Feasibility Study Investigating the Efficacy and Acceptability of a Pregnancy Focussed Online Cognitive Behavioural Therapy Package: Enjoy Your Bump
Phase: NA
Conditions: Perinatal Mental Health, Antenatal Depression, Antenatal Anxiety
Sponsor: University of Edinburgh

 
 
 
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Feasibility Study Investigating the Efficacy and Acceptability of a Pregnancy 
Focussed Online Cognitive Behavioural Therapy Package  
Enjoy Your Bump 
 
 
Co-sponsors 
University of Edinburgh & NHS Lothian 
ACCORD 
The Queen’s Medical Research Institute 
47 Little France Crescent 
Edinburgh 
EH16 4TJ 
Funder 
Tommy’s Edinburgh Maternal & Fetal Health Centre 
The University of Edinburgh,  
MRC Centre for Reproductive Health 
Queen's Medical Research Institute 
47 Little France Crescent, Edinburgh  
EH16 4TJ 
 
Edinburgh and Lothians Health Foundation 
2nd Floor, Waverley Gate 
2-4 Waterloo Place 
Edinburgh 
EH1 3EG 
Funding Reference Number 
[TBC] 
Chief Investigator 
Professor Rebecca Reynolds,  
Professor of Metabolic Medicine,  
MRC Centre for Reproductive Health,  

 
 
 
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University of Edinburgh.  
 
Co-investigators 
Dr Fiona Denison, Reader in Maternal and Fetal 
Health, MRC Centre for Reproductive Health, 
University of Edinburgh  
Professor Chris Williams, Professor of Psychosocial 
Psychiatry, Five Areas Ltd, PO BOX 9, Glasgow 
Ms Clare Wallace, Research Midwife, MRC Centre 
for Reproductive Health, University of Edinburgh  
 
 
 
Collaborator 
Dr Sarah Stock, Honorary Consultant and 
Subspecialist in Maternal and Fetal Medicine, MRC 
Centre for Reproductive Health, University of 
Edinburgh. 
Mrs Morag Dalton, Research Midwife, MRC Centre 
for Reproductive Health, University of Edinburgh. 
Dr Robby Steel, Consultant Liaison Psychiatrist, 
Department of Psychological Medicine, NHS 
Lothian.  
 
REC Number 
       
 
 
Version Number and Date 
Version 2.0 July 2017 
 
Co-sponsor Representative 
 
 
 
 
Protocol Author Details  
 
 
Professor Rebecca Reynolds, Professor of 
Metabolic Medicine, MRC Centre for Reproductive 
Health, University of Edinburgh.  

 
 
 
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Dr Fiona Denison, Reader in Maternal and Fetal 
Health, MRC Centre for Reproductive Health, 
University of Edinburgh  
Ms Clare Wallace, Research Midwife, MRC Centre 
for Reproductive Health, University of Edinburgh. 
 
Professor Chris Williams, Professor of Psychosocial 
Psychiatry, Five Areas Ltd, PO BOX 9, Glasgow 
 
 

 
 
 
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List of Abbreviations 
cCBT  Computerised Cognitive Behavioural Therapy 
CRF Clinical Research File 
CTIMP Clinical Trial of an Investigational Medicinal Product 
GAD- 7   Generalised Anxiety Disorder 7-item scale 
GAD -2 Generalised Anxiety Disorder 2 – item scale 
NHS 
National Health Service 
NICE National Institute for Clinical Excellence 
PHQ -2 Patient Health Questionnaire -2 (also known as the Whooley questionnaire) 
PHQ-9   Patient Health Questionnaire -9. 
 
PNMH Perinatal Mental Health 
 
EPDS Edinburgh Postnatal Depression Scale. 
 
