Quantification of stress and well-being using pulse, speech, and electrodermal data: Study concept and design

Introduction Mental disorders are a leading cause of disability worldwide and, among mental disorders, major depressive disorder was highly ranked in years lived with disability. Depression has a significant impact in the field of occupational health because it is particularly prevalent during working age. On the other hand, there are a growing number of studies on the relationship between “well-being” and employee productivity. To promote healthy and productive workplaces, this study aims to develop a technique to quantify stress and well-being in a way that does not disturb the workplace. Methods and analysis This is a single-arm prospective observational study. The target population is adult (>20 years old) workers at companies that often engage in desk work; specifically, a person who sits in front of a computer for at least half their work hours. The following data will be collected: a) participants’ background characteristics; b) participants’ biological data during the 4-week observation period using sensing devices such as a camera built into or connected to the computer (pulse wave data extracted from the facial video images), a microphone built into or connected to their work computer (voice data), and a wristband-type wearable device (electrodermal activity data, body motion data, and body temperature); c) stress, well-being, and depression rating scale assessment data (New Occupational Stress Questionnaire, Perceived Stress Scale, Satisfaction With Life Scale, Japanese version of Positive and Negative Affect Schedule, Japanese Flourishing Scale, Subjective Well-being / Ideal Happiness, and Japanese version of Patient Health Questionnaire-9). The analysis workflow is as follows: (1) primary analysis, comprised of using software to digitalize participants’ vital information; (2) secondary analysis, comprised of examining the relationship between the quantified vital data from (1), stress, well-being, and depression; (3) tertiary analysis, comprised of generating machine learning algorithms to estimate stress, well-being, and degree of depression in relation to each set of vital data as well as multimodal vital data. Ethics and dissemination Collected data and study results will be disseminated widely through conference presentations, journal publications, and/or mass media. The summarized results of our overall analysis will be supplied to participants. Registration UMIN000036814 STRENGTHS AND LIMITATIONS OF THIS STUDY ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial UMIN000036814 ### Clinical Protocols ### Funding Statement This work was supported by the Japan Agency for Medical Research and Development (AMED) (grant number 18le0110008h0001). The funding source did not participate in the design of this study and will not have any hand in the study's execution, analyses, or submission of results. Japan Agency for Medical Research and Development (AMED) 20F Yomiuri Shimbun Bldg. 1-7-1 Otemachi, Chiyoda-ku, Tokyo 100-0004 Japan Tel: +81-3-6870-2200, Fax: +81-3-6870-2241, Email: jimu-ask{at}amed.go.jp ### Author Declarations All relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript. Yes All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Not applicable