Digital Assessment of Well-being in New Parents

NCT ID: NCT04279093

Last Updated: 2022-05-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-14

Study Completion Date

2020-09-09

Brief Summary

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The mental health of new parents around the time of the birth of their baby has been identified as a key priority in the NHS (National Health Service) Long Term plan. At present, there is no nationally implemented method for monitoring parents' mental health, although the use of the Edinburgh Postnatal Depression Scale (EPDS) has been recommended. This is a paper based questionnaire administered by health visitors in the postnatal period. For the purposes of this project, the investigators contacted health visitors in Manchester to find out how they use EPDS in practice. Currently, health visitors only use the questionnaire if they feel there is a need during visits, and the questionnaire is not kept (only the overall score). Since almost 20% of mums develop postnatal depression, more systematic and thorough screening is needed.

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.

Detailed Description

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Conditions

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Postnatal Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* after 36 weeks gestation
* 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

* current stillbirth (women experiencing a stillbirth during the study will be withdrawn from the study)
* fetal abnormality
* multiple pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

Emily Eisner

OTHER

Sponsor Role lead

Responsible Party

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Emily Eisner

Research Associate

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Manchester

Manchester, Greater Manchester, United Kingdom

Site Status

Countries

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United Kingdom

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.

Reference Type DERIVED
PMID: 35606731 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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274007

Identifier Type: -

Identifier Source: org_study_id

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