Clinical trial NCT06066320: A Comparison of Acute Psychobiological Responses to Laboratory Stress Tests
Official title: A Comparison of Acute Psychobiological Responses to the Mannheim Multicomponent Stress Test and the Trier Social Stress Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Physiological
Stress, Psychological
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 31
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: Between subjects design to compare psychobiological responses in participants randomised to either the MMST or the TSST. Stratified block randomisation will be used to evenly distribute participants to the MMS or the TSST based upon sex (male or female) and trait anxiety (low STAI-T score \<40 or high STAI-T score ≥40).
Primary purpose: BASIC_SCIENCE

Brief summary: The Mannheim Multicomponent Stress Test (MMST) is a validated laboratory stress test that combines cognitive, emotional, acoustic and motivational stress components. However the utility of the MMST as a viable alternative to the more commonly used Trier social stress test (TSST) to elicit HPA reactivity remains unclear as meaningful increases in saliva cortisol (\> 2.5 nmol/l) have been shown to occur in \<50% of participants yet the TSST typically elicits meaningful increases in saliva cortisol in \>70% of participants; likely as a consequence of the greater social evaluative component in the TSST.

Using a randomised between groups design, this study aims to compare psychobiological responses to the MMST and TSST.


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
* are willing to provide saliva samples throughout 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 (excluding females taking oral combined contraception
* 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
* 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
* Endurance trained or engage in ≥3.5 hours of physical activity a week

Primary outcomes:
measure: Change in saliva cortisol (pre-post stress)
timeFrame: Change from 5 minutes pre to peak post stress test (MMST or TSST)
Secondary outcomes:
measure: State anxiety inventory (STAI-S) response to acute psychological stress
timeFrame: Change from 5 minutes pre to after stress challenge (immediately after acute psychological stress and 60 minutes after the test) will be compared.
measure: Heart rate
timeFrame: Continuously assessed from 30 minutes before to 60 minutes after the stress tests and control tests
measure: Salivary alpha amylase (sAA)
timeFrame: Change from 5 minutes pre to immediately post stress test
Other outcomes:
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: