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Completed

NCT Number: NCT06066320

A Comparison of Acute Psychobiological Responses to Laboratory Stress Tests

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.

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Key information

Conditions

Stress, Physiological Behavior Behavioral Symptoms Stress, Psychological

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Science, Liverpool John Moores University

Liverpool, Merseyside, L3 3AF, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MMST

Behavioral

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

TSST

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Registry information

Official study title

A Comparison of Acute Psychobiological Responses to the Mannheim Multicomponent Stress Test and the Trier Social Stress Test

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 4, 2023
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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