PES Pregnancy Experience Scale 
 
WEMWS Warwick Edinburgh Mental Wellbeing Scale  
PAI Prenatal Attachment Inventory 
MAI Maternal Attachment Inventory 
 

 
 
 
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1. INTRODUCTION 
 
1.1. 
Background 
 
Depression and anxiety during the perinatal period is one of the most common complications 
of childbearing, with a reported occurrence in 10-15% of pregnancies (1, 2). Depression in 
pregnancy has been linked to poorer obstetric outcomes such as an increased incidence of 
preterm birth, obstetric interventions such as caesarean sections, and low birth weight in 
infants (3).  In the longer term, depression and anxiety in pregnancy have been linked with 
poorer cognitive and developmental outcomes for the infant (4). It is reported that women can 
often be reluctant to seek professional support for depressive symptoms due to social stigma, 
potential long waiting times for face-to-face psychological therapies and the reported 
uncertainties of using pharmacological interventions during pregnancy (5).  
There is therefore an unmet need for an effective, low-cost, non-pharmacological intervention 
to help treat depressive symptoms during the perinatal period.  Computerised courses based 
on the Cognitive Behavioural Therapy (CBT) approach have a proven evidence base as an 
effective and acceptable intervention for depression in a non-pregnant population and is 
recommended by NICE as a low-intensity psychosocial intervention for mild-moderate 
depression.  The current NICE Guidelines pathway for Antenatal and Postnatal Mental Health 
signposts the practitioner to the general population guidelines when mild-moderate depression 
is suspected in pregnancy, however the content of generic depression sites are by very nature 
generic and aren’t adapted to meet the needs of expectant mothers. Therefore, generic cCBT 
packages are being put forward as a low-intensity intervention for mild-moderate depression 
in pregnancy without a strong evidence base to support its efficacy in this unique population 
experiencing a major life event and evolving psychosocial needs (6).   
Studies have highlighted that women are also increasingly turning to the internet to seek health 
related information in pregnancy, and many women would like health professionals to actively 
suggest suitable online resources (7). Advantages of the internet, including cCBT is that it can 
be accessed anonymously, at low cost and at a time and place convenient for the user. 
Although there is strong theoretical support for web-based interventions specific to supporting 
perinatal mental health, more evidence is required in order to fully evaluate its effectiveness.  
 
1.2. 
Rationale for the Study 
 
‘Enjoy Your Bump (EYB)’ is an online life skills course based on CBT principles which has 
been designed by Professor Chris Williams from the University of Glasgow to specifically 
support women in the antenatal period. A survey of women and health professionals has 
demonstrated that this is a resource that both groups find acceptable. The aim of this quasi-
experimental feasibility study is to evaluate the user experience and efficacy of this online 
programme as a non-pharmacological, low intensity intervention for women experiencing mild-

 
 
 
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moderate depressive symptoms in pregnancy. This will be achieved by measuring depression 
and anxiety as well as measures of attachment to the developing baby, pre and post 
intervention. It is hoped the results from this study will help inform whether this is a resource 
that should be made more widely available to women in the NHS. It is hypothesised that the 
‘Enjoy Your Bump’ will be an acceptable and effective intervention for women experiencing 
mild to moderate depressive symptoms in the antenatal period.   
 
2. STUDY OBJECTIVES 
 
2.1. Primary and Secondary Objectives 
Primary Objectives: 
i) Evaluate recruitment and retention to study and return of questionnaire data. 
ii) Evaluate feedback questionnaire data to assess acceptability of intervention.  
iii) Obtain an estimate of effect size for changes in anxiety, depression, social function 
and attachment to the developing baby. 
Secondary Objectives:  
i) Measure depression (PHQ-9, EPDS, PES, WEMWS) anxiety (GAD-7) scores before 
and after the intervention (immediately post-intervention and 12 weeks postnatal) 
ii) Evaluate Mother-baby relationship and attachment using PAI before and after 
intervention and MAI at 12 weeks postnatal. 
iii)  Measure pregnancy-experience pre and post intervetion. 
iv) Test the ability to deliver and support the intervention, and quantify how long it typically 
takes women to complete the intervention.  
2.2. Primary and Secondary Endpoints 
i) Completion of verbal screening, baseline scores, intervention (Enjoy Your Bump), post 
intervention questionnaire and 12-week postnatal follow-up questionnaires.    
 
