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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

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.


Condition or disease Intervention/treatment Phase
Epilepsy Anxiety Disorders and Symptoms Device: Participants Receiving VR-Exposure Therapy Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate Virtual Reality Exposure Therapy on People With Epilepsy and Related Anxiety
Actual Study Start Date : March 24, 2023
Actual Primary Completion Date : September 20, 2023
Actual Study Completion Date : September 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Epilepsy

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 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.




Primary Outcome Measures :
  1. 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.


  2. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.


  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05296057


Locations
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Canada, Ontario
Home based
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
York University
Investigators
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Principal Investigator: Lora Appel, Ph.D. University Health Network, Toronto
Additional Information:
Publications:

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Responsible Party: Lora Appel, Post-doc Research Fellow; Assistant Professor, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT05296057    
Other Study ID Numbers: AnxEpiVR
First Posted: March 25, 2022    Key Record Dates
Last Update Posted: October 23, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lora Appel, University Health Network, Toronto:
Epilepsy
Anxiety
Virtual Reality
Exposure Therapy
Cognitive Behavioural Therapy (CBT)
Neurological Disorder
Psychiatric Disorder
Psychiatric Co-Morbidities
Interictal Anxiety
Mental Health
Panic Disorder
Phobia
Social Phobia
Agoraphobia
Generalized Anxiety
Anticipatory Anxiety
Neurological Diseases
Psychopathology
Non-Pharmacological Intervention
Biomedical Technology
Mental Disorders
Virtual Reality Exposure Therapy
Additional relevant MeSH terms:
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Epilepsy
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases