BMJ Open · Medicine; Imperial College London, Department of Primary Care and Public Health ......

For peer review only

Tablet computers for implementing NICE antenatal mental health guidelines: protocol of a feasibility study

Journal: BMJ Open

Manuscript ID: bmjopen-2015-009930

Article Type: Protocol

Date Submitted by the Author: 07-Sep-2015

Complete List of Authors: Marcano-Belisario, Jose; Imperial College London, Department of Primary Care and Public Health Gupta, Ajay; Imperial College London, National Heart & Lung Institute O'Donoghue, John; Imperial College London, Department of Primary Care and Public Health Morrison, Cecily; Imperial College London, Department of Primary Care and Public Health Car, Josip; Nanyang Technological University, Lee Kong Chian School of

Medicine; Imperial College London, Department of Primary Care and Public Health

<b>Primary Subject Heading</b>:

Health informatics

Secondary Subject Heading: Health informatics, Mental health, Obstetrics and gynaecology, Public health

Keywords:

Information technology < BIOTECHNOLOGY & BIOINFORMATICS, Health informatics < BIOTECHNOLOGY & BIOINFORMATICS, MENTAL HEALTH, Prenatal diagnosis < OBSTETRICS, Depression & mood disorders < PSYCHIATRY, PUBLIC HEALTH

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Tablet computers for implementing NICE antenatal mental health guidelines: protocol of a feasibility

study

Corresponding author

José S Marcano-Belisario

Room 304, Reynolds Building, St Dunstan’s Road, London, W6 8RP, UK

[email protected]

Telephone: +44 (0)20 7594 0771

List of authors


Global eHealth Unit, Department of Primary Care and Public Health, Imperial College London, London, UK

Ajay K Gupta

National Heart & Lung Institute, Imperial College London, London, UK

John O’Donoghue

Global eHealth Unit, Department of Primary Care and Public Health, Imperial College London,

London, UK

Cecily Morrison


London, UK

Josip Car


London, UK

Keywords

mHealth

Perinatal depression

Screening

Self-administered surveys

Data collection

Word count

2948 words

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ABSTRACT

Introduction

Depression is one of the most common mental health disorders that may affect women during

pregnancy. The prompt identification of this disorder, and the provision of appropriate treatment,

may help to reduce the likelihood of postpartum depression, prevent more severe forms of the

disease, and reduce its intergeneration impact. Despite women’s repeated encounters with health

services throughout their antenatal care, depression often goes undiagnosed and untreated. This is

one area where mHealth could prove useful. We will assess the feasibility of using mobile devices to

incorporate depression screening into antenatal pathways. We will also assess if survey layout could

affect the quality of the data collected through these devices.

Methods and analysis

We will test the feasibility of using iPad Airs® for the administration of the Whooley questions and

the Edinburgh Postnatal Depression Scale (EPDS) to pregnant women attending antenatal clinics in

England. We will assess the impact of survey layout on the quality of the responses given to these

screening scales using a parallel randomised controlled study design. We will calculate the positive

predictive value (PPV), the negative predictive value (NPV) and the false omission rate (FOR) of the

Whooley questions in comparison with the EPDS. We will calculate differences in data equivalence,

time needed to complete the surveys, breakoff rates, data completeness and requests for help

between the two experimental groups: using all questions in one screen and navigation by vertical

scrolling, or a single question per screen and navigation by multiple pages.

Ethics and dissemination

This study has been approved by the National Research Ethics Service (NRES) Committee South East

Coast – Surrey (Reference 15/LO/0977).

Registration details

This study is being sponsored by Imperial College London (reference 15IC2687) and has been

included in the UK Clinical Research Network (CRN) Study Portfolio (UKCRNID number 19280).

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STRENGTHS OF THIS STUDY

• This study addresses an important area of unmet clinical need, which has a considerable

impact on healthcare systems and society in general.

• This study builds on the work that we did as part of a Cochrane systematic review looking at

the impact of mobile devices as a delivery mode on the quality of patient self-reported data.

• It will contribute to the evidence base for mobile health (mHealth).

• In the future, the lessons from this study will be interpreted in conjunction with those of

another study that will be looking at the feasibility of using mHealth for the recognition and

monitoring of depressive symptoms throughout pregnancy at home.

• It will attempt to identify usability issues that could impair the ability of already busy

healthcare professionals to perform their duties. This is in contrast to existing studies, where

mHealth interventions are deployed in highly controlled environments that do not resemble

the realities of a real-life clinical setting. Identifying these usability issues would allow us to

take actions to prevent their potential impact on healthcare professionals’ performance.

• It recognises the need for ensuring good data quality when data are used to inform clinical

and therapeutic decisions.

• It will explore the effect that survey presentation could have on the quality of the data

collected. This is in contrast to other studies in the medical literature, which have not

explored the factors that could affect data quality when using mHealth interventions.

LIMITATIONS OF THIS STUDY

• It will look at adult pregnant women only. The exclusion of teenage mothers-to-be could

result in the exclusion of a group at increased risk of mental health disorders.

• The exclusion of pregnant women who are not comfortable reading and writing in English,

may result in a sample that is not representative of certain communities in the UK.

• It will explore only mHealth as a delivery mode for identifying depressive symptoms, and not

for also delivering low-intensity psychological therapies.

• Lack of integration with clinical IT systems.

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INTRODUCTION

Maternal mental health is a key public health priority due to the impact it can have on a woman’s

well-being and on her child’s emotional, behavioural, cognitive and social development.[1-5]

Perinatal depression is one of the most common psychiatric disorders that can affect up to 15% of

women during pregnancy or within one year of giving birth. The direct and indirect financial costs of

perinatal depression to the health system, together with its direct impact on the mother and her

child, account for the majority of the overall costs to society of perinatal mental disorders.[5] In the

UK, these costs have been estimated at £8.1 billion for each one-year cohort of birth (with the

average costs of one case of perinatal depression estimated at £74k), 72% of which could be

attributed to the adverse effects experienced by the child.[2] For this reason, the early identification

of women who might be at risk of developing or have perinatal depression should be considered a

priority.[6]

Women appear to be at an increased risk of depression 3 to 6 months after childbirth.[1,4] Although

a recent longitudinal study found that symptoms of depression may be more prevalent at 4 years

postpartum.[7] Several factors are known to increase the likelihood of developing postpartum

depression.[1,6,8] Depression during pregnancy however, has been recognised as one of the most

important risk factors and one that is susceptible to early intervention. The point prevalence of

depression during the first, second and third trimesters of pregnancy has been estimated at 7.4%,

12.8% and 12%, respectively.[9] The timely identification of depression during these stages, and the

provision of appropriate treatment, can reduce the likelihood of developing postpartum depression,

prevent more severe forms of this disorder, and improve a woman’s general health status.[4,5]

Treating depression during pregnancy may also help reduce the intergenerational impact of this

condition.

Nonetheless, depression during pregnancy often goes undiagnosed and its routine screening is still

debated.[10] Validated screening tools, such as the Edinburgh Postnatal Depression Scale (EPDS),

can facilitate the early identification of depressive symptoms in pregnant women.[11] However,

cost-effectiveness is often cited as one of the key reasons against the routine screening for this

condition.[12] This is an area where smartphones and tablet computers could demonstrate their

value, in a field of study that is known as mobile health (mHealth). Thanks to their advanced

computational and networking capabilities, and overall popularity (in the first quarter of 2015, it was

reported that approximately 66% of adults in the UK owned a smartphone),[13] these devices could

facilitate depression screening and monitoring of symptoms[14] while reducing costs and

administrative burden.

Researchers from the School of Social Work at the University of Illinois and staff members at

Champaign-Urbanara Public Health District will be testing the use of tablet computers to implement

depression screening in maternal clinics.[15] They will be doing so during antenatal consultations.

Mobile devices could be used to screen for depression before a consultation, thus releasing some of

the consultation time. For this reason, we need to establish the feasibility of using these devices to

do so.

One aspect of delivering depression screening through mobile devices, is the impact that this

technology may have on data quality. This is to ensure that the data accurately reflect underlying

clinical changes. Our recent Cochrane review[16] suggests that collecting patient self-reported data

through apps is equivalent to collecting data through alternative delivery modes (i.e., paper, short

messaging service, laptops, plastic rulers, and personal digital assistants). This review also

highlighted that equivalence, and other data quality dimensions, could be affected by factors other

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than the delivery mode.[16] One of such factors is survey presentation. Unlike the survey

methodology literature however,[17,18] the effect of this factor on validated clinical tools has not

been systematically explored in the medical literature.

In this study we will assess the feasibility of implementing the recommendations from The National

Institute for Health and Care Excellence (NICE)[19] for recognising depression during pregnancy. We

will conduct our study in the waiting area of general practices, community midwiferies and hospitals

using iPad Air® tablets. We will evaluate the statistical properties of one of the validated instruments

recommended by this guideline. We will also assess if survey layout (as a component of survey

presentation) affects the quality of the responses collected through the screening instruments under

evaluation.

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METHODS AND ANALYSIS

study design

We will assess the feasibility of using iPad Air tablets® to administer a brief survey asking for

personal information, the Whooley questions and the EPDS (Appendix 1) to pregnant women

attending antenatal clinics across a number of primary and secondary care National Health Service

(NHS) centres in England. Study data will be collected and managed using Research Electronic Data

Capture (REDCap) tools hosted at Imperial College London.[20] REDCap mobile app version 1.19.4

(or later, if a new version becomes available) will be running on iOS version 8.4.1 (or later, if a new

version becomes available).

In order to evaluate the effect of survey layout on data quality, we will use a parallel, randomised

controlled study design. Pregnant women consenting to take part in this study will be randomly

assigned to complete (i) an app version of the Whooley questions and the EPDS in which all the

questions are presented on a single screen (app screening – scrolling layout), causing participants to

scroll vertically on the device; or (ii) an app version of the Whooley questions and the EPDS in which

only one question per page is presented at any given time (app screening – paging layout), causing

participants to navigate through multiple pages.

sample selection and recruitment

We will select our sample of participants from pregnant women attending antenatal clinics in

general practices, midwifery services and hospitals which are part of the NHS in England. Each

potential participant will be assessed by clinical staff against our inclusion and exclusion criteria

(Table 1).

Table 1. Participant inclusion and exclusion criteria

INCLUSION CRITERIA EXCLUSION CRITERIA

Women who are 18 years old or older Current diagnosis of mood [affective] disorders as specified in the 10th revision of the International Statistical Classification of Disease and Related Health Problems (ICD-10), Classification of Mental Health and Behavioural Disorders[21]

Pregnant and of any gestational age Currently receiving treatment for mood [affective] disorders

Any parity Recent personal history of mood [affective] disorders within the past 12 months

Attending antenatal clinics in participating NHS sites

Not comfortable reading and writing in English

On the day on the antenatal clinic, potential participants will be first approached in the waiting room

of the participating centres by a member of the clinical care team. If a potential participant

expresses her interest in this study, she will be introduced to one of our researchers who will explain

the details of the study to her. Potential participants will be provided with a patient information

sheet. The researcher will emphasise that the potential participant can ask any questions regarding

the study, and that she has at least 24 hours to decide on participation. Refusal to take part in this

study will not have an impact on a woman’s legal rights, medical care or on the relationship with her

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care providers. We will obtain written, informed consent from those women who, after receiving all

the relevant study information and asking study-related question, still wish to take part in this study.

interventions to be measured

Surveys

Non-validated, personal demographic survey

We will administer an 11-question survey to collect information about the woman’s age group,

ethnic background, marital status, employment status, level of education, smartphone or tablet

computer ownership, parity, and previous personal history of depression.

Whooley questions

The Whooley questions were developed as a case-finding instrument for depression in primary

care.[22] This 2-questions instrument assesses depressed mood and anhedonia that have been

present during the past month. Respondents are required to answer Yes or No to each question.

Edinburgh Postnatal Depression Scale (EPDS)

The EPDS is a 10-item self-administered survey that was developed to screen for perinatal

depression in the community.[23] This instrument assesses feelings of guilt, sleep disturbance,

reduced energy levels, anhedonia and suicidal ideation that have been present during the past 7

days. Each question is scored on a 4-point scale ranging from 0 to 3 points. An overall score is

calculated by adding the scores from each individual question. Overall scores between 10 and 12

points suggest increased risk for depression; scores of 13 points or more suggest that the diagnostic

criteria for major depression disorder have probably been met.[24] In addition, special attention

should be paid to item 10, as it deals with suicidal thoughts. Based on these scores, a clinician would

be prompted to refer a woman to a mental health professional.

The EPDS is a valid and reliable tool for identifying women who are at risk of depression, both during

pregnancy and postpartum. This instrument is also sensitive to changes in the severity of depression

over time.[23] The EPDS can be reproduced without further permission provided that the original

source of the scale is cited in each reproduced copy.

Screening for depression & effect of survey layout

Pregnant women taking part in our study will receive verbal instructions on how to complete the

surveys. Participants will also be informed that we will communicate their answers to the Whooley

questions and their scores on the EPDS to their clinicians, and that these results will be available for

discussion during her antenatal appointment. Participants’ results on the Whooley questions and on

the EPDS will be communicated to their general practitioners (GPs).

The researcher will also explain to participants that they can ask for help at any point while

completing the surveys, and that all questions should be directed to a member of the research team

(not to the clinical care team). We will offer help with the use of the device. However, we will not

offer help reading questions out loud to participants (as the Whooley questions and the EPDS are

intended to be used a self-administered instruments).

Participants will be asked to complete all the surveys while waiting for their appointment in the

waiting room of participating NHS sites. They will be randomised to one of two experimental

manipulations of the survey layout.

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Scrolling layout

In this experimental manipulation, all the surveys will be presented on a single screen (Figure 1).

Therefore, participants will need to scroll vertically in order to answer all the questions. They will be

able to scroll up and down as they wish and to modify the answers given to previous questions as

long as they do it before submitting their answers. Once a participant has submitted her answers, a

message acknowledging their participation will be displayed on the screen of the device and they

will no longer be able to modify their answers. Once all the surveys have been completed,

participants will be asked to return the iPad Air® to a member of the research team. Validation

procedures built into REDCap will ensure that participants are not able to submit unanswered

questions.

Paging layout

In this experimental manipulation, participants will only see one question on the screen at any given

time (Figure 2). They will need to select and submit their answer to the current question before

being able to move on to the next question. Participants will not be allowed to re-visit already

answered questions. Once a participant has submitted all her answers, a message acknowledging

her participation will be displayed on the screen of the device. Once all the surveys have been

completed, participants will be asked to return the iPad Air® to a member of the research team.

