Trier Social Stress Test in Virtual Reality

Sponsor
University Medical Center Groningen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05830435
Collaborator
University of Groningen (Other)
55
1
3
13.2
4.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Trier social stress test
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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. TSST-VR Friendly (control) TSST-VR-Neutral TSST-VR-Unfriendly Participants will be divided into three groups by means of block randomizationIn 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:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
Trier Social Stress Test in Virtual Reality
Actual Study Start Date :
Nov 25, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: TSST VR Friendly

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.

Experimental: TSST VR Neutral

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.

Experimental: TSST VR Unfriendly

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.

Outcome Measures

Primary Outcome Measures

  1. Change of levels of physical stress, HRV [continuously during the whole procedure, in total 75 minuten]

    Change from baseline to 75 min

Secondary Outcome Measures

  1. 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.]

    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.

  2. Social phobia [Baseline]

    Social phobia scores measured by the Social Phobia Inventory

  3. Sociodemographics [baseline]

    Age, gender, work

  4. Speech fluency [during the speech and math task, 10 minutes in total]

    Speech fluency as recorded during the speech and math task

  5. 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.]

    Change from baseline to the last waiting period

  6. Change of levels of physical stress, Skin conductance [continuously during the whole procedure, in total 75 minuten]

    Galvanic Skin Conductance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UMCG Groningen Netherlands 9713

Sponsors and Collaborators

  • University Medical Center Groningen
  • University of Groningen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Medical Center Groningen
ClinicalTrials.gov Identifier:
NCT05830435
Other Study ID Numbers:
  • TSST-VR
First Posted:
Apr 26, 2023
Last Update Posted:
Apr 26, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2023