Real-Time Assessment of Stress and Stress Response

NCT ID: NCT04100213

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2025-12-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

TSST

Group Type: EXPERIMENTAL

Trier Social Stress Test

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

TSST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Psychiatric University Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Stephan T. Egger

Senior Psychiatrists

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Psychiatrische Universitätsklinik Zürich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 34713030 (View on PubMed)

Other Identifiers

mHealth TSST-G

Identifier Type: -

Identifier Source: org_study_id