- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05830435
Trier Social Stress Test in Virtual Reality
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mathijs Nijland, MD
- Phone Number: 0031613986175
- Email: j.w.h.m.nijland@umcg.nl
Study Contact Backup
- Name: Catheleine Van Driel, MD PhD
- Email: cmg.van.driel@umcg.nl
Study Locations
-
-
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Groningen, Netherlands, 9713
- Recruiting
- UMCG
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: TSST VR Friendly
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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.
|
|
Experimental: TSST VR Neutral
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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.
|
|
Experimental: TSST VR Unfriendly
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of levels of physical stress, HRV
Time Frame: continuously during the whole procedure, in total 75 minuten
|
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
Time Frame: After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.
|
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.
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After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.
|
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Social phobia
Time Frame: Baseline
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Social phobia scores measured by the Social Phobia Inventory
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Baseline
|
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Sociodemographics
Time Frame: baseline
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Age, gender, work
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baseline
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Speech fluency
Time Frame: during the speech and math task, 10 minutes in total
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Speech fluency as recorded during the speech and math task
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during the speech and math task, 10 minutes in total
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Change of levels of physical stress, cortisol
Time Frame: After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.
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Change from baseline to the last waiting period
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After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.
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Change of levels of physical stress, Skin conductance
Time Frame: continuously during the whole procedure, in total 75 minuten
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Galvanic Skin Conductance
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continuously during the whole procedure, in total 75 minuten
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.
- Helminen EC, Morton ML, Wang Q, Felver JC. Stress Reactivity to the Trier Social Stress Test in Traditional and Virtual Environments: A Meta-Analytic Comparison. Psychosom Med. 2021 Apr 1;83(3):200-211. doi: 10.1097/PSY.0000000000000918.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TSST-VR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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