NCT02533310已完成不适用
Single-session Gamified Virtual Reality Exposure Therapy for Spider Phobia vs. Traditional Exposure Therapy: a Randomized Controlled Non-inferiority Trial
Stockholm University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Behavioral Approach Test (BAT)
研究概览
简要总结
The aim of this study is to examine the efficacy of virtual reality exposure therapy as a treatment for specific phobia (spiders). A gamified virtual reality simulation of one-session therapy (VR-OST) will be compared to the gold-standard treatment in the form of traditional one-session phobia treatment (OST) using in-vivo stimuli. This study was powered to detect a non-inferiority margin of a 2-point difference between groups.
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
- Single (Outcomes Assessor)
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
- •Score of 10 or less in Behavioral Approach Test
- •Individual meeting DSM-5 criteria according to interview for primary diagnosis of specific phobia, spider
- •Swedish residency
- •Fluent in Swedish
排除标准
- •Ongoing psychotherapy
- •Ongoing psychotropic medication (unless stabilized for three months)
- •Indication of suicidal ideation, as assessed by item 9 of the PHQ-9
- •Meets criteria for alcohol or substance use disorder
- •Meets criteria for serious mental disorder, such as bipolar disorder, schizophrenia or psychosis
- •Balance and/or eyesight problems (such as lack of stereoscopic vision) that could interfere with VR treatment
结局指标
主要结局
Behavioral Approach Test (BAT)
时间窗: Change from baseline on BAT (52 week)
The BAT consists of 13 approach steps measuring intensity of phobia symptoms, from approaching a few metres from to holding a spider.
次要结局
- Generalized Anxiety Disorder Assessment 7 (GAD-7)(Change from baseline in GAD-7 (3 year))
- Patient Health Questionnaire 9 (PHQ-9)(Change from baseline in PHQ-9 (3 year))
- Spider Phobia Questionnaire 31 (SPQ-31)(Change from baseline on SPQ-31 (3 year))
- Brunnsviken Brief Quality of Life Scale (BBQ)(Change from baseline in BBQ (3 year))
- Fear of Spiders Questionnaire 18 (FSQ-18)(Change from baseline in FSQ-18 (3 year))
- Diagnostic criteria for specific phobia according to interview (DSM-5)(Change from baseline for specific phobia (DSM-5) (3 years))
研究者
Per Carlbring
Professor of Psychology and Head of subdivision of Clinical Psychology
Stockholm University
研究点 (2)
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