Real-Time Assessment of Stress and Stress Response
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Cortisol
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Cortisol
时间窗: Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention
Saliva Cortisol Concentration
Subjective Stress
时间窗: Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention
Stress Questionnaire
次要结局
- Psychopathological Assessement(1 day)
- Psychiatric Diagnosis(1 day)
研究者
Stephan T. Egger
Senior Psychiatrists
Psychiatric University Hospital, Zurich