Postnatal DepressionDAWN-PNCT04279093
Digital Assessment of Well-being in New Parents
An observational study of Postnatal Depression, run by Emily Eisner at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postnatal Depression
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Apr 2020to 9 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- current stillbirth (women experiencing a stillbirth during the study will be withdrawn from the study)
- fetal abnormality
- multiple pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Manchester
Manchester, Greater Manchester, M13 9PL
About this study
Official title: Digital Assessment of Well-being in New Parents (DAWN-P)
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
- Being tested
- No intervention, but participants will use a smartphone app daily to complete the EPDS
- Keywords
- digital screening, mental health, smartphone app, postnatal depression, maternal mental health, paternal mental health
- Medical subject headings
- Depression, Postpartum, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, but participants will use a smartphone app daily to complete the EPDSOther
No intervention, but participants will use a smartphone app daily (ClinTouch DAWN-P) to complete the Edinburgh Postnatal Depression Scale
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention, but participants will use a smartphone app daily to complete the EPDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 weeks gestation until 6 weeks postpartum
Percentage of eligible individuals recruited to the study
Percentage of eligible individuals recruited to the study
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app
Measured: 6 weeks postpartum
abridged Mobile App Rating Scale
abridged Mobile App Rating Scale score
Measured: 6 weeks postpartum
Edinburgh Postnatal Depression Scale - app-based version
Edinburgh Postnatal Depression Scale - app-based version
Measured: 36 weeks gestation until 6 weeks postpartum
Edinburgh Postnatal Depression Scale - paper version
Edinburgh Postnatal Depression Scale - paper version
Measured: 36-37 weeks gestation; 5-6 weeks postpartum
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
Measured: 36 weeks gestation until 6 weeks postpartum
Qualitative interview data on participants' experience of using the app.
Qualitative interview data on participants' experience of using the app.
Measured: 6 weeks postpartum
Demographic questionnaire
Demographic questionnaire asking standard questions about participants' demographic characteristics - e.g. age, gender, employment status.
Measured: Baseline (36 weeks pregnant)
BMI (from casenotes)
BMI (from casenotes)
Measured: Baseline (36 weeks pregnant)
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)
Measured: Baseline (36 weeks pregnant)
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)
Measured: Baseline (36 weeks pregnant)
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)
Measured: Baseline (36 weeks pregnant)
parity (total number of pregnancies reaching viable gestational age)
parity (total number of pregnancies reaching viable gestational age)
Measured: Baseline (36 weeks pregnant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start14 Apr 2020
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emily Eisner
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Emily Eisner, Manchester Academic Health Science Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279093
- Sponsor's protocol ID
- 274007
- Acronym
- DAWN-P
- Status last verified
- Apr 2022
- First submitted
- 14 Feb 2020
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing of data beyond the research team will be on a per request basis; only that data which can be fully anonymised data will be shared.Qualitative data or full demographics will not be shared due to potential identifiability.
Publications
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.
PubMed 35606731
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Assessment of Well-being in New Parents (DAWN-P)
- ClinicalTrials.gov ID
- NCT04279093
- Acronym / sponsor ID
- DAWN-P / 274007
- Conditions
- Postnatal Depression
- Keywords
- digital screening, mental health, smartphone app, postnatal depression, maternal mental health, paternal mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Emily EisnerUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant/postpartum women and their partners | – | Other: No intervention, but participants will use a smartphone app daily to complete the EPDSThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- current stillbirth (women experiencing a stillbirth during the study will be withdrawn from the study)
- fetal abnormality
- multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, but participants will use a smartphone app daily to complete the EPDSNo intervention, but participants will use a smartphone app daily (ClinTouch DAWN-P) to complete the Edinburgh Postnatal Depression Scale | Other | Pregnant/postpartum women and their partners |
Primary outcome
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
Time frame: 36 weeks gestation until 6 weeks postpartum
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase
Percentage of eligible individuals recruited to the study
Time frame: Baseline
Percentage of eligible individuals recruited to the study
Dropout rate - percentage of participants who consent to take part in the study dropping out during the app use phase
Time frame: 36 weeks gestation until 6 weeks postpartum
Percentage of participants who consent to take part in the study dropping out during the app use phase
Percentage of participants completing at least a third of app-based assessments
Time frame: 36 weeks gestation until 6 weeks postpartum
Percentage of participants completing at least a third of app-based assessments. The a priori "accept" criterion will be >33% data points completed
Percentage of participants completing at least half of app-based assessments
Time frame: 36 weeks gestation until 6 weeks postpartum
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.
12 secondary outcomes
Transcripts from qualitative interviews with parents who have used the screening app regarding acceptability of the app
Time frame: 6 weeks postpartum
abridged Mobile App Rating Scale
Time frame: 6 weeks postpartum
Edinburgh Postnatal Depression Scale - app-based version
Time frame: 36 weeks gestation until 6 weeks postpartum
Edinburgh Postnatal Depression Scale - paper version
Time frame: 36-37 weeks gestation; 5-6 weeks postpartum
Number of adverse events occurring during the app-use phase of the study
Time frame: 36 weeks gestation until 6 weeks postpartum
Qualitative interview data on participants' experience of using the app.
Time frame: 6 weeks postpartum
Demographic questionnaire
Time frame: Baseline (36 weeks pregnant)
BMI (from casenotes)
Time frame: Baseline (36 weeks pregnant)
past psychiatric history as reported in casenotes (any history of major depression, previously prescribed psychiatric medication, previously referred for talking therapy)
Time frame: Baseline (36 weeks pregnant)
Answers to mental health screening questions at booking appointment (NICE, 2014: section 1.5.4)
Time frame: Baseline (36 weeks pregnant)
Details of current childbirth (mode of delivery, live/still birth, any major obstetric complications)
Time frame: Baseline (36 weeks pregnant)
parity (total number of pregnancies reaching viable gestational age)
Time frame: Baseline (36 weeks pregnant)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 35606731Eisner 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.
- Individual participant dataSharing planned: Undecided. Sharing of data beyond the research team will be on a per request basis; only that data which can be fully anonymised data will be shared.Qualitative data or full demographics will not be shared due to potential identifiability.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postnatal Depression, run by Emily Eisner at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of app based EPDS (Edinburgh Postnatal Depression Scale) assessments completed during the app-use phase (time frame: 36 weeks gestation until 6 weeks postpartum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279093, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.