Digital Assessment of Well-being in New Parents (DAWN-P)
Conditions: Postnatal Depression
Sponsor: Emily Eisner

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Research Protocol: Digital Assessment of Wellbeing in 
New Parents (DAWN-P) 
 
Contents 
 
Introduction ........................................................................................................................ 3 
Background ....................................................................................................................... 3 
Aim .................................................................................................................................... 4 
Study Objectives ................................................................................................................ 5 
Primary research question .............................................................................................. 5 
Secondary research questions ....................................................................................... 5 
Design ............................................................................................................................... 5 
Participants ........................................................................................................................ 6 
Inclusion and exclusion criteria ....................................................................................... 6 
Recruitment and consent ................................................................................................ 6 
DAWN-P smartphone app ................................................................................................. 7 
App design ..................................................................................................................... 7 
 ....................................................................................................................................... 8 
App registration .............................................................................................................. 8 
App setup and training ................................................................................................... 8 
Data collection ................................................................................................................... 9 
Demographics and casenote data .................................................................................. 9 
App-reported data .......................................................................................................... 9 
Telephone calls .............................................................................................................. 9 
Follow-up meeting and qualitative interview ..................................................................10 
Adverse events .............................................................................................................11 
Outcome measures ..........................................................................................................11 
Primary outcome measure ............................................................................................11 
Secondary outcome measures ......................................................................................11 
Data analysis ....................................................................................................................12 
Research Question 1 .....................................................................................................12 
Research Question 2 .....................................................................................................12 
Research Question 3 .....................................................................................................12 

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Research Question 4 .....................................................................................................13 
Research Question 5 .....................................................................................................13 
Research Question 6 .....................................................................................................13 
Research Question 7 .....................................................................................................13 
General procedural issues ................................................................................................13 
Financial reimbursement ...............................................................................................13 
Data monitoring and quality assurance ..........................................................................14 
Adverse events .............................................................................................................14 
Ethical and regulatory considerations ............................................................................14 
Data protection and confidentiality .................................................................................14 
Limits to confidentiality ..................................................................................................15 
Risks to participants ......................................................................................................15 
Risks to researchers (safe working procedures) ............................................................16 
Peer review ...................................................................................................................16 
Statement of indemnity ..................................................................................................16 
Funding .........................................................................................................................16 
Publication Policy ..........................................................................................................16 
References .......................................................................................................................17 
List of appendices .............................................................................................................18 
 
 

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Introduction 
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 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, we 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. 
 
We developed an app version of the EPDS which takes less than 2 minutes to complete on a 
smartphone. We anticipate 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.  
 
We 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. 
 
Background 
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 Long Term plan (Section 3.16; NHS England, 2019). 
Almost 20% of mums develop postnatal depression during the three months after giving birth 
(Gavin et al, 2005). For fathers, the rate of depression peaks slightly later, with 7.7% of 
fathers developing depression in the first three months, rising to 26% in the 3-6 months 
postpartum (Paulson and Bazemore, 2010). Early detection and treatment can reduce the 
risk of severe postnatal depression developing (Davies et al, 2003).  
 
At present, there is no nationally implemented method for monitoring parents’ mental health, 
although use of the Edinburgh Postnatal Depression Scale (EPDS; Appendix A) has been 
recommended (Davies et al, 2003; NICE, 2014). This is a widely-used paper-based 
questionnaire, typically administered by health visitors in the postnatal period. The EPDS 
shows moderate validity in both mothers (Eberhard-Gran et al, 2001; Gibson et al, 2005) and 
fathers (Edmondson et al, 2010). For the purposes of this project, we 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 so many new parents develop postnatal depression, 
more systematic and thorough screening is needed.  
 

