Digital Assessment of Well-being in New Parents

Postnatal Depression Clinical Trial

— DAWN-P  

Official title:

Digital Assessment of Well-being in New Parents (DAWN-P)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04279093
• Other study ID #: 274007
• Status: Completed
• Start date: April 14, 2020
• Est. completion date: September 9, 2020

Study information

• Verified date: April 2022
• Source: Manchester Academic Health Science Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 9, 2020
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Postnatal Depression

Intervention

Other:
• 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

Locations

Country	Name	City	State
United Kingdom	University of Manchester	Manchester	Greater Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Emily Eisner	Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase	Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase	36 weeks gestation until 6 weeks postpartum
Primary	Percentage of eligible individuals recruited to the study	Percentage of eligible individuals recruited to the study	Baseline
Primary	Dropout rate - percentage of participants who consent to take part in the study dropping out during the app use phase	Percentage of participants who consent to take part in the study dropping out during the app use phase	36 weeks gestation until 6 weeks postpartum
Primary	Percentage of participants completing at least a third of app-based assessments	Percentage of participants completing at least a third of app-based assessments. The a priori "accept" criterion will be >33% data points completed	36 weeks gestation until 6 weeks postpartum
Primary	Percentage of participants completing at least half of app-based assessments	Percentage of participants completing at least half of app-based assessments. The a priori target criterion will be 50% of participants submitting at least 50% of app-based assessments.	36 weeks gestation until 6 weeks postpartum
Secondary	Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app	Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app	6 weeks postpartum
Secondary	abridged Mobile App Rating Scale	abridged Mobile App Rating Scale score	6 weeks postpartum
Secondary	Edinburgh Postnatal Depression Scale - app-based version	Edinburgh Postnatal Depression Scale - app-based version	36 weeks gestation until 6 weeks postpartum
Secondary	Edinburgh Postnatal Depression Scale - paper version	Edinburgh Postnatal Depression Scale - paper version	36-37 weeks gestation; 5-6 weeks postpartum
Secondary	Number of adverse events occurring during the app-use phase of the study	Number of adverse events occurring during the app-use phase of the study	36 weeks gestation until 6 weeks postpartum
Secondary	Qualitative interview data on participants' experience of using the app.	Qualitative interview data on participants' experience of using the app.	6 weeks postpartum
Secondary	Demographic questionnaire	Demographic questionnaire asking standard questions about participants' demographic characteristics - e.g. age, gender, employment status.	Baseline (36 weeks pregnant)
Secondary	BMI (from casenotes)	BMI (from casenotes)	Baseline (36 weeks pregnant)
Secondary	past psychiatric history as reported in casenotes (any history of major depression, previously prescribed psychiatric medication, previously referred for talking therapy)	past psychiatric history as reported in casenotes (any history of major depression, previously prescribed psychiatric medication, previously referred for talking therapy)	Baseline (36 weeks pregnant)
Secondary	Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)	Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)	Baseline (36 weeks pregnant)
Secondary	Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)	Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)	Baseline (36 weeks pregnant)
Secondary	parity (total number of pregnancies reaching viable gestational age)	parity (total number of pregnancies reaching viable gestational age)	Baseline (36 weeks pregnant)