Does Stress Change EEG Measures in Students: A Feasibility Study (EEG_stress)

Does Stress Change EEG Measures in Students: A Feasibility Study.

Psychological stress is a frequent human affection and has a considerable impact on modern society, and tertiary-level students often report increased stress levels as the semester progresses. While many questionnaires assess psychological stress, they do not capture objective data. Much research has shown that electroencephalography (EEG) can capture objective markers of stress, and recent studies have shown that EEG can even classify stress levels.

This study aims to assess the feasibility of using EEG to objectively assess stress over the course of a semester of work in chiropractic students engaged in a Masters level course in Scotland.

Study Overview

• Status: Recruiting
• Conditions: Stress; Electroencephalogram

Detailed Description

The study's primary aim is to assess the feasibility of a more extensive future study. The investigators also hypothesise that as the semester progresses, participants will exhibit changes in their EEG outcomes that may be related to longitudinal or direct stressors.

Study design and setting This study will be an observational study with a stress-related questionnaire (Depression, Anxiety, and Stress Scale - 21 (DASS-21)) over three time-points.

Participants The investigators aim to recruit 10 participants and assess them three times over the course of their semester, early, middle, and late semester, with at least a four-week gap between each data collection. The investigators aim to recruit only healthy Scottish chiropractic students with no prior diagnosed mental disorder and who are capable of understanding the study procedure.

Procedure Following screening for eligibility and consent, i.e., visit one (baseline), participants will be asked to answer a questionnaire and undergo EEG measurement and Montreal imaging stress task (MIST). The same EEG and questionnaire procedure will be performed in the remaining two data collection sessions.

Each EEG recording session, with the participant seated, will consist of a two-minute resting state with the eyes closed for a baseline relaxation level among the participants. A following two-minute eyes-open phase will take place. After which, participants will be asked to perform the experimental phase of the MIST task, a following two-minute recording phase will be with the eyes open, and a final two-minute resting phase with eyes closed will conclude the task.

The investigators aim to conclude the data collection around 16 weeks after the initial participant is recruited.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Alice Cade, BSc, BSc(chiro), MHSc, PhD; Phone Number: +4401313320063; Email: alice@scotlandcollegechiro.ac.uk
• Study Contact Backup: Name: Ross MacDonald, MChiro; Phone Number: +440131 332 0063; Email: ross@scotlandcollegechiro.ac.uk

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH4 1HG
    • Recruiting
    • Scotland College of Chiropractic
    • Contact: Alice Cade, PhD; Phone Number: +6421400739; Email: alice@scotlandcollegechiro.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Scottish chiropractic college students

Description

Inclusion Criteria:

Healthy Scottish chiropractic students with no prior diagnosed mental disorder and who are capable of understanding the study procedure.

Exclusion Criteria:

A pre-diagnosed mental health disorder

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SCC students; Healthy adults attending and actively enrolled in the Scotland College of Chiropractic's degree program and who were without health issues or mental disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility recruitment rates	recruitment rates - how many people were recruited ove rthe study time period	0, 6, 12 weeks
Feasibility - retention	Participant retention - how many participants completed the full study	0, 6, 12 weeks
Feasibility - queries	queries from participants - how many question did participants ask and were they answerable	12 weeks
Feasibility - ease	Ease of data collection - was the data collection procedure manageable for the investigator	12 weeks
Feasibility - Adverse	Adverse events - were any adverse events either minor or significant, recorded at any time throughout the trial	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalogram recordings	Power spectra between 1 and 80 Hz (using the Fourier basis with a 2 s wide Hanning window) will be calculated based on clean data from all sensors (electrodes).	12 weeks
Electroencephalogram recordings	The average power of each classical frequency band (delta (1-4 Hz), theta (4.1-8 Hz), alpha (8.1-12 Hz), beta (12.1-32 Hz), and gamma (32.1-80 Hz). These measures will be used to test for differences in basic EEG parameters across conditions (rest, Montreal Imaging Stress Task (MIST)) and groups (early, middle and late timepoints), as well as for correlations with key demographic and clinical variables.	12 weeks
Electroencephalogram recordings	Time Frequency Analysis: For EEG data acquired during the Montreal Imaging Stress Task (MIST), we will also quantify continuous changes in power of EEG frequency bands as a function of time (i.e., prior to, during and after the Montreal Imaging Stress Task (MIST)).	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, Anxiety, and Stress Scale - 21 (DASS-21)	The DASS 21 is a 21-item self-report questionnaire designed to measure the severity of a range of symptoms common to both Depression and Anxiety. In completing the DASS, the individual is required to indicate the presence of a symptom over the previous week. Each item is scored from 0 (did not apply to me at all over the last week) to 3 (applied to me very much or most of the time over the past week). The DASS subscores Depression: ranges from 0-9 (normal) to 28+ (extremely severe depression) Anxiety: Ranges from 0-7 (normal) to 20+ (extremely severe anxiety) Stress: Ranges from 0-14 (normal) to 34+ (extremely severe stress)	12 weeks

Collaborators and Investigators

• Sponsor: Scotland College of Chiropractic
• Investigators: Principal Investigator: Alice Cade, BSc, BSc(chiro), MHSc, PhD, Scotland College of Chiropractic

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: stress; Electroencephalogram
• Other Study ID Numbers: 348503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon reasonable request, anonymised post-process eeg data will be made available
• IPD Sharing Time Frame: 01/10/2024 for up to two years (01/10/2026)
• IPD Sharing Access Criteria: Other researchers Via emailing the chief investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No