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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: PEBL Continuous Performance Task
A PEBL version of the Conners Continuous Performance Task
Other Names:
  • Conners Continuous Performance Task

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Redlands

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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