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
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 
Published: January 2024

Background
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.

Objective
This study aims to design and validate a remote multiparametric tool, including physiological and cognitive variables, to objectively assess mental well-being and distress.

Methods
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.

Results
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, we have recruited 41 participants. Most participants correspond to the group with mild to moderate psychological distress (n=20, 49%), followed by the high mental well-being group (n=13, 32%) and those diagnosed with a mental health condition (n=8, 20%). Data preprocessing is currently ongoing, and publication of the first results is expected by September 2024.

Conclusions
This study will establish an initial framework for a comprehensive mental health assessment tool, taking measurements from sophisticated devices, with the goal of progressing toward a remotely accessible and objectively measured approach that maintains an acceptable level of accuracy in clinical practice and epidemiological studies.

Trial Registration
OSF Registries N3GCH; https://doi.org/10.17605/OSF.IO/N3GCH

International Registered Report Identifier (IRRID)
DERR1-10.2196/51298