Validation procedures built into REDCap will ensure that participants are not able to submit

unanswered questions.

randomisation

We will utilise a block randomisation procedure to allocate participants to one of the two

experimental arms. Random numbers will be generated using Stata 13.0.[25] Each consecutive

number that is generated will be printed and put inside an opaque envelope, which will then be

sealed. Envelopes will be numbered in an ascending sequence. Once a participant has provided

informed consent, the researcher will take the relevant envelope, open it, and use the number

contained in it to allocate the participant to one of the 2 experimental groups. Researchers

conducting participant recruitment will not be involved in this randomisation procedure in order to

avoid recruitment bias.

outcomes

Positive predictive value (PPV) of the Whooley questions

We will calculate the number of pregnant women who answered Yes to any of the Whooley

questions AND who scored 10 points or higher on the EPDS, as a proportion of the total number of

pregnant women who answered Yes to any of the Whooley questions regardless of their EPDS

scores.

Negative predictive value (NPV) of the Whooley questions

We will calculate the number of pregnant women who answered No to both Whooley questions

AND who scored 9 points or less on the EPDS, as a proportion of the total number of pregnant

women who answered No to both Whooley questions regardless of their EPDS scores.

False omission rate (FOR) of the Whooley questions

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AND who scored 10 points of higher on the EPDS, as a proportion of the total number of pregnant


Mean overall scores on the EPDS

For each experimental group, we will sum the individual scores on the EPDS and will divide the total

by the number of participants in the group. We will also calculate the mean overall scores on the

EPDS for our total sample.

Breakoff rates

We will calculate the proportion of participants who interrupt the survey before reaching the end. In

such eventualities, we will document the reason for breakoff.

Time needed to complete surveys

We will measure the time in seconds between a participant starting to read the basic instructions on

how to complete the survey and the participants receiving the message acknowledging their

participation. We will also account for the time that participants spend experiencing problems,

distractions or making requests for help or clarification.

Proportion of complete EPDS records

We will define a complete record as one in which no question was left unanswered. Leaving

unanswered questions will not be possible due to the implementation of data validation procedures.

Therefore, data completeness will be a by-product of breakoff rates.

Proportion of participants requesting help

We will document the requests for help made by our participant. We will categorise participants into

3 groups: (i) one request for help; (ii) between 2 and 4 requests for help; and (iii) 5 or more requests

for help. We will compute the proportion of participants falling within each category.

Proportion of each type of request for help

We will document the reasons for each request for help. We will conduct a content analysis of these

requests in order to categorise them according to their nature.

sample size calculations

We powered our study according to the PPV, NPV and FOR of the Whooley questions. In order to

calculate these outcomes, we would need at least 30 events (defined as pregnant women scoring 10

points of more on the EPDS). Assuming a prevalence of depression in pregnant women of 12%, we

would need to recruit 250 participants in our study. We decided to recruit a total of 300 participants

to account for any eventualities, such as drop outs.

data analysis plan

Descriptive statistics

We will report the number of participants approached that did not meet our inclusion criteria, as

well as the reason for exclusion. We will also report the number of participants who refused to take

part in our study as a proportion of the total number of participants who were initially approached.

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We will report the following information for each experimental group:

• Demographic characteristics (as captured by our non-validated survey);

• Proportion of participants answering Yes to any of the Whooley questions;

• Proportion of participants scoring at each interval of the EPDS: between 0 and 9 points;

between 10 and 12 points; and 13 points or above;

• Proportion of participants scoring 2 or 3 points on question 10 of the EPDS;

• Mean time taken to complete the surveys;

• Proportion of participants making requests for help, and the proportion making each type of

request;

• Mean time spent dealing with requests for help; and

• Breakoff rates and reasons for breakoff

Inferential statistics

PPV, NPV, and FOR

We will calculate the PPV, NPV and FOR of the Whooley questions for the total sample of

participants, and will report these values as percentages. We will also test for significant differences

between the two experimental groups in these outcomes using a t-test.

Data equivalence

We will determine data equivalence between the experimental groups (scrolling and paging) by

testing for statistically significant differences in the mean overall scores on the EPDS. For this, we will

conduct a t-test. In addition, we will compare the proportion of women scoring (i) between 10 and

12 points, and (ii) 13 points or more on the EPDS between the two experimental groups using a t-

test.


We will compare the mean time needed by participants to complete the survey questionnaire

between the experimental groups using a t-test.

Data completeness

We will compare the proportion of complete records between the experimental groups using a t-

test.

Proportion of requests for help

We will compare the proportion of participants making requests for help between the experimental

groups. For this, we will conduct a t-test for each category in this endpoint: (i) one request; (ii)

between 2 and 4 requests; and (iii) 5 or more requests.

timeline

We expect recruitment of participants to take place between the end of September 2015 and

January 2016.

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ETHICS AND DISSEMINATION

This study has been reviewed and approved by the National Research Ethics Service (NRES)

Committee South East Coast – Surrey on the 09 July 2015 under the Research Ethics Committee

(REC) reference 15/LO/0977.

This study is being sponsored by Imperial College London under the reference number 15IC2687 and

has been included in the UK Clinical Research Network (CRN) Study Portfolio under the UKCRNID

number 19280.

Lastly, this study protocol has been registered in ClinicalTrials.gov under the identifier NCT02516982

(as required by the REC).

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17 Mavletova A, Couper M. Mobile Web Survey Design: Scrolling Versus Paging, SMS Versus E-Mail Invitations. J Surv Stat Methodol 2014;2(4):498-518 doi:10.1093/jssam/smu015 [published First Online: 25 August 2014]. 18 Wells T, Bailey JT, Link MW. Comparison of Smartphone and Online Computer Survey Administration. Soc Sci Comput Rev 2014;32(2):238-55 doi:10.1177/0894439313505829 [published First Online: 7 October 2013]. 19 National Collaborating Centre for Mental Health. Antenatal and postnatal mental health: clinical management and service guidance – Updated Edition. Leicester and London: The British Psychological Society and The Royal College of Psychiatrists 2014. 20 Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed

Inform 2009;42(2):377-81 doi:10.1016/j.jbi.2008.08.010 [published First Online: 30 September 2008]. 21 The World Health Organization. The ICD-10 classification of mental and behavioural disorders: Clinical descriptions and diagnostic guidelines. Geneva: World Health Organization, 1992. 22 Whooley MA, Avins AL, Miranda J, et al. Case-finding instruments for depression - Two questions are as good as many. J Gen Intern Med 1997;12(7):439-45. 23 Cox JL, Holden JM, Sagovsky R. Detection of Postnatal Depression - Development of the 10-Item Edinburgh Postnatal Depression Scale. Br J Psychiatry 1987;150:782-86. 24 Allbaugh LJ, Marcus SM, Ford EC, et al. Development of a screening and recruitment registry to facilitate perinatal depression research in obstetrics settings in the USA. Int J Gynaecol Obstet 2015;128(3):260-63 doi:10.1016/j.ijgo.2014.09.015 [published First Online: 11 November 2014]. 25 Stata. Stata Statistical Software [Program]. Version 13, 2013.

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AUTHORS’ CONTRIBUTIONS

Jose Marcano-Belisario developed the study protocol, and has been in charge of obtaining ethics and

governance approvals. He also drafted this manuscript.

Ajay K Gupta guided the study design, randomisation procedures and data analysis plan. He also

performed the sample size calculations.

Cecily Morrison, John O’Donoghue and Josip Car guided the development of the study protocol, and

have been supervising the work of Jose Marcano-Belisario.

All the authors reviewed and approved this manuscript.

