Acute Psychological StressNCT05413512

Stressor-evoked Brain and Cardiovascular Responses to Acute Psychological Stress

A study testing Acute psychological stress in people with Acute Psychological Stress, run by Baylor University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The present study will examine cardiovascular, metabolic, and neural responses to acute psychological stress using a cross-sectional approach. Read more about this study

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Acute Psychological Stress
What is being tested?: Acute psychological stress
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 1 siteUnited States
Study dates: 2 Mar 2020to 30 Sep 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

18-30 years old

Who cannot join

Chronic medical or neurological condition
Pregnant
Current illness or infection
Any condition that would prohibit engaging in physical exercise
Any metal implants in body
Claustrophobia

Trial locations and contacts

1 site in 1 country.

United States1 site

Baylor University
Waco, Texas, 76799

Other trials in United States

About this study

The present study will examine cardiovascular, metabolic, and neural responses to acute psychological stress using a cross-sectional approach.

Read the detailed description

All participants in this study will undergo an acute psychological stress paradigm, consisting of two acute psychological stress tasks (MSIT and Stoop). There is no formal randomization since al participants are randomized to undergo the acute psychological stress tasks.

Conditions: Acute Psychological Stress
Being tested: Acute psychological stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acute psychological stressOther
Experimental: Acute psychological stress Two, acute-psychological stress tasks known to reliably elicit a cardiovascular responses (Multi-source interference task; Stroop).

Study groups in NCT05413512
Study group	Role	What they receive
Acute psychological stress task (MSIT; Stroop)	Experimental	Multi-source interference task (MSIT; Stroop) Receives: Other: Acute psychological stress

What is being measured

The primary outcome is the main question the study is designed to answer.

Stressor-evoked Oxygen Consumption in mL/(kg·Min) (Stress - Baseline)
Stressor-evoked oxygen consumption. (Oxygen consumption during acute psychological stress task - Oxygen consumption during resting baseline).
Measured: 18 minutes (approximately 9 minutes for each task)
Heart Rate (Bpm) Measured by Electrocardiogram
Stressor-evoked heart rate. (Heart rate during acute psychological stress task - Heart rate during resting baseline).
Measured: 18 minutes (approximately 9 minutes for each stress task)
Neural Activity Measured by fMRI
Stressor-evoked neural activity.
Incongruent-vs-Congruent t at the group-level, filtered at 0.05 after FDR correction and with a cluster extent of 50 voxels.
Measured: 18 minutes (approximately 9 minutes for each stress task).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 202030 Sep 2021

First posted10 Jun 2022
Study start2 Mar 2020
Primary completion30 Sep 2021
Study completion30 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Psychological StressStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05413512
Sponsor's protocol ID: 1437575
Other IDs: K01HL145021
Status last verified: Jun 2025
First submitted: 5 Jun 2022
Last updated: 24 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is no plan to share IPD with other rsearchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Psychological Stress trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stressor-evoked Brain and Cardiovascular Responses to Acute Psychological Stress
ClinicalTrials.gov ID: NCT05413512
Acronym / sponsor ID: 1437575
Conditions: Acute Psychological Stress
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Baylor UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 2 Mar 2020 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 10 Jun 2022 (actual)
Results: Posted 24 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The present study will examine cardiovascular, metabolic, and neural responses to acute psychological stress using a cross-sectional approach.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Acute psychological stress task (MSIT; Stroop)	Experimental	Other: Acute psychological stressMulti-source interference task (MSIT; Stroop)

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

18-30 years old

Key exclusion criteria (6 listed)

Chronic medical or neurological condition
Pregnant
Current illness or infection
Any condition that would prohibit engaging in physical exercise
Any metal implants in body

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
Acute psychological stressExperimental: Acute psychological stress Two, acute-psychological stress tasks known to reliably elicit a cardiovascular responses (Multi-source interference task; Stroop).	Other	Acute psychological stress task (MSIT; Stroop)

Primary outcome

Stressor-evoked Oxygen Consumption in mL/(kg·Min) (Stress - Baseline)
Time frame: 18 minutes (approximately 9 minutes for each task)
Stressor-evoked oxygen consumption. (Oxygen consumption during acute psychological stress task - Oxygen consumption during resting baseline).
Heart Rate (Bpm) Measured by Electrocardiogram
Time frame: 18 minutes (approximately 9 minutes for each stress task)
Stressor-evoked heart rate. (Heart rate during acute psychological stress task - Heart rate during resting baseline).
Neural Activity Measured by fMRI
Time frame: 18 minutes (approximately 9 minutes for each stress task).
Stressor-evoked neural activity. Incongruent-vs-Congruent t at the group-level, filtered at 0.05 after FDR correction and with a cluster extent of 50 voxels.

Results and safety

Results posted to the registry on 24 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acute Psychological Stress	170	170

Primary outcome: Stressor-evoked Oxygen Consumption in mL/(kg·Min) (Stress - Baseline)

Time frame: 18 minutes (approximately 9 minutes for each task). Mean (Standard Deviation). Unit: mL/(kg·min)

Measure	Acute Psychological Stress Task n = 169
Stroop task	0.265 (0.452)
MSIT task	0.287 (0.431)

Primary outcome: Heart Rate (Bpm) Measured by Electrocardiogram

Time frame: 18 minutes (approximately 9 minutes for each stress task). Mean (Standard Deviation). Unit: beats per minute (bpm)

Measure	Acute Psychological Stress n = 167
Stroop task	4.926 (7.456)
MSIT	2.826 (6.317)

Population analysed: Data loss for 3 participants due to equipment malfunction.

Primary outcome: Neural Activity Measured by fMRI

Time frame: 18 minutes (approximately 9 minutes for each stress task).. Mean (Standard Error). Unit: BOLD signal (Incon - Con)

Measure	Acute Psychological Stress n = 160
L Parietal_inf (stroop)	0.71 (0.41)
R Angular (stroop)	0.54 (0.35)
R Supp_Motor_Area (stroop)	1 (0.65)
L Frontal_Inf_Tri (stroop)	0.85 (0.56)
L Parietal_Inf2 (stroop)	0.66 (0.45)
R Insula (stroop)	0.70 (0.50)
R Frontal_Inf_Oper (stroop)	0.76 (0.60)
R Vermis (stroop)	0.84 (0.68)

Population analysed: Participants who have full data for both acute psychological stress tasks during fMRI scanning.

Adverse events

Time frame: 4 total hours (participants were monitored during each of the 2 hour lab visits).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acute Psychological Stress	0 of 170 (0%)	0 of 170 (0%)	0 of 170

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. There is no plan to share IPD with other rsearchers.

Related trials for Acute Psychological Stress

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Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Not yet recruiting
Acute Effect of Aerobic Exercise on Cardiovascular Reactivity During a Mental Stress Test in Teachers
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Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
Not yet recruiting
Assessment of the Preventive Effect of Defusing on Traumatic Kindling
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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.

Annie Ginty, PhD principal investigator

Baylor 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 Acute psychological stress in people with Acute Psychological Stress, run by Baylor University at 1 site in United States.

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 1 inclusion and 6 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 24 Jun 2025. 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 States. 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?

Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Stressor-evoked Oxygen Consumption in mL/(kg·Min) (Stress - Baseline) (time frame: 18 minutes (approximately 9 minutes for each task)). 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?

On the ClinicalTrials.gov record for NCT05413512.

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 24 Jun 2025.