Clinical trial NCT05830435: Trier Social Stress Test in Virtual Reality
Official title: Trier Social Stress Test in Virtual Reality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Stress, Physiological
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: University of Groningen
First posted: 2023-04-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, a three-arm single blind randomized placebo-controlled trial will be conducted. The following conditions will be set up.

1. TSST-VR Friendly (control)
2. TSST-VR-Neutral
3. TSST-VR-Unfriendly Participants will be divided into three groups by means of block randomization
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Change of levels of physical stress, HRV
timeFrame: continuously during the whole procedure, in total 75 minuten
Secondary outcomes:
measure: Change of levels of psychological stress, state anxiety inventory STAI
timeFrame: After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.
measure: Social phobia
timeFrame: Baseline
measure: Sociodemographics
timeFrame: baseline
measure: Speech fluency
timeFrame: during the speech and math task, 10 minutes in total
measure: Change of levels of physical stress, cortisol
timeFrame: After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.
measure: Change of levels of physical stress, Skin conductance
timeFrame: continuously during the whole procedure, in total 75 minuten
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
References:
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.
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.