{
  "abstract": "Introduction Chronic inflammatory skin diseases, despite low mortality, significantly impair quality of life (QoL). Up to 80% of patients with dermatological conditions experience severe itch and poor sleep, as well as related mental health challenges such as anxiety and depression. The relationship between skin diseases and mental health highlights the challenges that doctors face in treating these conditions. Existing psychotherapeutics, such as mindfulness training, cognitive behavioural therapy and acceptance and commitment therapy, are widely used and effective in the treatment of mental health illnesses. However, there is limited evidence on the application of such interventions in dermatology, and most mental health apps lack robust clinical evaluation. We report the design of a randomised controlled trial to evaluate the efficacy and implementation of a mobile app containing dermatology-specified psychotherapeutic strategies in reducing QoL burden.Methods and analysis English-speaking patients aged 16 years and older with psoriasis, eczema or chronic urticaria will be recruited and randomised into the intervention arm (psychotherapeutic application) or active control group (Healthy365 app, a general wellness application managed by the Singapore Health Promotion Board). This allows a comparative assessment of app-usage-specific outcomes while preserving the blinding of all participants. The primary outcome is the change in the Dermatology Life Quality Index (DLQI) score from baseline to week 8. Secondary outcomes include physician-assessed disease severity at weeks 8 and 16 relative to baseline, differences in other patient-reported measures at weeks 8, 16 and 32, self-reported treatment adherence and initiation/escalation of systemic medications. To understand how patients engage with the app, we will evaluate the implementation process, focusing on key measures such as engagement, satisfaction and willingness to pay. Statistical analysis will be carried out on an intention-to-treat basis, and missing data will be analysed using last observation carried forward.All participants will receive both verbal and written study information that aligns with Good Clinical Practice guidelines. Ethical approval has been obtained from the National Healthcare Group’s Domain Specific Review Board (reference number: 2022/00751). Results will be disseminated via publication in a relevant journal. Data will be available from the corresponding author on reasonable request.Trial registration number NCT06702293.",
  "authors": [
    {
      "affiliations": [
        "Division of Dermatology, Department of Medicine, National University Hospital, Singapore",
        "Department of Medicine, National University of Singapore Yong Loo Lin School of Medicine, Singapore"
      ],
      "name": "Ellie Choi"
    },
    {
      "affiliations": [
        "Division of Dermatology, Department of Medicine, National University Hospital, Singapore"
      ],
      "name": "Valencia Long"
    },
    {
      "affiliations": [
        "Department of Medicine, National University of Singapore Yong Loo Lin School of Medicine, Singapore",
        "Carey Business School, Johns Hopkins University, Baltimore, Maryland, USA"
      ],
      "name": "Phillip Phan"
    },
    {
      "affiliations": [
        "Biostatistics Unit, National University Singapore Yong Loo Lin School of Medicine, Singapore"
      ],
      "name": "Liang Shen"
    },
    {
      "affiliations": [
        "Dermatology, National Skin Centre, Singapore"
      ],
      "name": "Ziying Vanessa Lim"
    },
    {
      "affiliations": [
        "Department of Dermatology, KK Women's and Children’s Hospital, Singapore"
      ],
      "name": "Mark Jean-Aan Koh"
    },
    {
      "affiliations": [
        "Department of Medicine, National University of Singapore Yong Loo Lin School of Medicine, Singapore"
      ],
      "name": "Jia Yi Chua"
    },
    {
      "affiliations": [
        "Cardiovascular Metabolic Translational Research Program, National University of Singapore, Singapore",
        "Department of Cardiology, National University Health System, Singapore"
      ],
      "name": "Mayank Dalakoti"
    },
    {
      "affiliations": [
        "Department of Psychological Medicine, National University Hospital, Singapore",
        "Department of Psychological Medicine, National University of Singapore, Singapore"
      ],
      "name": "Cyrus S Ho"
    },
    {
      "affiliations": [
        "Division of Dermatology, Department of Medicine, National University Hospital, Singapore",
        "Department of Medicine, National University of Singapore Yong Loo Lin School of Medicine, Singapore"
      ],
      "name": "Nisha Suyien Chandran"
    },
    {
      "affiliations": [
        "Centre for Behavioural and Implementation Science Interventions, National University of Singapore Yong Loo Lin School of Medicine, Singapore"
      ],
      "name": "Nick Sevdalis"
    },
    {
      "affiliations": [
        "Centre for Research in Health Systems Performance, National University of Singapore Yong Loo Lin School of Medicine, Singapore",
        "Department of Family Medicine, National University Health System, Singapore"
      ],
      "name": "Jose M Valderas"
    },
    {
      "affiliations": [
        "Psychology, National University of Singapore Faculty of Arts & Social Sciences, Singapore"
      ],
      "name": "Kean J Hsu"
    }
  ],
  "title": "Protocol for a double-blinded randomised controlled trial and process evaluation of a digital psychotherapeutic app in Singapore to improve symptom burden in patients with dermatological problems",
  "uid": "d1ca0b41-117b-5a22-a22a-3310e44742d8"
}