ACKNOWLEDGEMENTS

We would like to thank Dr Fiona Blake, Dr Vesna Švab, and Dr Paul Ramchandani for their feedback

on various versions of the study protocol.

We would also like to thank Becky Ward, Christopher Ente, Helen Riding, Leo Wan, Jayne Aldersen

and Sylvia Westrup for their guidance through the ethics and NHS permission application process.

Lastly, we would like to thank Dr Joanna Girling, Louise Page, Marie O’Connell and the team at West

Middlesex Hospital NHS Trust; Dr Talac Mahmud; Dr Samia Hasan; and Dr Justine Norman for their

interest is supporting patient recruitment for this study.

FUNDING STATEMENT

This work is being partly supported by a National Institute for Health Research (NIHR) Imperial

Biomedical Research Centre (BRC) award through the Population Health Theme.

COMPETING INTERESTS STATEMENT

The authors declare that they do not have any competing interest.

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LIST OF FIGURES

Figure 1. Scrolling layout (screenshot)

Figure 2. Paging layout (screenshot)

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Scrolling layout (screenshot)

541x722mm (72 x 72 DPI)

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Paging layout (screenshot)

541x722mm (72 x 72 DPI)

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Appendix 1. Personal information survey, Whooley questions and

Edinburgh Postnatal Depression Scale

Personal information survey 1. What is your age group?

a. 18 to 22 years

b. 23 to 27 years

c. 28 to 32 years

d. 33 to 37 years

e. 38 years or older

2. How would you describe your race/ethnicity?

a. White

i. British

ii. Irish

iii. Other

b. Mixed

i. White and Black Caribbean

ii. White and Black African

iii. White and Asian

iv. Other

c. Asian or Asian British

i. Indian

ii. Pakistani

iii. Bangladeshi

iv. Other

d. Black or Black British

i. Caribbean

ii. African

iii. Other

e. Other

i. Chinese

ii. Other

f. Not stated

3. What is your marital status?

a. Single

b. Married/In civil partnership

c. Divorced/Civil partnership that has been dissolved

d. Widowed

e. Separated

f. Not stated

4. What is your employment status?

a. Employed, full-time

b. Employed, part-time

c. Self-employed

d. Not employed, looking for work

e. Not employed, not looking for work

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f. Disability/Not able to work

5. What is your highest level of education?

a. University or college degree

b. University or college qualification below degree level

c. A Levels

d. GCSE

e. None of these

6. Do you own a smartphone (e.g., iPhone, Samsung, Blackberry, HTC, Sony)?

a. Yes

b. No

7. Do you own a tablet computer (e.g., iPad, iPad mini, Samsung tablet)?

a. Yes

b. No

8. Is this your first pregnancy?

a. Yes

b. No

9. (If answer to previous question is No) How many children have you given birth to?

10. When is your current baby due?

a. Please indicate an approximate date

11. Have you ever been diagnosed with depression?

a. Yes

b. No

Whooley Questions 1. Over the past month, have you been bothered by feeling down, depressed or hopeless?

a. Yes

b. No

2. Over the past month, have you been bothered by having little interest or pleasure in doing

things?

a. Yes

b. No

Edinburgh Postnatal Depression Scale As you are pregnant or have recently had a baby, we would like to know how you are feeling. Please

check the answer that comes closest to how you have felt IN THE PAST 7 DAYS, not just how you feel

today

In the past 7 days:

1. I have been able to laugh and see the funny side of things

• As much as I always could

• Not quite so much now

• Definitely not so much now

• Not at all

2. I have looked forward with enjoyment to things

• As much as I ever did

• Rather less than I used to

• Definitely less than I used to

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• Hardly at all

3. I have blamed myself unnecessarily when things went wrong

• Yes, most of the time

• Yes, some of the time

• Not very often

• No, never

4. I have been anxious or worried for no good reason

• No, not at all

• Hardly ever

• Yes, sometimes

• Yes, very often

5. I have felt scared or panicky for no very good reason

• Yes, quite a lot

• Yes, sometimes

• No, not much

• No, not at all

6. Things have been getting on top of me

• Yes, most of the time I haven’t been able to cope at all

• Yes, sometimes I haven’t been coping as well as usual

• No, most of the time I have coped quite well

• No, I have been coping as well as ever

7. I have been so unhappy that I have had difficulty sleeping


• Yes, sometimes

• Not very often

• No, not at all

8. I have felt sad or miserable


• Yes, quite often

• Not very often

• No, not at all

9. I have been so unhappy that I have been crying



• Only occasionally

• No, never

10. The thought of harming myself has occurred to me


• Sometimes

• Hardly ever

• Never

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Tablet computers for implementing NICE antenatal mental health guidelines: protocol of a feasibility study

Journal: BMJ Open

Manuscript ID bmjopen-2015-009930.R1

Article Type: Protocol

Date Submitted by the Author: 16-Oct-2015

Complete List of Authors: Marcano-Belisario, Jose; Imperial College London, Department of Primary Care and Public Health Gupta, Ajay; Imperial College London, National Heart & Lung Institute O'Donoghue, John; Imperial College London, Department of Primary Care and Public Health Morrison, Cecily; Imperial College London, Department of Primary Care and Public Health Car, Josip; Nanyang Technological University, Lee Kong Chian School of

Medicine; Imperial College London, Department of Primary Care and Public Health

<b>Primary Subject Heading</b>:

Health informatics

Secondary Subject Heading: Health informatics, Mental health, Obstetrics and gynaecology, Public health

Keywords:

Information technology < BIOTECHNOLOGY & BIOINFORMATICS, Health informatics < BIOTECHNOLOGY & BIOINFORMATICS, MENTAL HEALTH, Prenatal diagnosis < OBSTETRICS, Depression & mood disorders < PSYCHIATRY, PUBLIC HEALTH


BMJ Open on O

ctober 18, 2020 by guest. Protected by copyright.

http://bmjopen.bm

j.com/

BM

J Open: first published as 10.1136/bm

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Tablet computers for implementing NICE antenatal mental health guidelines: protocol of a feasibility

study

Corresponding author


Room 304, Reynolds Building, St Dunstan’s Road, London, W6 8RP, UK

[email protected]

Telephone: +44 (0)20 7594 0771

List of authors


Global eHealth Unit, Department of Primary Care and Public Health, Imperial College London, London, UK

Ajay K Gupta

National Heart & Lung Institute, Imperial College London, London, UK

John O’Donoghue


London, UK

Cecily Morrison


London, UK

Josip Car


London, UK

Keywords

mHealth

Perinatal depression

Screening

Self-administered surveys

Data collection

Word count

3395 words

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ABSTRACT

Introduction

Depression is one of the most common mental health disorders that may affect women during

pregnancy. The prompt identification of this disorder, and the provision of treatment, may help to

reduce the likelihood of postpartum depression, prevent severe forms of the disease, and reduce its

intergeneration impact. Despite women’s repeated encounters with health services throughout their

antenatal care, depression often goes undiagnosed. This is one area where mHealth could prove

useful. We will assess the feasibility of using tablets to incorporate depression screening into

antenatal pathways. We will also assess if survey layout could affect the quality of the data collected

through these devices.

