Real-Time Assessment of Stress and Stress Response

NCT04100213 | Withdrawn

• 1 other identifier: mHealth TSST-G
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Psychopathological Assessement

  1 day

• Psychiatric Diagnosis

  1 day

Study Arms (1)

TSST

EXPERIMENTAL

Behavioral: Trier Social Stress Test

Interventions

Trier Social Stress Test 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.

Also known as: TSST

TSST

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Psychiatric University Hospital, Zurich: lead

Study Sites (1)

Psychiatrische Universitätsklinik Zürich

Zurich, Canton of Zurich, 8032, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34713030 DERIVED

MeSH Terms

Conditions

Mental Disorders; Fractures, Stress; Stress, Psychological

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Psychiatrists

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 24, 2019
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)