Ambulatory Electrodermal Activity Measurements as Part of Identification and Prevention of Job Burnout

Depression Clinical Trial

Official title:

Ambulatory Electrodermal Activity Measurements as Part of Identification and Prevention of Job Burnout

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05317793
• Other study ID #: R21149
• Status: Active, not recruiting
• Start date: March 28, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 123
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Burnout, Professional
• Burnout, Psychological
• Depression
• Mental Health Issue

Locations

Country	Name	City	State
Finland	Heltti Oy	Helsinki
Finland	Solita Oy	Helsinki
Finland	Vincit Oyj	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Tampere University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Two-weeks
Secondary	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.	Two-weeks
Secondary	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.	Two-weeks
Secondary	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.	Two-weeks
Secondary	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.	Throughout the study 1.5 years: baseline, 6 months, 12 months, and 18 months