{
  "abstract": "Introduction The global burden of depression continues to rise despite evidence that prevention is feasible and cost-effective. Building on the Resilience Enhancement with Smartphone in Living ENvironmenTs (RESiLIENT) randomised controlled trial, the Best, Efficient and Affordable Training in Resilience in Constant Evolution (BEATRICE) platform trial evaluates and optimises smartphone-delivered cognitive–behavioural therapy (CBT) for adults with no to subthreshold depression. The primary objective is to minimise the Total Burden of Depression, measured by the integral of weekly to monthly Patient Health Questionnaire-8 (PHQ-8) scores over 12 months, through a living, adaptive platform trial that sequentially tests multiple clinical questions and personalised algorithms.Methods and analysis BEATRICE is a nationwide, digitally centralised, multi-arm platform trial conducted via the ‘Resilience Training App’. Eligible participants are adults (aged ≥18 years) with PHQ-8 ≤14, fluent in Japanese, owning a smartphone and not currently receiving mental health treatment. Recruitment takes place through health-insurance associations, companies, municipalities and online outreach. Participants are randomised centrally to CBT skill modules—behavioural activation, assertion training, behaviour therapy for insomnia, cognitive restructuringor problem-solving—delivered alone or in combination. Assessments are open-label and completed digitally by self-reports.The initial list of clinical questions to be examined in this platform trial includes: external validity of the personalised and optimised algorithm for first-line interventions, strategies to help individuals not on track during initial weeks, second-line interventions at 6 months, development of super-personalised and optimised therapy algorithm, that is, longitudinally personalised and optimised in response to individuals’ responses after the first-line assignment. The primary outcomes, sample sizes and statistical analyses differ depending on the clinical question addressed within the platform trial.Ethics and dissemination Approved by the Ethics Committee of Kyoto University Graduate School of Medicine (C1733). Results will be disseminated via peer-reviewed publications, conferences and public reports.Trial registration number UMIN000058696.",
  "authors": [
    {
      "affiliations": [
        "Office of Institutional Advancement and Communications, Kyoto University, Kyoto, Japan"
      ],
      "name": "Toshi A Furukawa"
    },
    {
      "affiliations": [
        "Department of Interdisciplinary Statistical Mathematics, The Institute of Statistical Mathematics, Tachikawa, Japan",
        "The Graduate Institute for Advanced Studies, The Graduate University for Advanced Studies, Tachikawa, Japan"
      ],
      "name": "Hisashi Noma"
    },
    {
      "affiliations": [
        "Department of Data Science for Business Innovation, Chuo University, Tokyo, Japan"
      ],
      "name": "Masahiro Kojima"
    },
    {
      "affiliations": [
        "Department of Health Promotion and Behavioral Sciences, Graduate School of Medicine/School of Public Health, Kyoto University, Kyoto, Japan"
      ],
      "name": "Aran Tajika"
    },
    {
      "affiliations": [
        "Department of Health Promotion and Behavioral Sciences, Graduate School of Medicine/School of Public Health, Kyoto University, Kyoto, Japan"
      ],
      "name": "Rie Toyomoto"
    },
    {
      "affiliations": [
        "Department of Neurodevelopmental Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Aichi, Japan"
      ],
      "name": "Masatsugu Sakata"
    },
    {
      "affiliations": [
        "Department of Next-Generation Organ Transplantation, Graduate School of Medicine, The University of Tokyo, Bunkyo, Tokyo, Japan"
      ],
      "name": "Yan Luo"
    },
    {
      "affiliations": [
        "Department of Health Promotion and Behavioral Sciences, Graduate School of Medicine and School of Public Health, Kyoto University, Kyoto, Japan"
      ],
      "name": "Kosuke Inoue,"
    },
    {
      "affiliations": [
        "Musashino University, Tokyo, Japan"
      ],
      "name": "Masaru Horikoshi"
    },
    {
      "affiliations": [
        "Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Aichi, Japan"
      ],
      "name": "Tatsuo Akechi"
    },
    {
      "affiliations": [
        "Department of Digital Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan"
      ],
      "name": "Norito Kawakami"
    },
    {
      "affiliations": [
        "Department of Social Epidemiology, Graduate School of Medicine and School of Public Health, Kyoto University, Kyoto, Japan"
      ],
      "name": "Naoki Kondo"
    },
    {
      "affiliations": [
        "Department of Health Informatics, Kyoto University School of Public Health, Kyoto, Japan"
      ],
      "name": "Takeo Nakayama"
    },
    {
      "affiliations": [
        "Department of Healthcare Epidemiology, Graduate School of Medicine, Kyoto University, Kyoto, Japan"
      ],
      "name": "Shingo Fukuma"
    },
    {
      "affiliations": [
        "Black Dog Institute, University of New South Wales, Sydney, New South Wales, Australia"
      ],
      "name": "Helen Christensen"
    },
    {
      "affiliations": [
        "Black Dog Institute, University of New South Wales, Sydney, New South Wales, Australia"
      ],
      "name": "Alexis Whitton"
    },
    {
      "affiliations": [
        "Department of Psychology, Trier University, Trier, Germany"
      ],
      "name": "Wolfgang Lutz"
    },
    {
      "affiliations": [
        "Department of Clinical, Neuro and Developmental Psychology, Amsterdam, Vrije Universiteit Amsterdam, The Netherlands"
      ],
      "name": "Pim Cuijpers"
    },
    {
      "affiliations": [
        "Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts, USA"
      ],
      "name": "Ronald C Kessler"
    },
    {
      "affiliations": [
        "Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK",
        "MRC Biostatistics Unit, University of Cambridge, Cambridge, UK"
      ],
      "name": "James Wason"
    },
    {
      "affiliations": [
        "Institute for Social Research, University of Michigan, Ann Arbor, Michigan, USA"
      ],
      "name": "Inbal Nahum-Shani"
    }
  ],
  "title": "Platform trial of smartphone-based cognitive–behavioural therapy (CBT) for depressive symptoms among people with no or subthreshold depression: a protocol for the Best, Efficient and Affordable Training in Resilience in Constant Evolution (BEATRICE) platform trial",
  "uid": "f0bc3170-b85f-5388-81ca-0b4c51db2a6c"
}