{
  "abstract": "Introduction Mobile health (mHealth) technologies have become increasingly popular for monitoring mental health symptoms and lifestyle behaviours, and are largely reported to be feasible and acceptable to users. However, to date, the efficacy of such technologies to improve perinatal mental health outcomes has been mixed. Within the perinatal context, much of this work has been done in the context of postpartum depression, stemming from electronic health records as well as cohort studies. There is, however, a dearth of studies focusing on depression in pregnancy, and machine learning-based clinical decision support systems remain underexplored. The HappyMums application has been developed to meet this need, and its use across Europe will be tested in this study.Methods and analysis A total of 1000 pregnant people currently suffering from, or at risk of, antenatal depression will be recruited across six countries. All participants will be between 13 and 28 weeks’ gestation and will be given access to the new purposefully developed HappyMums mobile application, to use from enrolment until 2 months postpartum. The application leverages passively collected data from smartphone sensors relating to physical activity and behaviour, as well as requiring active engagement from the user to complete mental health questionnaires and ‘game-like’ activities. Digital data types will be combined with traditional mental health measurement methods, such as standardised questionnaires and interviews, to develop novel predictive models capable of identifying mental health trajectories in women at risk of developing antenatal depression and to test the app’s utility for use as personalised risk prediction and depression identification tool. The primary outcome of this study is to determine what proportion of users will continue to use the mobile application and engage with its tasks and activities at least weekly, while secondary exploratory outcomes include assessing usability of the app and testing the predictive ability of a novel machine learning-based model. These outcomes will, for the first time, be assessed by integrating active as well as passive data.Ethics and dissemination Ethical approval has been granted by local research ethics committees in each recruiting centre. At King’s College London (leading the clinical study), the study was reviewed by the East of England—Essex Research Ethics Committee and granted favourable opinion (REC reference 24/EE/0129). All other sites collecting participant data have the study approved for local delivery. Findings relating to the primary and secondary outcomes will be submitted for publication in open access, peer-reviewed journals, as well as presentations at conferences as symposia or posters. Findings will be made available to a non-specialist audience through open access digital mental health magazines and promotion on social media.Trial registration number NCT06578845.",
  "authors": [
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, England, UK"
      ],
      "name": "Kristi Priestley"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, England, UK"
      ],
      "name": "Riddhi Laijawala"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, England, UK"
      ],
      "name": "Katie Hazelgrove"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, England, UK"
      ],
      "name": "Rebecca Bind"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, England, UK"
      ],
      "name": "Lavinia Rebecchini"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, England, UK"
      ],
      "name": "Nicole Mariani"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, England, UK"
      ],
      "name": "Sorcha Alford"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, England, UK"
      ],
      "name": "Madeline Kirkpatrick"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, England, UK"
      ],
      "name": "Francesca Mancino"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, England, UK"
      ],
      "name": "Seungyoung Kim"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, England, UK"
      ],
      "name": "Suvasthiga Pushpakanthan"
    },
    {
      "affiliations": [
        "Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy"
      ],
      "name": "Alessandra Biaggi"
    },
    {
      "affiliations": [
        "Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy"
      ],
      "name": "Libera Cavaliere"
    },
    {
      "affiliations": [
        "Biological Psychiatry Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy"
      ],
      "name": "Maria Grazia Di Benedetto"
    },
    {
      "affiliations": [
        "Department of Psychology, Catholic University of Croatia, Zagreb, Croatia"
      ],
      "name": "Marijana Matijaš"
    },
    {
      "affiliations": [
        "Department of Psychology, Catholic University of Croatia, Zagreb, Croatia"
      ],
      "name": "Maja Žutić"
    },
    {
      "affiliations": [
        "Department of Psychology, Catholic University of Croatia, Zagreb, Croatia"
      ],
      "name": "Maja Brekalo"
    },
    {
      "affiliations": [
        "Department of Psychology, Catholic University of Croatia, Zagreb, Croatia"