3. STUDY DESIGN 
We propose a quasi-experimental design, in which an identified population: pregnant women 
with mild to moderate chronic PNMH identified with score ≥2 on PHQ-2 and/or a score ≥2 on 
GAD -2,  and who are 16-32+6 weeks’ gestation will be approached by a member of the 
research team and  encouraged to engage with intervention (cCBT programme Enjoy Your 
Bump). Outcomes: an assessment of recruitment, retention and return of questionnaire data. 
In addition, outcome data will be measured pre-intervention, immediately post-intervention 
and 12 weeks postnatal. 
 
 
 

 
 
 
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Recruitment: Pre-screening 
 
 
 
 
 
Women will be identified for participation in this study by three different means: 

 
 
 
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1. Answering ‘yes’ to one or both of the routine mental health screening question at 
booking with their community midwife. The two routine questions asked at a booking 
appointment are as follows: 
 
“During the past month have you often been bothered by feeling down, depressed 
hopeless?” 
 
“During the past month have you often been bothered by having little interest or 
pleasure in doing things?” 
 
Midwife will then give participant flyer about the project, and ask if they would be happy to sign 
a ‘consent to be contacted slip’ and advise them that research team may be in touch. 
 
2. Referred to the study by a member of the healthcare team, who has identified concerns 
with mental health in the antenatal period (prior to 32+6 weeks of pregnancy). Only 
women who have a signed a ‘consent to be contacted’ slip will be referred.  
 
3. Self-refer to study having received a flyer about study from a member of the healthcare 
team.   
 
 Answering ‘yes’ to one or both routine mental health screening questions at booking 
(approximately 8-11 weeks of pregnancy), will prompt the community midwife to give a flyer 
to the woman giving an overview of the study. They will ask women if they are happy to sign 
a ‘consent to be contacted’ slip. If the woman is happy to do so, the midwife will advise the 
woman that a member of the research team may approach them. The flyer will also contain 
contact information if potential participants wish to contact the research team themselves. Our 
research midwives manage two specialist antenatal clinics on behalf of the NHS (Obesity and 
preterm birth clinic). They are an essential part of the overall NHS Lothian team caring for 
women in pregnancy. Each hold an honorary contract with NHS Lothian and ensure they meet 
the standards required by the Trust to support and care for women during pregnancy. As a 
member of the clinical care team to whom the patient has been referred or directly in their 
capacity as a researcher they may approach women within the maternity setting to participate 
in research.  
 
A member of the research team will personally approach these women who have consented 
to be contacted when they attend for their booking scan and ask if they would be interested in 
taking part. Alternatively, potential participants will be contacted via telephone by a member 
of the research team following their first scan. If potential participants are interested in 
participating they will be given a participant information sheet (either in person or via post).   
  
 
Alternatively, women may be referred to the study by a member of the healthcare team, who 
has identified concerns with mental health in the antenatal period (prior to 32+6 weeks of 
pregnancy). In this instance, a member of the healthcare team will give a flyer giving an 
overview of the study to the woman, and ask if she would be willing to sign a ‘consent to be 
contacted’ slip.  They would then make a referral to the research team who will then meet with 
the woman or contact the woman via telephone to gauge interest, answer any questions and 
invite for pre-screening. A patient information sheet shall be given/sent out in the post.  
 
Prior to invitation to attend for the first visit for this project, interested volunteers will be 
assessed for eligibility to take part in this study by being asked by the researcher either face 
to face in the antenatal clinic setting or over the telephone, the two questions in the PHQ-2 
and GAD-2 questionnaires. Those who score ≥2 on either questionnaire will be eligible for 

 
 
 
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study and invited to meet the researcher for  consent and first visit. The PHQ-2 and GAD-2 
are short, standardised screening tools that identifies people at highest risk of depression. 
Those who are ineligible will be thanked for their time and given an information leaflet 
signposting them to appropriate perinatal mental health support. This will either be given in 
person, or if screening occurs over the phone this leaflet will be sent in the post.   
 
Women will be at least 16+0 and less than 32+6 weeks pregnant when they attend to consent 
to this study. The meeting will take place in a clinical setting within Lothian which is most 
convenient for the woman to travel to. During the first visit the following process will occur: 
 
 
 
Study 

 
 
 
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Consented  participants will: 
i) Complete questionnaires to obtain baseline scores. They will be asked to complete: 
a. Patient Health Questionnaire – 9( PHQ-9)  
b. Edinburgh Postnatal Depression Score (EPDS) 
c. Pregnancy Experience Scale (PES) 
d. Warwick Edinburgh Mental Wellbeing Scale (WEMWS) 
e. Prenatal Attachment Inventory (PAI) 
f. Generalized Anxiety Disorder 7-item scale (GAD-7) 
ii) The participant will then be allocated a unique code to unlock access the EYB website. 
They will register to the website with the help and support of a member of the study 
team who will ensure the participant understands the website and can navigate to 
the five core ‘Change Modules’ which they will need to complete as part of the 
intervention. Each module takes the form of an online slideshow with audio. 
Participants work through the slides at their own pace. There is no data input 
required from them to complete the module. Each module has worksheets that 
accompany the content. Participants will be given all the worksheets at this first 
session. These worksheets are for participants own reference and do not need to 
be seen by the research team.   Before leaving the session, participants will be 
given a leaflet signposting them to further perinatal mental health support.  
iii) The participant will have up to 38+0 weeks gestation to work through and complete the 
five modules and accompanying worksheets. During this time, participants will be 
offered ongoing support from a Research Midwife in the form of phone call and/or 
text message no more frequently than once weekly. We anticipate that the 
intervention will take about 5-8 weeks to complete.  
iv) On completion of the intervention, (up to 38+0 weeks gestation) participants will be 
invited to attend to repeat all measurements of assessment obtained prior to the 
intervention. This can be gathered either face to face or via telephone. .  In 
addition, participants will be asked to complete an anonymous evaluation 
questionnaire online detailing their experience of the intervention. 
v) 12 weeks following the birth of their baby, participants will be invited to complete all 
questionnaires other than the PES and PAI for the final time. The MAI will be used 
to assess attachment. These measures shall be collected face to face or via 
telephone.   
The volunteers will be thanked for their participation in the study. The participant data collected 
will be coded and anonymised. 
 
 
 
During the study, if the researcher has any concerns regarding the mental wellbeing of 
participants they will respond using the standard risk management protocols used in NHS 
Lothian and make the appropriate referrals in consultation with the participant. In this instance, 
a member of the research team will also contact the woman’s named midwife and/or 
obstetrician to discuss and make them aware of the concerns. After consultation, if thought 
appropriate, a referral would be made to perinatal mental health services and/or contact made 
with the woman’s GP. At the screening phase of the study participants will be given a leaflet 
detailing further mental health support available.  
 
 
4. STUDY POPULATION 
 
4.1. Number of participants 

 
 
 
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We are seeking approval to recruit up to 120 participants. It is anticipated that there may be a 
high dropout rate of women who fail to engage with the programme or do not complete it and 
this information will be recorded as part of testing the efficacy of the programme. A current 
survey-based study has found that while women were happy to be recruited, approximately 
15% fully completed all five modules of the programme and questionnaires, and 30% 
completed at least three of the five core modules.  
 
4.2. Inclusion/exclusion criteria 
Inclusion Criteria 
 
≥ 18 years old  
 
Singleton pregnancy 
Mild to moderate chronic PNMH identified with score ≥2 on PHQ-2 or GAD-2  
 
16+0 – 32+6 weeks’ gestation at time of recruitment.  
 
Exclusion Criteria: 
 
Severe 
PNMH 
problem- 
schizophrenia, 
bipolar 
disorder; 
substance 
abuse/dependence, active risk of self-harm.  
 
Already receiving psychological therapy. 
 
Insufficient English language to engage with intervention or complete questionnaires. 
 
Unable to give informed consent.  
 
Illiterate 
 
No internet access 
 
Taking part in another current research project focussed on mental health. 
 
  
4.3. 
 Identification of participants  
As part of the routine clinical antenatal booking appointment, all women are asked the 
following two questions about their mental health: 
 
“During the past month have you often been bothered by feeling down, 
depressed hopeless?” 
 
 
“During the past month have you often been bothered by having little interest 
or pleasure in doing things?” 
 
