EpilepsyAnxEpiVRNCT05296057
Pilot to Evaluate VR-Therapy on People With Epilepsy and Related Anxiety
A study testing Participants Receiving VR-Exposure Therapy Treatment in people with Epilepsy and Anxiety Disorders and Symptoms, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy, Anxiety Disorders and Symptoms
- What is being tested?
- Participants Receiving VR-Exposure Therapy Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 24 Mar 2023to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate Virtual Reality Exposure Therapy on People With Epilepsy and Related Anxiety
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.
Read more
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.
Read the 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.
- Conditions
- Epilepsy, Anxiety Disorders and Symptoms
- Being tested
- Participants Receiving VR-Exposure Therapy 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
- Medical subject headings
- Epilepsy, Anxiety Disorders, Nervous System Diseases, Mental Disorders, Psychological Well-Being, Panic Disorder, Phobic Disorders, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants Receiving VR-Exposure Therapy TreatmentDevice
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 group | Role | What they receive |
|---|---|---|
| Participants Receiving VR-Exposure Therapy Treatment | Experimental | All participants will be receiving the experimental VR-exposure therapy treatment. Receives: Device: Participants Receiving VR-Exposure Therapy Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline scores using the Epilepsy Anxiety Survey Instrument (EASI)
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.
Measured: Baseline and post-intervention (i.e., one week after completing the VR-ET intervention)
Change in baseline scores using the Perceived Stress Scale (PSS)
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.
Measured: Baseline and post-intervention (i.e., one week after completing the VR-ET intervention)
Secondary outcomes (1)
Feasibility and appropriateness of the study procedures and evaluation instruments
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.
Measured: One week after completing the VR-ET intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start24 Mar 2023
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- York University
- Responsible party
- Principal investigator, Lora Appel, University Health Network, Toronto
- Investigators
- Lora Appel, Ph.D., Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296057
- Sponsor's protocol ID
- AnxEpiVR
- Acronym
- AnxEpiVR
- Status last verified
- Oct 2023
- First submitted
- 15 Mar 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blocher JB, Fujikawa M, Sung C, Jackson DC, Jones JE. Computer-assisted cognitive behavioral therapy for children with epilepsy and anxiety: a pilot study. Epilepsy Behav. 2013 Apr;27(1):70-6. doi: 10.1016/j.yebeh.2012.12.014. Epub 2013 Feb 1.
PubMed 23376339Deng W, Hu D, Xu S, Liu X, Zhao J, Chen Q, Liu J, Zhang Z, Jiang W, Ma L, Hong X, Cheng S, Liu B, Li X. The efficacy of virtual reality exposure therapy for PTSD symptoms: A systematic review and meta-analysis. J Affect Disord. 2019 Oct 1;257:698-709. doi: 10.1016/j.jad.2019.07.086. Epub 2019 Jul 30.
PubMed 31382122Hingray C, McGonigal A, Kotwas I, Micoulaud-Franchi JA. The Relationship Between Epilepsy and Anxiety Disorders. Curr Psychiatry Rep. 2019 Apr 29;21(6):40. doi: 10.1007/s11920-019-1029-9.
PubMed 31037466Maples-Keller JL, Yasinski C, Manjin N, Rothbaum BO. Virtual Reality-Enhanced Extinction of Phobias and Post-Traumatic Stress. Neurotherapeutics. 2017 Jul;14(3):554-563. doi: 10.1007/s13311-017-0534-y.
PubMed 28512692Munger Clary HM. Anxiety and epilepsy: what neurologists and epileptologists should know. Curr Neurol Neurosci Rep. 2014 May;14(5):445. doi: 10.1007/s11910-014-0445-9.
PubMed 24652453Newsom-Davis I, Goldstein LH, Fitzpatrick D. Fear of seizures: an investigation and treatment. Seizure. 1998 Apr;7(2):101-6.
PubMed 9627199Novakova B, Harris PR, Ponnusamy A, Reuber M. The role of stress as a trigger for epileptic seizures: a narrative review of evidence from human and animal studies. Epilepsia. 2013 Nov;54(11):1866-76. doi: 10.1111/epi.12377. Epub 2013 Oct 1.