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Smartphone apps have been shown to be acceptable for monitoring symptoms of a range of 
mental health problems such as depression (Firth et al, 2017), psychosis (Berry et al, 2016) 
and bipolar disorder (Nicholas et al, 2015). Apps have a number of advantages over paper 
based questionnaires: they can be accessed at times and places convenient to the 
individual, since smartphones tend to be carried on one’s person and their use is often 
integrated within daily life (Ben-Zeev et al, 2013). Monitoring with an app is less resource 
intensive, meaning that assessments can be more frequent, reducing the risk of retrospective 
recall bias since the period to be recalled is shortened (Ben-Zeev et al, 2012). Native 
smartphone apps also have advantages over web-based systems as they are less 
dependent on a good data or Wifi connection and therefore more accessible in rural locations 
and for low income users (Ben-Zeev et al, 2013). Moreover, native apps are widely used in 
the general population so they may be a low stigma way of assessing mental health (Berry et 
al, 2019; Bucci et al, 2018) and they can include automated features such as reminders, 
generation of graphs and secure upload of data.  
 
There has been no research to date examining the feasibility, acceptability, validity and 
safety of using a smartphone app to screen for depression in new parents during the early 
postpartum period. For clarity: feasibility relates to whether people will actually use an app for 
this purpose; acceptability concerns to whether people like using an app for this purpose; 
validity examines whether the app measures what it is supposed to measure, by comparing it 
with current gold-standard assessments; safety evaluates whether there are any adverse 
effects of using the app. 
 
We searched the literature for studies or study protocols testing smartphone apps to screen 
for postnatal depression in new parents and found none published to date. Although we 
found one study (Jiménez-Serrano et al, 2015) describing the development of an app for this 
purpose (within the Spanish healthcare system), the app’s feasibility, acceptability and 
validity have not yet been tested. We found several studies examining the use of one-off 
screening using a tablet device in the postnatal period (e.g. during clinic visits), but none 
using a smartphone app to screen on a repeated measures basis postnatally. Similarly, we 
found a number of studies (Hantsoo et al, 2017; Faherty et al, 2017; Tsai et al, 2014; 
Krishnamurti et al, 2017) and one protocol (Belisario et al, 2017) using a smartphone app to 
screen for depression during pregnancy but not during the postnatal period. Overall, there 
appears to be a gap in the literature in terms of screening for postnatal depression using a 
smartphone app. 
 
Therefore, we developed an app version of the EPDS (the ClinTouch DAWN-P app) which 
takes less than 2 minutes to complete on a smartphone. We anticipate that this will be a 
more accessible and practical method of conducting this important assessment than using 
paper based questionnaires. 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.  
 
Aim 
The aim of the study is to investigate whether it is feasible, acceptable, valid and safe to use 
a smartphone app to screen for depression in new parents during the early postnatal period. 

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Study Objectives 
Primary research question 
1: Is it feasible to use a smartphone app to screen for postnatal depression in mums and 
their partners during the 6 weeks postpartum? (measures of feasibility will include: 
percentage of eligible individuals recruited to the study; dropout rate; percentage of app-
based assessments completed during the app-use phase; percentage of participants 
completing at least a third of app-based assessments; percentage of participants completing 
at least half of app-based assessments; timing of responses during the 2 hour response 
period) 
 
Secondary research questions 
2. Do mums and their partners find it acceptable to use a smartphone app for this purpose? 
(abridged Mobile App Rating Scale and qualitative interviews) 
 
3. Is it valid to use a smartphone app for this purpose? (comparison of app based 
assessment with gold-standard paper questionnaire assessment) 
 
4. Is it safe to use a smartphone app for this purpose? (adverse events will be monitored 
throughout the study) 
 
5. What are participants' experiences of using an app for this purpose? (qualitative 
interviews) 
 
6. Who is most likely to use an app for this purpose? (analysis of baseline clinical and/or 
demographic predictors of app engagement during the study) 
 
7. How long do participants use an app for this purpose? (analysis of pattern of app use over 
time during the study) 
 
 
Design 
This is a longitudinal feasibility study comprising: 
 
A baseline meeting for app setup and training. 
 
A 6-10 week follow up period in which participants are asked to use the app once per 
day to answer questions about their mental health (from late pregnancy until their 
baby is 6 weeks old). 
 
A follow-up meeting, to debrief, conduct questionnaires and a brief qualitative 
interview. 
 

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Participants 
Inclusion and exclusion criteria 
We 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. 
 
