| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fear of Public Speaking (Subclinical) | Other: Exposure-based eye contact training in Virtual Reality (VR) | Not Applicable |
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:
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 (Clinical Trial) |
| Actual Enrollment : | 96 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized controlled single-blind study design. |
| Masking: | Single (Investigator) |
| Masking Description: | Investigators evaluating the (external) performance in the in vivo Public Speech Test (PST) will be blinded (unaware of group assignment of participants, single-blind). |
| Primary Purpose: | Other |
| Official Title: | Randomized Controlled Trial on the Efficacy of a VR Exposure-based Eye Contact Training to Reduce Fear of Public Speaking |
| Actual Study Start Date : | June 1, 2019 |
| Actual Primary Completion Date : | July 31, 2019 |
| Actual Study Completion Date : | September 20, 2019 |
| 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 |
| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| Switzerland | |
| University of Basel, Division of Cognitive Neuroscience | |
| Basel, BS, Switzerland, 4055 | |
| Study Director: | Dominique de Quervain, MD | University of Basel, Division of Cognitive Neuroscience |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 22, 2019 | ||||
| First Posted Date ICMJE | May 31, 2019 | ||||
| Last Update Posted Date | October 30, 2019 | ||||
| Actual Study Start Date ICMJE | June 1, 2019 | ||||
| Actual Primary Completion Date | July 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Investigation of the Efficacy of a VR Exposure-based Eye Contact Training to Reduce Fear of Public Speaking | ||||
| Official Title ICMJE | Randomized Controlled Trial on the Efficacy of a VR Exposure-based Eye Contact Training to Reduce Fear of Public Speaking | ||||
| 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:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized controlled single-blind study design. Masking: Single (Investigator)Masking Description: Investigators evaluating the (external) performance in the in vivo Public Speech Test (PST) will be blinded (unaware of group assignment of participants, single-blind). Primary Purpose: Other
|
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| Condition ICMJE | Fear of Public Speaking (Subclinical) | ||||
| Intervention ICMJE | 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. |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
96 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | September 20, 2019 | ||||
| Actual Primary Completion Date | July 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years to 40 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Switzerland | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03970187 | ||||
| Other Study ID Numbers ICMJE | 2019-00514 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Prof. Dominique de Quervain, MD, University of Basel | ||||
| Study Sponsor ICMJE | Prof. Dominique de Quervain, MD | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University of Basel | ||||
| Verification Date | October 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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