Randomized Controlled Trial on the Efficacy of a Gamified Augmented Reality Exposure-based Application in Subjects With Fear of Spiders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Subjective fear (SUDS) in the in vivo BAT
研究概览
简要总结
Investigation of the efficacy of a gamified augmented reality exposure app in individual with fear of spiders.
详细描述
The study will be conducted as a randomized controlled between subject trial. The study consists of two visits and a home training for one group. 60 participants between 18 and 40 years with clinical or subclinical fear of spiders will take part in the study.
All assessments of outcome will be conducted on one visit for each participant, including an in vivo BAT. The experimental group will participate in a home training with the app, spanning over two weeks (6x30-minutes sessions), whereas the control group will not receive any treatment (untreated comparison group).
Six weeks after the first visit all participants undergo the assessments of outcome, including a second in vivo BAT. The BAT will take place 4 weeks after completion of the home training. This design allows a direct comparison and therefore an estimation of the efficacy of the gamified AR exposure therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will be randomly (matched by clinical relevance of fear of spiders and sex) allocated to treatment groups (experimental group, control group). The experimenter evaluating the primary outcome will be blinded (unaware of group assignment of participants, single-blind).
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fear of spiders
- •BAT score before exposure between 1-8
- •Physically healthy
- •Fluent in German
排除标准
- •BDI-II sumscore >=20 and/or item 9 >=1
- •Concurrent psychotherapy or pharmacotherapy
- •Previous exposure-based therapy for spider phobia
- •Parallel participation in another study
- •Chronic medication intake (except oral contraceptives)
- •Medication intake before visits (less than 24h)
- •Alcohol intake before visits (less than 12 h)
- •Cannabis or other psychoactive substances (including benzodiazepines) intake before visits (less than 5 days)
- •For women: Current pregnancy
结局指标
主要结局
Subjective fear (SUDS) in the in vivo BAT
时间窗: 6 weeks after day one (4 weeks after completion of home training)
During the BAT participants will be placed in front of a closed room with a spider in it and will be asked to open the door and approach a living house spider measuring about 5 cm, which will be placed in a sealed transparent plastic container on a table at the far end of the room. The participant will be requested to approach the spider and if possible, to touch the container, to remove the lid, insert a hand, and try to pick up and hold the spider for at least 20 s. Pre-defined scores ranging from 0 = refuses to enter the test room to 12 = holds the spider for at least 20 s will be given when the BAT was completed after 3 minutes or terminated by the participant. SUDS for fear and disgust will be taken during the BAT on the same score as on day one, ranging from 0 = no fear to 10 = maximum fear.
次要结局
- Self-reported change in fear of spiders(6 weeks after day one (4 weeks after completion of home training))
- Performance Behavioural Approach Test (BAT) in vivo(6 weeks after day one (4 weeks after completion of home training))
- Clinical rating for specific phobia (DSM-V)(6 weeks after day one (4 weeks after completion of home training))
- Spider Beliefs Questionnaire (SBQ)(6 weeks after day one (4 weeks after completion of home training))
- Subjective disgust (SUDS) in the in vivo BAT(6 weeks after day one (4 weeks after completion of home training))
- Fear of spiders Questionnaire (FSQ)(6 weeks after day one (4 weeks after completion of home training))
研究者
Prof. Dominique de Quervain, MD
Director Division of Cognitive Neuroscience
University of Basel