Recruitment and consent 
Clinicians at St Mary’s hospital will identify potential participants by reviewing the medical 
records of pregnant women attending the Antenatal Assessment Unit and/or the Antenatal 
Clinic (both non-emergency settings). Clinicians identifying potential participants will be part 
of their direct care team; they will provide initial information about the study, either verbally or 
using the initial information sheet (Appendix B). Posters (Appendix B) will also be displayed 
in St Mary’s hospital to allow potential participants the opportunity to self-refer to the study.  
 
Clinicians approaching potential participants about the study will make it clear that taking part 
is completely voluntary. If the person decides not to participate, the clinician will ask them to 
briefly state their reasons for not wanting to do so. The clinician will reiterate that participation 
is voluntary and make it clear that they are under no obligation to supply this information 
about their reasons for declining to participate. If the potential participant gives reasons for 
declining to participate, this reason will be entered completely anonymously into a 
spreadsheet (Appendix Q). A summary of this information will be reported anonymously in 
final study reports and will be used to inform future studies (e.g. if most people declined to 
participate because the smartphone app asked them to answer questions too often, a future 
version of the study might use an adapted version of the app with less frequent questions). 
 
If the service user is interested in participating, the clinician will either: 
a) ask the potential participant to complete a consent-to-contact form (Appendix L) and pass 
on their contact details to the research team and provide initial information to confirm 
eligibility; 
or 
b) complete the informed consent process for the study themselves and then pass the 
participant's details on to the research team, along with the signed consent form (Appendix 
D). 
 
If the potential participant is interested, the clinician or a researcher will provide a Participant 
Information Sheet (Appendix C). Where possible, the participant will have at least 24 hours to 

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read the information before having the opportunity to discuss it with the clinician/researcher. 
In this face-to-face meeting they will have the opportunity to discuss the information and ask 
any questions. If the potential participant wishes to take part they will be asked to sign a 
consent form (Appendix D). 
 
When a pregnant woman has consented to take part in the study, she will be asked if she 
has a partner who would potentially be interested in participating. If so, separate consent will 
be sought from the partner. 
 
The participant information sheet will make it clear that the participant is free to withdraw 
from the study at any time without giving a reason. Demographic and clinical information will 
be retained in the event that the participant withdraws. Data provided during the study will be 
retained unless the participant requests otherwise. Participants who withdraw during the app 
use phase of the study will be asked if they would be willing to take part in a qualitative 
interview. As this is a feasibility study it is important that the views of withdrawing participants 
are represented in the qualitative interviews if at all possible in order to inform future studies. 
However, it will be made clear to the participant that it is up to them whether they take part in 
qualitative interviews; they are under no obligation to do so. 
 
DAWN-P smartphone app 
App design 
The software for the ClinTouch DAWN-P app will be based on that of the original ClinTouch 
app. ClinTouch is a smartphone-based platform for a range of m-health interventions 
designed to help people with mental health disorders to monitor their own symptoms and 
prevent relapse. We have been developing and testing it since 2009. Using “experience-
driven design”, it has been developed with patients, clinicians and NHS health professionals 
and an academic team with software engineers at the University of Manchester, funded by 
MRC grants of £1.5m. It can be deployed in any long term mental or physical health 
condition. It works as a personalised smartphone application which triggers, collects and 
wirelessly uploads symptom data to a central server several times daily. We have shown that 
it is acceptable and feasible for people with mental health problems over extended periods. 
We have shown that the data collected are valid as measured against gold-standard rating 
scales. However, it has not yet been specifically tested for screening for emerging mental 
health conditions in a sample of parents during the postnatal period.  
 
The DAWN-P app will alert participants once per day (using a beep and a visual notification 
on the phone screen) and ask them to complete a series of questions about their mental 
health: namely, the ten items from the Edinburgh Postnatal Depression Scale (Appendix A). 
Each question will be displayed on the screen along with the four possible responses, 
chosen via radio buttons (see Figure 1). After each alert, participants will have a 2 hour 
response window in which to answer the questions. Their responses will be uploaded to a 
secure server at the University of Manchester. The research team will be able to log in via a 
password-protected web interface to view participants’ responses.  
 
