000134670 001__ 134670 000134670 005__ 20240424142036.0 000134670 0247_ $$2doi$$a10.2196/51298 000134670 0248_ $$2sideral$$a138188 000134670 037__ $$aART-2024-138188 000134670 041__ $$aeng 000134670 100__ $$aCastro Ribeiro, Thais 000134670 245__ $$aDesign 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 000134670 260__ $$c2024 000134670 5060_ $$aAccess copy available to the general public$$fUnrestricted 000134670 5203_ $$aBackground: 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. 000134670 536__ $$9info:eu-repo/grantAgreement/ES/DGA/T39-23R$$9info:eu-repo/grantAgreement/ES/ISCIII/CP21-00078$$9info:eu-repo/grantAgreement/EUR/MICINN/TED2021-131106B-I00 000134670 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/ 000134670 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000134670 700__ $$aGarcía Pagès, Esther 000134670 700__ $$aBallester, Laura 000134670 700__ $$aVilagut, Gemma 000134670 700__ $$aGarcía Mieres, Helena 000134670 700__ $$aSuárez Aragonès, Víctor 000134670 700__ $$aAmigo, Franco 000134670 700__ $$0(orcid)0000-0003-1272-0550$$aBailón, Raquel$$uUniversidad de Zaragoza 000134670 700__ $$aMortier, Philippe 000134670 700__ $$aPérez Sola, Víctor 000134670 700__ $$aSerrano-Blanco, Antoni 000134670 700__ $$aAlonso, Jordi 000134670 700__ $$aAguiló, Jordi 000134670 7102_ $$15008$$2800$$aUniversidad de Zaragoza$$bDpto. Ingeniería Electrón.Com.$$cÁrea Teoría Señal y Comunicac. 000134670 773__ $$g13 (2024), e51298 [15 pp.]$$tJMIR Research Protocols$$x1929-0748 000134670 8564_ $$s448045$$uhttps://zaguan.unizar.es/record/134670/files/texto_completo.pdf$$yVersión publicada 000134670 8564_ $$s2491815$$uhttps://zaguan.unizar.es/record/134670/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000134670 909CO $$ooai:zaguan.unizar.es:134670$$particulos$$pdriver 000134670 951__ $$a2024-04-24-13:25:50 000134670 980__ $$aARTICLE