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Real-Time Assessment of Stress and Stress Response

Real-Time Assessment of Stress and Stress Response

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04100213
Enrollment
0
Registered
2019-09-24
Start date
2025-12-01
Completion date
2025-12-01
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychiatric Disorder, Stress, Physiological, Stress, Psychological, Stress Reaction

Keywords

Stress, Stress Reaction, Trier Social Stress Test, Digital Phenotyping

Brief 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. 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.

Interventions

BEHAVIORALTrier Social Stress Test

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.

Sponsors

Psychiatric University Hospital, Zurich
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
CortisolChange from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the interventionSaliva Cortisol Concentration
Subjective StressChange from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the interventionStress Questionnaire

Secondary

MeasureTime frameDescription
Psychopathological Assessement1 daySymptom Questionnaire
Psychiatric Diagnosis1 dayStructured psychiatric Interview

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026