Stress, PhysiologicalNCT04714450
Assessing the Repeatability of a Psychological Stress Test
A study testing Experimental: MMST+ in people with Stress, Physiological and Stress, Psychological, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
To establish the efficacy and repeatability of a suitable psychological stress test. The Mannheim Multicomponent Stress Test (MMST) is a validated laboratory stress test that combines cognitive, emotional, acoustic and motivational stress components. 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?
- Experimental: MMST+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Apr 2021to 19 Jul 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
- test negative for coronavirus (COVID-19)
- are willing to provide saliva samples throughout and complete the MMST 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
- 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 14Show fewer
- have a recent or ongoing viral or bacterial illness in past 4 weeks
- test positive for coronavirus (COVID-19)
- 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
- report unusually high levels of recent or ongoing life stress over the last month; as assessed by the perceived stress scale (PSS) i.e. rating ≥ 13 indicates high perception of recent and ongoing life stress
- 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: Assessing the Efficacy and Repeatability of the Mannheim Multicomponent Stress Test
To establish the efficacy and repeatability of a suitable psychological stress test. The Mannheim Multicomponent Stress Test (MMST) is a validated laboratory stress test that combines cognitive, emotional, acoustic and motivational stress components. Despite the test increasing self-reported levels of stress, meaningful changes in saliva cortisol are typically observed in only half of all participants. In addition, the MMST is susceptible to habituation of the cortisol response upon repeated exposures, limiting its current usefulness for repeated measures. Given the multicomponent nature of the MMST, there is potential for components of the test to be manipulated to overcome these limitations i.e., increase the magnitude of the saliva cortisol response and mitigate against habituation effects. In addition, a supplementary topic of interest is to what extent cortisol responses to acute laboratory stress tests, like the MMST, relate to the well described rise in morning cortisol ~30 minutes after awakening. This may be of clinical relevance given that blunted cortisol response upon awakening and in response to acute psychological stress tests have been associated with poor health outcomes.
The primary objective of the current study is to investigate if the MMST elicits a meaningful increase in saliva cortisol.
Read more
The secondary objective is to investigate the efficacy of mitigation strategies to overcome habituation to the MMST.
A supplementary objective is to to investigate the relationship between the saliva cortisol response upon awakening and the saliva cortisol response to the MMST.
- Conditions
- Stress, Physiological, Stress, Psychological
- Being tested
- Experimental: MMST+
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: MMST+Behavioural
The format of the MMST will remain the same; however, the white noise, images and math task will be modified to mitigate habituation effects.
| Study group | Role | What they receive |
|---|---|---|
| MMST control | No intervention | Not described |
| MMST+ | Experimental | Not described Receives: Behavioral: Experimental: MMST+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in saliva cortisol (pre-post MMST)
Changes in the concentration of saliva free cortisol assessed by ELISA.
Measured: Change from 5 minutes pre to peak post stress test/no stress control condition
Change in subjective stress response (Subjective stress scale) (0-9 Likert scale)
Questionnaire comprised of a 10-point rating scale from 0 to 9 (0 - no subjective stress experience at all; 9 - extreme experience of subjective stress experience.
Measured: Change from 5 minutes pre to immediately post stress test/no stress control condition
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
Secondary outcomes (2)
Change in emotional response to stress
Questionnaire used to determine the extent to which participants felt the MMST was difficult, challenging, and upsetting. Using a 7-pt scale (1 = not at all; 7 = extremely) participants rate their level of nervousness during the laboratory task. Participants will also rate the level of effort they put into the task on a scale ranging from 1 (didn't try at all) to 7 (tried as hard as I could), which will be used as a manipulation check.
Measured: Change from 5 minutes pre to immediately post stress test/no stress control condition
Rumination measure
Questionnaire used to determine the extent of rumination about an induced stressful situation. Using a 7-pt scale (1= not at all, 7 = all the time), participants indicate the extent to which they; thought about the test (stress test and control) after having completed it, criticised themselves about not performing well, thought about other past experiences of being evaluated, thought about the anxiety they felt during the task.
