Stress, PsychologicalNCT05830435
Trier Social Stress Test in Virtual Reality
A study testing Trier social stress test in people with Stress, Psychological and Stress, Physiological, run by University Medical Center Groningen at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Stress, Physiological
- What is being tested?
- Trier social stress test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Nov 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Catheleine Van Driel, MD PhD contact
About this study
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
- Being tested
- Trier social stress test
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier social stress testBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TSST VR Friendly | Active comparator | Not described Receives: Behavioral: Trier social stress test |
| TSST VR Neutral | Experimental | Not described Receives: Behavioral: Trier social stress test |
| TSST VR Unfriendly | Experimental | Not described Receives: Behavioral: Trier social stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of levels of physical stress, HRV
Change from baseline to 75 min
Measured: continuously during the whole procedure, in total 75 minuten
Secondary outcomes (6)
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.
Measured: After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.
Social phobia
Social phobia scores measured by the Social Phobia Inventory
Measured: Baseline
Sociodemographics
Age, gender, work
Measured: baseline
Speech fluency
Speech fluency as recorded during the speech and math task
Measured: during the speech and math task, 10 minutes in total
Change of levels of physical stress, cortisol
Change from baseline to the last waiting period
Measured: 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
Galvanic Skin Conductance
Measured: continuously during the whole procedure, in total 75 minuten
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start25 Nov 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Groningen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830435
- Sponsor's protocol ID
- TSST-VR
- Status last verified
- Apr 2023
- First submitted
- 13 Mar 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8255414Helminen 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.
PubMed 33534392
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trier Social Stress Test in Virtual Reality
- ClinicalTrials.gov ID
- NCT05830435
- Acronym / sponsor ID
- TSST-VR
- Conditions
- Stress, Psychological, Stress, Physiological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- University of Groningen
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- History of photosensitive epilepsy
- Hearing loss
- Pregnant woman
- Women who breastfeed
- Taking heart rate altering medication such as beta-blockers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trier social stress testTSST-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. | Behavioural | TSST VR Friendly, TSST VR Neutral, TSST VR Unfriendly |
Primary outcome
Change of levels of physical stress, HRV
Time frame: continuously during the whole procedure, in total 75 minuten
Change from baseline to 75 min
6 secondary outcomes
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.
Social phobia
Time frame: Baseline
Sociodemographics
Time frame: baseline
Speech fluency
Time frame: 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 of levels of physical stress, Skin conductance
Time frame: continuously during the whole procedure, in total 75 minuten
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Background: PubMed 8255414Kirschbaum 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.
- Background: PubMed 33534392Helminen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catheleine Van Driel, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trier social stress test in people with Stress, Psychological and Stress, Physiological, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathijs Nijland, MD (0031613986175, j.w.h.m.nijland@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of levels of physical stress, HRV (time frame: continuously during the whole procedure, in total 75 minuten). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05830435, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.