- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06066320
A Comparison of Acute Psychobiological Responses to Laboratory Stress Tests
A Comparison of Acute Psychobiological Responses to the Mannheim Multicomponent Stress Test and the Trier Social Stress Test
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Merseyside
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Liverpool, Merseyside, United Kingdom, L3 3AF
- Faculty of Science, Liverpool John Moores University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MMST
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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
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Active Comparator: TSST
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in saliva cortisol (pre-post stress)
Time Frame: Change from 5 minutes pre to peak post stress test (MMST or TSST)
|
Changes in the concentration of saliva free cortisol assessed by ELISA.
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Change from 5 minutes pre to peak post stress test (MMST or TSST)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: Continuously assessed from 30 minutes before to 60 minutes after the stress tests and control tests
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Continuous measurement of heart rate will be assessed using a telemetric chest strap.
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Continuously assessed from 30 minutes before to 60 minutes after the stress tests and control tests
|
|
State anxiety inventory (STAI-S) response to acute psychological stress
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.
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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)
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Change from 5 minutes pre to after stress challenge (immediately after acute psychological stress and 60 minutes after the test) will be compared.
|
|
Salivary alpha amylase (sAA)
Time Frame: Change from 5 minutes pre to immediately post stress test
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a biomarker for stress-induced activity of the sympathetic nervous system (SNS), assessed by ELISA.
|
Change from 5 minutes pre to immediately post stress test
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Neil P Walsh, PHD, Liverpool John Moores University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORION study 1B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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