Clinical trial NCT04714450: Assessing the Repeatability of a Psychological Stress Test
Official title: Assessing the Efficacy and Repeatability of the Mannheim Multicomponent Stress Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Physiological
Stress, Psychological
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Danone Nutricia Research
First posted: 2021-01-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators propose a parallel experimental trial examining physiological and psychological responses to a socio-evaluative stress task (The Mannheim Multicomponent Stress Test; MMST) under laboratory conditions. Participants will be tested on three occasions in a randomised order, with each trial separated by 7 days. On two occasions, participants will be complete a socially evaluated math-based serial addition task whilst simultaneously viewing a series of positive and negative images and in the presence of white noise (duration \~ 5 minutes). On the other occasion, participants will rest quietly and will be exposed to a short film and some images that are not designed to induce anxiety or stress for the same duration as the stress test in the stress induction room. The non-stress control condition, will occur either 1-week preceding or 1-week following both MMST trials, thereby controlling for order effects influencing baseline physiological and psychological outcome measures.
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in saliva cortisol (pre-post MMST)
timeFrame: Change from 5 minutes pre to peak post stress test/no stress control condition
measure: Change in subjective stress response (Subjective stress scale) (0-9 Likert scale)
timeFrame: Change from 5 minutes pre to immediately post stress test/no stress control condition
measure: Heart rate
timeFrame: Continuously assessed from 30 minutes before to 60 minutes after the stress tests and control tests
Secondary outcomes:
measure: Change in emotional response to stress
timeFrame: Change from 5 minutes pre to immediately post stress test/no stress control condition
measure: Rumination measure
timeFrame: Assessed +60 minutes after the stress tests and no stress control condition
Other outcomes:
measure: Saliva cortisol awakening response (CAR)
timeFrame: Assessing upon awakening, and every 15 minutes for the first 45 minutes after awakening (i.e. +15, +30, +45, +60 minutes after awakening)
measure: Salivary alpha amylase (sAA)
timeFrame: Change from 5 minutes pre to immediately post stress test/no stress control condition
Locations:
city: Liverpool
country: United Kingdom
facility: Faculty of Science, Liverpool John Moores University
state: Merseyside
Study officials:
affiliation: Liverpool John Moores University
name: Neil P Walsh, PHD
role: PRINCIPAL_INVESTIGATOR
References: