{
  "abstract": "Introduction Over 50% of patients participating in cardiac rehabilitation (CR) experience poor sleep and/or, closely related, psychological stress. Although stress management interventions are generally available, they are typically underutilised in CR, and sleep remains an underaddressed component within CR. This is concerning, as poor sleep and stress not only reinforce each other but are also associated with poorer cardiovascular health and lower quality of life. Therefore, the primary aim of the OPtimising CArdiac REhabilitation by REfining Sleep and STress (RESST) study is to investigate the (cost-)effectiveness of adding a behavioural intervention targeted at improving sleep and managing stress during CR (RESST intervention) on sleep and psychological stress. Furthermore, the study aims to explore the (bidirectional) associations between sleep, stress and lifestyle behaviours.Methods and analysis This parallel-arm multicentre randomised controlled trial will include 200 CR patients across 3 major CR centres in the Netherlands who experience poor sleep and/or stress. Patients will be randomised in a 1:1 ratio to standard CR or standard CR with the RESST intervention. Standard CR is a structured programme combining exercise, lifestyle guidance and risk management. On top of standard CR, the RESST intervention consists of 5 in-person group sessions targeting sleep and stress and is based on Acceptance and Commitment Therapy and Cognitive Behavioural Therapy. Primary outcomes are accelerometer-assessed and self-reported sleep and perceived stress. Secondary outcomes include quality of life, psychosocial well-being, chronic stress biomarkers (hair cortisol and cortisone), momentary fatigue, momentary stress and physical activity. Linear mixed models will be used to assess changes in outcomes at 3-month (after intervention and/or CR completed) and 6-month follow-up. The momentary data collected with ecological momentary assessment and accelerometry will be analysed using multilevel linear mixed models to explore the (bidirectional) relationship between sleep, stress and other lifestyle components such as physical activity.Ethics and dissemination This study was approved by the ethics committee of Erasmus MC, Erasmus University Medical Centre, Rotterdam, the Netherlands (MEC-2024-0238). The findings will be disseminated through publications in peer-reviewed journals, presentations at academic conferences and professional and patient publications.Trial registration number NCT06505109.",
  "authors": [
    {
      "affiliations": [
        "Department of Rehabilitation Medicine, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands",
        "Capri Cardiac Rehabilitation, Rotterdam, The Netherlands"
      ],
      "name": "Inge van Loon"
    },
    {
      "affiliations": [
        "Department of Rehabilitation Medicine, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands",
        "Capri Cardiac Rehabilitation, Rotterdam, The Netherlands"
      ],
      "name": "Esmée Ooms"
    },
    {
      "affiliations": [
        "The Netherlands Institute of Mental Health and Addiction, Trimbos Institute, Utrecht, The Netherlands"
      ],
      "name": "Annemarie Luik"
    },
    {
      "affiliations": [
        "Capri Cardiac Rehabilitation, Rotterdam, The Netherlands"
      ],
      "name": "Madoka Sunamura"
    },
    {
      "affiliations": [
        "Capri Cardiac Rehabilitation, Rotterdam, The Netherlands"
      ],
      "name": "Tamara Wally"
    },
    {
      "affiliations": [
        "Cardiovascular Institute, Department of Cardiology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands"
      ],
      "name": "Eric Boersma"
    },
    {
      "affiliations": [
        "Department of Cardiology, Máxima Medical Centre, Eindhoven/Veldhoven, The Netherlands"
      ],
      "name": "Tom Vromen"
    },
    {
      "affiliations": [
        "Department of Cardiology, Máxima Medical Centre, Eindhoven/Veldhoven, The Netherlands"
      ],
      "name": "Nicole Tenbült-van Limpt"
    },
    {
      "affiliations": [
        "Department of Rehabilitation Medicine, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands"
      ],
      "name": "Hans Bussmann"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Division of Endocrinology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands",
        "Obesity Center CGG, Department of Internal Medicine, Division of Endocrinology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands"
      ],
      "name": "Mariette Boon"
    },
    {
      "affiliations": [
        "Department of Neurology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands"
      ],
      "name": "Maartje Louter"
    },
    {
      "affiliations": [
        "Erasmus School of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, The Netherlands"
      ],
      "name": "Ken Redekop"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, Section Nursing Science, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands",
        "Department of Neonatal and Pediatric Intensive Care, Division of Pediatric Intensive Care, Erasmus MC Sophia Children’s Hospital, University Medical Centre Rotterdam, Rotterdam, The Netherlands"
      ],
      "name": "Erwin Ista"
    },
    {
      "affiliations": [
        "Department of Rehabilitation Medicine, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands"
      ],
      "name": "Rita van den Berg-Emons"
    },
    {
      "affiliations": [
        "Department of Rehabilitation Medicine, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands",
        "Capri Cardiac Rehabilitation, Rotterdam, The Netherlands"
      ],
      "name": "Nienke ter Hoeve"
    },
    {
      "affiliations": [],
      "name": "on behalf of the other OPTICARE-RESST Consortium members"
    }
  ],
  "title": "Optimising sleep and managing stress by integrating a behavioural intervention during cardiac rehabilitation: rationale and design of the OPTICARE-RESST multicentre randomised controlled trial",
  "uid": "74e94984-964a-5313-9199-1dc53ebbfcd0"
}