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

NCT05296057 | Completed

• 1 other identifier: AnxEpiVR
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Anxiety Disorders and Symptoms

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; Mental Disorders; Virtual Reality Exposure Therapy

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

• Feasibility and appropriateness of the study procedures and evaluation instruments

  One week after completing the VR-ET intervention

Other Outcomes (2)

• Anxiety levels after each VR-exposure therapy session

  Each day of the VR-ET intervention (approximately two weeks)

• Changes in safety-seeking behaviours after completing the VR-ET intervention

  One week after completing the VR-ET intervention

Study Arms (1)

Participants Receiving VR-Exposure Therapy Treatment

EXPERIMENTAL

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

Device: Participants Receiving VR-Exposure Therapy Treatment

Interventions

Participants Receiving VR-Exposure Therapy Treatment DEVICE

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.

Participants Receiving VR-Exposure Therapy Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• York University: collaborator

Study Sites (1)

Home based

Toronto, Ontario, Canada

Location

Related Publications (19)

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• Hingray 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.

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  PMID: 24361763 BACKGROUND

• Tychsen 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.

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  PMID: 23458462 BACKGROUND

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• Kourtesis P, Collina S, Doumas LAA, MacPherson SE. Validation of the Virtual Reality Neuroscience Questionnaire: Maximum Duration of Immersive Virtual Reality Sessions Without the Presence of Pertinent Adverse Symptomatology. Front Hum Neurosci. 2019 Nov 26;13:417. doi: 10.3389/fnhum.2019.00417. eCollection 2019.

  PMID: 31849627 BACKGROUND

• Gray HG, Tchao D, Lewis-Fung S, Pardini S, Harris LR, Appel L. Virtual Reality Therapy for People With Epilepsy and Related Anxiety: Protocol for a 3-Phase Pilot Clinical Trial. JMIR Res Protoc. 2023 Jan 24;12:e41523. doi: 10.2196/41523.

  PMID: 36692939 DERIVED

Related Links

• What is exposure therapy?
• More than seizures: In people with epilepsy, social anxiety affects quality of life
• Epilepsy and memory
• Antidepressant medications
• Igroup Presence Questionnaire (IPQ)

MeSH Terms

Conditions

Epilepsy; Anxiety Disorders; Nervous System Diseases; Mental Disorders; Psychological Well-Being; Panic Disorder; Phobic Disorders; Phobia, Social; Agoraphobia; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Personal Satisfaction; Behavior

Study Officials

• Lora Appel, Ph.D.

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doc Research Fellow; Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 25, 2022
• Study Start: March 24, 2023
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)