Eisner Emily, Agass Ria, Camacho Elizabeth, Falana Adedamola, Hann Mark, Ifezue Anulika, Lemetyinen Henna, Myers Holly, Stockton-Powdrell Charlotte, Tower Clare, Watson Kylie, Whelan Pauline, Wittkowski Anja, Lewis Shôn
Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.
Pilot Feasibility Stud. 2025 Apr 12;11(1):47. doi: 10.1186/s40814-025-01631-7.
BACKGROUND: Meta-analyses indicate that 17% of mothers experience postnatal depression (PND) in the year following childbirth, with suicide the leading cause of direct maternal death between 6 weeks and 12 months postpartum. The consequences and costs of PND are particularly high due to impacts on infants as well as parents. If detected, PND usually responds well to psychological treatment and/or medication but national reports indicate > 50% of cases are undetected. To improve detection, we developed a digital screening system (CareLoop PND) whereby mothers use an app to monitor their mood daily using a validated measure (Edinburgh Postnatal Depression Scale; EPDS), with real-time responses uploaded to a secure server. In this paper, we describe the protocol of a study to determine feasibility of delivering a full-scale RCT comparing digital screening with standard NHS practice. METHODS: In this single-blind randomised feasibility trial, participants (n = 80) will be recruited during late pregnancy from two NHS maternity services and randomised (1:1) to receive CareLoop PND alongside their usual NHS care, or usual care alone. Those in the experimental arm will use the CareLoop PND app daily from ≥ 36 weeks' pregnancy until 8 weeks postpartum. During this period, participants scoring above EPDS screening thresholds (via the app or standard care) will be assessed to confirm diagnosis. True positive PND cases identified by digital screening will be referred to services for support. A blinded researcher will conduct follow-up assessments using clinical and health economic measures at 8 weeks and 6 months postpartum. At 8 weeks postpartum, experimental arm participants will also provide qualitative and quantitative feedback exploring app usability, acceptability, and implementation. Feasibility of delivering a full-scale RCT will be evaluated using a priori criteria relating to app engagement, study retention and completion of candidate primary outcome measures. CONCLUSIONS: Digital screening could increase appropriate referral to perinatal mental health care. However, prior to roll out in NHS services, evidence of efficacy and cost-effectiveness is needed. The current study protocol will determine whether a full-scale RCT examining efficacy and cost-effectiveness is feasible and will inform the design of such a trial. TRIAL REGISTRATION: Prospective ISRCTN registration (03/07/23): ISRCTN10781027; https://www.isrctn.com/ISRCTN10781027 .
背景:荟萃分析表明,17%的母亲在分娩后的一年内会经历产后抑郁症(PND),自杀是产后6周和12个月之间孕产妇直接死亡的主要原因。由于对婴儿和父母都会产生影响,产后抑郁症的后果和成本特别高。如果能够被检测出来,产后抑郁症通常对心理治疗和/或药物治疗反应良好,但国家报告显示,超过50%的病例未被检测到。为了改善检测情况,我们开发了一种数字筛查系统(CareLoop PND),通过该系统母亲们可以使用一款应用程序,利用经过验证的测量工具(爱丁堡产后抑郁量表;EPDS)每日监测自己的情绪,并将实时反应上传到一个安全的服务器。在本文中,我们描述了一项研究的方案,以确定开展一项将数字筛查与英国国家医疗服务体系(NHS)标准做法进行比较的全面随机对照试验(RCT)的可行性。 方法:在这项单盲随机可行性试验中,将在妊娠晚期从两个NHS产科服务机构招募参与者(n = 80),并将其随机分组(1:1),一组在接受常规NHS护理的同时使用CareLoop PND,另一组仅接受常规护理。试验组的参与者将从妊娠≥36周开始直至产后8周每天使用CareLoop PND应用程序。在此期间,对爱丁堡产后抑郁量表筛查阈值以上(通过应用程序或标准护理)的参与者进行评估以确诊。通过数字筛查确定的真正的产后抑郁症阳性病例将被转介到相关服务机构以获得支持。一名盲法研究人员将在产后8周和6个月时使用临床和卫生经济学指标进行随访评估。在产后8周时,试验组的参与者还将提供定性和定量反馈,以探讨应用程序的可用性、可接受性和实施情况。将使用与应用程序参与度、研究保留率和候选主要结局指标完成情况相关的先验标准来评估开展全面随机对照试验的可行性。 结论:数字筛查可以增加围产期心理健康护理的适当转诊。然而,在NHS服务中推广之前,需要有疗效和成本效益的证据。当前的研究方案将确定一项检验疗效和成本效益的全面随机对照试验是否可行,并为该试验的设计提供信息。 试验注册:前瞻性国际标准随机对照试验编号注册(2023年7月3日):ISRCTN10781027;https://www.isrctn.com/ISRCTN10781027 。
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