ElectroencephalogramEEG_stressNCT06636253
Does Stress Change EEG Measures in Students: A Feasibility Study
An observational study of Electroencephalogram and Stress, run by Scotland College of Chiropractic at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electroencephalogram, Stress
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Scottish chiropractic college students
Who may be able to join
- Healthy Scottish chiropractic students with no prior diagnosed mental disorder and who are capable of understanding the study procedure.
Who cannot join
- A pre-diagnosed mental health disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Scotland College of Chiropractic
Edinburgh, EH4 1HG
Alice Cade, PhD, +6421400739, alice@scotlandcollegechiro.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Electroencephalogram, Stress
- Keywords
- Electroencephalogram, stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Feasibility recruitment rates
recruitment rates - how many people were recruited ove rthe study time period
Measured: 0, 6, 12 weeks
Feasibility - retention
Participant retention - how many participants completed the full study
Measured: 0, 6, 12 weeks
Feasibility - queries
queries from participants - how many question did participants ask and were they answerable
Measured: 12 weeks
Feasibility - ease
Ease of data collection - was the data collection procedure manageable for the investigator
Measured: 12 weeks
Feasibility - Adverse
Adverse events - were any adverse events either minor or significant, recorded at any time throughout the trial
Measured: 12 weeks
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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)).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start15 Oct 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroencephalogramStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scotland College of Chiropractic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Cade, Scotland College of Chiropractic
- Investigators
- Alice Cade, BSc, BSc(chiro), MHSc, PhD, Principal investigator, Scotland College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636253
- Sponsor's protocol ID
- 348503
- Acronym
- EEG_stress
- Status last verified
- Nov 2024
- First submitted
- 12 Sep 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request, anonymised post-process eeg data will be made available
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Stress Change EEG Measures in Students: A Feasibility Study.
- ClinicalTrials.gov ID
- NCT06636253
- Acronym / sponsor ID
- EEG_stress / 348503
- Conditions
- Electroencephalogram, Stress
- Keywords
- Electroencephalogram, stress
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Scotland College of ChiropracticUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 10 Oct 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Scottish chiropractic college students
Key inclusion criteria (1 listed)
- Healthy Scottish chiropractic students with no prior diagnosed mental disorder and who are capable of understanding the study procedure.
Key exclusion criteria (1 listed)
- A pre-diagnosed mental health disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility recruitment rates
Time frame: 0, 6, 12 weeks
recruitment rates - how many people were recruited ove rthe study time period
Feasibility - retention
Time frame: 0, 6, 12 weeks
Participant retention - how many participants completed the full study
Feasibility - queries
Time frame: 12 weeks
queries from participants - how many question did participants ask and were they answerable
Feasibility - ease
Time frame: 12 weeks
Ease of data collection - was the data collection procedure manageable for the investigator
Feasibility - Adverse
Time frame: 12 weeks
Adverse events - were any adverse events either minor or significant, recorded at any time throughout the trial
3 secondary outcomes
Electroencephalogram recordings
Time frame: 12 weeks
Electroencephalogram recordings
Time frame: 12 weeks
Electroencephalogram recordings
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: Yes. Upon reasonable request, anonymised post-process eeg data will be made available
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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.
Alice Cade, BSc, BSc(chiro), MHSc, PhD principal investigator
Scotland College of Chiropractic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electroencephalogram and Stress, run by Scotland College of Chiropractic at 1 site in United Kingdom.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Dec 2024. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Cade, BSc, BSc(chiro), MHSc, PhD (+4401313320063, alice@scotlandcollegechiro.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility recruitment rates (time frame: 0, 6, 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2024.