A Comparison of Acute Psychobiological Responses to Laboratory Stress Tests

NCT ID: NCT06066320

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-26

Study Completion Date

2023-10-09

Brief Summary

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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.

Detailed Description

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Conditions

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Stress, Physiological Stress, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants will be unaware of the true nature of experimental trials until a final debrief scheduled after acute stress exposure.

Study Groups

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MMST

Group Type EXPERIMENTAL

MMST

Intervention Type 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

Group Type ACTIVE_COMPARATOR

TSST

Intervention Type 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.

Interventions

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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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liverpool John Moores University

OTHER

Sponsor Role lead

Responsible Party

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Daniel Kashi

Postdoctoral Research Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neil P Walsh, PHD

Role: PRINCIPAL_INVESTIGATOR

Liverpool John Moores University

Locations

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Faculty of Science, Liverpool John Moores University

Liverpool, Merseyside, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ORION study 1B

Identifier Type: -

Identifier Source: org_study_id

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