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Completed

NCT Number: NCT04714450

Assessing the Repeatability of a Psychological Stress Test

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.

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Key information

Conditions

Stress, Physiological Behavior Behavioral Symptoms Stress, Psychological

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Science, Liverpool John Moores University

Liverpool, Merseyside, L3 3AF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: MMST+

Behavioral

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

Primary outcomes

  1. Change in saliva cortisol (pre-post MMST)

    Time frame: 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.

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

    Time frame: 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.

  3. Heart rate

    Time frame: 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.

Secondary outcomes

  1. Change in emotional response to stress

    Time frame: Change from 5 minutes pre to immediately post stress test/no stress control condition

    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.

  2. Rumination measure

    Time frame: Assessed +60 minutes after the stress tests and no stress control condition

    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.

Other outcomes

  1. Saliva cortisol awakening response (CAR)

    Time frame: Assessing upon awakening, and every 15 minutes for the first 45 minutes after awakening (i.e. +15, +30, +45, +60 minutes after awakening)

    A biomarker for Hypothalamic Pituitary Adrenal activity; a naturally occurring increase in cortisol upon waking, assessed by ELISA.

  2. Salivary alpha amylase (sAA)

    Time frame: Change from 5 minutes pre to immediately post stress test/no stress control condition

    a biomarker for stress-induced activity of the sympathetic nervous system (SNS), assessed by ELISA.

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Collaborators

  • Danone Nutricia Research

Registry information

Official study title

Assessing the Efficacy and Repeatability of the Mannheim Multicomponent Stress Test

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2021
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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