BJPsych Open (Sep 2024)
Identifying digital biomarkers of illness activity and treatment response in bipolar disorder with a novel wearable device (TIMEBASE): protocol for a pragmatic observational clinical study
- Gerard Anmella,
- Filippo Corponi,
- Bryan M. Li,
- Ariadna Mas,
- Marina Garriga,
- Miriam Sanabra,
- Isabella Pacchiarotti,
- Marc Valentí,
- Iria Grande,
- Antoni Benabarre,
- Anna Giménez-Palomo,
- Isabel Agasi,
- Anna Bastidas,
- Myriam Cavero,
- Miquel Bioque,
- Clemente García-Rizo,
- Santiago Madero,
- Néstor Arbelo,
- Andrea Murru,
- Silvia Amoretti,
- Anabel Martínez-Aran,
- Victoria Ruiz,
- Yudit Rivas,
- Giovanna Fico,
- Michele De Prisco,
- Vincenzo Oliva,
- Aleix Solanes,
- Joaquim Radua,
- Ludovic Samalin,
- Allan H. Young,
- Antonio Vergari,
- Eduard Vieta,
- Diego Hidalgo-Mazzei
Affiliations
- Gerard Anmella
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Filippo Corponi
- ORCiD
- School of Informatics, University of Edinburgh, UK
- Bryan M. Li
- ORCiD
- School of Informatics, University of Edinburgh, UK
- Ariadna Mas
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Marina Garriga
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Miriam Sanabra
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Isabella Pacchiarotti
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Marc Valentí
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Iria Grande
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Antoni Benabarre
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Anna Giménez-Palomo
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Isabel Agasi
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain
- Anna Bastidas
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Myriam Cavero
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Miquel Bioque
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; Institute of Neurosciences (UBNeuro), University of Barcelona, Spain; and Barcelona Clinic Schizophrenia Unit, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
- Clemente García-Rizo
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; Institute of Neurosciences (UBNeuro), University of Barcelona, Spain; and Barcelona Clinic Schizophrenia Unit, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
- Santiago Madero
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; Institute of Neurosciences (UBNeuro), University of Barcelona, Spain; and Barcelona Clinic Schizophrenia Unit, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
- Néstor Arbelo
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; Institute of Neurosciences (UBNeuro), University of Barcelona, Spain; and Barcelona Clinic Schizophrenia Unit, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
- Andrea Murru
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Silvia Amoretti
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Anabel Martínez-Aran
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Victoria Ruiz
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain
- Yudit Rivas
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain
- Giovanna Fico
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Michele De Prisco
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Vincenzo Oliva
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Aleix Solanes
- ORCiD
- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; Institute of Neurosciences (UBNeuro), University of Barcelona, Spain; and Imaging of Mood- and Anxiety-Related Disorders (IMARD) Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
- Joaquim Radua
- ORCiD
- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; Institute of Neurosciences (UBNeuro), University of Barcelona, Spain; Imaging of Mood- and Anxiety-Related Disorders (IMARD) Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Early Psychosis: Interventions & Clinical Detection (EPIC) Laboratory, Department of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK; and Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Sweden
- Ludovic Samalin
- ORCiD
- Institut Pascal (UMR 6602), Department of Psychiatry, CHU Clermont-Ferrand, University of Clermont Auvergne, CNRS, Clermont Auvergne INP, France; and Association Française de Psychiatrie Biologique et Neuropsychopharmacologie (AFPBN), Saint Germain en Laye, France
- Allan H. Young
- ORCiD
- Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, UK
- Antonio Vergari
- ORCiD
- School of Informatics, University of Edinburgh, UK
- Eduard Vieta
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- Diego Hidalgo-Mazzei
- ORCiD
- Digital Innovation Group, Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Department of Psychiatry and Psychology, Hospital Clínic de Barcelona, Spain; Department of Psychiatry and Psychology, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Biomedical Research Networking Centre Consortium on Mental Health (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain; Department of Medicine, School of Medicine and Health Sciences, University of Barcelona, Spain; and Institute of Neurosciences (UBNeuro), University of Barcelona, Spain
- DOI
- https://doi.org/10.1192/bjo.2024.716
- Journal volume & issue
-
Vol. 10
Abstract
Background Bipolar disorder is highly prevalent and consists of biphasic recurrent mood episodes of mania and depression, which translate into altered mood, sleep and activity alongside their physiological expressions. Aims The IdenTifying dIgital bioMarkers of illnEss activity and treatment response in BipolAr diSordEr with a novel wearable device (TIMEBASE) project aims to identify digital biomarkers of illness activity and treatment response in bipolar disorder. Method We designed a longitudinal observational study including 84 individuals. Group A comprises people with acute episode of mania (n = 12), depression (n = 12 with bipolar disorder and n = 12 with major depressive disorder (MDD)) and bipolar disorder with mixed features (n = 12). Physiological data will be recorded during 48 h with a research-grade wearable (Empatica E4) across four consecutive time points (acute, response, remission and episode recovery). Group B comprises 12 people with euthymic bipolar disorder and 12 with MDD, and group C comprises 12 healthy controls who will be recorded cross-sectionally. Psychopathological symptoms, disease severity, functioning and physical activity will be assessed with standardised psychometric scales. Physiological data will include acceleration, temperature, blood volume pulse, heart rate and electrodermal activity. Machine learning models will be developed to link physiological data to illness activity and treatment response. Generalisation performance will be tested in data from unseen patients. Results Recruitment is ongoing. Conclusions This project should contribute to understanding the pathophysiology of affective disorders. The potential digital biomarkers of illness activity and treatment response in bipolar disorder could be implemented in a real-world clinical setting for clinical monitoring and identification of prodromal symptoms. This would allow early intervention and prevention of affective relapses, as well as personalisation of treatment.
Keywords
