Centre for Psychiatry Research, Department of Clinical Neuroscience, Stockholm Health Care Services & Karolinska Institutet, Stockholm, Sweden
Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
BMJ Open. 2023 Feb 28;13(2):e068908. doi: 10.1136/bmjopen-2022-068908.
Our aim is to investigate whether a shortened digital self-care intervention is non-inferior to, and cost-effective compared with, a comprehensive and therapist-guided cognitive behavioural therapy treatment for atopic dermatitis (AD).
This is a single-blind, randomised clinical non-inferiority trial at Karolinska Institutet, a medical university in Stockholm, Sweden. We will recruit 174 adult participants with AD through self-referral. Participants will be randomised 1:1 to the two experimental conditions. Participants randomised to guided care will receive internet-delivered cognitive behavioural therapy for 12 weeks. Participants randomised to digital self-care will have access to this self-guided intervention for 12 weeks. At post-treatment (primary endpoint), non-inferiority will be tested and resource use will be compared between the two treatment groups. Cost-effectiveness will be explored at 1-year follow-up. Potential mediators will be investigated. Data will be analysed intention to treat. We define non-inferiority as a three-point difference on the primary outcome measure (Patient-oriented Eczema Measure). Recruitment started in November 2022.
This study is approved by the Swedish ethics authority (reg. no 2021-06704-01) and is preregistered at ClinicalTrials.gov. The study will be reported according to the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. The results of the study will be published in peer-reviewed scientific journals and disseminated to patient organisations and media.
NCT05517850.
我们的目的是研究缩短的数字自我护理干预是否与全面的、由治疗师指导的认知行为疗法治疗特应性皮炎（AD）等效，并且具有成本效益。
这是一项在瑞典斯德哥尔摩卡罗林斯卡研究所进行的单盲、随机临床非劣效性试验。我们将通过自我推荐招募 174 名患有 AD 的成年参与者。参与者将被 1:1 随机分为两组实验条件。随机分配到指导护理组的参与者将接受为期 12 周的互联网提供的认知行为疗法。随机分配到数字自我护理组的参与者将可以使用这种自我指导的干预措施 12 周。在治疗后（主要终点），将测试非劣效性，并比较两组治疗组之间的资源使用情况。在 1 年随访时将探讨成本效益。将调查潜在的中介因素。数据将按照意向治疗进行分析。我们将非劣效性定义为主要结局测量（患者导向的湿疹测量）的三点差异。招募工作于 2022 年 11 月开始。
本研究已获得瑞典伦理委员会的批准（注册号 2021-06704-01），并在 ClinicalTrials.gov 上预先注册。该研究将按照非药物试验的《统一报告标准声明》进行报告。研究结果将发表在同行评议的科学期刊上，并分发给患者组织和媒体。
NCT05517850。
