A Comparison of Acute Psychobiological Responses to Laboratory Stress Tests

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06066320
• Other study ID #: ORION study 1B
• Status: Completed
• Phase: N/A
• Start date: April 26, 2023
• Est. completion date: October 9, 2023

Study information

• Verified date: September 2023
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 9, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress, Physiological
• Stress, Psychological

Intervention

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
• 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.

Locations

Country	Name	City	State
United Kingdom	Faculty of Science, Liverpool John Moores University	Liverpool	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool John Moores University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	State anxiety inventory (STAI-S) response to acute psychological stress	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.
Secondary	Heart rate	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
Secondary	Salivary alpha amylase (sAA)	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