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

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• dc.contributor.author Castro Ribeiro, Thaís
• dc.contributor.author García Pagès, Esther
• dc.contributor.author Ballester Coma, Laura
• dc.contributor.author Vilagut Saiz, Gemma, 1975-
• dc.contributor.author García Mieres, Helena
• dc.contributor.author Suárez Aragonès, Víctor
• dc.contributor.author Amigo, Franco
• dc.contributor.author Bailón, Raquel
• dc.contributor.author Mortier, Philippe
• dc.contributor.author Pérez Solá, Victor
• dc.contributor.author Serrano-Blanco, Antoni
• dc.contributor.author Alonso Caballero, Jordi
• dc.contributor.author Aguiló Llobet, Jordi
• dc.date.accessioned 2024-06-07T06:15:05Z
• dc.date.available 2024-06-07T06:15:05Z
• dc.date.issued 2024
• dc.description.abstract 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.
• dc.description.sponsorship This study is receiving funding from the Centro de Investigación Biomédica en Red (CIBER) de Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN, Instituto de Salud Carlos III [ISCIII], Madrid, Spain) and the CIBER de Epidemiología y Salud Pública (CIBERESP, ISCIII, Madrid, Spain) for CIBERESP-BBN Collaboration Projects and the Departament de Recerca i Universitats of the Generalitat de Catalunya (AGAUR 2021 SGR 00624). This work is also partially funded by Ministerio de Ciencia e Innovación and European Social Fund, Spain (TED2021-131106B-I00), and the European Social Fund (European Union). PM received funding from the ISCIII-FSE (Fondo Social Europeo; Miguel Servet grant CP21/00078). RB received funding from the BSICoS (Biomedical Signal Interpretation and Computational Simulation) group (T39 23R) by the Aragon Government.
• dc.format.mimetype application/pdf
• dc.identifier.citation Castro Ribeiro T, García Pagès E, Ballester L, Vilagut G, García Mieres H, Suárez Aragonès V, et al. 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. JMIR Res Protoc. 2024 Mar 29;13:e51298. DOI: 10.2196/51298
• dc.identifier.doi http://dx.doi.org/10.2196/51298
• dc.identifier.issn 1929-0748
• dc.identifier.uri http://hdl.handle.net/10230/60385
• dc.language.iso eng
• dc.publisher JMIR Publications
• dc.relation.ispartof JMIR Res Protoc. 2024 Mar 29;13:e51298
• dc.relation.projectID info:eu-repo/grantAgreement/ES/3PE/TED2021-131106B-I00
• dc.rights © Thais Castro Ribeiro, Esther García Pagès, Laura Ballester, Gemma Vilagut, Helena García Mieres, Víctor Suárez Aragonès, Franco Amigo, Raquel Bailón, Philippe Mortier, Víctor Pérez Sola, Antoni Serrano-Blanco, Jordi Alonso, Jordi Aguiló. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 29.03.2024. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword Anxiety
• dc.subject.keyword Depression
• dc.subject.keyword Experimental protocol
• dc.subject.keyword mHealth
• dc.subject.keyword Mental health
• dc.subject.keyword Mental well-being
• dc.subject.keyword Mobile health
• dc.subject.keyword Physiological variables
• dc.subject.keyword Remote monitoring
• dc.title 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
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion