Psychiatric DisorderNCT04100213
Real-Time Assessment of Stress and Stress Response
A study testing Trier Social Stress Test in people with Psychiatric Disorder and Stress Reaction, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
Trial summary
Stress is a complex natural phenomenon, frequently related to a physiological response, including heart rate, heart rate variability, respiratory rate, skin conductance and temperature. The subjective experience varies greatly; broadly, it may be conceived as a freeze, flight, fight, fright or faint response. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Disorder, Stress Reaction, Stress, Psychological
- 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
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2025to 1 Dec 2025
- 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
- Participants are competent to give informed consent.
- Participants are right handed
- German language proficiency as a native speaker or level B1
- Diagnosis of a cluster C personality disorder according to ICD-10; or
- Diagnosis of depressive disorder according to ICD-10; or
- Diagnosis of schizophrenia or schizoaffective disorder according to ICD-10; or
- Without a current psychiatric disorder.
Who cannot join
- Low Intelligence as confirmed by failure to complete regular compulsory education.
- Pregnancy or over two weeks delay in the menstrual cycle.
- Previous participation in a psychological trial involving psychosocial stress assessment.
- Current neurological disorder.
- Current cardiovascular disorder.
- Current respiratory disorder.
- Current substance use or withdrawal.
- Any change in medication in the previous week.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatrische Universitätsklinik Zürich
Zurich, Canton of Zurich, 8032
About this study
Stress is a complex natural phenomenon, frequently related to a physiological response, including heart rate, heart rate variability, respiratory rate, skin conductance and temperature. The subjective experience varies greatly; broadly, it may be conceived as a freeze, flight, fight, fright or faint response. Many studies have demonstrated the negative influence of psychological stress on health and well-being. Through the digital phenotyping of physiological and psychological stress reactions, in a controlled laboratory setting (Trier Social Stress Test- TSST) and real-life situations, in a population of healthy participants and patients with a major psychiatric disorder, we expect to find reliable and valid digital biomarkers. The results of this study will, therefore, not only contribute to a better understanding of stress and stress response but also have the potential to improve diagnostic and treatment approaches.
- Being tested
- Trier Social Stress Test
- Keywords
- Stress, Stress Reaction, Trier Social Stress Test, Digital Phenotyping
- Medical subject headings
- Mental Disorders, Fractures, Stress, 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
Also called TSST
The TSST-G is a psychological paradigm which combines high levels of social-evaluative threat and uncontrollability in a group setting. The TSST-G will proceed in groups of three to five participants (from the same diagnostic group). The TSST-G consists of three phases: a briefing; the psychological test itself, followed by a debriefing phase. Each phase will last 40, 20 and 60 minutes, respectively. The briefing and debriefing of the TSST-G will be conducted by experienced psychotherapists. The TSST-G itself will be conducted by personal unknown to the participants.
| Study group | Role | What they receive |
|---|---|---|
| TSST | 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.
Cortisol
Saliva Cortisol Concentration
Measured: Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention
Subjective Stress
Stress Questionnaire
Measured: Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention
Secondary outcomes (2)
Psychopathological Assessement
Symptom Questionnaire
Measured: 1 day
Psychiatric Diagnosis
Structured psychiatric Interview
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Dec 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Why it stopped: Not enough participants were willing to enroll.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric University Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan T. Egger, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100213
- Sponsor's protocol ID
- mHealth TSST-G
- Status last verified
- Dec 2025
- First submitted
- 18 Sep 2019
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Egger ST, Knorr M, Bobes J, Bernstein A, Seifritz E, Vetter S. Real-Time Assessment of Stress and Stress Response Using Digital Phenotyping: A Study Protocol. Front Digit Health. 2020 Oct 15;2:544418. doi: 10.3389/fdgth.2020.544418. eCollection 2020.
PubMed 34713030
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Assessment of Stress and Stress Response
- ClinicalTrials.gov ID
- NCT04100213
- Acronym / sponsor ID
- mHealth TSST-G
- Keywords
- Stress, Stress Reaction, Trier Social Stress Test, Digital Phenotyping
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough participants were willing to enroll.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Psychiatric University Hospital, ZurichUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 24 Sep 2019 (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.
Stress is a complex natural phenomenon, frequently related to a physiological response, including heart rate, heart rate variability, respiratory rate, skin conductance and temperature. The subjective experience varies greatly; broadly, it may be conceived as a freeze, flight, fight, fright or faint response. Many studies have demonstrated the negative influence of psychological stress on health and well-being. Through the digital phenotyping of physiological and psychological stress reactions, in a controlled laboratory setting (Trier Social Stress Test- TSST) and real-life situations, in a population of healthy participants and patients with a major psychiatric disorder, we expect to find reliable and valid digital biomarkers. The results of this study will, therefore, not only contribute to a better understanding of stress and stress response but also have the potential to improve diagnostic and treatment approaches.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TSST | 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 (7 listed)
- Participants are competent to give informed consent.
- Participants are right handed
- German language proficiency as a native speaker or level B1
- Diagnosis of a cluster C personality disorder according to ICD-10; or
- Diagnosis of depressive disorder according to ICD-10; or
Key exclusion criteria (8 listed)
- Low Intelligence as confirmed by failure to complete regular compulsory education.
- Pregnancy or over two weeks delay in the menstrual cycle.
- Previous participation in a psychological trial involving psychosocial stress assessment.
- Current neurological disorder.
- Current cardiovascular disorder.
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 TestAlso: TSSTThe TSST-G is a psychological paradigm which combines high levels of social-evaluative threat and uncontrollability in a group setting. The TSST-G will proceed in groups of three to five participants (from the same diagnostic group). The TSST-G consists of three phases: a briefing; the psychological test itself, followed by a debriefing phase. Each phase will last 40, 20 and 60 minutes, respectively. The briefing and debriefing of the TSST-G will be conducted by experienced psychotherapists. The TSST-G itself will be conducted by personal unknown to the participants. | Behavioural | TSST |
Primary outcome
Cortisol
Time frame: Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention
Saliva Cortisol Concentration
Subjective Stress
Time frame: Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention
Stress Questionnaire
2 secondary outcomes
Psychopathological Assessement
Time frame: 1 day
Psychiatric Diagnosis
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Derived from this study: PubMed 34713030Egger ST, Knorr M, Bobes J, Bernstein A, Seifritz E, Vetter S. Real-Time Assessment of Stress and Stress Response Using Digital Phenotyping: A Study Protocol. Front Digit Health. 2020 Oct 15;2:544418. doi: 10.3389/fdgth.2020.544418. eCollection 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Psychiatric Disorder and Stress Reaction, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 8 Dec 2025. 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 Switzerland. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol (time frame: Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention). The study lists 2 primary outcomes in all. 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 NCT04100213, which also lists 1 linked publication.
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 8 Dec 2025.