Digital Assessment of Wellbeing in New Parents (DAWN-P): protocol of a randomised feasibility trial comparing digital screening for maternal postnatal depression with usual care screening.
Emily Eisner, Ria Agass, Elizabeth Camacho, Adedamola Falana, Mark Hann, Anulika Ifezue, Henna Lemetyinen, Holly Myers, Charlotte Stockton-Powdrell, Clare Tower, Kylie Watson, Pauline Whelan, Anja Wittkowski, Shôn Lewis
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引用次数: 0
Abstract
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.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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