Back to resultsA Comparison of Acute Psychobiological Responses to Laboratory Stress Tests
Primary Purpose
Stress, Physiological, Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MMST
TSST
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 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
Sites / Locations
- Faculty of Science, Liverpool John Moores University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MMST
TSST
Arm Description
Outcomes
Primary Outcome Measures
Change in saliva cortisol (pre-post stress)
Changes in the concentration of saliva free cortisol assessed by ELISA.
Secondary Outcome Measures
State anxiety inventory (STAI-S) response to acute psychological stress
assessed using the state scale of the state trait anxiety inventory (STAI-S), consisting of a 20-item scale for measuring the intensity of anxiety as an emotional state (S-Anxiety). The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80)
Heart rate
Continuous measurement of heart rate will be assessed using a telemetric chest strap.
Salivary alpha amylase (sAA)
a biomarker for stress-induced activity of the sympathetic nervous system (SNS), assessed by ELISA.
Full Information
NCT ID
NCT06066320
First Posted
September 27, 2023
Last Updated
October 24, 2023
Sponsor
Liverpool John Moores University
1. Study Identification
Unique Protocol Identification Number
NCT06066320
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
July 14, 2023 (Actual)
Study Completion Date
October 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liverpool John Moores University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
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).
Masking
Participant
Masking Description
Participants will be unaware of the true nature of experimental trials until a final debrief scheduled after acute stress exposure.
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MMST
Arm Type
Experimental
Arm Title
TSST
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
MMST
Intervention Description
Participants randomised to the MMST group will complete the computer based paced auditory serial addition task (PASAT-C) in the presence of one observer and is informed that incorrect answers result in reduced monetary compensation. Simultaneously, the participant is exposed to emotionally evocative images and white noise via headphones
Intervention Type
Behavioral
Intervention Name(s)
TSST
Intervention Description
Participants randomly assigned to the TSST condition will be exposed to a traditional TSST protocol. The TSST consists of a preparation phase (5 min), followed by a mock job interview and a mental arithmetic task (5 min each) in front of a panel consisting of two observers and a video recording device.
Primary Outcome Measure Information:
Title
Change in saliva cortisol (pre-post stress)
Description
Changes in the concentration of saliva free cortisol assessed by ELISA.
Time Frame
Change from 5 minutes pre to peak post stress test (MMST or TSST)
Secondary Outcome Measure Information:
Title
State anxiety inventory (STAI-S) response to acute psychological stress
Description
assessed using the state scale of the state trait anxiety inventory (STAI-S), consisting of a 20-item scale for measuring the intensity of anxiety as an emotional state (S-Anxiety). The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80)
Time Frame
Change from 5 minutes pre to after stress challenge (immediately after acute psychological stress and 60 minutes after the test) will be compared.
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
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
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
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
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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A Comparison of Acute Psychobiological Responses to Laboratory Stress Tests
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