Trier Social Stress Test in Virtual Reality

Study Overview
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Brief Summary
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Background The Trier Social Stress Test (TSST) is a valid and gold standard way for inducing psychosocial stress and is widely used in research and diagnostics. One of the downsides of the TSST is the difficulty to maintain the same experimental conditions repeatedly. A TSST in virtual reality (TSST-VR) is constant and requires far less time and personnel. Our TSST-VR version consist of three stress levels (no stress, moderate stress, high stress), a novelty in this field. Aim The aim is to investigate whether there is a statistically significantly greater increase directly after the TSST-VR in psychological and physiological stress parameters in the moderate and high stress levels compared to the no stress condition (control). Method A randomized controlled trial is conducted in healthy adults, with the three stress levels as conditions. Cortisol and questionnaires on anxiety and physical arousal are measured at baseline, during and after the TSST. Heart rate is measured continuously and adverse events are monitored.

Official Title
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Trier Social Stress Test in Virtual Reality

Conditions
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Stress, Psychological, Stress, Physiological

Intervention / Treatment
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* Behavioral: Trier social stress test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participants, not having a psychiatric diagnosis in the last three years or currently having an endocrine disorders Aged between 18 and 65 years Good understanding of the Dutch language Normal or corrected-to-normal vision and hearing Exclusion Criteria: History of photosensitive epilepsy Hearing loss Pregnant woman Women who breastfeed Taking heart rate altering medication such as beta-blockers. Pregnant woman and woman who breastfeed are excluded because they have a different hormone levels which can intervene with the stress reaction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this study, a three-arm single blind randomized placebo-controlled trial will be conducted. The following conditions will be set up. TSST-VR Friendly (control) TSST-VR-Neutral TSST-VR-Unfriendly Participants will be divided into three groups by means of block randomization
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TSST VR Friendly<br> | Behavioral: Trier social stress test<br>* TSST-VR-friendly: The assistant behind the desk asks the participant to prepare a small talk on their favourite holiday within 5 minutes. Then the participant is asked to tell about his holiday for 5 minutes. Then the participant is asked to do a simple math task: adding the number 5 to 0 for 5 minutes. The research assistant gives friendly gestures and verbal encouragements. TSST-VR-neutral: The assistant asks the participant to prepare a speech for a job interview in the upcoming 5 minutes. Then the participant is asked to deliver the speech for 5 minutes in front of two panelists and camera. Then the participant is asked to do a math task, subtracting the number 13 from 1022 for 5 minutes. During the performance the two panellist have neutral gestures and give neutral verbal instructions. TSST-VR unfriendly: The procedure of the TSST-VR unfriendly is the same as the neutral TSST-VR, with the addition that the two panellist give unfriendly gestures such as tapping on the table.<br>|
| Experimental: TSST VR Neutral<br> | Behavioral: Trier social stress test<br>* TSST-VR-friendly: The assistant behind the desk asks the participant to prepare a small talk on their favourite holiday within 5 minutes. Then the participant is asked to tell about his holiday for 5 minutes. Then the participant is asked to do a simple math task: adding the number 5 to 0 for 5 minutes. The research assistant gives friendly gestures and verbal encouragements. TSST-VR-neutral: The assistant asks the participant to prepare a speech for a job interview in the upcoming 5 minutes. Then the participant is asked to deliver the speech for 5 minutes in front of two panelists and camera. Then the participant is asked to do a math task, subtracting the number 13 from 1022 for 5 minutes. During the performance the two panellist have neutral gestures and give neutral verbal instructions. TSST-VR unfriendly: The procedure of the TSST-VR unfriendly is the same as the neutral TSST-VR, with the addition that the two panellist give unfriendly gestures such as tapping on the table.<br>|
| Experimental: TSST VR Unfriendly<br> | Behavioral: Trier social stress test<br>* TSST-VR-friendly: The assistant behind the desk asks the participant to prepare a small talk on their favourite holiday within 5 minutes. Then the participant is asked to tell about his holiday for 5 minutes. Then the participant is asked to do a simple math task: adding the number 5 to 0 for 5 minutes. The research assistant gives friendly gestures and verbal encouragements. TSST-VR-neutral: The assistant asks the participant to prepare a speech for a job interview in the upcoming 5 minutes. Then the participant is asked to deliver the speech for 5 minutes in front of two panelists and camera. Then the participant is asked to do a math task, subtracting the number 13 from 1022 for 5 minutes. During the performance the two panellist have neutral gestures and give neutral verbal instructions. TSST-VR unfriendly: The procedure of the TSST-VR unfriendly is the same as the neutral TSST-VR, with the addition that the two panellist give unfriendly gestures such as tapping on the table.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of levels of physical stress, HRV | Change from baseline to 75 min | continuously during the whole procedure, in total 75 minuten | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of levels of psychological stress, state anxiety inventory STAI | Change from baseline to the last waiting period. 6 questions each scoring 1-4, with a total score of 24. A higher score indicates for more stress and anxiety. | After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period. | 
| Social phobia | Social phobia scores measured by the Social Phobia Inventory | Baseline | 
| Sociodemographics | Age, gender, work | baseline | 
| Speech fluency | Speech fluency as recorded during the speech and math task | during the speech and math task, 10 minutes in total | 
| Change of levels of physical stress, cortisol | Change from baseline to the last waiting period | After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period. | 
| Change of levels of physical stress, Skin conductance | Galvanic Skin Conductance | continuously during the whole procedure, in total 75 minuten |