Choi Ellie, Long Valencia, Phan Phillip, Shen Liang, Lim Ziying Vanessa, Koh Mark Jean-Aan, Chua Jia Yi, Dalakoti Mayank, Ho Cyrus S, Chandran Nisha Suyien, Sevdalis Nick, Valderas Jose M, Hsu Kean J
Division of Dermatology, Department of Medicine, National University Hospital, Singapore
Department of Medicine, National University of Singapore Yong Loo Lin School of Medicine, Singapore.
BMJ Open. 2025 Jul 25;15(7):e098266. doi: 10.1136/bmjopen-2024-098266.
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.
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.
NCT06702293.
慢性炎症性皮肤病尽管死亡率较低，但会严重损害生活质量（QoL）。高达80%的皮肤病患者会经历严重瘙痒、睡眠不佳，以及焦虑和抑郁等相关心理健康问题。皮肤病与心理健康之间的关系凸显了医生在治疗这些疾病时面临的挑战。现有的心理治疗方法，如意念训练、认知行为疗法和接纳与承诺疗法，在心理健康疾病的治疗中被广泛使用且有效。然而，关于此类干预措施在皮肤科应用的证据有限，并且大多数心理健康应用程序缺乏有力的临床评估。我们报告了一项随机对照试验的设计，以评估一款包含皮肤科特定心理治疗策略的移动应用程序在减轻生活质量负担方面的疗效和实施情况。
将招募16岁及以上患有银屑病、湿疹或慢性荨麻疹的英语患者，并将其随机分为干预组（心理治疗应用程序）或积极对照组（健康365应用程序，由新加坡健康促进委员会管理的一款一般健康应用程序）。这使得在保持所有参与者盲态的同时，能够对应用程序使用特定的结果进行比较评估。主要结局是从基线到第8周皮肤病生活质量指数（DLQI）评分的变化。次要结局包括相对于基线，医生在第8周和第16周评估的疾病严重程度、在第8周、第16周和第32周其他患者报告指标的差异、自我报告的治疗依从性以及全身用药的起始/升级情况。为了解患者如何使用该应用程序，我们将评估实施过程，重点关注参与度、满意度和支付意愿等关键指标。将基于意向性分析进行统计分析，缺失数据将采用末次观察结转法进行分析。所有参与者都将收到符合良好临床实践指南的口头和书面研究信息。已获得国家医疗集团领域特定审查委员会的伦理批准（参考编号：2022/00751）。结果将通过在相关期刊上发表进行传播。如有合理请求，相应作者将提供数据。
NCT06702293。
