Trier Social Stress Test in Virtual Reality
Primary Purpose
Stress, Psychological, Stress, Physiological
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Trier social stress test
Sponsored by
About this trial
This is an interventional diagnostic trial for Stress, Psychological
Eligibility Criteria
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.
Sites / Locations
- UMCGRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
TSST VR Friendly
TSST VR Neutral
TSST VR Unfriendly
Arm Description
Outcomes
Primary Outcome Measures
Change of levels of physical stress, HRV
Change from baseline to 75 min
Secondary Outcome Measures
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.
Social phobia
Social phobia scores measured by the Social Phobia Inventory
Sociodemographics
Age, gender, work
Speech fluency
Speech fluency as recorded during the speech and math task
Change of levels of physical stress, cortisol
Change from baseline to the last waiting period
Change of levels of physical stress, Skin conductance
Galvanic Skin Conductance
Full Information
NCT ID
NCT05830435
First Posted
March 13, 2023
Last Updated
April 13, 2023
Sponsor
University Medical Center Groningen
Collaborators
University of Groningen
1. Study Identification
Unique Protocol Identification Number
NCT05830435
Brief Title
Trier Social Stress Test in Virtual Reality
Official Title
Trier Social Stress Test in Virtual Reality
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen
Collaborators
University of Groningen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Stress, Physiological
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TSST VR Friendly
Arm Type
Active Comparator
Arm Title
TSST VR Neutral
Arm Type
Experimental
Arm Title
TSST VR Unfriendly
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Trier social stress test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of levels of physical stress, HRV
Description
Change from baseline to 75 min
Time Frame
continuously during the whole procedure, in total 75 minuten
Secondary Outcome Measure Information:
Title
Change of levels of psychological stress, state anxiety inventory STAI
Description
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.
Time Frame
After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.
Title
Social phobia
Description
Social phobia scores measured by the Social Phobia Inventory
Time Frame
Baseline
Title
Sociodemographics
Description
Age, gender, work
Time Frame
baseline
Title
Speech fluency
Description
Speech fluency as recorded during the speech and math task
Time Frame
during the speech and math task, 10 minutes in total
Title
Change of levels of physical stress, cortisol
Description
Change from baseline to the last waiting period
Time Frame
After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.
Title
Change of levels of physical stress, Skin conductance
Description
Galvanic Skin Conductance
Time Frame
continuously during the whole procedure, in total 75 minuten
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathijs Nijland, MD
Phone
0031613986175
Email
j.w.h.m.nijland@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Catheleine Van Driel, MD PhD
Email
cmg.van.driel@umcg.nl
Facility Information:
Facility Name
UMCG
City
Groningen
ZIP/Postal Code
9713
Country
Netherlands
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8255414
Citation
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.
Results Reference
background
PubMed Identifier
33534392
Citation
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.
Results Reference
background
Learn more about this trial
Trier Social Stress Test in Virtual Reality
We'll reach out to this number within 24 hrs