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

NCT03970187 | Completed

• 1 other identifier: 2019-00514
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Fear of Public Speaking (Subclinical)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

• 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

• 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

Other Outcomes (3)

• Feature-specific external and self-assessment of performance in an in vivo public speech test (VAS-ratings)

  Assessing change between baseline and predefined follow-up time points during 11 weeks

• Vocal indices of stress

  Assessing change between baseline and predefined follow-up time points during 11 weeks

• Simulation sickness in VR

  Assessing change between baseline and predefined follow-up time points during 11 weeks

Study Arms (2)

Exposure

EXPERIMENTAL

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)

Control

NO INTERVENTION

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

Interventions

Exposure-based eye contact training in Virtual Reality (VR) OTHER

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.

Exposure

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dominique de Quervain, MD: lead

Study Sites (1)

University of Basel, Division of Cognitive Neuroscience

Basel, Canton of Basel-City, 4055, Switzerland

Location

MeSH Terms

Conditions

Glossophobia

Study Officials

• Dominique de Quervain, MD

  University of Basel, Division of Cognitive Neuroscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators evaluating the (external) performance in the in vivo Public Speech Test (PST) will be blinded (unaware of group assignment of participants, single-blind).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Division of Cognitive Neuroscience

Model Details: Randomized controlled single-blind study design.

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 31, 2019
• Study Start: June 1, 2019
• Primary Completion: July 31, 2019
• Study Completion: September 20, 2019
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)