Measured: Assessed +60 minutes after the stress tests and no stress control condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start23 Apr 2021
- Primary completion19 Jul 2023
- Study completion19 Jul 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
- The investigators propose a parallel experimental trial examining physiological and psychological responses to a socio-evaluative stress task (The Mannheim Multicomponent Stress Test; MMST) under laboratory conditions. Participants will be tested on three occasions in a randomised order, with each trial separated by 7 days. On two occasions, participants will be complete a socially evaluated math-based serial addition task whilst simultaneously viewing a series of positive and negative images and in the presence of white noise (duration \~ 5 minutes). On the other occasion, participants will rest quietly and will be exposed to a short film and some images that are not designed to induce anxiety or stress for the same duration as the stress test in the stress induction room. The non-stress control condition, will occur either 1-week preceding or 1-week following both MMST trials, thereby controlling for order effects influencing baseline physiological and psychological outcome measures.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Nutricia Research
- 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
- NCT04714450
- Sponsor's protocol ID
- ORION Study 1A
- Status last verified
- Oct 2023
- First submitted
- 12 Jan 2021
- Last updated
- 6 Oct 2023
- Results posted
- 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 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy and Repeatability of the Mannheim Multicomponent Stress Test
- ClinicalTrials.gov ID
- NCT04714450
- Acronym / sponsor ID
- ORION Study 1A
- Conditions
- Stress, Physiological, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Danone Nutricia Research
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 19 Jan 2021 (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.
To establish the efficacy and repeatability of a suitable psychological stress test. The Mannheim Multicomponent Stress Test (MMST) is a validated laboratory stress test that combines cognitive, emotional, acoustic and motivational stress components. Despite the test increasing self-reported levels of stress, meaningful changes in saliva cortisol are typically observed in only half of all participants. In addition, the MMST is susceptible to habituation of the cortisol response upon repeated exposures, limiting its current usefulness for repeated measures. Given the multicomponent nature of the MMST, there is potential for components of the test to be manipulated to overcome these limitations i.e., increase the magnitude of the saliva cortisol response and mitigate against habituation effects. In addition, a supplementary topic of interest is to what extent cortisol responses to acute laboratory stress tests, like the MMST, relate to the well described rise in morning cortisol ~30 minutes after awakening. This may be of clinical relevance given that blunted cortisol response upon awakening and in response to acute psychological stress tests have been associated with poor health outcomes.
The primary objective of the current study is to investigate if the MMST elicits a meaningful increase in saliva cortisol.
The secondary objective is to investigate the efficacy of mitigation strategies to overcome habituation to the MMST.
A supplementary objective is to to investigate the relationship between the saliva cortisol response upon awakening and the saliva cortisol response to the MMST.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators propose a parallel experimental trial examining physiological and psychological responses to a socio-evaluative stress task (The Mannheim Multicomponent Stress Test; MMST) under laboratory conditions. Participants will be tested on three occasions in a randomised order, with each trial separated by 7 days. On two occasions, participants will be complete a socially evaluated math-based serial addition task whilst simultaneously viewing a series of positive and negative images and in the presence of white noise (duration ~ 5 minutes). On the other occasion, participants will rest quietly and will be exposed to a short film and some images that are not designed to induce anxiety or stress for the same duration as the stress test in the stress induction room. The non-stress control condition, will occur either 1-week preceding or 1-week following both MMST trials, thereby controlling for order effects influencing baseline physiological and psychological outcome measures.
| Arm | Type | Receives |
|---|---|---|
| MMST control | No intervention | – |
| MMST+ | Experimental | Behavioral: Experimental: MMST+ |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants who…
- have read and signed the study informed consent
- are healthy, recreationally active men and women aged 18-35 years
- test negative for coronavirus (COVID-19)
- are willing to provide saliva samples throughout and complete the MMST through the duration of the study
Key exclusion criteria (14 listed)
- Participants who…
- have a recent history or are a current smoker
- are currently taking prescription/Over-the-counter medication
- 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 |
|---|---|---|
| Experimental: MMST+The format of the MMST will remain the same; however, the white noise, images and math task will be modified to mitigate habituation effects. | Behavioural | MMST+ |
Primary outcome
Change in saliva cortisol (pre-post MMST)
Time frame: Change from 5 minutes pre to peak post stress test/no stress control condition
Changes in the concentration of saliva free cortisol assessed by ELISA.
Change in subjective stress response (Subjective stress scale) (0-9 Likert scale)
Time frame: Change from 5 minutes pre to immediately post stress test/no stress control condition
Questionnaire comprised of a 10-point rating scale from 0 to 9 (0 - no subjective stress experience at all; 9 - extreme experience of subjective stress experience.
Heart rate
Time frame: 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.
2 secondary outcomes
Change in emotional response to stress
Time frame: Change from 5 minutes pre to immediately post stress test/no stress control condition
Rumination measure
Time frame: Assessed +60 minutes after the stress tests and no stress control condition
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 6 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 Experimental: MMST+ 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 6 inclusion and 14 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 6 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 MMST) (time frame: Change from 5 minutes pre to peak post stress test/no stress control condition). The study lists 3 primary outcomes in all. 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 6 Oct 2023.