A Comparison of Acute Psychobiological Responses to Laboratory Stress Tests

October 24, 2023 updated by: Daniel Kashi, Liverpool John Moores University

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

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L3 3AF
        • Faculty of Science, Liverpool John Moores University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
Active Comparator: TSST
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.

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.
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
Continuous measurement of heart rate will be assessed using a telemetric chest strap.
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.
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)
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Neil P Walsh, PHD, Liverpool John Moores University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2023

Primary Completion (Actual)

July 14, 2023

Study Completion (Actual)

October 9, 2023

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

September 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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