Trier Social Stress Test in Virtual Reality

April 13, 2023 updated by: University Medical Center Groningen

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

Recruiting

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Groningen, Netherlands, 9713
        • Recruiting
        • UMCG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
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.

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.
After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.
Social phobia
Time Frame: Baseline
Social phobia scores measured by the Social Phobia Inventory
Baseline
Sociodemographics
Time Frame: baseline
Age, gender, work
baseline
Speech fluency
Time Frame: during the speech and math task, 10 minutes in total
Speech fluency as recorded during the speech and math task
during the speech and math task, 10 minutes in total
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.
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.
Change of levels of physical stress, Skin conductance
Time Frame: continuously during the whole procedure, in total 75 minuten
Galvanic Skin Conductance
continuously during the whole procedure, in total 75 minuten

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

April 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress, Psychological

Clinical Trials on Trier social stress test

Subscribe