Clinical trial NCT05317793: Ambulatory Electrodermal Activity Measurements as Part of Identification and Prevention of Job Burnout
Official title: Ambulatory Electrodermal Activity Measurements as Part of Identification and Prevention of Job Burnout
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Burnout, Professional
Mental Health Issue
Anxiety
Depression
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
First posted: 2022-04-08
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Knowledge workers from three Finnish companies.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Nickel sensitivity

Primary outcomes:
measure: Association between electrodermal activity and valence measurements with burnout
timeFrame: Two-weeks
Secondary outcomes:
measure: Association between electrodermal activity and valence measurements with anxiety
timeFrame: Two-weeks
measure: Association between electrodermal activity and valence measurements with depression
timeFrame: Two-weeks
measure: Association between electrodermal activity and valence measurements with job engagement
timeFrame: Two-weeks
measure: Association between electrodermal activity and valence measurements with burnout
timeFrame: Throughout the study 1.5 years: baseline, 6 months, 12 months, and 18 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Heltti Oy
city: Helsinki
country: Finland
facility: Solita Oy
city: Tampere
country: Finland
facility: Vincit Oyj
Study officials:
affiliation: Tampere University
name: Saija Mauno, Professor
role: STUDY_DIRECTOR
References: