Investigation of the Efficacy of a VR Exposure-based Eye Contact Training‬ to Reduce Fear of Public Speaking

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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. 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.

Official Title
-----------------
Randomized Controlled Trial on the Efficacy of a VR Exposure-based Eye Contact Training‬ to Reduce Fear of Public Speaking

Conditions
-----------------
Fear of Public Speaking (Subclinical)

Intervention / Treatment
-----------------
* Other: Exposure-based eye contact training in Virtual Reality (VR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled single-blind study design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure<br>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)<br>* 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.<br>|
| No Intervention: Control<br>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 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessing change between baseline and predefined follow-up time points during 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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 | 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 | 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). | 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). | 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 | Assessing change between baseline and predefined follow-up time points during 11 weeks | 
| Physiological measures | Salivary cortisol levels | Assessing change between baseline and predefined follow-up time points during 11 weeks |