Methods and analysis

We will test the feasibility of using iPad Airs® for the administration of the Whooley questions and

the Edinburgh Postnatal Depression Scale (EPDS) to pregnant women attending antenatal clinics in

England. We will assess the impact of survey layout on the quality of the responses given to these

screening scales using a parallel randomised controlled study design. We will calculate the positive

predictive value (PPV), the negative predictive value (NPV) and the false omission rate (FOR) of the

Whooley questions in comparison with the EPDS. We will calculate differences in data equivalence,

time needed to complete the surveys, breakoff rates, data completeness and requests for help

between the two experimental groups: using all questions in one screen and navigation by vertical

scrolling, or a single question per screen and navigation by multiple pages.

Ethics and dissemination

This study has been approved by the National Research Ethics Service Committee South East Coast –

Surrey.

Our findings will be disseminated through academic peer-reviewed publications, conferences, and

discussion with peers.

Registration details

This study is being sponsored by Imperial College London and has been included in the UK Clinical

Research Network Study Portfolio.

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STRENGTHS OF THIS STUDY

• It addresses an important area of unmet clinical need, which has a considerable impact on

healthcare systems and society in general.

• It will contribute to the evidence base for mobile health (mHealth) applied to mental health.

• It will attempt to identify implementation issues (arising from the introduction of an

mHealth intervention into a clinical process) that could impair the ability of already busy

healthcare professionals to perform their clinical duties. This is in contrast to some existing

studies, where mHealth interventions are deployed in highly controlled environments that

do not capture the realities of clinical settings.

• It will explore the effect that survey presentation could have on the quality of the data

collected (when using a validated scale). This is in contrast to other studies in the medical

literature (that assess mHealth interventions), which have not explored how these additional

factors could affect data quality.

LIMITATIONS OF THIS STUDY

• It will look at adult pregnant women only. The exclusion of teenage mothers-to-be could

result in the exclusion of a group at increased risk of mental health disorders.

• The exclusion of pregnant women who are not comfortable reading and writing in English

may result in a sample that is not representative of certain communities in the UK.

• It will explore mHealth as a delivery mode for a depression screening validated scale.

However, it will not evaluate the potential of mHealth as a delivery mode for evidence-

based interventions.

• The app used in this study lacks integration with clinical IT systems.

• Our findings might only be generalisable to devices with similar technical specifications that

are being used in similar clinical settings.

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INTRODUCTION

Maternal mental health is a key public health priority due to the impact it can have on a woman’s

well-being and on her child’s emotional, behavioural, cognitive and social development.[1-5]

Perinatal depression is one of the most common psychiatric disorders that can affect up to 15% of

women during pregnancy or within one year of giving birth. The direct and indirect financial costs of

perinatal depression to the health system, together with its direct impact on the mother and her

child, account for the majority of the overall costs to society of perinatal mental disorders.[5] In the

UK, these costs have been estimated at £8.1 billion for each one-year cohort of birth (with the

average costs of one case of perinatal depression estimated at £74k), 72% of which could be

attributed to the adverse effects experienced by the child.[2] For this reason, the early identification

of women who might be at risk of developing or have perinatal depression should be considered a

priority.[6]

Women appear to be at an increased risk of depression 3 to 6 months after childbirth.[1,4] Although

a recent longitudinal study found that symptoms of depression may be more prevalent at 4 years

postpartum.[7] Several factors are known to increase the likelihood of developing postpartum

depression.[1,6,8] Depression during pregnancy however, has been recognised as one of the most

important risk factors and one that is susceptible to early intervention. The point prevalence of

depression during the first, second and third trimesters of pregnancy has been estimated at 7.4%,

12.8% and 12%, respectively.[9] The timely identification of depression during these stages, and the

provision of appropriate treatment, can reduce the likelihood of developing postpartum depression,

prevent more severe forms of this disorder, and improve a woman’s general health status.[4,5]

Treating depression during pregnancy may also help reduce the intergenerational impact of this

condition.

Nonetheless, depression during pregnancy often goes undiagnosed and its routine screening is still

debated.[10] Validated screening tools, such as the Edinburgh Postnatal Depression Scale (EPDS),

can facilitate the early identification of depressive symptoms in pregnant women.[11] However,

cost-effectiveness is often cited as one of the key reasons against the routine screening for this

condition.[12] This is an area where smartphones and tablet computers could demonstrate their

value, in a field of study that is known as mobile health (mHealth). Thanks to their advanced

computational and networking capabilities, and overall popularity (in the first quarter of 2015, it was

reported that approximately 66% of adults in the UK owned a smartphone),[13] these devices could

facilitate depression screening and monitoring of symptoms[14] while reducing costs and

administrative burden.

Researchers from the School of Social Work at the University of Illinois and staff members at

Champaign-Urbanara Public Health District will be testing the use of tablet computers to implement

depression screening in maternal clinics.[15] They will be doing so during antenatal consultations.

Mobile devices could be used to screen for depression before a consultation, thus releasing some of

the consultation time. For this reason, we need to establish the feasibility of using these devices to

do so.

One aspect of delivering depression screening through mobile devices, is the impact that this

technology may have on data quality. This is to ensure that the data accurately reflect underlying

clinical changes. Our recent Cochrane review[16] suggests that collecting patient self-reported data

through apps is equivalent to collecting data through alternative delivery modes (i.e., paper, short

messaging service, laptops, plastic rulers, and personal digital assistants). This review also

highlighted that equivalence, and other data quality dimensions, could be affected by factors other

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than the delivery mode.[16] One of such factors is survey presentation. Unlike the survey

methodology literature however,[17,18] the effect of this factor on validated clinical tools has not

been systematically explored in the medical literature.

In this study we will assess the feasibility of implementing the recommendations from The National

Institute for Health and Care Excellence (NICE)[19] for recognising depression during pregnancy. We

will conduct our study in the waiting area of general practices, community midwiferies and hospitals

using iPad Air® tablets. We will evaluate the statistical properties of one of the validated instruments

recommended by this guideline. We will also assess if survey layout (as a component of survey

presentation) affects the quality of the responses collected through the screening instruments under

evaluation.

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METHODS AND ANALYSIS

study design

We will assess the feasibility of using iPad Air tablets® to administer a brief survey asking for

personal information, the Whooley questions and the EPDS (Appendix 1) to pregnant women

attending antenatal clinics across a number of primary and secondary care National Health Service

(NHS) centres in England. iPad Air® tablets have a 9.7-inch (diagonal) retina display, with a 2048-by-

1536 resolution at 264 pixels per inch. Study data will be collected and managed using Snap® surveys

tools.[20] Snap Mobile® app version 4.0.30 (or later, if a new version becomes available) will be

running on iOS version 9.0.2 (or later, if a new version becomes available).

In order to evaluate the effect of survey layout on data quality, we will use a parallel, randomised

controlled study design. Pregnant women consenting to take part in this study will be randomly

assigned to complete (i) an app version of the Whooley questions and the EPDS in which all the

questions are presented on a single screen (app screening – scrolling layout), causing participants to

scroll vertically on the device; or (ii) an app version of the Whooley questions and the EPDS in which

only one question per page is presented at any given time (app screening – paging layout), causing

participants to navigate through multiple pages.

pilot phase

We piloted both versions of the surveys used in this study (paging layout and scrolling layout) with 4

staff members at the Department of Primary Care and Public Health at Imperial College London. This

phase allowed us to identify (and rectify) the following issues:

• Font size

• Consistency of response formats (in particular, observed differences between yes-no

questions and multiple choice questions with a single answer)

• Framing of the survey results

sample selection and recruitment

We will select our sample of participants from pregnant women attending antenatal clinics in

general practices, midwifery services and hospitals which are part of the NHS in England. Each

potential participant will be assessed by clinical staff against our inclusion and exclusion criteria

(Table 1).

