NCT06098352

Brief 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?
  • 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2013

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2013

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

8 days

First QC Date

October 18, 2023

Last Update Submit

October 18, 2023

Conditions

Keywords

stressanxietyblood pressureskin conductance levelheart rate variabilityattention

Outcome Measures

Primary Outcomes (3)

  • Blood pressure

    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

    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

    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 Outcomes (4)

  • State Trait Anxiety Inventory (STAI)

    Questionnaire completed on day of enrollment (<30 minutes)

  • Perceived Stress Scale (PSS-10)

    Questionnaire completed on day of enrollment (<30 minutes)

  • Mindful Awareness and Attention Scale (MAAS)

    Questionnaire completed on day of enrollment (<30 minutes)

  • PEBL Continuous Performance Task Foil Accuracy Rate

    14 minute attention task on the day of the experiment

Study Arms (1)

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.

Behavioral: PEBL Continuous Performance Task

Interventions

A PEBL version of the Conners Continuous Performance Task

Also known as: Conners Continuous Performance Task
PEBL Continuous Performance Task

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English language proficiency
  • First year, first semester student enrolled in Students Together Empowering Peers course at the University of Redlands

You may not qualify if:

  • severe mental health issues
  • currently taking anti-anxiety medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Redlands

Redlands, California, 92373, United States

Location

Related Publications (5)

  • 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.

    PMID: 12703651BACKGROUND
  • 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.

    PMID: 6668417BACKGROUND
  • Spielberger, C.D., R.L. Gorsuch, and R.E. Lushene, Manual for the state-trait anxiety inventory. 1970: Consulting Psychologists Press, Palo Alto, CA.

    BACKGROUND
  • The PEBL Project. (2019). PEBL. Retrieved from https://pebl.sourceforge.net

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Lisa E Olson, Ph.D.

    University of Redlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants will be measured at baseline and then during an attention task.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biology

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 24, 2023

Study Start

September 17, 2013

Primary Completion

September 25, 2013

Study Completion

September 25, 2013

Last Updated

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Anonymized participant data will be provided upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Starting after publication, and up to 10 years after publication
Access Criteria
Will be provided to researchers affiliated with an academic institution upon request

Locations