Real-Time Assessment of Stress and Stress Response

Study Overview
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Brief Summary
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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.

Official Title
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Real-Time Assessment of Stress and Stress Response

Conditions
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Psychiatric Disorder, Stress Reaction, Stress, Psychological, Stress, Physiological

Intervention / Treatment
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* Behavioral: Trier Social Stress Test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TSST<br> | Behavioral: Trier Social Stress Test<br>* 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.<br>* Other names: TSST;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Stress Reaction, Trier Social Stress Test, Digital Phenotyping