Randomized Controlled Trial on the Efficacy of a VR Exposure-based Eye Contact Training to Reduce Fear of Public Speaking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Subjective Units of Distress Scale (SUDS, fear)
研究概览
简要总结
Investigation of the efficacy of an eye contact training App in virtual reality, based on principles of exposure therapy for the treatment for subjects with fear of public speaking.
详细描述
The study will be conducted as a randomized controlled single-blind study in a parallel groups design.
Participants will be divided into groups afraid of public speaking with and without fulfilling the criteria of social anxiety (according to DSM-V), which can represent a clinically relevant and more generalized form of public speaking anxiety. The treatment for the participants solely differs in terms of whether they receive (1) the VR exposure or (2) a fear-unrelated VR task (study phase 1) or no treatment at all (study phase 2), resulting in the following 2 groups:
- Group 1 (treatment group) consists of individuals with fear of public speaking that will (in study phase 1) receive a three-session VR exposure and undergo (in study phase 2) a 2-week treatment period with the same VR scenarios, each repeated three times.
- Group 2 (control group) consists of individuals with fear of public speaking that will not receive any active treatment but complete a distractor task in VR in study phase 1 and no treatment in study phase 2.
In study phase 1, the treatment group receives three VR exposure sessions each lasting for 20 minutes, whereas the control group completes three virtual distractor tasks (e.g. virtual tours) of identical duration. In study phase 2, the treatment group completes a home training spanning two weeks (9 x 20-minutes sessions), whereas the control group does not receive any treatment (untreated comparison group).
In study phase 1, before and after the virtual exposure session, participants undergo an in vivo PST to assess the acute effects of the VR exposure-based eye contact training App.
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 (Investigator)
盲法说明
Investigators evaluating the (external) performance in the in vivo Public Speech Test (PST) 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 public speaking, assessed by two separate aspects:
- •High fear in social situations including the potential of being evaluated by others
- •Social situations can only be withstood under high fear or are avoided
- •Aged between 18-40
- •Fluent in German
排除标准
- •BDI-II sumscore >= 20
- •Suicidal ideation (BDI-II item 9 > 0)
- •Serious medical or psychological condition, other than social anxiety (including Depression, Epilepsy and Migraine)
- •Concurrent psychotherapy
- •Previous exposure-based therapy for social anxiety (including public speaking anxiety) or other anxiety disorders
- •Parallel participation in another psychological or medical study
- •Chronic medication intake (except oral contraceptives)
- •Chronic drug intake (i.e. LSD, mushrooms, Ecstasy, MDMA, amphetamines etc.)
- •Medication intake before visits (less than 24 h)
- •Alcohol intake before visits (less than 12 h)
- •Cannabis or other psychoactive substances (including benzodiazepines) intake before visits (less than 5 days)
- •Restricted 3D sight
- •For women: Current pregnancy
研究组 & 干预措施
Exposure
Phase 1 (visit 1): 60 minutes exposure-based eye contact training in VR Phase 2 (home training): 9 blocks of 20 minutes exposure-based eye contact training in VR, distributed over a total duration of maximally 2 weeks
干预措施: Exposure-based eye contact training in Virtual Reality (VR) (Other)
Control
Phase 1 (visit 1): waitlist. In order to prevent systematic preparation for the subsequent PST, a 60 minutes virtual reality games with fear-unrelated content will serve as the control intervention.
Phase 2 (home training): waitlist
结局指标
主要结局
Subjective Units of Distress Scale (SUDS, fear)
时间窗: Assessing change between baseline and predefined follow-up time points during 11 weeks
Fear of public speaking is quantified by means of SUDS-ratings during a Public Speaking Test (PST) in vivo.
次要结局
- Global external assessment of performance in an in vivo public speech test(Assessing change between baseline and predefined follow-up time points during 11 weeks)
- Fear of eye contact (SUDS, eye contact)(Assessing change between baseline and predefined follow-up time points during 11 weeks)
- Global self-assessment of performance in an in vivo public speech test(Assessing change between baseline and predefined follow-up time points during 11 weeks)
- Global subjectively perceived improvement of fear, eye contact and performance after single VR-exposure/waitlist(Assessed at visit 1 after completing the second PST)
- Global subjectively perceived improvement of fear, eye contact and performance after VR-training/waitlist(Assessed at visit 2 after completing the PST)
- Physiological measures(Assessing change between baseline and predefined follow-up time points during 11 weeks)
- Total time of eye contact during an in vivo public speech test(Assessing change between baseline and predefined follow-up time points during 11 weeks)
- Questionnaire for social anxiety (Soziale-Phobie-Inventar; SPIN)(Assessing change between baseline and predefined follow-up time points during 11 weeks)
- Questionnaire for fear of negative evaluation (The Furcht vor negativer Evaluation - Kurzskala; FNE-K)(Assessing change between baseline and predefined follow-up time points during 11 weeks)
- Eye-tracking measures(Assessing change between baseline and predefined follow-up time points during 11 weeks)
研究者
Prof. Dominique de Quervain, MD
Director Division of Cognitive Neuroscience
University of Basel