oVRcome Self-guided Virtual Reality for Specific Phobias: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Severity Measure for Specific Phobia-Adult American Psychological Association
研究概览
简要总结
Specific phobias: fear of flying, heights, spiders, dogs and needles are the extremely common and exposure therapy (ET) is the first line of treatment. Using Virtual Reality (VR), participants will have control in gradual exposure to their fears. oVRcome (https://www.ovrcome.io/ Virtual reality app), is a self-help VRET for specific phobias, that is delivered through a smartphone application (app) in combination with a low cost headset that holds the smartphone and uses 360º video. The investigators hypothesize that oVRcome is effective in reducing specific phobia symptoms.
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
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •are between 18-64 years old
- •Have a fear of flying, heights, spiders, dogs, needles and score above 4 on the Brief Standard Self rating scale for phobic patients (Marks, I. Matthews ,A (1979) Behaviour Research and Therapy)
- •have access to a smart phone and internet
- •willing to participate in the research study and providing informed consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •present with symptoms of severe depression or suicidality respectively as measured with the PHQ-9; total score > 19
- •have insufficient knowledge of the English language
- •are under current treatment for specific phobia or psychotropic medication (unless on stable dosage for the previous 3 months and no changes planned during the study period).
结局指标
主要结局
Severity Measure for Specific Phobia-Adult American Psychological Association
时间窗: Week 6
The Severity Measure for Specific Phobia-Adult is a 10-item self-report measure that assesses the severity of specific phobia in individuals age 18 and older. The total score can range from 0 to 40 with higher scores indicating greater severity of specific phobia.
次要结局
- Brief Fear of Negative Evaluation Scale(6 weeks, 12 weeks, 18 weeks)
- Changes in behaviour that may have been previously avoided because of the phobia(Weeks 6 and 12)
- Brief Standard Self rating scale for phobic patients(6 weeks, 12 weeks, 18 weeks)
- Clinical Global Impression of Change (CGI-C)(weekly (Weeks 1-6))
- Subjective Units of Distress Scale(Week 4, 5 and 6)
- Modified Gatineau Presence Questionnaire First item(Week 4, 5 and 6)
- Patient Health Questionnaire - PHQ 9(6 weeks, 12 weeks, 18 weeks)
- Fast Motion Sickness Scale (FMS)(Week 4, 5 and 6)