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
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 impa...
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BMC
2025-04-01
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| Series: | Pilot and Feasibility Studies |
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| Online Access: | https://doi.org/10.1186/s40814-025-01631-7 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Emily Eisner |
| collection | DOAJ |
| description | 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. Trial registration Prospective ISRCTN registration (03/07/23): ISRCTN10781027; https://www.isrctn.com/ISRCTN10781027 . |
| format | Article |
| id | doaj-art-daf42cbe383a4f369f5950db6496bf74 |
| institution | OA Journals |
| issn | 2055-5784 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMC |
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| series | Pilot and Feasibility Studies |
| spelling | doaj-art-daf42cbe383a4f369f5950db6496bf742025-08-20T02:11:58ZengBMCPilot and Feasibility Studies2055-57842025-04-0111111310.1186/s40814-025-01631-7Digital Assessment of Wellbeing in New Parents (DAWN-P): protocol of a randomised feasibility trial comparing digital screening for maternal postnatal depression with usual care screeningEmily Eisner0Ria Agass1Elizabeth Camacho2Adedamola Falana3Mark Hann4Anulika Ifezue5Henna Lemetyinen6Holly Myers7Charlotte Stockton-Powdrell8Clare Tower9Kylie Watson10Pauline Whelan11Anja Wittkowski12Shôn Lewis13Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, University of ManchesterMersey and West Lancashire Teaching Hospitals NHS TrustInstitute of Population Health, University of LiverpoolGreater Manchester Mental Health NHS Foundation TrustCentre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, University of ManchesterManchester University NHS Foundation TrustGreater Manchester Mental Health NHS Foundation TrustGreater Manchester Mental Health NHS Foundation TrustDivision of Informatics, Imaging and Data Sciences, Faculty of Biology, Medicine and Health, Centre for Health Informatics, University of ManchesterManchester University NHS Foundation TrustManchester University NHS Foundation TrustDivision of Informatics, Imaging and Data Sciences, Faculty of Biology, Medicine and Health, Centre for Health Informatics, University of ManchesterDivision of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, University of ManchesterDivision of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, University of ManchesterAbstract 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 .https://doi.org/10.1186/s40814-025-01631-7Postnatal depressionDigital mental healthmHealthSmartphoneMaternal mental healthScreening |
| spellingShingle | 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 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 Pilot and Feasibility Studies Postnatal depression Digital mental health mHealth Smartphone Maternal mental health Screening |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Postnatal depression Digital mental health mHealth Smartphone Maternal mental health Screening |
| url | https://doi.org/10.1186/s40814-025-01631-7 |
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