- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06098352
The Impact of a Continuous Performance Task on the Stress Response
October 18, 2023 updated by: Lisa Olson, University of Redlands
The goal of this clinical trial is to learn about the impact of taking a continuous performance attention test on the physiological stress response in college students. The main questions it aims to answer are:
- Does taking an attention test cause participants to have increases in heart rate, blood pressure, and sweat?
- Does taking an attention test cause participants to have a decrease in heart rate variability?
- Are there relationships between participants' levels of anxiety, perceived stress, and mindfulness to their physiological changes?
Participants will
- Answer questionnaires about anxiety, stress, and mindfulness
- Have baseline measurements taken for blood pressure, sweat, and heart rate variability
- Take the PEBL Continuous Performance Task (a 14 minute attention test) while having the measurements listed above taken again
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The PEBL Continuous Performance Task is an example of a mental stressor which requires vigilance and effort.
We hypothesize that a sympathetic nervous system response will be evident in comparing physiological parameters during the attention task versus the preceding resting baseline period.
Exploratory analyses will assess relationships between psychological measures of anxiety, stress, and mindfulness with this physiological response and the number of errors on the attention test.
Study Type
Interventional
Enrollment (Actual)
20
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
-
-
California
-
Redlands, California, United States, 92373
- University of Redlands
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- English language proficiency
- First year, first semester student enrolled in Students Together Empowering Peers course at the University of Redlands
Exclusion Criteria:
- severe mental health issues
- currently taking anti-anxiety medication
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: PEBL Continuous Performance Task
Participants will take the PEBL Continuous Performance Task, a 14 minute attention test requiring participants to press the space bar when certain letters are shown on the screen.
|
A PEBL version of the Conners Continuous Performance Task
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: Measured once after an 8 minute resting baseline, then 2 minutes into the attention task, and 10 minutes into the attention task. Data collection was then complete.
|
Systolic and diastolic
|
Measured once after an 8 minute resting baseline, then 2 minutes into the attention task, and 10 minutes into the attention task. Data collection was then complete.
|
|
Skin conductance level
Time Frame: Measured continuously during an 8 minute resting baseline, then continuously for the 14 minute attention task. Data collection was then complete.
|
levels of sweat due to sympathetic nervous system activation
|
Measured continuously during an 8 minute resting baseline, then continuously for the 14 minute attention task. Data collection was then complete.
|
|
Heart rate variability
Time Frame: Measured continuously during an 8 minute resting baseline, then continuously for the 14 minute attention task. Data collection was then complete.
|
Normalized high frequency HRV
|
Measured continuously during an 8 minute resting baseline, then continuously for the 14 minute attention task. Data collection was then complete.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Trait Anxiety Inventory (STAI)
Time Frame: Questionnaire completed on day of enrollment (<30 minutes)
|
Spielberger, C.D., R.L. Gorsuch, and R.E.
Lushene, 1970.
Scores on each of the state and trait sections range from 20 (low anxiety) to 80 (high anxiety)
|
Questionnaire completed on day of enrollment (<30 minutes)
|
|
Perceived Stress Scale (PSS-10)
Time Frame: Questionnaire completed on day of enrollment (<30 minutes)
|
Cohen, S., T. Kamarck, and R. Mermelstein.
Journal of Health and Social Behavior, 1983.
Scores range from 0 (low perceived stress) to 40 (high perceived stress)
|
Questionnaire completed on day of enrollment (<30 minutes)
|
|
Mindful Awareness and Attention Scale (MAAS)
Time Frame: Questionnaire completed on day of enrollment (<30 minutes)
|
Brown, K.W. and R.M. Ryan.
Journal of Personality and Social Psychology, 2003.
Scores range from 1 (least mindful) to 6 (most mindful)
|
Questionnaire completed on day of enrollment (<30 minutes)
|
|
PEBL Continuous Performance Task Foil Accuracy Rate
Time Frame: 14 minute attention task on the day of the experiment
|
For trials where participants were presented with a foil, the percent in which the participant did not commit a commission error (participant correctly did not press spacebar).
Ranges from 0 - 100% accuracy.
|
14 minute attention task on the day of the experiment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lisa E Olson, Ph.D., University of Redlands
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
- Spielberger, C.D., R.L. Gorsuch, and R.E. Lushene, Manual for the state-trait anxiety inventory. 1970: Consulting Psychologists Press, Palo Alto, CA.
- The PEBL Project. (2019). PEBL. Retrieved from https://pebl.sourceforge.net
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)
September 17, 2013
Primary Completion (Actual)
September 25, 2013
Study Completion (Actual)
September 25, 2013
Study Registration Dates
First Submitted
October 18, 2023
First Submitted That Met QC Criteria
October 18, 2023
First Posted (Actual)
October 24, 2023
Study Record Updates
Last Update Posted (Actual)
October 24, 2023
Last Update Submitted That Met QC Criteria
October 18, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2013-31-REDLANDS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymized participant data will be provided upon request
IPD Sharing Time Frame
Starting after publication, and up to 10 years after publication
IPD Sharing Access Criteria
Will be provided to researchers affiliated with an academic institution upon request
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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