Real-Time Assessment of Stress and Stress Response

Not Applicable

Recruiting

• Conditions: Stress Reaction; Psychiatric Disorder; Stress, Psychological; Stress, Physiological
• Interventions: Behavioral: Trier Social Stress Test

• Registration Number: NCT04100213
• Lead Sponsor: Psychiatric University Hospital, Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-24
• Status Verified: 2023-11
• Study Start: 2023-11-01
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TSST	Trier Social Stress Test	-

Primary Outcome Measures

Name	Time	Method
Cortisol	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	Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention	Stress Questionnaire

Secondary Outcome Measures

Name	Time	Method
Psychopathological Assessement	1 day	Symptom Questionnaire
Psychiatric Diagnosis	1 day	Structured psychiatric Interview

Trial Locations

Locations (1)

Psychiatrische Universitätsklinik Zürich; 🇨🇭 Zürich, Switzerland