Trier Social Stress Test in Virtual Reality

Stress, Psychological Clinical Trial

Official title:

Trier Social Stress Test in Virtual Reality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830435
• Other study ID #: TSST-VR
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: University Medical Center Groningen
• Contact: Mathijs Nijland, MD
• Phone: 0031613986175
• Email: j.w.h.m.nijland[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 31, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stress, Physiological
• Stress, Psychological

Intervention

Behavioral:
• Trier social stress test
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.

Locations

Country	Name	City	State
Netherlands	UMCG	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	University of Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of levels of physical stress, HRV	Change from baseline to 75 min	continuously during the whole procedure, in total 75 minuten
Secondary	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.
Secondary	Social phobia	Social phobia scores measured by the Social Phobia Inventory	Baseline
Secondary	Sociodemographics	Age, gender, work	baseline
Secondary	Speech fluency	Speech fluency as recorded during the speech and math task	during the speech and math task, 10 minutes in total
Secondary	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.
Secondary	Change of levels of physical stress, Skin conductance	Galvanic Skin Conductance	continuously during the whole procedure, in total 75 minuten