PubMed 24117321Siqueira NF, Oliveira FLBB, de Souza EAP. Impaired responsibility dimension of self-esteem of Brazilian adolescents with epilepsy. Epilepsy Behav. 2017 Aug;73:1-5. doi: 10.1016/j.yebeh.2017.05.009. Epub 2017 Jun 9.
PubMed 28605627Grewe P, Lahr D, Kohsik A, Dyck E, Markowitsch HJ, Bien CG, Botsch M, Piefke M. Real-life memory and spatial navigation in patients with focal epilepsy: ecological validity of a virtual reality supermarket task. Epilepsy Behav. 2014 Feb;31:57-66. doi: 10.1016/j.yebeh.2013.11.014. Epub 2013 Dec 18.
PubMed 24361763Tychsen L, Thio LL. Concern of Photosensitive Seizures Evoked by 3D Video Displays or Virtual Reality Headsets in Children: Current Perspective. Eye Brain. 2020 Feb 11;12:45-48. doi: 10.2147/EB.S233195. eCollection 2020.
PubMed 32104130Wang Z, Luo Z, Li S, Luo Z, Wang Z. Anxiety screening tools in people with epilepsy: A systematic review of validated tools. Epilepsy Behav. 2019 Oct;99:106392. doi: 10.1016/j.yebeh.2019.06.035. Epub 2019 Sep 12.
PubMed 31521915Mula M. Treatment of anxiety disorders in epilepsy: an evidence-based approach. Epilepsia. 2013 Mar;54 Suppl 1:13-8. doi: 10.1111/epi.12101.
PubMed 23458462Beyenburg S, Mitchell AJ, Schmidt D, Elger CE, Reuber M. Anxiety in patients with epilepsy: systematic review and suggestions for clinical management. Epilepsy Behav. 2005 Sep;7(2):161-71. doi: 10.1016/j.yebeh.2005.05.014.
PubMed 16054870Gur-Ozmen S, Leibetseder A, Cock HR, Agrawal N, von Oertzen TJ. Screening of anxiety and quality of life in people with epilepsy. Seizure. 2017 Feb;45:107-113. doi: 10.1016/j.seizure.2016.11.026. Epub 2016 Dec 6.
PubMed 27984808Kotwas I, McGonigal A, Bastien-Toniazzo M, Bartolomei F, Micoulaud-Franchi JA. Stress regulation in drug-resistant epilepsy. Epilepsy Behav. 2017 Jun;71(Pt A):39-50. doi: 10.1016/j.yebeh.2017.01.025. Epub 2017 May 8.
PubMed 28494323
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Virtual Reality Exposure Therapy on People With Epilepsy and Related Anxiety
- ClinicalTrials.gov ID
- NCT05296057
- Acronym / sponsor ID
- AnxEpiVR / AnxEpiVR
- Conditions
- Epilepsy, Anxiety Disorders and Symptoms
- Keywords
- Epilepsy, Anxiety, Virtual Reality, Exposure Therapy, Cognitive Behavioural Therapy (CBT), Neurological Disorder, Psychiatric Disorder, Psychiatric Co-Morbidities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- York University
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving VR-Exposure Therapy Treatment | Experimental | Device: Participants Receiving VR-Exposure Therapy TreatmentAll participants will be receiving the experimental VR-exposure therapy treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants Receiving VR-Exposure Therapy TreatmentIn 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. | Device | Participants Receiving VR-Exposure Therapy Treatment |
Primary outcome
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.
1 secondary outcome
Feasibility and appropriateness of the study procedures and evaluation instruments
Time frame: One week after completing the VR-ET intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 23376339Blocher JB, Fujikawa M, Sung C, Jackson DC, Jones JE. Computer-assisted cognitive behavioral therapy for children with epilepsy and anxiety: a pilot study. Epilepsy Behav. 2013 Apr;27(1):70-6. doi: 10.1016/j.yebeh.2012.12.014. Epub 2013 Feb 1.
- Background: PubMed 31382122Deng W, Hu D, Xu S, Liu X, Zhao J, Chen Q, Liu J, Zhang Z, Jiang W, Ma L, Hong X, Cheng S, Liu B, Li X. The efficacy of virtual reality exposure therapy for PTSD symptoms: A systematic review and meta-analysis. J Affect Disord. 2019 Oct 1;257:698-709. doi: 10.1016/j.jad.2019.07.086. Epub 2019 Jul 30.
- Background: PubMed 31037466Hingray C, McGonigal A, Kotwas I, Micoulaud-Franchi JA. The Relationship Between Epilepsy and Anxiety Disorders. Curr Psychiatry Rep. 2019 Apr 29;21(6):40. doi: 10.1007/s11920-019-1029-9.
- Background: PubMed 28512692Maples-Keller JL, Yasinski C, Manjin N, Rothbaum BO. Virtual Reality-Enhanced Extinction of Phobias and Post-Traumatic Stress. Neurotherapeutics. 2017 Jul;14(3):554-563. doi: 10.1007/s13311-017-0534-y.
- Background: PubMed 24652453Munger Clary HM. Anxiety and epilepsy: what neurologists and epileptologists should know. Curr Neurol Neurosci Rep. 2014 May;14(5):445. doi: 10.1007/s11910-014-0445-9.
- Background: PubMed 9627199Newsom-Davis I, Goldstein LH, Fitzpatrick D. Fear of seizures: an investigation and treatment. Seizure. 1998 Apr;7(2):101-6.
- Background: PubMed 24117321Novakova B, Harris PR, Ponnusamy A, Reuber M. The role of stress as a trigger for epileptic seizures: a narrative review of evidence from human and animal studies. Epilepsia. 2013 Nov;54(11):1866-76. doi: 10.1111/epi.12377. Epub 2013 Oct 1.
- Background: PubMed 28605627Siqueira NF, Oliveira FLBB, de Souza EAP. Impaired responsibility dimension of self-esteem of Brazilian adolescents with epilepsy. Epilepsy Behav. 2017 Aug;73:1-5. doi: 10.1016/j.yebeh.2017.05.009. Epub 2017 Jun 9.
- Background: PubMed 24361763Grewe P, Lahr D, Kohsik A, Dyck E, Markowitsch HJ, Bien CG, Botsch M, Piefke M. Real-life memory and spatial navigation in patients with focal epilepsy: ecological validity of a virtual reality supermarket task. Epilepsy Behav. 2014 Feb;31:57-66. doi: 10.1016/j.yebeh.2013.11.014. Epub 2013 Dec 18.
- Background: PubMed 32104130Tychsen L, Thio LL. Concern of Photosensitive Seizures Evoked by 3D Video Displays or Virtual Reality Headsets in Children: Current Perspective. Eye Brain. 2020 Feb 11;12:45-48. doi: 10.2147/EB.S233195. eCollection 2020.
- Background: PubMed 31521915Wang Z, Luo Z, Li S, Luo Z, Wang Z. Anxiety screening tools in people with epilepsy: A systematic review of validated tools. Epilepsy Behav. 2019 Oct;99:106392. doi: 10.1016/j.yebeh.2019.06.035. Epub 2019 Sep 12.
- Background: PubMed 23458462Mula M. Treatment of anxiety disorders in epilepsy: an evidence-based approach. Epilepsia. 2013 Mar;54 Suppl 1:13-8. doi: 10.1111/epi.12101.
- What is exposure therapy?Link provided by the sponsor.
- More than seizures: In people with epilepsy, social anxiety affects quality of lifeLink provided by the sponsor.
- Epilepsy and memoryLink provided by the sponsor.
- Antidepressant medicationsLink provided by the sponsor.
- Igroup Presence Questionnaire (IPQ)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lora Appel, Ph.D. principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants Receiving VR-Exposure Therapy Treatment in people with Epilepsy and Anxiety Disorders and Symptoms, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05296057, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.