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临床试验/NCT04714450
NCT04714450已完成不适用

Assessing the Efficacy and Repeatability of the Mannheim Multicomponent Stress Test

Liverpool John Moores University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年4月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Change in subjective stress response (Subjective stress scale) (0-9 Likert scale)

研究概览

简要总结

To establish the efficacy and repeatability of a suitable psychological stress test. The Mannheim Multicomponent Stress Test (MMST) is a validated laboratory stress test that combines cognitive, emotional, acoustic and motivational stress components. Despite the test increasing self-reported levels of stress, meaningful changes in saliva cortisol are typically observed in only half of all participants. In addition, the MMST is susceptible to habituation of the cortisol response upon repeated exposures, limiting its current usefulness for repeated measures. Given the multicomponent nature of the MMST, there is potential for components of the test to be manipulated to overcome these limitations i.e., increase the magnitude of the saliva cortisol response and mitigate against habituation effects. In addition, a supplementary topic of interest is to what extent cortisol responses to acute laboratory stress tests, like the MMST, relate to the well described rise in morning cortisol ~30 minutes after awakening. This may be of clinical relevance given that blunted cortisol response upon awakening and in response to acute psychological stress tests have been associated with poor health outcomes.

The primary objective of the current study is to investigate if the MMST elicits a meaningful increase in saliva cortisol.

The secondary objective is to investigate the efficacy of mitigation strategies to overcome habituation to the MMST.

A supplementary objective is to to investigate the relationship between the saliva cortisol response upon awakening and the saliva cortisol response to the MMST.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

Saliva samples will be identified by participant identification number only. Technicians assessing levels of biological measures in these samples will be blind to condition.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Participants who...
  • •have read and signed the study informed consent
  • •are healthy, recreationally active men and women aged 18-35 years
  • •test negative for coronavirus (COVID-19)
  • •are willing to provide saliva samples throughout and complete the MMST through the duration of the study
  • •are using monophasic birth control (women only)

排除标准

  • •Participants who...
  • •have a recent history or are a current smoker
  • •are currently taking prescription/Over-the-counter medication
  • •consume ≥ 91 units of alcohol per month
  • •have a clinically diagnosed history of cardiovascular and/or metabolic disease including diabetes and abnormal blood pressure
  • •are pregnant
  • •have a recent or ongoing viral or bacterial illness in past 4 weeks
  • •test positive for coronavirus (COVID-19)
  • •have a clinically diagnosed psychiatric disorder
  • •have a clinically diagnosed sleeping disorder
  • •have a clinically diagnosed gambling addiction
  • •BMI ≥ 30 kg/m2 - calculated in the online health screening questionnaire
  • •report unusually high levels of recent or ongoing life stress over the last month; as assessed by the perceived stress scale (PSS) i.e. rating ≥ 13 indicates high perception of recent and ongoing life stress
  • •Endurance trained or engage in ≥3.5 hours of physical activity a week

研究组 & 干预措施

MMST control

No Intervention

MMST+

Experimental

干预措施: Experimental: MMST+ (Behavioral)

结局指标

主要结局

Change in subjective stress response (Subjective stress scale) (0-9 Likert scale)

时间窗: Change from 5 minutes pre to immediately post stress test/no stress control condition

Questionnaire comprised of a 10-point rating scale from 0 to 9 (0 - no subjective stress experience at all; 9 - extreme experience of subjective stress experience.

Heart rate

时间窗: Continuously assessed from 30 minutes before to 60 minutes after the stress tests and control tests

Continuous measurement of heart rate will be assessed using a telemetric chest strap.

Change in saliva cortisol (pre-post MMST)

时间窗: Change from 5 minutes pre to peak post stress test/no stress control condition

Changes in the concentration of saliva free cortisol assessed by ELISA.

次要结局

  • Rumination measure(Assessed +60 minutes after the stress tests and no stress control condition)
  • Change in emotional response to stress(Change from 5 minutes pre to immediately post stress test/no stress control condition)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Kashi

Doctor

Liverpool John Moores University

研究点 (1)

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