A Comparison of Acute Psychobiological Responses to Laboratory Stress Tests

NCT06066320 | Completed

• 1 other identifier: ORION study 1B
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Physiological; Stress, Psychological

Outcome Measures

Primary Outcomes (1)

• Change in saliva cortisol (pre-post stress)

  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 Outcomes (3)

• State anxiety inventory (STAI-S) response to acute psychological stress

  Change from 5 minutes pre to after stress challenge (immediately after acute psychological stress and 60 minutes after the test) will be compared.

• Heart rate

  Continuously assessed from 30 minutes before to 60 minutes after the stress tests and control tests

• Salivary alpha amylase (sAA)

  Change from 5 minutes pre to immediately post stress test

Study Arms (2)

MMST

EXPERIMENTAL

Behavioral: MMST

TSST

ACTIVE COMPARATOR

Behavioral: TSST

Interventions

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

MMST

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.

TSST

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool John Moores University: lead

Study Sites (1)

Faculty of Science, Liverpool John Moores University

Liverpool, Merseyside, L3 3AF, United Kingdom

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Neil P Walsh, PHD

  Liverpool John Moores University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of the true nature of experimental trials until a final debrief scheduled after acute stress exposure.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Officer

Model Details: 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).

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: April 26, 2023
• Primary Completion: July 14, 2023
• Study Completion: October 9, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)