Table 1. Participant inclusion and exclusion criteria

INCLUSION CRITERIA EXCLUSION CRITERIA

Women who are 18 years old or older Current diagnosis of mood [affective] disorders as specified in the 10th revision of the International Statistical Classification of Disease and Related Health Problems (ICD-10), Classification of Mental Health and Behavioural Disorders[21]

Pregnant and of any gestational age Currently receiving treatment for mood [affective] disorders

Any parity Recent personal history of mood [affective] disorders within the past 12 months

Attending antenatal clinics in participating NHS sites

Not comfortable reading and writing in English

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On the day on the antenatal clinic, potential participants will be first approached in the waiting room

of the participating centres by a member of the clinical care team. If a potential participant

expresses her interest in this study, she will be introduced to one of our researchers who will explain

the details of the study to her. Potential participants will be provided with a patient information

sheet. The researcher will emphasise that the potential participant can ask any questions regarding

the study. If a potential participant agrees to take part in this study, she will be consented and will

complete the study procedures then. Otherwise, if she is unsure about participation, she will have at

least 24 hours to decide. In this case, she would only take part in the study if she comes into contact

with the research team during a future antenatal clinic.

Refusal to take part in this study will not have an impact on a woman’s legal rights, medical care or

on the relationship with her care providers. We will obtain written, informed consent from those

women who, after receiving all the relevant study information and asking study-related question,

still wish to take part in this study.

interventions to be measured

Surveys

Non-validated, personal demographic survey

We will administer an 11-question survey to collect information about the woman’s age group,

ethnic background, marital status, employment status, level of education, smartphone or tablet

computer ownership, parity, and previous personal history of depression.

Whooley questions

The Whooley questions were developed as a case-finding instrument for depression in primary

care.[22] This 2-questions instrument assesses depressed mood and anhedonia that have been

present during the past month. Respondents are required to answer Yes or No to each question.

Edinburgh Postnatal Depression Scale (EPDS)

The EPDS is a 10-item self-administered survey that was developed to screen for perinatal

depression in the community.[23] This instrument assesses feelings of guilt, sleep disturbance,

reduced energy levels, anhedonia and suicidal ideation that have been present during the past 7

days. Each question is scored on a 4-point scale ranging from 0 to 3 points. An overall score is

calculated by adding the scores from each individual question. Overall scores between 10 and 12

points suggest increased risk for depression; scores of 13 points or more suggest that the diagnostic

criteria for major depression disorder have probably been met.[24] In addition, special attention

should be paid to item 10, as it deals with suicidal thoughts. Based on these scores, a clinician would

be prompted to refer a woman to a mental health professional.

The EPDS is a valid and reliable tool for identifying women who are at risk of depression, both during

pregnancy and postpartum. This instrument is also sensitive to changes in the severity of depression

over time.[23] The EPDS can be reproduced without further permission provided that the original

source of the scale is cited in each reproduced copy.

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Screening for depression & effect of survey layout

Pregnant women taking part in our study will receive verbal instructions on how to complete the

surveys. Participants will also be informed that we will communicate their answers to the Whooley

questions and their scores on the EPDS to their clinicians, and that these results will be available for

discussion during her antenatal appointment. Participants’ results on the Whooley questions and on

the EPDS will be communicated to their general practitioners (GPs).

The researcher will also explain to participants that they can ask for help at any point while

completing the surveys, and that all questions should be directed to a member of the research team

(not to the clinical care team). We will offer help with the use of the device. However, we will not

offer help reading questions out loud to participants (as the Whooley questions and the EPDS are

intended to be used a self-administered instruments).

Participants will be asked to complete all the surveys while waiting for their appointment in the

waiting room of participating NHS sites. They will be randomised to one of two experimental

manipulations of the survey layout.

Scrolling layout

In this experimental manipulation, all the surveys will be presented on a single screen (Figure 1).

Therefore, participants will need to scroll vertically in order to answer all the questions. They will be

able to scroll up and down as they wish and to modify the answers given to previous questions as

long as they do it before submitting their answers. Once a participant has submitted her answers, a

message acknowledging their participation will be displayed on the screen of the device and they

will no longer be able to modify their answers. Once all the surveys have been completed,

participants will be asked to return the iPad Air® to a member of the research team. Validation

procedures built into Snap® surveys will ensure that participants are not able to submit unanswered

questions.

Paging layout

In this experimental manipulation, participants will only see one question on the screen at any given

time (Figure 2). They will need to select and submit their answer to the current question before

being able to move on to the next question. Participants will not be allowed to re-visit already

answered questions. Once a participant has submitted all her answers, a message acknowledging

her participation will be displayed on the screen of the device. Once all the surveys have been

completed, participants will be asked to return the iPad Air® to a member of the research team.

Validation procedures built into Snap® surveys will ensure that participants are not able to submit

unanswered questions.

randomisation

We will utilise a block randomisation procedure to allocate participants to one of the two

experimental arms. Random numbers will be generated using Stata 13.0.[25] Each consecutive

number that is generated will be printed and put inside an opaque envelope, which will then be

sealed. Envelopes will be numbered in an ascending sequence. Once a participant has provided

informed consent, the researcher will take the relevant envelope, open it, and use the number

contained in it to allocate the participant to one of the 2 experimental groups. Researchers

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conducting participant recruitment will not be involved in this randomisation procedure in order to

avoid recruitment bias.

outcomes

Positive predictive value (PPV) of the Whooley questions

We will calculate the number of pregnant women who answered Yes to any of the Whooley

questions AND who scored 10 points or higher on the EPDS, as a proportion of the total number of

pregnant women who answered Yes to any of the Whooley questions regardless of their EPDS

scores.

Negative predictive value (NPV) of the Whooley questions


AND who scored 9 points or less on the EPDS, as a proportion of the total number of pregnant


False omission rate (FOR) of the Whooley questions


AND who scored 10 points of higher on the EPDS, as a proportion of the total number of pregnant


Mean overall scores on the EPDS

For each experimental group, we will sum the individual scores on the EPDS and will divide the total

by the number of participants in the group. We will also calculate the mean overall scores on the

EPDS for our total sample.

Breakoff rates

We will calculate the proportion of participants who interrupt the survey before reaching the end. In

such eventualities, we will document the reason for breakoff.


We will measure the time in seconds between a participant starting to read the basic instructions on

how to complete the survey and the participants receiving the message acknowledging their

participation. We will also account for the time that participants spend experiencing problems,

distractions or making requests for help or clarification.

Proportion of complete EPDS records

We will define a complete record as one in which no question was left unanswered. Leaving

unanswered questions will not be possible due to the implementation of data validation procedures.

Therefore, data completeness will be a by-product of breakoff rates.

Proportion of participants requesting help

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We will document the requests for help made by our participant. We will categorise participants into

3 groups: (i) one request for help; (ii) between 2 and 4 requests for help; and (iii) 5 or more requests

for help. We will compute the proportion of participants falling within each category.

Proportion of each type of request for help

We will document the reasons for each request for help. This information will be captured through a

post study procedures survey that researchers will have to complete. We will conduct a content

analysis of these requests in order to categorise them according to their nature.

sample size calculations

We powered our study according to the PPV, NPV and FOR of the Whooley questions. In order to

calculate these outcomes, we would need at least 30 events (defined as pregnant women scoring 10

points of more on the EPDS). Assuming a prevalence of depression in pregnant women of 12%, we

would need to recruit 250 participants in our study. We decided to recruit a total of 300 participants

to account for any eventualities, such as drop outs.

data analysis plan

Descriptive statistics

We will report the number of participants approached that did not meet our inclusion criteria, as

well as the reason for exclusion. We will also report the number of participants who refused to take

part in our study as a proportion of the total number of participants who were initially approached.

