Clinical trial NCT06636253: Does Stress Change EEG Measures in Students: A Feasibility Study
Official title: Does Stress Change EEG Measures in Students: A Feasibility Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Electroencephalogram
Stress
Keywords: Electroencephalogram
stress
Lead sponsor: Scotland College of Chiropractic
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Scottish chiropractic college students

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility recruitment rates
timeFrame: 0, 6, 12 weeks
measure: Feasibility - retention
timeFrame: 0, 6, 12 weeks
measure: Feasibility - queries
timeFrame: 12 weeks
measure: Feasibility - ease
timeFrame: 12 weeks
measure: Feasibility - Adverse
timeFrame: 12 weeks
Secondary outcomes:
measure: Electroencephalogram recordings
timeFrame: 12 weeks
measure: Electroencephalogram recordings
timeFrame: 12 weeks
measure: Electroencephalogram recordings
timeFrame: 12 weeks
Other outcomes:
measure: Depression, Anxiety, and Stress Scale - 21 (DASS-21)
timeFrame: 12 weeks
Locations:
city: Edinburgh
country: United Kingdom
facility: Scotland College of Chiropractic
Study officials:
affiliation: Scotland College of Chiropractic
name: Alice Cade, BSc, BSc(chiro), MHSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: