Digital Assessment of Well-being in New Parents

NCT04279093 | Completed

• 1 other identifier: 274007
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Postnatal Depression

Keywords

digital screening; mental health; smartphone app; postnatal depression; maternal mental health; paternal mental health

Outcome Measures

Primary Outcomes (5)

• 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

• Percentage of eligible individuals recruited to the study

  Percentage of eligible individuals recruited to the study

  Baseline

• 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

• 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

• 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 Outcomes (12)

• Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app

  6 weeks postpartum

• abridged Mobile App Rating Scale

  6 weeks postpartum

• Edinburgh Postnatal Depression Scale - app-based version

  36 weeks gestation until 6 weeks postpartum

• Edinburgh Postnatal Depression Scale - paper version

  36-37 weeks gestation; 5-6 weeks postpartum

• Number of adverse events occurring during the app-use phase of the study

  36 weeks gestation until 6 weeks postpartum

Study Arms (1)

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.

Other: No intervention, but participants will use a smartphone app daily to complete the EPDS

Interventions

No intervention, but participants will use a smartphone app daily to complete the EPDS OTHER

No intervention, but participants will use a smartphone app daily (ClinTouch DAWN-P) to complete the Edinburgh Postnatal Depression Scale

Pregnant/postpartum women and their partners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• current stillbirth (women experiencing a stillbirth during the study will be withdrawn from the study)
• fetal abnormality
• multiple pregnancy
• male or female partners of a mum participating in the study
• aged over 18
• fluent in English.

Sponsors & Collaborators

• Emily Eisner: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

University of Manchester

Manchester, Greater Manchester, M13 9PL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35606731 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Psychological Well-Being

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 20, 2020
• Study Start: April 14, 2020
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

GB (1)