We will report the following information for each experimental group:

• Demographic characteristics (as captured by our non-validated survey);

• Proportion of participants answering Yes to any of the Whooley questions;

• Proportion of participants scoring at each interval of the EPDS: between 0 and 9 points;

between 10 and 12 points; and 13 points or above;

• Proportion of participants scoring 2 or 3 points on question 10 of the EPDS;

• Mean time taken to complete the surveys;

• Proportion of participants making requests for help;

• Proportion of participants making each type of request;

• Mean time spent dealing with requests for help; and

• Breakoff rates and reasons for breakoff

Inferential statistics

PPV, NPV, and FOR

We will calculate the PPV, NPV and FOR of the Whooley questions for the total sample of

participants, and will report these values as percentages. We will also test for significant differences

between the two experimental groups in these outcomes using a t-test.

Data equivalence

We will determine data equivalence between the experimental groups (scrolling and paging) by

testing for statistically significant differences in the mean overall scores on the EPDS. For this, we will

conduct a t-test. In addition, we will compare the proportion of women scoring (i) between 10 and

12 points, and (ii) 13 points or more on the EPDS between the two experimental groups using a t-

test.

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We will compare the mean time needed by participants to complete the survey questionnaire

between the experimental groups using a t-test.

Data completeness

We will compare the proportion of complete records between the experimental groups using a t-

test.

Proportion of requests for help

We will compare the proportion of participants making requests for help between the experimental

groups. For this, we will conduct a t-test for each category in this endpoint: (i) one request; (ii)

between 2 and 4 requests; and (iii) 5 or more requests.

timeline

We expect recruitment of participants to take place between October 2015 and the end of February

2016.

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CONCLUSION

We believe that this study addresses an important area of unmet clinical need, which has a direct

and indirect impact on health systems and society. It will also contribute to build the evidence base

for mHealth, particularly when applied to mental health. Unlike other studies in the medical

literature, this study will evaluate how survey layout could affect the quality of the responses

collected using a validated scale. Evaluating how different factors could affect data quality becomes

important when data are used to inform clinical and therapeutic decisions. In addition, this study will

also evaluate some of the implementation issues that might arise when deploying an mHealth

intervention, and that could affect its successful adoption.

The technical specifications of a device, such as screen size, could influence user interaction and thus

the quality of responses. In addition, usage patterns (in terms of the type of interactions, duration

and frequency of an interaction, and the type of activities that occur during an interaction) vary

depending on the type of device and the setting in which it is being used. For these reasons, our

findings might only be generalisable to iPad Air® tablets (or devices with similar technical

specifications) that are being used in clinical settings. Therefore, in a future study, we will explore

issues associated with the at-home collection of mood data during pregnancy, using participants’

own devices.

The findings from this feasibility study will inform a larger trial evaluating the integration of this

intervention into routine antenatal pathways, and the potential impact on clinical outcomes.

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ETHICS AND DISSEMINATION

This study has been reviewed and approved by the National Research Ethics Service (NRES)

Committee South East Coast – Surrey on the 09 July 2015 under the Research Ethics Committee

(REC) reference 15/LO/0977.

This study is being sponsored by Imperial College London under the reference number 15IC2687 and

has been included in the UK Clinical Research Network (CRN) Study Portfolio under the UKCRNID

number 19280.

Lastly, this study protocol has been registered in ClinicalTrials.gov under the identifier NCT02516982

(as required by the REC).

The findings of this study will be disseminated through academic peer-reviewed publications, poster

presentations and abstracts at academic and professional conferences, discussion with peers, social

media, and the Global eHealth Unit website. The findings of this study will also inform Jose Marcano

Belisario’s PhD thesis.

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REFERENCES

1 Abdollahi F, Zarghami M, Azhar MZ, et al. Predictors and incidence of post-partum depression: a longitudinal cohort study. J Obstet Gynaecol Res 2014;40(12):2191-200 doi:10.1111/jog.12471 [published Online First: 11 August 2014]. 2 Bauer A, Parsonage M, Knapp M, et al. The costs of perinatal mental health problems. London: Centre for Mental Health and London School of Economics 2014. 3 Satyanarayana VA, Lukose A, Srinivasan K. Maternal mental health in pregnancy and child behavior. Indian J Psychiatry 2011;53(4):351-61 doi:10.4103/0019-5545.91911 [published Online First: 16 January 2012]. 4 Yazici E, Kirkan TS, Aslan PA, et al. Untreated depression in the first trimester of pregnancy leads to postpartum depression: high rates from a natural follow-up study. Neuropsychiatr Dis Treat 2015;11:405-11 doi:10.2147/NDT.S77194 [published Online First: 19 February 2015]. 5 Thomas N, Komiti A, Judd F. Pilot early intervention antenatal group program for pregnant women with anxiety and depression. Arch Womens Ment Health 2014;17(6):503-9 doi:10.1007/s00737-014-0447-2 [published Online First: 30 July 2014]. 6 Parker GB, Hegarty B, Paterson A, et al. Predictors of post-natal depression are shaped distinctly by the measure of 'depression'. J Affect Disord 2015;173:239-44 doi:10.1016/j.jad.2014.10.066 [published Online First: 20 November 2014]. 7 Woolhouse H, Gartland D, Mensah F, et al. Maternal depression from early pregnancy to 4 years postpartum in a prospective pregnancy cohort study: implications for primary health care. BJOG 2015;122(3):312-21 doi:10.1111/1471-0528.12837 [published Online First: 21 May 2014]. 8 Mohamad Yusuff AS, Tang L, Binns CW, et al. Prevalence and risk factors for postnatal depression in Sabah, Malaysia: a cohort study. Women Birth 2015;28(1):25-9 doi:10.1016/j.wombi.2014.11.002 [published Online First: 24 November 2014]. 9 Bennett HA, Einarson A, Taddio A, et al. Prevalence of depression during pregnancy: systematic review. Obstet Gynecol 2004;103(4):698-709. 10 Tsai AC, Tomlinson M, Dewing S, et al. Antenatal depression case finding by community health workers in South Africa: feasibility of a mobile phone application. Arch Womens Ment Health 2014;17(5):423-31 doi:10.1007/s00737-014-0426-7 [published Online First: 30 March 2014]. 11 Hewitt C, Gilbody S, Brealey S, et al. Methods to identify postnatal depression in primary care: an integrated evidence synthesis and value of information analysis. Health Technol Assess 2009;13(36):1-145,147-230. 12 Paulden M, Palmer S, Hewitt C, et al. Screening for postnatal depression in primary care: cost effectiveness analysis. BMJ 2009;339:b5203 doi:http://dx.doi.org/10.1136/bmj.b5203 [published Online First: 23 December 2009]. 13 Ofcom. Facts & Figures: Secondary Facts & Figures 2015. http://media.ofcom.org.uk/facts/ [date accessed: 18 August 2015]. 14 BinDhim NF, Shaman AM, Trevena L, et al. Depression screening via a smartphone app: cross-country user characteristics and feasibility. J Am Med Inform Assoc 2015;22(1):29-34 doi:10.1136/amiajnl-2014-002840 [published Online First: 17 October 2014].

