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

NCT ID: NCT03970187

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2019-09-20

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.

Conditions

Fear of Public Speaking (Subclinical)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prof. Dominique de Quervain, MD

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dominique de Quervain, MD

Director Division of Cognitive Neuroscience

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dominique de Quervain, MD

Role: STUDY_DIRECTOR

University of Basel, Division of Cognitive Neuroscience

Locations

University of Basel, Division of Cognitive Neuroscience

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

2019-00514

Identifier Type: -

Identifier Source: org_study_id