Clinical trial NCT04279093: Digital Assessment of Well-being in New Parents
Official title: Digital Assessment of Well-being in New Parents (DAWN-P)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postnatal Depression
Keywords: digital screening
mental health
smartphone app
postnatal depression
maternal mental health
paternal mental health
Lead sponsor: Manchester Academic Health Science Centre
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2020-02-20
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators aim to recruit 20 women in late pregnancy from the Antenatal Assessment Unit and the Antenatal Clinic at St Mary's Hospital, Manchester. Their partners will be invited to participate where applicable.

Brief summary: 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.


Eligibility criteria: The investigators aim to recruit 20 women in late pregnancy from the Antenatal Assessment Unit and the Antenatal Clinic at St Mary's Hospital, Manchester. Their partners will be invited to participate where applicable.

Inclusion criteria for pregnant women:

* after 36 weeks gestation
* aged over 18 years
* fluent in English
* under the care of Manchester University NHS Foundation Trust

Exclusion criteria for pregnant women:

* current stillbirth (women experiencing a stillbirth during the study will be withdrawn from the study)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

Inclusion criteria for partners:

* male or female partners of a mum participating in the study
* aged over 18
* fluent in English.

Primary outcomes:
measure: Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
timeFrame: 36 weeks gestation until 6 weeks postpartum
measure: Percentage of eligible individuals recruited to the study
timeFrame: Baseline
measure: Dropout rate - percentage of participants who consent to take part in the study dropping out during the app use phase
timeFrame: 36 weeks gestation until 6 weeks postpartum
measure: Percentage of participants completing at least a third of app-based assessments
timeFrame: 36 weeks gestation until 6 weeks postpartum
measure: Percentage of participants completing at least half of app-based assessments
timeFrame: 36 weeks gestation until 6 weeks postpartum
Secondary outcomes:
measure: Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app
timeFrame: 6 weeks postpartum
measure: abridged Mobile App Rating Scale
timeFrame: 6 weeks postpartum
measure: Edinburgh Postnatal Depression Scale - app-based version
timeFrame: 36 weeks gestation until 6 weeks postpartum
measure: Edinburgh Postnatal Depression Scale - paper version
timeFrame: 36-37 weeks gestation; 5-6 weeks postpartum
measure: Number of adverse events occurring during the app-use phase of the study
timeFrame: 36 weeks gestation until 6 weeks postpartum
measure: Qualitative interview data on participants' experience of using the app.
timeFrame: 6 weeks postpartum
measure: Demographic questionnaire
timeFrame: Baseline (36 weeks pregnant)
measure: BMI (from casenotes)
timeFrame: Baseline (36 weeks pregnant)
measure: past psychiatric history as reported in casenotes (any history of major depression, previously prescribed psychiatric medication, previously referred for talking therapy)
timeFrame: Baseline (36 weeks pregnant)
measure: Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)
timeFrame: Baseline (36 weeks pregnant)
measure: Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)
timeFrame: Baseline (36 weeks pregnant)
measure: parity (total number of pregnancies reaching viable gestational age)
timeFrame: Baseline (36 weeks pregnant)
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester
state: Greater Manchester
Study officials:
References:
citation: 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.