StressNCT06098352
The Impact of a Continuous Performance Task on the Stress Response
A study testing PEBL Continuous Performance Task in people with Stress, run by University of Redlands at 1 site in United States.
Trial summary
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?… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- PEBL Continuous Performance Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2013to 25 Sep 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English language proficiency
- First year, first semester student enrolled in Students Together Empowering Peers course at the University of Redlands
Who cannot join
- severe mental health issues
- currently taking anti-anxiety medication
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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
Read the 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.
- Conditions
- Stress
- Being tested
- PEBL Continuous Performance Task
- Keywords
- stress, anxiety, blood pressure, skin conductance level, heart rate variability, attention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEBL Continuous Performance TaskBehavioural
Also called Conners Continuous Performance Task
A PEBL version of the Conners Continuous Performance Task
| Study group | Role | What they receive |
|---|---|---|
| PEBL Continuous Performance Task | Experimental | 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. Receives: Behavioral: PEBL Continuous Performance Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Systolic and diastolic
Measured: 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
levels of sweat due to sympathetic nervous system activation
Measured: Measured continuously during an 8 minute resting baseline, then continuously for the 14 minute attention task. Data collection was then complete.
Heart rate variability
Normalized high frequency HRV
Measured: Measured continuously during an 8 minute resting baseline, then continuously for the 14 minute attention task. Data collection was then complete.
Secondary outcomes (4)
State Trait Anxiety Inventory (STAI)
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)
Measured: Questionnaire completed on day of enrollment (<30 minutes)
Perceived Stress Scale (PSS-10)
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)
Measured: Questionnaire completed on day of enrollment (<30 minutes)
Mindful Awareness and Attention Scale (MAAS)
Brown, K.W. and R.M. Ryan. Journal of Personality and Social Psychology, 2003. Scores range from 1 (least mindful) to 6 (most mindful)
Measured: Questionnaire completed on day of enrollment (<30 minutes)
PEBL Continuous Performance Task Foil Accuracy Rate
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.
Measured: 14 minute attention task on the day of the experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start17 Sep 2013
- Primary completion25 Sep 2013
- Study completion25 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- All participants will be measured at baseline and then during an attention task.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Redlands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Olson, University of Redlands
- Investigators
- Lisa E Olson, Ph.D., Principal investigator, University of Redlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098352
- Sponsor's protocol ID
- 2013-31-REDLANDS
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized participant data will be provided upon request
Publications
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.
PubMed 12703651Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Spielberger, 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
Bautista BR, Gurning J, Marks M, Ortyn D, Salinas R, Olson LE. The sympathetic nervous system response to a Continuous Performance Task. MicroPubl Biol. 2024 Jun 12;2024:10.17912/micropub.biology.001059. doi: 10.17912/micropub.biology.001059. eCollection 2024.
PubMed 38938412
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Continuous Performance Task on the Stress Response
- ClinicalTrials.gov ID
- NCT06098352
- Acronym / sponsor ID
- 2013-31-REDLANDS
- Conditions
- Stress
- Keywords
- stress, anxiety, blood pressure, skin conductance level, heart rate variability, attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of RedlandsUniversity, hospital or other
- Study start
- 17 Sep 2013 (actual)
- Primary completion
- 25 Sep 2013 (actual)
- Study completion
- 25 Sep 2013 (actual)
- First posted
- 24 Oct 2023 (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.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be measured at baseline and then during an attention task.
| Arm | Type | Receives |
|---|---|---|
| PEBL Continuous Performance Task | Experimental | Behavioral: PEBL Continuous Performance TaskParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English language proficiency
- First year, first semester student enrolled in Students Together Empowering Peers course at the University of Redlands
Key exclusion criteria (2 listed)
- severe mental health issues
- currently taking anti-anxiety medication
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 |
|---|---|---|
| PEBL Continuous Performance TaskAlso: Conners Continuous Performance TaskA PEBL version of the Conners Continuous Performance Task | Behavioural | PEBL Continuous Performance Task |
Primary outcome
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
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
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
4 secondary outcomes
State Trait Anxiety Inventory (STAI)
Time frame: Questionnaire completed on day of enrollment (<30 minutes)
Perceived Stress Scale (PSS-10)
Time frame: Questionnaire completed on day of enrollment (<30 minutes)
Mindful Awareness and Attention Scale (MAAS)
Time frame: 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
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 24 Oct 2023.
- Background: PubMed 12703651Brown 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundSpielberger, C.D., R.L. Gorsuch, and R.E. Lushene, Manual for the state-trait anxiety inventory. 1970: Consulting Psychologists Press, Palo Alto, CA.
- BackgroundThe PEBL Project. (2019). PEBL. Retrieved from https://pebl.sourceforge.net
- Derived from this study: PubMed 38938412Bautista BR, Gurning J, Marks M, Ortyn D, Salinas R, Olson LE. The sympathetic nervous system response to a Continuous Performance Task. MicroPubl Biol. 2024 Jun 12;2024:10.17912/micropub.biology.001059. doi: 10.17912/micropub.biology.001059. eCollection 2024.
- Individual participant dataSharing planned: Yes. Anonymized participant data will be provided upon request
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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.
Lisa E Olson, Ph.D. principal investigator
University of Redlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEBL Continuous Performance Task in people with Stress, run by University of Redlands 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 2 inclusion and 2 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 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 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?
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?
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.). 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 NCT06098352, which also lists 5 linked publications.
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 Oct 2023.