 
 

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Figure 1: Mock-up of a question 
from the DAWN-P app 
 
 
 
 
 
 
 
 
 
 
 
App registration 
The original ClinTouch app was ruled not to be a Type 1 medical device by the Medicines 
and Healthcare products Regulatory Agency (MHRA). The same would apply to the 
ClinTouch DAWN-P app; thus, it does not require registration with MHRA.  
 
According to the MHRA guidance document entitled ‘Medical device stand-alone software 
including apps’ 
(https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_da
ta/file/717865/Software_flow_chart_Ed_1-05.pdf), the app does not have a ‘medical 
purpose’ (pg.10 of the guidance) and does not ‘work in combination with one or more 
devices’ (pg. 6), so is not classed as a medical device. For the purposes of the present 
study, the app is analogous to a paper diary, being used purely to collect data rather than to 
make a diagnosis or prompt participants to seek help. 
 
App setup and training 
At the beginning of the study, the DAWN-P app will be installed on the participant’s phone (if 
suitable) or they will be lent a study phone to use for the duration of the study. In cases 
where the participant is lent a phone, all phones remain the property of Affigo for the duration 
of the study and participants will sign a form confirming that they will return the phone on 
completion of or withdrawal from the study.  
 
The clinician/researcher will train the participant in how to use the app. Participants will 
spend some time familiarising themselves with the app, in the presence of the 
clinician/researcher, and will answer some practice questions on the app to check that they 
feel confident in using it. They will have the opportunity to ask the clinician/researcher any 
questions about the app at this stage. At the end of the initial app setup and training meeting, 
participants will be given a paper version of the EPDS and a stamped addressed envelope to 
take home with them.  

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Data collection 
Demographics and casenote data  
Participants (pregnant women and partners) will be asked to complete a demographic 
questionnaire (Appendix M) during the app training session, including the following: age, 
gender, ethnicity, employment status, whether English first language, past psychiatric history 
(any history of major depression, previously prescribed psychiatric medication, previously 
referred for talking therapy).  
 
For participating pregnant women, the following additional information will be gathered from 
casenotes: BMI, past psychiatric history as reported in casenotes (any history of major 
depression, previously prescribed psychiatric medication, previously referred for talking 
therapy), answers to mental health screening questions at booking appointment (NICE, 
2014: section 1.5.4), details of current childbirth (mode of delivery, live/still birth, any major 
obstetric complications), parity (total number of pregnancies reaching viable gestational age).  
 
App-reported data 
Participants (mums and their partners) will be asked to answer the ten EPDS questions, via 
the app, once per day until their baby is 6 weeks old. The questions are likely to take a 
maximum of 2 minutes to complete on each occasion. As not all births will occur on the due 
date, the exact length of time that participants are asked to use the app for will vary to some 
extent: 
 
Someone giving birth at 36 weeks would complete the app for 6 weeks in total 
 
Someone giving birth at 38 weeks (their due date), would complete the app for 2 
weeks before and 6 weeks after the birth (8 weeks in total). 
 
Someone giving birth at 40 weeks gestation would complete the app for 4 weeks 
before and 6 weeks after giving birth (10 weeks in total). 
 
Telephone calls 
The researcher will phone the participant at the end of the first week and then fortnightly after 
that (e.g. at the end of weeks 3, 5 and 7 for someone giving birth on their due date) to thank 
them for participating, troubleshoot any technical difficulties with the app, ask whether they 
have any queries or concerns, and encourage them to continue participating. If applicable, 
these phone calls will provide an opportunity for the participant to tell the researcher that they 
are no longer able to participate in the study for any reason, including, but not limited to, the 
unlikely event that the participant’s baby’s contracts a serious illness or dies. 
 
After the first week of app use, participants will be asked to complete the paper version of the 
EPDS that they were given in the baseline meeting. The researcher will send them a text 
message (from the researcher’s work mobile phone) to remind them to do so (see Appendix 
N for text message template). In the 1 week phone call, the researcher will ask the 
participant to either read out their answers from the questionnaire during a phone call, or 
alternatively to email an anonymous photograph of the questionnaire to the researcher. 
Participants will then be asked to return the original paper copy in the stamped addressed 

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envelope. Answers from the paper based questionnaire will be compared to app-reported 
answers from the previous week to check the validity of the app-based measure. 
 
