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Real-Time Assessment of Stress and Stress Response

P

Psychiatric University Hospital, Zurich

Status

Withdrawn

Conditions

Stress Reaction
Psychiatric Disorder
Stress, Physiological
Stress, Psychological

Treatments

Behavioral: Trier Social Stress Test

Study type

Interventional

Funder types

Other

Identifiers

NCT04100213
mHealth TSST-G

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

TSST
Experimental group
Treatment:
Behavioral: Trier Social Stress Test

Trial contacts and locations

1

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Central trial contact

Stephan T. Egger, MD

Data sourced from clinicaltrials.gov

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