Women who answer yes to one or both questions will be given summary information about 
the study by a member of the healthcare team. Alternatively, if a healthcare provider identifies 
a concern with a woman’s mental health in the antenatal period prior to 32 weeks gestation, 
they can refer the woman to the research team. In additions to referrals from the community 

 
 
 
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setting,  a research midwife will screen TRAK for potential participants attending. two specialist 
antenatal clinics managed by our research midwives on behalf of the NHS (Obesity and 
preterm birth clinic). They are an essential part of the overall NHS Lothian team caring for 
women in pregnancy. Each hold an honorary contract with NHS Lothian and ensure they meet 
the standards required by the Trust to support and care for women during pregnancy. As a 
member of the clinical care team to whom the patient has been referred or directly in their 
capacity as a researcher they may approach women within the maternity setting to discuss 
participation in research. A research midwife will personally approach these women when they 
attend for their booking scan and ask if they would be interested in taking part. Alternatively, 
potential participants will be contacted via telephone. Interested women will be given an 
information sheet about the study and the researcher will answer any questions she may have. 
There is no pre-agreed specified time to consent. However, participants should be given time 
for reflection and their consent informed and voluntary.  The participant also has the right to 
make an immediate decision to consent.  If they are interested in participating and are beyond 
16+0 weeks, a member of the research team will confirm eligibility using the PHQ-2 and GAD-
2.   
4.4. 
Co-enrolment  
We do not anticipate that participants being involved in other clinical studies will affect their 
ability to be involved in this study, unless the other study is addressing mental health. 
4.5. 
 Consent  
If a participant agrees to take part and meets eligibility by being verbally asked the questions 
on the PHQ-2 and GAD-2 Questionnaires, the research midwife, principal investigator, or other 
trained and delegated member of the research team will go through the study information with 
the patient and take written informed consent. Participants will have been given a patient 
information leaflet prior to agreeing to take part.. There is then no pre-agreed specified time 
to consent. However, potential participants should be given time for questions and reflection 
and their consent informed and voluntary. The participant also has the right to make an 
immediate decision to consent.   
4.6 Risks and Benefits to Participants 
 
There are few apparent risks to participating in this study.  As we are looking to recruit women 
with mild-moderate symptoms of depression, it is important to back-up the online intervention 
with support from an appropriately trained individual and be able to signpost/refer women 
appropriately for further support.   During the study, if the researcher has concerns regarding 
the mental wellbeing of participants beyond their scope of practice they will make the 
appropriate referrals in consultation with the participant. In this instance, a member of the 
research team will contact the woman’s named midwife and/or obstetrician to discuss and 
make them aware of the concerns. After consultation, if thought appropriate, a referral would 
be made to perinatal mental health services and/or contact made with the woman’s GP. 
Participants will be given a leaflet at the outset of the study signposting them to further mental 
health support.  
 

 
 
 
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Although there is little current evidence regarding cCBT in the pregnant population the strength 
of the evidence with regard to the general population suggests that participants may potentially 
derive some benefit from participating in this study.  
 
 
4.6. 
Participant Withdrawal 
Participants can withdraw themselves from the study at any stage without giving a reason.  
Participants will be made aware that withdrawing from the study will not affect their care in any 
way.   
 
5. SAFETY 
No safety reporting is applicable or required for this study.  
 
6. DATA COLLECTION 
Data will be collected as follows: 
Demographics will be gathered from participant’s health records including age, BMI, Parity, 
previous mental health history and postcode.  
Participant’s depression, anxiety and attachment scores will be collected using standardised 
assessment tools PHQ-9, GAD-7, PES, WEMWS, EPDS, PAI and MAI respectively. 
Participants will be allocated a code and their data entered onto a coded Clinical Research 
File.  
Qualitative data will be gathered by asking participants to complete an online evaluation 
questionnaire following the intervention.  
 
7. STUDY OVERSIGHT 
The PI and other study investigators will provide study oversight. The Research Governance 
and QA office (University of Edinburgh) will review the study and determine if an independent 
risk assessment will be performed by an ACCORD Clinical Trials Monitor to decide (a) if 
monitoring is required and (b) if so, at what level. An independent risk assessment may also 
be carried out by the ACCORD Quality Assurance Group to determine if an audit should be 
performed before, during and/or after the study and if so, at what locations and at what 
frequency.” 
 
