- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05413512
Stressor-evoked Brain and Cardiovascular Responses to Acute Psychological Stress
June 7, 2022 updated by: Annie Ginty, Baylor University
The present study will examine the relationship between metabolically excessive cardiovascular and neural responses to acute psychological stress using a cross-sectional approach.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All participants in this study will undergo an acute psychological stress paradigm, there will be no randomization or assignment since all participants will complete the same tasks.
Sample size was calculated based off of recent papers examining multivariate pattern brain responses predicting cardiovascular responses to stress.
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Waco, Texas, United States, 76799
- Baylor University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
18-30 years old
Exclusion Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acute psychological stress
Participants will undergo an acute psychological stress task that has been shown to elicit neural, cardiovascular, and psychological (feelings of stressfulness) responses.
|
Participants will undergo an acute psychological stress task that has been shown to elicit neural, cardiovascular, and psychological (feelings of stressfulness) responses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oxygen consumption
Time Frame: 20 minutes
|
20 minutes
|
Heart rate (bpm) measured by electrocardiogram
Time Frame: 20 minutes
|
20 minutes
|
Neural activity measured by fMRI
Time Frame: 20 minutes
|
20 minutes
|
Additional heart rate
Time Frame: 20 minutes
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2020
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
June 5, 2022
First Submitted That Met QC Criteria
June 7, 2022
First Posted (Actual)
June 10, 2022
Study Record Updates
Last Update Posted (Actual)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 7, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1437575
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to share IPD with other rsearchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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