Investigation of the Efficacy of a VR Exposure-based Eye Contact Training‬ to Reduce Fear of Public Speaking (ASSIST-2019)

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

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.

Study Overview

• Status: Completed
• Conditions: Fear of Public Speaking (Subclinical)
• Intervention / Treatment: Other: Exposure-based eye contact training in Virtual Reality (VR)

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4055
      • University of Basel, Division of Cognitive Neuroscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Other: Exposure-based eye contact training in Virtual Reality (VR); 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.
NO_INTERVENTION: 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

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Prof. Dominique de Quervain, MD
• Investigators: Study Director: Dominique de Quervain, MD, University of Basel, Division of Cognitive Neuroscience

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): July 31, 2019
• Study Completion (ACTUAL): September 20, 2019

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (ACTUAL): May 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2019-00514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No