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Behavioural Intervention

Virtual Reality Exposure Therapy for Epilepsy-related Anxiety (AnxEMU Trial)

N/A
Waitlist Available
Led By Esther Bui
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals who are at least 18 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (t0), post-intervention (t2), 1-month follow-up (t3)
Awards & highlights

AnxEMU Trial Summary

This trial will evaluate the impact of Virtual Reality (VR) Exposure Therapy (ET) on people with epilepsy who experience anxiety to help reduce it and assess if the study procedures are easy to follow.

Who is the study for?
This trial is for adults with epilepsy admitted to the EMU who experience anxiety related to their condition. They must not have photosensitive epilepsy, recent changes in certain medications, or conditions that prevent safe VR headset use.Check my eligibility
What is being tested?
The study tests if Virtual Reality Exposure Therapy (VR-ET) can reduce seizure-specific anxiety in epileptic patients. Participants are randomly assigned to either a VR-ET group or a control group and complete sessions twice daily for 10 days.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the VR headset, temporary dizziness or nausea especially if prone to motion sickness, and possible emotional distress due to exposure therapy.

AnxEMU Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

AnxEMU Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (t0), post-intervention (t2), 1-month follow-up (t3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (t0), post-intervention (t2), 1-month follow-up (t3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Epilepsy Anxiety Survey Instrument (EASI)
Fast Motion Sickness (FMS) Scale
Follow-Up Interview (approx. 15 min)
+9 more

AnxEMU Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: VR-ETExperimental Treatment1 Intervention
Group 1 will receive the VR-ET for up to 10 days while in the EMU and complete a set of questionnaires at the first visit and after the last day of VR. A researcher will conduct a short exit interview with participants about their experience during their second visit. There will be a one-month follow-up phone interview with a researcher and participants will complete a final set of questionnaires.
Group II: Group 2: Neutral GameActive Control1 Intervention
Group 2 will have access to a VR device with a "neutral" game for up to 10 days while in the EMU and complete a set of questionnaires at the first visit and after the last day of VR. A researcher will conduct a short exit interview with participants about their experience during their second visit. There will be a one-month follow-up phone interview with a researcher and participants will complete a final set of questionnaires.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,505 Total Patients Enrolled
3 Trials studying Anxiety Disorders
421 Patients Enrolled for Anxiety Disorders
Esther BuiPrincipal InvestigatorUniversity Health Network, Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical investigation currently enrolling participants?

"According to information found on clinicaltrials.gov, this particular medical study is not currently enrolling patients. Initially posted January 1st 24 and last edited August 31st 23, it has since ceased recruitment activities. However, there are presently 746 other studies that require participants' participation"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety
2024. "Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028945.
All > Anxiety Disorder > Epilepsy
~9 spots leftby Jan 2025
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