In the final phone call, the researcher will arrange a face-to-face follow up meeting with the 
participant. 
 
Follow-up meeting and qualitative interview 
At the end of the app use phase of the study, the researcher will arrange a follow up meeting 
with the participant to debrief and return the study phone (if applicable). During this meeting 
they will ask the participant to complete a paper version of the EPDS (for further validity 
checks against app-based assessment) and an abridged version of the Mobile App Rating 
Scale (Gumley et al, 2019; Appendix E) to assess app acceptability.  
 
Participants will also be asked to take part in a brief qualitative interview exploring their 
experiences of using an app for screening for postnatal depression and their views on the 
acceptability of this screening method. Informed consent will be gathered for this using a 
separate consent form (Appendix F), including specific consent to audio-record the interview. 
Women and their partners will be interviewed separately. 
 
As many participants as possible will be interviewed, including some who dropped out of the 
app-use phase of study. This will ensure that a balance of views are gathered regarding the 
acceptability of the app-based screening. For individuals who dropped out of the app use 
phase, the Research Associate will emphasise that participation in the qualitative interview is 
entirely voluntary and it is up to the participant whether they want to do so. If the individual 
does not wish to participate, the Research Associate will thank them for their participation to 
date and assure them that their decision not to participate in the qualitative interviews will not 
affect the care that they receive from the NHS Trust. As stated above, separate consent will 
be sought for qualitative interviews in order to be sure that participants fully agree to 
participate. 
 
Interviews will be conducted by a Research Associate (EE) experienced in conducting and 
analysing qualitative interviews and with personal, lived experience of postnatal depression. 
Interviews will last around 30 minutes and will be audio recorded. A detailed topic guide is 
given in Appendix G. Throughout the interview, the approach will be flexible in terms of the 
order of questions and the vocabulary used, and probe questions will be used where 
applicable to prompt further elaboration by the interviewee. It is worth noting that the 
example questions and topic guide are necessarily preliminary. Topics may be further 
developed during the course of the interviews. The researcher will make brief notes after 
each interview on a proforma (Appendix H), including, for example, any important contextual 
details during the interview and whether any alterations to the topic guide are needed for the 
next interview. Audio recorded interviews will be transcribed verbatim and analysed using 
framework analysis.  
 

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Adverse events 
To assess the safety of the app, adverse events will be monitored throughout the study. As is 
standard practice for this type of study, we will complete the Health Research Authority form 
(https://www.hra.nhs.uk/documents/1087/safety-report-form-non-ctimp.docx) to report any 
serious adverse events.  
 
We will also record all untoward medical occurrences or clinical indications, their relatedness 
to the DAWN-P app, their seriousness and intensity and whether or not the event was 
anticipated, as recommended by Bradstreet and colleagues (2019).  
 
Outcome measures 
Primary outcome measure 
The feasibility of using a smartphone app to screen for postnatal depression in mums and 
their partners during the 6 weeks postpartum.  
 
(Research question 1: Is it feasible to use a smartphone app to screen for postnatal 
depression in mums and their partners during the 6 weeks postpartum?) 
 
Measures of feasibility will include: percentage of eligible individuals recruited to the study; 
dropout rate; percentage of app-based assessments completed during the app-use phase; 
percentage of participants completing at least a third of app-based assessments; percentage 
of participants completing at least half of app-based assessments; timing of responses 
during the 2 hour response period. 
 
Secondary outcome measures 
2. Qualitative (interviews) and quantitative (abridged Mobile App Rating Scale) data on 
acceptability (Research Question 2: do mums and their partners find it acceptable to use a 
smartphone app for this purpose?) 
 
3. App based assessment of postnatal depression using a digital version of the Edinburgh 
Postnatal Depression Scale will be compared with a gold-standard questionnaire version of 
the Edinburgh Postnatal Depression Scale. (Research question 3: Is it valid to use a 
smartphone app for this purpose?) 
 
4. Occurrence of adverse events (Research question 4: Is it safe to use a smartphone app 
for this purpose?) 
 
5. Qualitative interview data on participants' experience of using the app. (Research question 
5: What are participants' experiences of using an app for this purpose?) 
 
