Skip to main content
Clinical Trials/NCT04100213
NCT04100213
Withdrawn
Not Applicable

Real-Time Assessment of Stress and Stress Response

Psychiatric University Hospital, Zurich1 site in 1 country120 target enrollmentDecember 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychiatric Disorder
Sponsor
Psychiatric University Hospital, Zurich
Enrollment
120
Locations
1
Primary Endpoint
Cortisol
Status
Withdrawn
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2025
End Date
December 1, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Psychiatric University Hospital, Zurich
Responsible Party
Principal Investigator
Principal Investigator

Stephan T. Egger

Senior Psychiatrists

Psychiatric University Hospital, Zurich

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Psychopathological Assessement(1 day)
  • Psychiatric Diagnosis(1 day)

Study Sites (1)

Loading locations...

Similar Trials