Real-Time Assessment of Stress and Stress Response

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 Overview

• Status: Recruiting
• Conditions: Stress, Psychological; Stress, Physiological; Psychiatric Disorder; Stress Reaction
• Intervention / Treatment: Behavioral: Trier Social Stress Test

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephan T. Egger, MD; Phone Number: +41523049340; Email: stephan.egger@puk.zh.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8032
    • Recruiting
    • Psychiatrische Universitätsklinik Zürich
    • Contact: Stephan T Egger, MD; Phone Number: +4152304940; Email: stephan.egger@puk.zh.ch
    • Contact: Godehard Weniger, MD; Phone Number: +41523049341; Email: godehard.weniger@puk.zh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TSST

Behavioral: Trier 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.; Other Names: TSST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol	Saliva Cortisol Concentration	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	Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychopathological Assessement	Symptom Questionnaire	1 day
Psychiatric Diagnosis	Structured psychiatric Interview	1 day

Collaborators and Investigators

• Sponsor: Psychiatric University Hospital, Zurich

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Stress, Stress Reaction, Trier Social Stress Test, Digital Phenotyping
• Additional Relevant MeSH Terms: Behavioral Symptoms; Fractures, Bone; Wounds and Injuries; Problem Behavior; Stress, Psychological; Mental Disorders; Fractures, Stress
• Other Study ID Numbers: mHealth TSST-G

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No