6. Baseline clinical and demographic information and measures of app engagement. 
(Research question 6: Who is most likely to use an app for this purpose?) 
 
7. Pattern of app use over time during the study. Research question 7: How long do 
participants use an app for this purpose?) 

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Data analysis 
Research Question 1 
Question: Is it feasible to use a smartphone app to screen for postnatal depression in mums 
and their partners during the 6 weeks postpartum?  
 
Analysis: we will provide a descriptive summary of the following: percentage of eligible 
individuals recruited to the study; dropout rate; percentage of app-based assessments 
completed during the app-use phase; percentage of participants completing at least a third of 
app-based assessments; percentage of participants completing at least half of app-based 
assessments; timing of responses during the 2 hour response period.  
 
The a priori “accept” criterion will be >33% data points completed, with the “target” criterion 
being 50% of participants submitting 50% of data entries. 
 
Research Question 2 
Question: Do mums and their partners find it acceptable to use a smartphone app for this 
purpose? 
 
Analysis: audio-recorded qualitative interviews will be transcribed verbatim and analysed 
using framework analysis, with a particular focus on a priori themes relating to acceptability 
(themes generated from the interview topic guide). Contextual notes written by the 
researcher at the time of the interview and excerpts from the researcher’s reflective journal 
will be used to further inform the analysis.  
 
Descriptive statistics summarising the quantitative data from the abridged Mobile App Rating 
Scale will also be reported. 
 
Research Question 3 
Question: Is it valid to use a smartphone app for this purpose? 
 
Analysis: Repeated-measures app-reported data (up to 7 data-points per person from daily 
assessments for one week) will be compared with a one off gold-standard questionnaire 
measure (Edinburgh Postnatal Depression Scale) at for two one-week periods (first and last 
week of the 8 week app use period) in two ways.  
 
Firstly, mixed effects models will be used to account for clustering by participant due to the 
repeated measures nature of the app use data. Mixed effects models will be constructed as 
follows: app-reported scores as the dependent variable, a fixed effect of the gold standard 
questionnaire score and a random effect of participant. The fixed effect coefficient can be 
interpreted as the average change in app-reported score for a 1-point change in gold-
standard questionnaire score. Given that the two measures use the same scoring system, 
the nearer the fixed effect coefficient is to one, the better. 
 

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Secondly, the average score from the repeated measures app-reported data will also be 
compared to the score on the gold standard measure using Spearman's correlation. This 
does not account for clustering by participant but will allow comparison with other app-use 
studies that do not use mixed effects models to assess validity. 
 
Research Question 4 
Question: Is it safe to use a smartphone app for this purpose?  
 
Analysis: Adverse events will be monitored throughout the study; descriptive statistics will be 
used to summarise the number of these and whether appear to be are related to or unrelated 
to app use. 
 
Research Question 5 
Question: What are participants' experiences of using an app for this purpose?  
 
Analysis: audio-recorded qualitative interviews will be transcribed verbatim and analysed 
using framework analysis, with a particular focus on a posteriori themes (‘emergent’ themes, 
not specifically determined by the topic guide but that contribute to the research question 
regarding participants’ experiences of using the app). Contextual notes written by the 
researcher at the time of the interview and excerpts from the researcher’s reflective journal 
will be used to further inform the analysis. 
 
Research Question 6 
Question: Who is most likely to use an app for this purpose?  
 
Analysis: Effects of baseline clinical and demographic variables on percentage app 
completion will be examined using Spearman’s correlation (continuous variables), Mann-
Whitney or Kruskal-Wallis tests (categorical variables). 
 
Research Question 7 
Question: How long do participants use an app for this purpose?  
 
Analysis: The pattern of app completion will be examined with mixed effects models with a 
random effect of participant and a fixed effect of time and percentage app completion as the 
dependent variable. 
 
General procedural issues 
Financial reimbursement 
Participants will receive up to £60 in shopping vouchers for participation in the study: £20 for 
each research visit and a further £20 on completion of the study. They will also be given £10 
phone credit per month while they are participating in the app use phase of the study (up to 
£20). 
 

