Randomized Controlled Trial on the Efficacy of a Virtual Reality Paradigm to Reduce Fear of Heights in a Clinical and Subclinical Population With Fear of Heights
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Performance Behavioural Avoidance Test (BAT) in vivo
研究概览
简要总结
Investigation of the effectiveness and acceptability and usability of a VR height exposure App in individuals with fear of heights.
详细描述
The study will be conducted as a randomized controlled between subject trial. The study consists of two study phases. In study phase 1 the experimental group takes part in three VR exposure sessions (duration 20min each), whereas the control group takes part in three virtual tours (duration 20min each). All VR sessions and assessments of outcomes will be conducted on one study day for each participant.
In study phase 2 the experimental group will participate in a home training, spanning over two weeks (6x30-minutes sessions), whereas the control group will not receive any treatment (untreated comparison group). Assessment of outcomes will be conducted 3-5 weeks after completion of home trainings.
Group 1 (experimental group) consists of individuals with clinical and subclinical fear of heights, that will receive a three-session VR exposure (study phase 1) and take part in a 2-week treatment period with the same VR scenarios (study phase 2). Group 2 (control group) consists of individuals with clinical and subclinical fear of heights that will not receive any active treatment, but will participate in fear-unrelated tasks in study phase 1 or receive no treatment at all (study phase 2).
This design allows a direct comparison and therefore an estimation of the effectiveness of the VR exposure therapy. Before and after the virtual exposure/tours participants will undergo an in vivo BAT to assess the effects of the VR exposure therapy.
80 participants between 18 and 60 years with clinical or subclinical fear of heights will take part in the study. Two to three months after having finished study phase 1 the participants will be contacted again and asked to take part in study phase 2. All participants undergo a third in vivo BAT during study phase 2. The BAT will take place 3-5 weeks after completion of the home training.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be randomly (matched by clinical relevance of fear of heights 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical fear of heights (DSM-V) or subclinical fear of heights (fulfilment of DSM-C criteria A-E and G, but not F: distress/impairment)
- •Physically healthy
- •Aged between 18-60
- •Fluent in German
排除标准
- •Depression (BDI-II > 8)
- •Suicidal ideation (BDI-II item 9 > 0)
- •Concurrent psychotherapy or pharmacotherapy
- •Previous therapy for height phobia
- •Parallel participation in another study
- •Pregnancy (will be excluded with a pregnancy test during screening)
- •Chronic medication intake (except oral contraceptives)
- •Alcohol and medication intake before visit (less than 12 h)
- •Cannabis or other psychoactive substances (including benzodiazepines) intake before visit (less than 5 days)
- •Sleep-inducing drugs (incl. antihistamines) intake before visit (less than five days)
- •Restricted 3D sight
研究组 & 干预措施
Exposure
Study phase 1: The experimental intervention in the experimental group consists of three 20-minutes VR exposures (total duration in VR: 60 minutes).
Study phase 2: The experimental intervention in the experimental group consists of six 30-minutes VR exposures as home training (total duration in VR: 3 hours) within two weeks.
干预措施: VR App (Other)
Control
Study phase 1: The control group will not receive any active treatment. Instead they will use an App to make virtual tours (three times 20 minutes, total duration in VR: 60 minutes).
Study phase 2: The control group will not receive any active treatment (untreated comparison group).
结局指标
主要结局
Performance Behavioural Avoidance Test (BAT) in vivo
时间窗: study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training
Change in BAT performance after VR exposure from baseline (before VR exposure). During the BAT participants will be requested to climb up to the Uetliberg Tower while continuously looking to the ground level. Participants will be asked to only proceed as far as their anxiety allows them. On each of the 14 platforms participants will be asked to lean on a predefined area of the railing (and touch it with their upper body) and to look down to the ground for 10 seconds, if their fear allows them to do so. The BAT will be terminated as soon as the participant indicates feeling uncomfortable to proceed (adapted from Emmelkamp, 2002 and Coelho, 2006) or the 10 minutes period, given to them to perform the complete task, runs out.
次要结局
- Acrophobia Questionnaire (AQ)(study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training)
- Danger Expectancy Scale (DES)(study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training)
- Anxiety Expectancy Scale (AES)(study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training)
- Attitudes Towards Heights Questionnaire (ATHQ)(study phase 1: on study day within 1h after VR exposure, study phase 2: 3-5 weeks after completion of home training)
研究者
Prof. Dominique de Quervain, MD
Prof Dr. med.
University of Basel