      ],
      "name": "Sandra Nakić Radoš"
    },
    {
      "affiliations": [
        "Institute of Psychology, SWPS University, Warsaw, Poland"
      ],
      "name": "Katarzyna Żukowska"
    },
    {
      "affiliations": [
        "Institute of Psychology, SWPS University, Warsaw, Poland"
      ],
      "name": "Anna Braniecka"
    },
    {
      "affiliations": [
        "Faculty of Psychology, SWPS University, Warsaw, Poland"
      ],
      "name": "Marta Jackowska"
    },
    {
      "affiliations": [
        "Psychiatry and Clinical Psychobiology Unit, Division of Neurosciences, IRCCS San Raffaele Scientific Institute, Milan, Italy"
      ],
      "name": "Margherita Bessi"
    },
    {
      "affiliations": [
        "Psychiatry and Clinical Psychobiology Unit, Division of Neurosciences, IRCCS San Raffaele Scientific Institute, Milan, Italy"
      ],
      "name": "Elena Agnoletto"
    },
    {
      "affiliations": [
        "Psychiatry and Clinical Psychobiology Unit, Division of Neurosciences, IRCCS San Raffaele Scientific Institute, Milan, Italy"
      ],
      "name": "Elisa Maria Teresa Melloni"
    },
    {
      "affiliations": [
        "Psychiatry and Clinical Psychobiology Unit, Division of Neurosciences, IRCCS San Raffaele Scientific Institute, Milan, Italy"
      ],
      "name": "Francesco Benedetti"
    },
    {
      "affiliations": [
        "R&D, Ab.Acus srl, Milan, Italy"
      ],
      "name": "Maria Bulgheroni"
    },
    {
      "affiliations": [
        "R&D, Ab.Acus srl, Milan, Italy"
      ],
      "name": "Margherita La Gamba"
    },
    {
      "affiliations": [
        "Barcelona Artificial Intelligence in Medicine Lab (BCN-AIM), Facultat de Matemàtiques i Informàtica, Universitat de Barcelona, Barcelona, Spain"
      ],
      "name": "Carlos Martín Isla"
    },
    {
      "affiliations": [
        "Barcelona Artificial Intelligence in Medicine Lab (BCN-AIM), Facultat de Matemàtiques i Informàtica, Universitat de Barcelona, Barcelona, Spain"
      ],
      "name": "Cristian Izquierdo Morcillo"
    },
    {
      "affiliations": [
        "Barcelona Artificial Intelligence in Medicine Lab (BCN-AIM), Facultat de Matemàtiques i Informàtica, Universitat de Barcelona, Barcelona, Spain",
        "Institució Catalana de Recerca i Estudis Avançats (ICREA), Barcelona, Spain"
      ],
      "name": "Karim Lekadir"
    },
    {
      "affiliations": [
        "Department of Psychology, University of Helsinki Finland, Helsinki, Finland"
      ],
      "name": "Verna Salo"
    },
    {
      "affiliations": [
        "Department of Psychology, University of Helsinki Finland, Helsinki, Finland"
      ],
      "name": "Tiina Seikku"
    },
    {
      "affiliations": [
        "Department of Psychology, University of Helsinki Finland, Helsinki, Finland"
      ],
      "name": "Katri Räikkönen"
    },
    {
      "affiliations": [
        "Institute of Medical Psychology, Charité—Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Medical Psychology, Berlin, Germany",
        "German Center for Child and Adolescent Health, Berlin, Germany"
      ],
      "name": "Malvika Godara"
    },
    {
      "affiliations": [
        "Institute of Medical Psychology, Charité—Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Medical Psychology, Berlin, Germany"
      ],
      "name": "Ulrike Maria Schneider-Schmid"
    },
    {
      "affiliations": [
        "Institute of Medical Psychology, Charité—Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Medical Psychology, Berlin, Germany",
        "German Center for Child and Adolescent Health, Berlin, Germany",
        "Development, Health, and Disease Research Program, University of California, Irvine, California, USA",
        "German Center for Mental Health, Berlin, Germany"
      ],
      "name": "Sonja Entringer"
    },
    {
      "affiliations": [
        "Institute of Medical Psychology, Charité—Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Medical Psychology, Berlin, Germany",
        "German Center for Child and Adolescent Health, Berlin, Germany",
        "Development, Health, and Disease Research Program, University of California, Irvine, California, USA",
        "German Center for Mental Health, Berlin, Germany"
      ],
      "name": "Claudia Buß"
    },
    {
      "affiliations": [
        "Tommy’s, United Kingdom, London, UK"
      ],
      "name": "Deirdre de Barra"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, England, UK"
      ],
      "name": "Anthony Woods"
    },
    {
      "affiliations": [
        "Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK"
      ],
      "name": "Paola Dazzan"
    },
    {
      "affiliations": [
        "Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, Italy",
        "Biological Psychiatry Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy"
      ],
      "name": "Annamaria Cattaneo"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, England, UK"
      ],
      "name": "Carmine Pariante"
    }
  ],
  "title": "HappyMums mobile application study protocol: use of a smartphone application to gather data predictive of antenatal depression",
  "uid": "8d266775-58b0-53da-933d-7d9b49d88783"
}