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Data monitoring and quality assurance 
The study will be subject to the audit and monitoring regime of the University of Manchester. 
Adverse events 
Adverse events will be monitored and recorded during the study, including Serious Adverse 
events. As per ethics committee requirements, Serious Adverse Events will be reported to 
the REC immediately if they are related to the intervention and are unexpected. 
 
Ethical and regulatory considerations 
NHS Research Ethics Committee approval will be obtained before commencing research. 
The study will be conducted in full conformance with all relevant legal requirements and the 
principles of the Declaration of Helsinki, Good Clinical Practice (GCP) and the UK Policy 
Framework for Health and Social Care Research 2017. 
 
Data protection and confidentiality 
All participants will be allocated a unique study number. From then on, all participant data will 
be identified by this number only. Participant data will be stored securely and will only be 
accessible by the research team. Interview recordings will be transferred to a secure server 
at the University of Manchester. Other pseudonymised data will be kept on a secure 
University of Manchester server or in a locked filing cabinet (depending on the format). 
Personal information will be kept in a separate locked cabinet. The pseudonymisation key 
will be stored (separately from study data) in a locked filing cabinet in a locked office at the 
University of Manchester 
 
Participants’ responses to the questions on the phone app will be uploaded to a secure 
server at the University of Manchester (using the same system as the CareLoop study; REC 
reference 14/WM/0045). The informatics team who developed the system (and who will 
design the app) have a long experience of safeguarding the secure transfer and storage of 
this type of data and have previously explored the pertinent ethical issues in detail. The three 
general principles of information security (confidentiality, integrity and availability) are 
followed in the design and implementation of the system (NHS, 2009). All data transmitted to 
and from the server(s) will be encrypted over https with strong ciphers as detailed in the 
Approved Cryptographic Algorithms Good Practice Guidelines (NHS, 2012). Cipher Suites 
will be implemented in compliance with Section 6 (“Preferred uses of cryptographic 
algorithms in security protocols”) of the Good Practice Guidelines.  Members of the research 
team will be given their own individual logins for the web interface (via which participant data 
can be accessed) with their own username and password. Management of login accounts 
and passwords will be in accordance with the User Account Management Standard 
Operating Procedure. To ensure the safety of the data communicated, the pass phrase will 
be communicated to the recipient independently of the encrypted data, as recommended in 
the NHS Information Governance Guidelines (Department of Health, 2008). In cases where 
participant data is downloaded via the web interface or emailed to members of the research 
team for further analysis, this data will be anonymised and securely encrypted with a pass 
phrase of appropriate length and complexity.    
 

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In line with University of Manchester policy, data will be safely stored for 5 years after the last 
publication of the study and then destroyed. Consent forms will be kept as essential 
documents until the relevant research data are destroyed, at which point the consent forms 
will also be destroyed. Other personally identifiable information such as contact details will be 
deleted as soon as they are no longer required.  
 
Limits to confidentiality 
All participants will be informed about the limits of confidentiality during the consent process. 
This includes that information may be passed on to a clinician if the researcher is concerned 
that there is a risk to the service user themselves or to another person.  
 
If the EPDS question (paper or app version) related to thoughts of self-harm (Q10: “The 
thought of harming myself has occurred to me”) is rated as “yes, quite often” or “sometimes”, 
the research team will pass this information on to the GP. On week days (Monday-Friday), 
this will be done the same day; if thoughts of self-harm are disclosed at the weekend, this 
information will be passed to the GP on the next working day. If a participant continues to 
report self-harm on the EPDS Q10, the GP will be updated once a week.  
 
In other cases where the patient may be a risk to themselves or another person, all relevant 
information will be taken into account and all cases in which the researcher believes there 
may be cause for concern will be discussed with a consultant psychiatrist (SL) and/or 
consultant obstetrician (CT/GS) on the research team and information will be passed on to 
the service user’s GP if appropriate. 
 
If information gathered using the paper version of the Edinburgh Postnatal Depression Scale 
(EPDS) suggests that the participant may be developing postnatal depression, the 
researcher will ask for the participant’s permission to pass this information on to their GP. If 
they decline, information will only be passed on if we believe there is a risk of harm to the 
participant or to another person. 
 