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15 Pineros-Leano M, Tabb KM, Sears H, et al. Clinic staff attitudes towards the use of mHealth technology to conduct perinatal depression screenings: a qualitative study. Fam Pract 2015;32(2):211-5 doi:10.1093/fampra/cmu083 [published First Online: 22 December 2014]. 16 Marcano Belisario JS, Jamsek J, Huckvale K, et al. Comparison of self-administered survey questionnaire responses collected using mobile apps versus other methods. Cochrane Database Syst Rev 2015;7:MR000042 doi:10.1002/14651858.MR000042.pub2 [published First Online: 27 July 2015] 17 Mavletova A, Couper M. Mobile Web Survey Design: Scrolling Versus Paging, SMS Versus E-Mail Invitations. J Surv Stat Methodol 2014;2(4):498-518 doi:10.1093/jssam/smu015 [published First Online: 25 August 2014]. 18 Wells T, Bailey JT, Link MW. Comparison of Smartphone and Online Computer Survey Administration. Soc Sci Comput Rev 2014;32(2):238-55 doi:10.1177/0894439313505829 [published First Online: 7 October 2013]. 19 National Collaborating Centre for Mental Health. Antenatal and postnatal mental health: clinical management and service guidance – Updated Edition. Leicester and London: The British Psychological Society and The Royal College of Psychiatrists 2014. 20 Snap® surveys. Available online: http://www.snapsurveys.com/ [Accessed 14 October 2015]. 21 The World Health Organization. The ICD-10 classification of mental and behavioural disorders: Clinical descriptions and diagnostic guidelines. Geneva: World Health Organization, 1992. 22 Whooley MA, Avins AL, Miranda J, et al. Case-finding instruments for depression - Two questions are as good as many. J Gen Intern Med 1997;12(7):439-45. 23 Cox JL, Holden JM, Sagovsky R. Detection of Postnatal Depression - Development of the 10-Item Edinburgh Postnatal Depression Scale. Br J Psychiatry 1987;150:782-86. 24 Allbaugh LJ, Marcus SM, Ford EC, et al. Development of a screening and recruitment registry to facilitate perinatal depression research in obstetrics settings in the USA. Int J Gynaecol Obstet 2015;128(3):260-63 doi:10.1016/j.ijgo.2014.09.015 [published First Online: 11 November 2014]. 25 Stata. Stata Statistical Software [Program]. Version 13, 2013.

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AUTHORS’ CONTRIBUTIONS

Jose Marcano-Belisario developed the study protocol, and has been in charge of obtaining ethics and

governance approvals. He also drafted this manuscript.

Ajay K Gupta guided the study design, randomisation procedures and data analysis plan. He also

performed the sample size calculations.

Cecily Morrison, John O’Donoghue and Josip Car guided the development of the study protocol, and

have been supervising the work of Jose Marcano-Belisario.

All the authors reviewed and approved this manuscript.

ACKNOWLEDGEMENTS

We would like to thank Dr Fiona Blake, Dr Vesna Švab, and Dr Paul Ramchandani for their feedback

on various versions of the study protocol.

We would also like to thank Becky Ward, Christopher Ente, Helen Riding, Leo Wan, Jayne Aldersen

and Sylvia Westrup for their guidance through the ethics and NHS permission application process.

Lastly, we would like to thank Dr Joanna Girling, Louise Page, Marie O’Connell and the team at West

Middlesex Hospital NHS Trust; Dr Talac Mahmud; Dr Samia Hasan; and Dr Justine Norman for their

interest is supporting patient recruitment for this study.

FUNDING STATEMENT

This work is being partly supported by a National Institute for Health Research (NIHR) Imperial

Biomedical Research Centre (BRC) award through the Population Health Theme.

COMPETING INTERESTS STATEMENT

The authors declare that they do not have any competing interest.

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LIST OF FIGURES

Figure 1. Scrolling layout (screenshot)

Figure 2. Paging layout (screenshot)

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Scrolling layout (screenshot)

148x198mm (300 x 300 DPI)

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Paging layout (screenshot)

148x198mm (300 x 300 DPI)

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Appendix 1. Personal information survey, Whooley questions and

Edinburgh Postnatal Depression Scale

Personal information survey 1. What is your age group?

a. 18 to 22 years

b. 23 to 27 years

c. 28 to 32 years

d. 33 to 37 years

e. 38 years or older

2. How would you describe your race/ethnicity?

a. White

i. British

ii. Irish

iii. Other

b. Mixed

i. White and Black Caribbean

ii. White and Black African

iii. White and Asian

iv. Other

c. Asian or Asian British

i. Indian

ii. Pakistani

iii. Bangladeshi

iv. Other

d. Black or Black British

i. Caribbean

ii. African

iii. Other

e. Other

i. Chinese

ii. Other

f. Not stated

3. What is your marital status?

a. Single

b. Married/In civil partnership

c. Divorced/Civil partnership that has been dissolved

d. Widowed

e. Separated

f. Not stated

4. What is your employment status?

a. Employed, full-time

b. Employed, part-time

c. Self-employed

d. Not employed, looking for work

e. Not employed, not looking for work

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f. Disability/Not able to work

5. What is your highest level of education?

a. University or college degree

b. University or college qualification below degree level

c. A Levels

d. GCSE

e. None of these

6. Do you own a smartphone (e.g., iPhone, Samsung, Blackberry, HTC, Sony)?

a. Yes

b. No

7. Do you own a tablet computer (e.g., iPad, iPad mini, Samsung tablet)?

a. Yes

b. No

8. Is this your first pregnancy?

a. Yes

b. No

9. (If answer to previous question is No) How many children have you given birth to?

10. When is your current baby due?

a. Please indicate an approximate date

11. Have you ever been diagnosed with depression?

a. Yes

b. No

Whooley Questions 1. Over the past month, have you been bothered by feeling down, depressed or hopeless?

a. Yes

b. No

2. Over the past month, have you been bothered by having little interest or pleasure in doing

things?

a. Yes

b. No

Edinburgh Postnatal Depression Scale As you are pregnant or have recently had a baby, we would like to know how you are feeling. Please

check the answer that comes closest to how you have felt IN THE PAST 7 DAYS, not just how you feel

today

In the past 7 days:

1. I have been able to laugh and see the funny side of things

• As much as I always could

• Not quite so much now

• Definitely not so much now

• Not at all

2. I have looked forward with enjoyment to things

• As much as I ever did

• Rather less than I used to

• Definitely less than I used to

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• Hardly at all

3. I have blamed myself unnecessarily when things went wrong


• Yes, some of the time

• Not very often

• No, never

4. I have been anxious or worried for no good reason

• No, not at all

• Hardly ever

• Yes, sometimes

• Yes, very often

5. I have felt scared or panicky for no very good reason

• Yes, quite a lot

• Yes, sometimes

• No, not much

• No, not at all

6. Things have been getting on top of me

• Yes, most of the time I haven’t been able to cope at all

• Yes, sometimes I haven’t been coping as well as usual

• No, most of the time I have coped quite well

• No, I have been coping as well as ever

7. I have been so unhappy that I have had difficulty sleeping


• Yes, sometimes

• Not very often

• No, not at all

8. I have felt sad or miserable



• Not very often

• No, not at all

9. I have been so unhappy that I have been crying



• Only occasionally

• No, never

10. The thought of harming myself has occurred to me


• Sometimes

• Hardly ever

• Never

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