Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
23 participants
OBSERVATIONAL
2020-04-14
2020-09-09
Brief Summary
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The investigators developed an app version of the EPDS which takes less than 2 minutes to complete on a smartphone. It is anticpated that this will be a more accessible and practical method of conducting this important assessment. This project is a feasibility study to find out whether an app would be a feasible, acceptable, valid and safe way to monitor perinatal mental health in women and their partners.
The investigators aim to recruit 20 women and their partners in late pregnancy (after 36 weeks gestation) and ask them to use the app. The app will prompt completion of the EPDS once per day until 6 weeks postnatally. Participants' responses on the app will be transferred to a secure server at the University of Manchester. Participants will be invited to complete a paper version of the EPDS at the beginning and end of the study to check validity. They will also be asked to complete a questionnaire measuring the acceptability of the app and to take part in a brief qualitative interview at the end of the study.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant/postpartum women and their partners
The investigators aim to recruit 20 women in late pregnancy from the Antenatal Assessment Unit and the Antenatal Clinic at St Mary's Hospital. Their partners will be invited to participate where applicable.
Inclusion and exclusion criteria for pregnant women are as follows:
* Inclusion: after 36 weeks gestation, aged over 18 years and fluent in English, under the care of Manchester University NHS Foundation Trust
* Exclusion: current stillbirth (women experiencing a stillbirth during the study will be withdrawn from the study), fetal abnormality, or multiple pregnancy
Inclusion criteria for partners: male or female partners of a mum participating in the study, aged over 18 and fluent in English.
No intervention, but participants will use a smartphone app daily to complete the EPDS
No intervention, but participants will use a smartphone app daily (ClinTouch DAWN-P) to complete the Edinburgh Postnatal Depression Scale
Interventions
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No intervention, but participants will use a smartphone app daily to complete the EPDS
No intervention, but participants will use a smartphone app daily (ClinTouch DAWN-P) to complete the Edinburgh Postnatal Depression Scale
Eligibility Criteria
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Inclusion Criteria
* aged over 18 years
* fluent in English
* under the care of Manchester University NHS Foundation Trust
* male or female partners of a mum participating in the study
* aged over 18
* fluent in English.
Exclusion Criteria
* fetal abnormality
* multiple pregnancy
18 Years
ALL
Yes
Sponsors
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Manchester University NHS Foundation Trust
OTHER_GOV
Emily Eisner
OTHER
Responsible Party
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Emily Eisner
Research Associate
Locations
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University of Manchester
Manchester, Greater Manchester, United Kingdom
Countries
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References
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Eisner E, Lewis S, Stockton-Powdrell C, Agass R, Whelan P, Tower C. Digital screening for postnatal depression: mixed methods proof-of-concept study. BMC Pregnancy Childbirth. 2022 May 23;22(1):429. doi: 10.1186/s12884-022-04756-2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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274007
Identifier Type: -
Identifier Source: org_study_id
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