8. STATISTICS AND DATA ANALYSIS 
 

 
 
 
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8.2. Proposed analyses 
We will use simple descriptive statistics to describe the participant demographics.  
Differences in scores from before and after the intervention will be tested using paired t-tests. 
Summary statistics of data obtained from the other questionnaires will be described and used 
as pilot data to calculate sample size for future studies. 
The comments in the feedback questionnaire will be analysed using thematic analysis to 
identify themes within the interviews.  
 
DATA PROTECTION 
 
9.1. Data Protection 
All Investigators and study staff involved with this study will comply with the requirements of 
the Data Protection Act 1998 with regard to the collection, storage, processing and disclosure 
of personal information and will uphold the Act’s core principles. Access to collated participant 
data will be restricted to the study team. 
Computers used to collate the data will have limited access measures via user names and 
passwords. 
Published results will not contain any personal data that could allow identification of individual 
participants. 
 
9.2. Data Storage 
Data collected during the course of this study will be securely stored on a password-protected 
computer or in a locked office within Simpsons Centre for Reproductive Health at Edinburgh 
Royal Infirmary. Only research team members have access to this office. No data with 
identifying information will leave the research office. .  
 
9.3. Data Archiving 
Data collected during the course of this study will be securely stored for a minimum of 5 
years. 
 
9.4. Confidentiality  
All evaluation forms, reports, and other records will be identified in a manner designed to 
maintain participant confidentiality.  All records will be kept in a secure storage area with 

 
 
 
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limited access.  Clinical information will not be released without the written permission of the 
participant.  The Investigator and study staff involved with this study will not disclose or use 
for any purpose other than performance of the study, any data, record, or other unpublished, 
confidential information disclosed to those individuals for the purpose of the study.  Prior 
written agreement from the sponsor or its designee will be obtained for the disclosure of any 
said confidential information to other parties. 
 
9. REFERENCES 
 
1. Gavin, N., Gaynes, B., Lohr, K., Meltzer-Brody, S., Gartlehner, G., & Swinson, T. (2005). 
Perinatal depression: a systematic review of prevalence and incidence. Obstetrics & 
Gynecology, 106(5 part 1), 1071-1083. 
 
 
2. Melville, J., Gavin, A., Guo, Y., Fan, M., Katon, W., Melville, J. L., & ... Katon, W. J. (2010). 
Depressive disorders during pregnancy: prevalence and risk factors in a large urban 
sample. Obstetrics & Gynecology, 116(5), 1064-1070. doi:10.1097/AOG.0b013e3181f60b0a 
 
3. Yedid Sion, M., Harlev, A., Weintraub, A. Y., Sergienko, R., & Sheiner, E. (2016). Is 
antenatal depression associated with adverse obstetric and perinatal outcomes?. Journal Of 
Maternal-Fetal & Neonatal Medicine, 29(6), 863-867. doi:10.3109/14767058.2015.1023708 
 
4. Milgrom, J., Holt, C., Holt, C., Ross, J., Ericksen, J., & Gemmill, A. (2015). Feasibility study 
and pilot randomised trial of an antenatal depression treatment with infant follow-up. Archives 
Of Women's Mental Health, 18(5), 717-730. doi:10.1007/s00737-015-0512-5 
5. Kim, J., La Porte, L., Corcoran, M., Magasi, S., Batza, J., & Silver, R. (2010). Barriers to 
mental health treatment among obstetric patients at risk for depression. American Journal Of 
Obstetrics & Gynecology, 202(3), 312.e1-5. doi:10.1016/j.ajog.2010.01.004 
6. Lee, E. W., Denison, F. C., Hor, K., & Reynolds, R. M. (2016). Web-based interventions for 
prevention and treatment of perinatal mood disorders: a systematic review. BMC Pregnancy 
& Childbirth, 161-8. doi:10.1186/s12884- Honorary Consultant and Subspecialist in Maternal 
and Fetal Medicine016-0831-1 
7. Lagan, B., Sinclair, M., & Kernohan, W. (2010). Internet use in pregnancy informs women's 
decision making: a web-based survey. Birth: Issues In Perinatal Care, 37(2), 106-115. 
doi:10.1111/j.1523-536X.2010.00390.x