Design of a Remote Multiparametric Tool to Assess Mental Well-Being and Distress in Young People (mHealth Methods in Mental Health Research Project): Protocol for an Observational Study

• Published in: JMIR research protocols 2024-03, Vol.13, p.e51298-e51298
• Main Authors: Castro Ribeiro, Thais, García Pagès, Esther, Ballester, Laura, Vilagut, Gemma, García Mieres, Helena, Suárez Aragonès, Víctor, Amigo, Franco, Bailón, Raquel, Mortier, Philippe, Pérez Sola, Víctor, Serrano-Blanco, Antoni, Alonso, Jordi, Aguiló, Jordi
• Format: Article
• Language: English
• Subjects: Accuracy; Anxiety; Cognitive ability; Dementia; Head injuries; Health promotion; Heart rate; Intellectual disabilities; Medical research; Mental depression; Mental disorders; Mental health; Observational studies; Physiology; Psychosis; Questionnaires; Schizophrenia; Stress; Stress response; Telemedicine; University students
• ISSN: 1929-0748; 1929-0748
• DOI: 10.2196/51298

Mental health conditions have become a substantial cause of disability worldwide, resulting in economic burden and strain on the public health system. Incorporating cognitive and physiological biomarkers using noninvasive sensors combined with self-reported questionnaires can provide a more accurate characterization of the individual's well-being. Biomarkers such as heart rate variability or those extracted from the electrodermal activity signal are commonly considered as indices of autonomic nervous system functioning, providing objective indicators of stress response. A model combining a set of these biomarkers can constitute a comprehensive tool to remotely assess mental well-being and distress. This study aims to design and validate a remote multiparametric tool, including physiological and cognitive variables, to objectively assess mental well-being and distress. This ongoing observational study pursues to enroll 60 young participants (aged 18-34 years) in 3 groups, including participants with high mental well-being, participants with mild to moderate psychological distress, and participants diagnosed with depression or anxiety disorder. The inclusion and exclusion criteria are being evaluated through a web-based questionnaire, and for those with a mental health condition, the criteria are identified by psychologists. The assessment consists of collecting mental health self-reported measures and physiological data during a baseline state, the Stroop Color and Word Test as a stress-inducing stage, and a final recovery period. Several variables related to heart rate variability, pulse arrival time, breathing, electrodermal activity, and peripheral temperature are collected using medical and wearable devices. A second assessment is carried out after 1 month. The assessment tool will be developed using self-reported questionnaires assessing well-being (short version of Warwick-Edinburgh Mental Well-being Scale), anxiety (Generalized Anxiety Disorder-7), and depression (Patient Health Questionnaire-9) as the reference. We will perform correlation and principal component analysis to reduce the number of variables, followed by the calculation of multiple regression models. Test-retest reliability, known-group validity, and predictive validity will be assessed. Participant recruitment is being carried out on a university campus and in mental health services. Recruitment commenced in October 2022 and is expected to be completed by June 2024. As of July 2023, w