Fear of Public Speaking (Subclinical)ASSIST-2019NCT03970187
Investigation of the Efficacy of a VR Exposure-based Eye Contact Training to Reduce Fear of Public Speaking
A study testing Exposure-based eye contact training in Virtual Reality (VR) in people with Fear of Public Speaking (Subclinical), run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear of Public Speaking (Subclinical)
- What is being tested?
- Exposure-based eye contact training in Virtual Reality (VR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2019to 20 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Division of Cognitive Neuroscience
Basel, Canton of Basel-City, 4055
About this study
Official title: 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.
Read the 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)
- Being tested
- Exposure-based eye contact training in Virtual Reality (VR)
- Medical subject headings
- Glossophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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
Measured: Assessing change between baseline and predefined follow-up time points during 11 weeks
Physiological measures
Salivary cortisol levels
Measured: Assessing change between baseline and predefined follow-up time points during 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start1 Jun 2019
- Primary completion31 Jul 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of Public Speaking (Subclinical)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled single-blind study design.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dominique de Quervain, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dominique de Quervain, MD, University of Basel
- Investigators
- Dominique de Quervain, MD, Study director, University of Basel, Division of Cognitive Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970187
- Sponsor's protocol ID
- 2019-00514
- Other IDs
- 2019
- Acronym
- ASSIST-2019
- Status last verified
- Oct 2019
- First submitted
- 22 May 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Efficacy of a VR Exposure-based Eye Contact Training to Reduce Fear of Public Speaking
- ClinicalTrials.gov ID
- NCT03970187
- Acronym / sponsor ID
- ASSIST-2019 / 2019-00514
- Conditions
- Fear of Public Speaking (Subclinical)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Prof. Dominique de Quervain, MDUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled single-blind study design.
| Arm | Type | Receives |
|---|---|---|
| Exposure | Experimental | Other: Exposure-based eye contact training in Virtual Reality (VR)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 |
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Exposure |
Primary outcome
Subjective Units of Distress Scale (SUDS, fear)
Time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Fear of public speaking is quantified by means of SUDS-ratings during a Public Speaking Test (PST) in vivo.
10 secondary outcomes
Global external assessment of performance in an in vivo public speech test
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
Time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Fear of eye contact (SUDS, eye contact)
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
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
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
Time frame: Assessed at visit 2 after completing the PST
Questionnaire for social anxiety (Soziale-Phobie-Inventar; SPIN)
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)
Time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Eye-tracking measures
Time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Physiological measures
Time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique de Quervain, MD study director
University of Basel, Division of Cognitive Neuroscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure-based eye contact training in Virtual Reality (VR) in people with Fear of Public Speaking (Subclinical), run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Units of Distress Scale (SUDS, fear) (time frame: Assessing change between baseline and predefined follow-up time points during 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.