Assessing the Repeatability of a Psychological Stress Test

Stress, Psychological Clinical Trial

Official title:

Assessing the Efficacy and Repeatability of the Mannheim Multicomponent Stress Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714450
• Other study ID #: ORION Study 1A
• Status: Completed
• Phase: N/A
• Start date: April 23, 2021
• Est. completion date: July 19, 2023

Study information

• Verified date: October 2023
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 19, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Stress, Physiological
• Stress, Psychological

Intervention

Behavioral:
• Experimental: MMST+
The format of the MMST will remain the same; however, the white noise, images and math task will be modified to mitigate habituation effects.

Locations

Country	Name	City	State
United Kingdom	Faculty of Science, Liverpool John Moores University	Liverpool	Merseyside

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool John Moores University	Danone Nutricia Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Saliva cortisol awakening response (CAR)	A biomarker for Hypothalamic Pituitary Adrenal activity; a naturally occurring increase in cortisol upon waking, assessed by ELISA.	Assessing upon awakening, and every 15 minutes for the first 45 minutes after awakening (i.e. +15, +30, +45, +60 minutes after awakening)
Other	Salivary alpha amylase (sAA)	a biomarker for stress-induced activity of the sympathetic nervous system (SNS), assessed by ELISA.	Change from 5 minutes pre to immediately post stress test/no stress control condition
Primary	Change in saliva cortisol (pre-post MMST)	Changes in the concentration of saliva free cortisol assessed by ELISA.	Change from 5 minutes pre to peak post stress test/no stress control condition
Primary	Change in subjective stress response (Subjective stress scale) (0-9 Likert scale)	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.	Change from 5 minutes pre to immediately post stress test/no stress control condition
Primary	Heart rate	Continuous measurement of heart rate will be assessed using a telemetric chest strap.	Continuously assessed from 30 minutes before to 60 minutes after the stress tests and control tests
Secondary	Change in emotional response to stress	Questionnaire used to determine the extent to which participants felt the MMST was difficult, challenging, and upsetting. Using a 7-pt scale (1 = not at all; 7 = extremely) participants rate their level of nervousness during the laboratory task. Participants will also rate the level of effort they put into the task on a scale ranging from 1 (didn't try at all) to 7 (tried as hard as I could), which will be used as a manipulation check.	Change from 5 minutes pre to immediately post stress test/no stress control condition
Secondary	Rumination measure	Questionnaire used to determine the extent of rumination about an induced stressful situation. Using a 7-pt scale (1= not at all, 7 = all the time), participants indicate the extent to which they; thought about the test (stress test and control) after having completed it, criticised themselves about not performing well, thought about other past experiences of being evaluated, thought about the anxiety they felt during the task.	Assessed +60 minutes after the stress tests and no stress control condition