An interventional study of Exposure-based eye contact training in Virtual Reality (VR) in Fear of Public Speaking (Subclinical), sponsored by Prof. Dominique de Quervain, MD. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-30.
Sponsored by Prof. Dominique de Quervain, MD · Not applicable, Interventional, and Other
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.
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:
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.
In study phase 2, the participants undergo a third in vivo PST to assess the training effects of the VR exposure-based eye contact training after two weeks of home training.
This design allows a direct isolation and comparison of acute effects (study phase 1) and of training effects (study phase 2) and therefore enables an overall estimation of the effectiveness of the VR exposure-based eye contact training.
Approximately 96 participants between 18 and 40 years with fear of public speaking will take part in the study. Approximately 1 to 5 weeks after having finished the first study phase, all participants that have not dropped out will take part in the second study phase.
Prof. Dominique de Quervain, MD is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: Exposure-based eye contact training in Virtual Reality (VR)
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
The intervention is an App for virtual reality. The VR App provides three different virtual scenarios. Participants will be asked to stand in front of a virtual audience and to maintain eye contact with audience members. The advance to higher difficulty levels is according to a pre-defined exposure scheme. Participants will be given all instructions via the App. There will be three sessions on one day (duration of 20 min each) in study phase 1. The indication is disproportionate fear of being evaluated by others and reduced eye contact as a typical avoidance strategy in individuals with fear of public speaking. In the study phase 2, there will be nine sessions spanning over two weeks (duration of 20 min each, with maximally one session per day). The indication is disproportionate fear of being evaluated by others and reduced eye contact as a typical avoidance strategy in individuals with fear of public speaking.
Subjective Units of Distress Scale (SUDS, fear)
Fear of public speaking is quantified by means of SUDS-ratings during a Public Speaking Test (PST) in vivo.
Time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Global external assessment of performance in an in vivo public speech test
The global external assessment of performance is done by averaging VAS-ratings (range from 0 = very bad performance to 100 = very good performance) of the PST from three independent members of a committee (experimenters) and a forth experimenter that will rate the performances using a video and audio recording from the speeches.
Time frame: 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
Total time of eye contact is measured by a mobile eye tracking device from Pupil Labs and operationalized by the number of frames the gaze is in predefined regions of interest comprising the eyes of the committee members.
Time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Fear of eye contact (SUDS, eye contact)
Fear of public speaking is quantified by means of SUDS-ratings during a Public Speaking Test (PST) in vivo.
Time frame: 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
The global self-assessment of performance is done by a VAS-ratings (range from 0 = very bad performance to 100 = very good performance) of the PST
Time frame: 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
Global subjectively perceived improvement of fear, eye contact and performance by the VR eye contact training App will be done by VAS-ratings
Time frame: Assessed at visit 1 after completing the second PST
Global subjectively perceived improvement of fear, eye contact and performance after VR-training/waitlist
Global subjectively perceived improvement of fear, eye contact and performance by the VR eye contact training App will be done by VAS-ratings
Time frame: Assessed at visit 2 after completing the PST
Questionnaire for social anxiety (Soziale-Phobie-Inventar; SPIN)
The SPIN is a 17-item questionnaire developed by the Psychiatry and Behavioral Sciences Department at Duke University. It is effective in screening for, and measuring the severity of fear related to the negative evaluation by others. The 17 items cover different aspects of the anxiety such as fear, avoidance, and physiological symptoms on 5-point Likert scales. The statements of the SPIN items indicate the particular signs of public speaking anxiety (e.g. "I am bothered by blushing in front of people"). The SPIN demonstrates solid psychometric properties and is valid as a measurement for the severity and clinical relevance of fear related symptoms (Connor et al., 2000).
Time frame: 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)
The FNE-K is a frequently used, valid, and reliable self-report questionnaire consisting of 12 items measuring fear and distress related to negative evaluation by others (e.g. "I am afraid that people will find fault with me") on 4-point Likert scales. The FNE-K has demonstrated good reliability and validity (Reichenberger et al., 2016).
Time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Eye-tracking measures
Gaze behaviour (fixation frequency and location, scan path characteristics) and pupil size
Time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Physiological measures
Salivary cortisol levels
Time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Feature-specific external and self-assessment of performance in an in vivo public speech test (VAS-ratings)
Feature-specific assessment of the participants performance in the in vivo PST is measured by VAS-ratings (from 0 = very bad to 100 = very good) from three independent members of a committee. A forth experimenter will rate the performances using a video and audio recording from the speeches. 8 specific VAS-ratings covering nonverbal aspects of performances (e.g. facial expression, gestures etc.) are divided into two subscales with 4 VAS-ratings each (1 = speech, 2 = appearance).
Time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Vocal indices of stress
Vocal indices of stress comprise f.e. level and variability of the fundamental frequency or the active speech duration. They will be measured by analysing the audio recordings during the PST.
Time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Simulation sickness in VR
Safety outcome, assessed by the Simulator Sickness Questionnaire (SSQ)
Time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks
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Prof. Dominique de Quervain, MD