A Comparison of Acute Psychobiological Responses to Laboratory Stress Tests

Sponsor

Liverpool John Moores University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06066320

Collaborator

(none)

Enrollment

Location

Arms

5.5

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress, Physiological Stress, Psychological	Behavioral: MMST Behavioral: TSST	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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).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).

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Apr 26, 2023

Actual Primary Completion Date :

Jul 14, 2023

Anticipated Study Completion Date :

Oct 9, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MMST	Behavioral: 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	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.

Arm

Intervention/Treatment

Experimental: MMST

Behavioral: 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

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.

Outcome Measures

Primary Outcome Measures

Change in saliva cortisol (pre-post stress) [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 Outcome Measures

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.]
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)
Heart rate [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.
Salivary alpha amylase (sAA) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Science, Liverpool John Moores University	Liverpool	Merseyside	United Kingdom	L3 3AF

Sponsors and Collaborators

Liverpool John Moores University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daniel Kashi, Postdoctoral Research Officer, Liverpool John Moores University

ClinicalTrials.gov Identifier:

NCT06066320

Other Study ID Numbers:

ORION study 1B

First Posted:

Oct 4, 2023

Last Update Posted:

Oct 4, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stress, Psychological

Study Results

No Results Posted as of Oct 4, 2023