Burnout, ProfessionalNCT05317793
Ambulatory Electrodermal Activity Measurements as Part of Identification and Prevention of Job Burnout
An observational study of Burnout, Professional and Mental Health Issue, run by Tampere University Hospital at 3 sites in Finland.
Trial summary
The study investigates the associations of ambulatory electrodermal activity (EDA) measurements with mental well-being at work, especially job burnout. Appropriate statistical methods are applied to predict burnout with EDA measurements combined with self-report surveys on emotional valence. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Mental Health Issue, Anxiety
- How many people
- 123 participants
- Where
- 3 sitesFinland
- Study dates
- 28 Mar 2022to 31 Dec 2026
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Knowledge workers from three Finnish companies.
Who may be able to join
- Healthy volunteers, but they may have mental health issues
- Employed by one of the target organizations in the beginning of the study
- Informed consent in a written form by the study subject
Who cannot join
- Nickel sensitivity
Trial locations and contacts
3 sites in 1 country.
About this study
The study investigates the associations of ambulatory electrodermal activity (EDA) measurements with mental well-being at work, especially job burnout. Appropriate statistical methods are applied to predict burnout with EDA measurements combined with self-report surveys on emotional valence.
Read the detailed description
The aim of the study is to complement burnout research by considering ambulatory electrodermal activity (EDA) measurements as part of the identification and definition of the burnout phenomenon. Previous studies have shown that assessment methods for the physiological identification of burnout do not yet exist and that more information on the physiological markers of burnout is needed. The study also complements the understanding of how and in what cases ambulatory measurements of EDA can be justified, for example, as an occupational health care tool.
The study investigates the association between ambulatory EDA measurements and mental well-being, especially job burnout, and the potential of the measurements in supporting better mental health at work. According to research the EDA measurements alone do not always provide sufficient information and often context related information is needed to improve the interpretation of the measurement. Therefore, the EDA measurements are complemented with the self-reported emotional valence.
The state of mental well-being is defined using Peter Warr's model of affective well-being. The model proposes that two dimensions of emotion, arousal and emotional valence, together can provide information / be used to describe one's affective well-being at work. The model is further based on the circumplex model of affect.
Previous studies of EDA have shown that the measurement method has a potential role in assisting the diagnosis of some mental disorders, such as anxiety and depression. However, the measurements have been largely tied to laboratory settings and have not been able to be utilized in everyday life. The development of health and well-being technology has brought to the market methods for measuring the electrical conductivity of the skin, which are suitable for ambulatory measurements, but whose suitability must be critically assessed.
Within this study it is hypothesized that the average variation of the sympathetic nervous system activity measured with EDA and combined with a self-reported emotional valence is associated with mental well-being at work, as burnout measured with the Burnout Assessment Tool (BAT-12), anxiety measured with Generalized Anxiety Disorder (GAD-7) Scale, depression measured with Beck Depression Inventory (BDI-21), and job engagement measured with Utrecht Work Engagement Scale (UWES-9).
The study is longitudinal, consisting of four measurement periods at six-month interval. One measurement period of EDA and valence is two weeks. EDA and emotional valence are recorded with a commercially available Moodmetric smart ring and Moodmetric mobile app. EDA is measured with using the Moodmetric index which is calculated from the EDA raw signal produced by the Moodmetric smart ring. EDA and valence measurements are then compared with BAT-12, GAD-7, BDI-21, UWES-9 that measure burnout, anxiety, depression, and job engagement respectively. The survey data (BAT-12, GAD-7, BDI-21, and UWES-9) is gathered after every two-week measurement period is over. 150 voluntary knowledge workers from three Finnish companies are invited to participate in the study.
- Conditions
- Burnout, Professional, Mental Health Issue, Anxiety, Depression
- Medical subject headings
- Burnout, Professional, Anxiety Disorders, Depression
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 |
|---|---|---|
| Professionals | 150 knowledge workers from three Finnish companies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between electrodermal activity and valence measurements with burnout
Association between combined EDA and emotional valence measurements with burnout as measured with BAT-12. The cut-off scores for mild, moderate, and severe burnout are 1.00-2.58, 2.59-3.01 and 3.02-5.00 respectively.
Measured: Two-weeks
Secondary outcomes (4)
Association between electrodermal activity and valence measurements with anxiety
Association between combined EDA and emotional valence measurements with anxiety as measured with GAD-7. The cut-off scores for mild, moderate, and severe anxiety are 5-9, 10-14, 15-21 respectively.
Measured: Two-weeks
Association between electrodermal activity and valence measurements with depression
Association between combined EDA and emotional valence measurements with depression as measured with BDI-21. The cut-off scores for mild mood disturbance, borderline clinical depression, moderate depression, severe depression, and extreme depression are 11-16, 17-20, 21-30, 31-40, and over 40 respectively.
Measured: Two-weeks
Association between electrodermal activity and valence measurements with job engagement
Association between combined EDA and emotional valence measurements with job engagement as measured with UWES-9. Norm scores for very low, low, average, high, and very high are 1.77 or below, 1.78-2.88, 2.89-4.66, 4.67-5.50, and over 5.51 respectively.
Measured: Two-weeks
Association between electrodermal activity and valence measurements with burnout
Association between combined EDA and emotional valence measurements with burnout as measured with BAT-12. The cut-off values for mild, moderate, and severe burnout are 1.00-2.58, 2.59-3.01 and 3.02-5.00 respectively.
