Trier Social Stress Test in Virtual Reality

NCT05830435 | Unknown

• 1 other identifier: TSST-VR
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological; Stress, Physiological

Outcome Measures

Primary Outcomes (1)

• Change of levels of physical stress, HRV

  Change from baseline to 75 min

  continuously during the whole procedure, in total 75 minuten

Secondary Outcomes (6)

• Change of levels of psychological stress, state anxiety inventory STAI

  After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.

• Social phobia

  Baseline

• Sociodemographics

  baseline

• Speech fluency

  during the speech and math task, 10 minutes in total

• Change of levels of physical stress, cortisol

  After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.

Study Arms (3)

TSST VR Friendly

ACTIVE COMPARATOR

Behavioral: Trier social stress test

TSST VR Neutral

EXPERIMENTAL

Behavioral: Trier social stress test

TSST VR Unfriendly

EXPERIMENTAL

Behavioral: Trier social stress test

Interventions

Trier social stress test BEHAVIORAL

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.

TSST VR Friendly; TSST VR Neutral; TSST VR Unfriendly

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• University of Groningen: collaborator

Study Sites (1)

UMCG

Groningen, 9713, Netherlands

RECRUITING

Related Publications (2)

• 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.

  PMID: 8255414 BACKGROUND

• 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.

  PMID: 33534392 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Central Study Contacts

Mathijs Nijland, MD

CONTACT

0031613986175; j.w.h.m.nijland@umcg.nl

Catheleine Van Driel, MD PhD

CONTACT

cmg.van.driel@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 26, 2023
• Study Start: November 25, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 31, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)