Randomized Controlled Trial Evaluating the Impact of Virtual Reality Exposure Therapy on Epilepsy/Seizure-Specific Interictal Anxiety In People With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- QOLIE - 31
研究概览
简要总结
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:
- Can virtual reality exposure therapy (VR-ET) help reduce ES-interictal anxiety in this population?
- 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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
QOLIE - 31
时间窗: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
A 31-item questionnaire measuring overall quality of life including emotional well-being and role limitations in people with epilepsy. Scores range from 0 to 100, where higher scores reflect higher quality of life.
Liebowitz Social Anxiety Scale
时间窗: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
A 24-item scale used to assess fear and avoidance of a range of social interactions and performance situations. Scores range from 0 to 144, where higher scores indicate more severe social anxiety.
Fast Motion Sickness (FMS) Scale
时间窗: Intervention Period (T1)
A single assessment question where motion sickness (nausea and general discomfort) is rated on a visual analog scale ranging from 0 (no sickness at all) to 20 (severe sickness). This scale will be used as a measure of simulator sickness immediately after using VR.
Epilepsy Anxiety Survey Instrument (EASI)
时间窗: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
An 18-item questionnaire designed specifically to assess anxiety in people with epilepsy. Scores can range from 0 to 54, where higher scores indicate more severe anxiety.
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
时间窗: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
A 6-item screening tool for major depressive disorder (MDD) in people with epilepsy. Scores can range from 6 to 24, where higher scores indicate more severe depression.
GAD-7
时间窗: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
A 7-item scale used to screen for generalized anxiety disorder. Scores range from 0 to 21, where higher scores indicate more severe anxiety.
Mobility Inventory for Agoraphobia
时间窗: Baseline (T0), Post-Intervention (T2), 1-Month Follow-Up (T3)
On this instrument, 26 situations and locations (including shopping malls, public transit, and social gatherings) are rated for avoidance both when accompanied by a trusted companion and when alone. Average scores for each subscale (accompanied vs alone) range from 1 (never avoid) to 5 (always avoid). The instrument also collects information on panic attacks, with a score ranging from 1 (very mild) to 5 (extremely severe).
System Usability Scale (SUS)
时间窗: Post-Intervention (T2)
A 10-item survey that provides a quick assessment of the usability of various products and services, including hardware, software, mobile devices, websites and applications. Scores range from 0 to 100, with higher scores indicating higher level of usability.
Igroup Presence Questionnaire (IPQ)
时间窗: Post-Intervention (T2)
Several subscales to measure sense of presence, spatial presence, involvement, and experienced realism while in the virtual environment. Average scores for the different subscales range from 0 to 6, with higher scores indicating higher sense of presence/realism.
Follow-Up Interview (approx. 15 min)
时间窗: 1-Month Follow-Up (T3)
The follow-up phone interview will take place one month post-intervention. The researcher will call the participant and inquire about their general and ES-interictal anxiety levels, as well as their current levels of, and any perceived changes in, fear/comfort and avoidance of feared scenarios.
Subjective Units of Distress/Discomfort Scale (SUDS)
时间窗: Intervention Period (T1)
A single assessment question where level of anxiety is rated on a visual analog scale ranging from 0 (no distress; totally relaxed) to 100 (highest anxiety/distress that you have ever felt). This scale will be used to measure anxiety immediately before and after VR exposures.
Post-Intervention Interview (approx. 15 min)
时间窗: Post-Intervention (T2)
The semi-structured exit interview will be conducted by a researcher the day after the participant has completed their final VR session. The purpose of this interview is to collect feedback on the VR-system usability and training, treatment delivery, overall experience, and (experimental arm only) effectiveness of VR exposure scenes. Participants will also be asked about the intervention's perceived change on their anxiety.
次要结局
未报告次要终点