: One week after completing the VR-ET intervention ]
    The investigators will evaluate if participants' responses in the post-intervention interview suggest that they are engaging in less safety-seeking behaviours after completing VR-ET.
Original Other Pre-specified Outcome Measures
 (submitted: March 15, 2022)
Epilepsy-related anxiety levels after each VR-exposure therapy session [ Time Frame: 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:
  1. Immediately before the exposure
  2. One minute after completing the exposure
  3. Ten minutes after completing the exposure
  4. 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.
 
Descriptive Information
Brief Title  ICMJE Pilot to Evaluate VR-Therapy on People With Epilepsy and Related Anxiety
Official Title  ICMJE Pilot Study to Evaluate Virtual Reality Exposure Therapy on People With Epilepsy and Related Anxiety
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Anxiety Disorders and Symptoms
Intervention  ICMJE Device: Participants Receiving VR-Exposure Therapy Treatment
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.
Study Arms  ICMJE Experimental: Participants Receiving VR-Exposure Therapy Treatment
All participants will be receiving the experimental VR-exposure therapy treatment.
Intervention: Device: Participants Receiving VR-Exposure Therapy Treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2022)
5
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2022)
10
Actual Study Completion Date  ICMJE September 20, 2023
Actual Primary Completion Date September 20, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Individuals with self-reported epilepsy aged 18-65
  • Individuals that identify as having anxiety related to epilepsy
  • Individuals that live in the city of Toronto

Exclusion criteria:

  • PwE who were ever told by a neurologist that they have photosensitive epilepsy or photoparoxysmal responses
  • PwE that ever found, regardless of what a neurologist may have told them, that they have photosensitive epilepsy
  • 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 medical marijuana in the last twelve weeks
  • PwE that have tonic-clonic seizures more than once a month
  • People with psychogenic non-epileptic seizures
  • PwE that were ever told by a neurologist that stress might be a seizure trigger for them
  • PwE that ever found, regardless of what a neurologist may have told them, that stress may be a seizure trigger for them
  • Individuals that have been diagnosed with panic disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05296057
Other Study ID Numbers  ICMJE AnxEpiVR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lora Appel, University Health Network, Toronto
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Health Network, Toronto
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE York University
Investigators  ICMJE
Principal Investigator: Lora Appel, Ph.D. University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP