Epilepsy Clinical Trial
— AnxEpiVROfficial title:
Pilot Study to Evaluate Virtual Reality Exposure Therapy on People With Epilepsy and Related Anxiety
Verified date | October 2023 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | September 20, 2023 |
Est. primary completion date | September 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Home based | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | York University |
Canada,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Anxiety levels after each VR-exposure therapy session | 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:
Before the exposure Immediately after completing the exposure 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. |
Each day of the VR-ET intervention (approximately two weeks) | |
Other | Changes in safety-seeking behaviours 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. | One week after completing the VR-ET intervention | |
Primary | 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. |
Baseline and post-intervention (i.e., one week after completing the VR-ET intervention) | |
Primary | 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. | Baseline and post-intervention (i.e., one week after completing the VR-ET intervention) | |
Secondary | 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. | One week after completing the VR-ET intervention |
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