A Comparison of Acute Psychobiological Responses to Laboratory Stress Tests

Study Overview
=================
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.

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

Conditions
-----------------
Stress, Physiological, Stress, Psychological

Intervention / Treatment
-----------------
* Behavioral: MMST
* Behavioral: TSST


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMST<br> | Behavioral: MMST<br>* 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<br>|
| Active Comparator: TSST<br> | Behavioral: TSST<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 
| 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 |