Clinical trial NCT06028945: Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety
Official title: Randomized Controlled Trial Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety In People With Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Anxiety Disorders
Keywords: Epilepsy
Anxiety
Virtual Reality
Exposure Therapy
Cognitive Behavioural Therapy
Seizure
Interictal Anxiety
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional, Randomized, Pilot, Pragmatic, Open label
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized control trial is to evaluate the impact of Virtual Reality (VR) Exposure Therapy (ET) on people with epilepsy who experience epilepsy/seizure-specific (ES) interictal anxiety. The main questions it aims to answer are:

1. Can virtual reality exposure therapy (VR-ET) help reduce ES-interictal anxiety in this population?
2. Are the study procedures sufficiently simple for participants to follow?

Study Design Summary:

* Fourteen (14) participants will be randomized into either an Experimental arm (receiving VR-ET) or Control arm
* Participants will be expected to have VR-ET twice a day (5 min/session) for up to 10 days
* Participants will complete self-reported questionnaires about anxiety, depression, quality life, and avoidance behaviours at baseline (T0), after completing their VR program (T2), and at a one-month follow-up (T3).
* Participants will have a short interview with a researcher after completing their VR program (T2) as well as at a one-month follow-up (T3).

Researchers will attempt to answer the study questions based on outcome measures taken at various timepoints and qualitative feedback from interviews.

Detailed description: BASELINE VISIT #1 (T0):

The first study visit will take place at the participant's bedside in the EMU with a member of the research team. The participant will be asked to complete several questionnaires including: demographic/health history, anxiety, depression, avoidance behaviours, and quality of life. The researcher will show the participant a short neutral video with the VR device and check for symptoms of motion sickness that might occur using a scale from 0 to 20. Next the participant will work with the researcher to identify the most appropriate exposure therapy scenario. Finally the participant will be randomized into either Group 1 (Experimental Group) or Group 2 (Control Group) and receive training on the VR system specific to their group assignment.

INTERVENTION (T1):

Participants will be encouraged to use the VR system throughout their EMU stay, twice per day for up to 10 days. Each session will involve using VR for approximately 5 minutes. The intervention may last fewer than 10 days if any participant is discharged early from the EMU, or (for Group 1 participants) all levels of the exposure therapy is completed in less than 10 days. Before and after each exposure, participants will be asked to rate their anxiety level on a scale from 0 to 100. After each exposure, participants will also be asked to rate any motion sickness that might result from using VR on a scale from 0 to 20.

POST-INTERVENTION VISIT #2 (T2)

The second study visit will take place after the participant's last VR session. Participants will be asked to repeat questionnaires from Visit #1 on anxiety, depression, avoidance behaviours, and quality of life. Participants will also complete questionnaires about sense of presence in VR and usability of the system. Finally participants will have a short interview with the researcher to discuss their experience using VR and any thoughts about whether the intervention had an impact on their anxiety.

1-MONTH FOLLOW-UP VISIT #3 (T3)

The third study visit will take place one (1) month after Visit #2. A researcher will follow-up with a phone interview and provide a link through email for participants to repeat baseline questionnaires about anxiety, depression, avoidance behaviours, and quality of life. However if participants prefer, they may request the researcher to record their responses to the questionnaires over the phone rather than completing the web-based questionnaires.

Eligibility criteria: Inclusion Criteria:

* Individuals who are at least 18 years old
* Individuals admitted to the EMU
* Individuals who have self-reported anxiety related to having epilepsy or seizures
* Individuals who score \<15 on the Fast Motion Sickness (FMS) after the VR neutral demo

Exclusion Criteria:

* Individuals with an unconfirmed epilepsy diagnosis
* Individuals with stereotaxic EEG monitoring
* Individuals with photosensitive epilepsy
* Individuals with open wounds on the face or cervical conditions or injuries that would make it unsafe for use the VR headset
* Individuals who have started an antidepressant, antianxiety drug, or medical marijuana in the last twelve weeks
* Individuals who cannot speak or understand English

Primary outcomes:
measure: Fast Motion Sickness (FMS) Scale
timeFrame: Baseline (T0)
measure: Epilepsy Anxiety Survey Instrument (EASI)
timeFrame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
measure: Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
timeFrame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
measure: Liebowitz Social Anxiety Scale
timeFrame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
measure: GAD-7
timeFrame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
measure: QOLIE - 31
timeFrame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
measure: Mobility Inventory for Agoraphobia
timeFrame: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
measure: Subjective Units of Distress/Discomfort Scale (SUDS)
timeFrame: Intervention Period (T1)
measure: Fast Motion Sickness (FMS) Scale
timeFrame: Intervention Period (T1)
measure: System Usability Scale (SUS)
timeFrame: Post-Intervention (T2)
measure: Igroup Presence Questionnaire (IPQ)
timeFrame: Post-Intervention (T2)
measure: Post-Intervention Interview (approx. 15 min)
timeFrame: Post-Intervention (T2)
measure: Follow-Up Interview (approx. 15 min)
timeFrame: 1-Month Follow-Up (T3)
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Esther Bui
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Munger 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.
citation: Munger Clary HM, Giambarberi L, Floyd WN, Hamberger MJ. Afraid to go out: Poor quality of life with phobic anxiety in a large cross-sectional adult epilepsy center sample. Epilepsy Res. 2023 Feb;190:107092. doi: 10.1016/j.eplepsyres.2023.107092. Epub 2023 Jan 16.
citation: Deng 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.
citation: 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.
citation: Gribkoff VK, Lum-Ragan JT. Evidence for nitric oxide synthase inhibitor-sensitive and insensitive hippocampal synaptic potentiation. J Neurophysiol. 1992 Aug;68(2):639-42. doi: 10.1152/jn.1992.68.2.639.
citation: McConnell EA. Assessing a quadriplegic's severe headache. Nursing. 1990 Jan;20(1):84-7. No abstract available.
citation: 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.
citation: Tchao D, Lewis-Fung S, Gray H, Pardini S, Harris LR, Appel L. Describing epilepsy-related anxiety to inform the design of a virtual reality exposure therapy: Results from Phase 1 of the AnxEpiVR clinical trial. Epilepsy Behav Rep. 2023 Jan 16;21:100588. doi: 10.1016/j.ebr.2023.100588. eCollection 2023.