Stress, PhysiologicalNCT06066320
A Comparison of Acute Psychobiological Responses to Laboratory Stress Tests
A study testing MMST and TSST in people with Stress, Physiological and Stress, Psychological, run by Liverpool John Moores University at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Physiological, Stress, Psychological
- What is being tested?
- MMST and TSST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Apr 2023to 9 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Faculty of Science, Liverpool John Moores University
Liverpool, Merseyside, L3 3AF
About this study
Official title: A Comparison of Acute Psychobiological Responses to the Mannheim Multicomponent Stress Test and the Trier Social Stress Test
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
- Being tested
- MMST, TSST
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMSTBehavioural
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
TSSTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MMST | Experimental | Not described Receives: Behavioral: MMST |
| TSST | Active comparator | Not described Receives: Behavioral: TSST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in saliva cortisol (pre-post stress)
Changes in the concentration of saliva free cortisol assessed by ELISA.
Measured: 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
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)
Measured: 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.
Measured: 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.
Measured: Change from 5 minutes pre to immediately post stress test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start26 Apr 2023
- Primary completion14 Jul 2023
- Study completion9 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PhysiologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Kashi, Liverpool John Moores University
- Investigators
- Neil P Walsh, PHD, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066320
- Sponsor's protocol ID
- ORION study 1B
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Acute Psychobiological Responses to the Mannheim Multicomponent Stress Test and the Trier Social Stress Test
- ClinicalTrials.gov ID
- NCT06066320
- Acronym / sponsor ID
- ORION study 1B
- Conditions
- Stress, Physiological, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| MMST | Experimental | Behavioral: MMST |
| TSST | Active comparator | Behavioral: TSST |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMSTParticipants 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 | Behavioural | MMST |
| TSSTParticipants 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. | Behavioural | TSST |
Primary outcome
Change in saliva cortisol (pre-post stress)
Time frame: Change from 5 minutes pre to peak post stress test (MMST or TSST)
Changes in the concentration of saliva free cortisol assessed by ELISA.
3 secondary outcomes
State anxiety inventory (STAI-S) response to acute psychological stress
Time frame: 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
Time frame: Continuously assessed from 30 minutes before to 60 minutes after the stress tests and control tests
Salivary alpha amylase (sAA)
Time frame: Change from 5 minutes pre to immediately post stress test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil P Walsh, PHD principal investigator
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMST and TSST in people with Stress, Physiological and Stress, Psychological, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in saliva cortisol (pre-post stress) (time frame: Change from 5 minutes pre to peak post stress test (MMST or TSST)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.