This is not an interventional study and the app-based version of the EPDS has not yet been 
validated. Therefore, we will not automatically inform a participant’s GP if their scores on the 
app appear to be above threshold for possible postnatal depression. However, if we believe 
there is a risk of harm to the participant or to another person we will disclose this, as outlined 
above.  
 
Risks to participants 
We believe that the risks of taking part in the research are minimal. During the 
questionnaires we will ask participants about their mental health. For some people this may 
be a sensitive topic. The researchers will be aware of this possibility. They will check if 
participants have any concerns and provide the opportunity to discuss these if necessary. If 
participants find the questionnaires, interviews or using the phone app stressful, they are free 
to discontinue without having to give a reason. Participants can also request a break at any 
point if they wish. The Research Associate (Emily Eisner) is an experienced mental health 

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16 
 
researcher who has lived experience of postnatal depression. She is familiar with the 
challenges encountered by new parents and by people with mental health problems. 
 
The only other disadvantage of taking part in the study is giving up time to meet or talk on the 
phone with the researcher and to answer the questions on the phone app. We will make sure 
that all meetings with the researcher take place at a time and location that is convenient for 
the participant. Where possible these meetings will be combined with the participant’s visits 
to St Mary’s Hospital. We will also find out from participants when are the most convenient 
time(s) of day and day(s) of the week for them to receive phone calls from the researcher so 
as to cause minimal intrusion to their routine. 
 
Risks to researchers (safe working procedures) 
Home visits with the study population are generally likely to be low risk. The researcher will 
follow the School of Health Sciences (University of Manchester) policy and Trust-specific 
lone worker policies for home visits. A risk assessment will be undertaken regarding safety 
for lone home visits. If there are any concerns, the researcher will arrange a joint visit or will 
book a room at a local NHS service to meet the participant.  
 
During a visit the researcher will leave contact details and a proposed time for the end of the 
appointment with a member of the research team. An arrangement will be made for the 
researcher to phone the research team on leaving the participant’s home, or the person 
undertaking the safety check will phone at the proposed end time if they have not heard from 
the researcher. If attempts to contact the researcher are unsuccessful, a pre-arranged 
escalation procedure will be acted upon. 
 
Peer review 
This protocol has been peer reviewed by Prof Kathryn Abel, Professor of Psychological 
Medicine. 
 
Statement of indemnity 
The University has insurance available in respect of research involving human subjects that 
provides cover for legal liabilities arising from its actions or those of its staff or supervised 
students.  The University also has insurance available that provides compensation for non-
negligent harm to research subjects occasioned in circumstances that are under the control 
of the University. 
 
Funding  
The study is funded by two NHS Trusts (Greater Manchester Mental Health NHS Foundation 
Trust and Manchester University NHS Foundation Trust), via Health Innovation Manchester. 
 
Publication Policy 
The study protocol will be published, either on the clinicaltrials.gov website or as an open 
access publication in JMIR Research Protocols (https://www.researchprotocols.org/). 
 

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The study results will be disseminated via peer reviewed journal publication and conference 
presentation. We will distribute a leaflet summarising the study results to any participants 
who would like to receive it. We will also publicise the results within the NHS trust from which 
participants were recruited. 
 
References 
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among people with serious mental illness: opportunities for future services. Adm Policy 
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List of appendices 
 
Appendix A. 
Edinburgh Postnatal Depression Scale 
Appendix B. 
Initial study information leaflet/poster 
Appendix C. 
Participant Information Sheet 
Appendix D. 
Consent form (app use phase) 
Appendix E. 
Full/abridged MARS (depending what we decide) 
Appendix F. 
Consent form (qualitative interview) 
Appendix G. 
Topic guide (qualitative interview) 
Appendix H. 
Post interview report form (qualitative interview) 
Appendix I. 
Letter to GP 
Appendix J. 
Cover letter for initial information 
Appendix K. 
Follow-up reminder letter 
Appendix L. 
Consent to contact form 
Appendix M. 
Self-report demographic questionnaire 
Appendix N. 
Text message template 
Appendix O. 
Screenshot of app screen 
Appendix P. 
Chief Investigator’s CV