Assessing the Repeatability of a Psychological Stress Test
Primary Purpose
Stress, Physiological, Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Experimental: MMST+
Sponsored by
About this trial
This is an interventional basic science trial for Stress, Physiological
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
Sites / Locations
- Faculty of Science, Liverpool John Moores University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
MMST control
MMST+
Arm Description
Outcomes
Primary Outcome Measures
Change in saliva cortisol (pre-post MMST)
Changes in the concentration of saliva free cortisol assessed by ELISA.
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.
Heart rate
Continuous measurement of heart rate will be assessed using a telemetric chest strap.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04714450
First Posted
January 12, 2021
Last Updated
October 5, 2023
Sponsor
Liverpool John Moores University
Collaborators
Danone Nutricia Research
1. Study Identification
Unique Protocol Identification Number
NCT04714450
Brief Title
Assessing the Repeatability of a Psychological Stress Test
Official Title
Assessing the Efficacy and Repeatability of the Mannheim Multicomponent Stress Test
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 23, 2021 (Actual)
Primary Completion Date
July 19, 2023 (Actual)
Study Completion Date
July 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liverpool John Moores University
Collaborators
Danone Nutricia Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Physiological, Stress, Psychological
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Saliva samples will be identified by participant identification number only. Technicians assessing levels of biological measures in these samples will be blind to condition.
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MMST control
Arm Type
No Intervention
Arm Title
MMST+
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Experimental: MMST+
Intervention Description
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 Outcome Measure Information:
Title
Change in saliva cortisol (pre-post MMST)
Description
Changes in the concentration of saliva free cortisol assessed by ELISA.
Time Frame
Change from 5 minutes pre to peak post stress test/no stress control condition
Title
Change in subjective stress response (Subjective stress scale) (0-9 Likert scale)
Description
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.
Time Frame
Change from 5 minutes pre to immediately post stress test/no stress control condition
Title
Heart rate
Description
Continuous measurement of heart rate will be assessed using a telemetric chest strap.
Time Frame
Continuously assessed from 30 minutes before to 60 minutes after the stress tests and control tests
Secondary Outcome Measure Information:
Title
Change in emotional response to stress
Description
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.
Time Frame
Change from 5 minutes pre to immediately post stress test/no stress control condition
Title
Rumination measure
Description
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.
Time Frame
Assessed +60 minutes after the stress tests and no stress control condition
Other Pre-specified Outcome Measures:
Title
Saliva cortisol awakening response (CAR)
Description
A biomarker for Hypothalamic Pituitary Adrenal activity; a naturally occurring increase in cortisol upon waking, assessed by ELISA.
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)
Title
Salivary alpha amylase (sAA)
Description
a biomarker for stress-induced activity of the sympathetic nervous system (SNS), assessed by ELISA.
Time Frame
Change from 5 minutes pre to immediately post stress test/no stress control condition
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil P Walsh, PHD
Organizational Affiliation
Liverpool John Moores University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Science, Liverpool John Moores University
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L3 3AF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessing the Repeatability of a Psychological Stress Test
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