Clinical trial NCT04100213: Real-Time Assessment of Stress and Stress Response
Official title: Real-Time Assessment of Stress and Stress Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychiatric Disorder
Stress Reaction
Stress, Psychological
Stress, Physiological
Keywords: Stress, Stress Reaction, Trier Social Stress Test, Digital Phenotyping
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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.

Primary outcomes:
measure: Cortisol
timeFrame: Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention
measure: Subjective Stress
timeFrame: Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention
Secondary outcomes:
measure: Psychopathological Assessement
timeFrame: 1 day
measure: Psychiatric Diagnosis
timeFrame: 1 day
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Psychiatrische Universitätsklinik Zürich
Study officials:
References:
citation: 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.