Measured: Throughout the study 1.5 years: baseline, 6 months, 12 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start28 Mar 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Sponsor
- Investigators
- Saija Mauno, Professor, Study director, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317793
- Sponsor's protocol ID
- R21149
- Status last verified
- Apr 2025
- First submitted
- 14 Mar 2022
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following physiological and survey data will be available to other researchers after the study is over, reported and the data irrevocably anonymized: * Electrodermal activity measurements recorded with the Moodmetric smart ring * Self-reported emotional valence recorded with the Moodmetric mobile app * Burnout Assessment Tool (BAT) survey results * Beck Depression Inventory (BD1-21) survey results * Generalized Anxiety Disorder Scale (GAD-7) survey results * Utrecht Work Engagement Scale (UWES-9) survey results * Job satisfaction survey results The final IPD sharing plan will be made with the assistance of Finnish Social Science Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Electrodermal Activity Measurements as Part of Identification and Prevention of Job Burnout
- ClinicalTrials.gov ID
- NCT05317793
- Acronym / sponsor ID
- R21149
- Conditions
- Burnout, Professional, Mental Health Issue, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 2022 (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 study investigates the associations of ambulatory electrodermal activity (EDA) measurements with mental well-being at work, especially job burnout. Appropriate statistical methods are applied to predict burnout with EDA measurements combined with self-report surveys on emotional valence.
Detailed description
The aim of the study is to complement burnout research by considering ambulatory electrodermal activity (EDA) measurements as part of the identification and definition of the burnout phenomenon. Previous studies have shown that assessment methods for the physiological identification of burnout do not yet exist and that more information on the physiological markers of burnout is needed. The study also complements the understanding of how and in what cases ambulatory measurements of EDA can be justified, for example, as an occupational health care tool.
The study investigates the association between ambulatory EDA measurements and mental well-being, especially job burnout, and the potential of the measurements in supporting better mental health at work. According to research the EDA measurements alone do not always provide sufficient information and often context related information is needed to improve the interpretation of the measurement. Therefore, the EDA measurements are complemented with the self-reported emotional valence.
The state of mental well-being is defined using Peter Warr's model of affective well-being. The model proposes that two dimensions of emotion, arousal and emotional valence, together can provide information / be used to describe one's affective well-being at work. The model is further based on the circumplex model of affect.
Previous studies of EDA have shown that the measurement method has a potential role in assisting the diagnosis of some mental disorders, such as anxiety and depression. However, the measurements have been largely tied to laboratory settings and have not been able to be utilized in everyday life. The development of health and well-being technology has brought to the market methods for measuring the electrical conductivity of the skin, which are suitable for ambulatory measurements, but whose suitability must be critically assessed.
Within this study it is hypothesized that the average variation of the sympathetic nervous system activity measured with EDA and combined with a self-reported emotional valence is associated with mental well-being at work, as burnout measured with the Burnout Assessment Tool (BAT-12), anxiety measured with Generalized Anxiety Disorder (GAD-7) Scale, depression measured with Beck Depression Inventory (BDI-21), and job engagement measured with Utrecht Work Engagement Scale (UWES-9).
The study is longitudinal, consisting of four measurement periods at six-month interval. One measurement period of EDA and valence is two weeks. EDA and emotional valence are recorded with a commercially available Moodmetric smart ring and Moodmetric mobile app. EDA is measured with using the Moodmetric index which is calculated from the EDA raw signal produced by the Moodmetric smart ring. EDA and valence measurements are then compared with BAT-12, GAD-7, BDI-21, UWES-9 that measure burnout, anxiety, depression, and job engagement respectively. The survey data (BAT-12, GAD-7, BDI-21, and UWES-9) is gathered after every two-week measurement period is over. 150 voluntary knowledge workers from three Finnish companies are invited to participate in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Professionals | – | –150 knowledge workers from three Finnish companies. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Knowledge workers from three Finnish companies.
Key inclusion criteria (3 listed)
- Healthy volunteers, but they may have mental health issues
- Employed by one of the target organizations in the beginning of the study
- Informed consent in a written form by the study subject
Key exclusion criteria (1 listed)
- Nickel sensitivity
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
Association between electrodermal activity and valence measurements with burnout
Time frame: Two-weeks
Association between combined EDA and emotional valence measurements with burnout as measured with BAT-12. The cut-off scores for mild, moderate, and severe burnout are 1.00-2.58, 2.59-3.01 and 3.02-5.00 respectively.
4 secondary outcomes
Association between electrodermal activity and valence measurements with anxiety
Time frame: Two-weeks
Association between electrodermal activity and valence measurements with depression
Time frame: Two-weeks
Association between electrodermal activity and valence measurements with job engagement
Time frame: Two-weeks
Association between electrodermal activity and valence measurements with burnout
Time frame: Throughout the study 1.5 years: baseline, 6 months, 12 months, and 18 months
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 1 May 2025.
- Individual participant dataSharing planned: Yes. The following physiological and survey data will be available to other researchers after the study is over, reported and the data irrevocably anonymized: * Electrodermal activity measurements recorded with the Moodmetric smart ring * Self-reported emotional valence recorded with the Moodmetric mobile app * Burnout Assessment Tool (BAT) survey results * Beck Depression Inventory (BD1-21) survey results * Generalized Anxiety Disorder Scale (GAD-7) survey results * Utrecht Work Engagement Scale (UWES-9) survey results * Job satisfaction survey results The final IPD sharing plan will be made with the assistance of Finnish Social Science Data Archive.
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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.
Saija Mauno, Professor study director
Tampere University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burnout, Professional and Mental Health Issue, run by Tampere University Hospital at 3 sites in Finland.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. 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?
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?
Association between electrodermal activity and valence measurements with burnout (time frame: Two-weeks). 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 1 May 2025.