Clinical trial NCT04700501: Enjoy Your Bump - Implementation Study
Official title: On-line Cognitive Behavioural Therapy Intervention in Pregnancy 'Enjoy Your Bump': an Antenatal Intervention for Perinatal Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antenatal Depression
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Tommy's
First posted: 2021-01-08
Enrollment: 51
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: implementation study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Enjoy Your Bump is an implementation study relating to antenatal maternal mental health in women who have mild to moderate feelings of depression and anxiety. The investigators aim to address the following research question: Is a pregnancy-specific online CBT based life skills course (EYB) delivered antenatally clinically effective in improving maternal anxiety symptom scores immediately post-intervention and at 12 weeks postpartum?

The investigators hypothesise that a pregnancy specific on-line CBT intervention delivered antenatally will improve PNMH during pregnancy and that this will be sustained at 3 months post-partum with beneficial effects for mother and child.

The pregnancy specific online CBT tool Enjoy Your Bump (EYB) course teaches CBT-based life skills to expecting mothers in a fun and low-jargon way. Participants are asked to complete 5 'core' modules and encouraged to take their time to learn, reflect and practice these new life skills.

The investigators anticipate recruiting approximately 100 women to participate in this implementation study. Mental health assessments will be conducted before starting the CBT programme, on completion of the programme and again at 6-12 weeks postnatal. The investigators anticipate an improvement in maternal mental health assessment scores in women who have completed the course and the investigators hope to observe a longer term effect in scores at 6-12 weeks postnatal.

Detailed description: One in four women have mental health problems, such as feeling anxious or depressed, during pregnancy and following childbirth. This not only impacts on the woman's own wellbeing but can also adversely affect the physical development and mental wellbeing of her child. The National Health Service (NHS) Long Term Plan aims to be able to provide better access to quality psychological interventions for women with mental health problems in pregnancy. Since the start of the Covid-19 outbreak in March 2020, pregnant women have been placed in a vulnerable group. There have been dramatic changes to maternity services in the community and hospital settings with remote midwife visits and changes to antenatal services. The normal support from friends and family has been reduced due to the current social distancing guidelines. This has all led to an increase in levels of stress and anxiety in the antenatal population.

The investigators have developed a unique pregnancy-specific on-line educational CBT based life skills course called Enjoy Your Bump (EYB). Unlike other CBT tools currently in use, this tool is specifically designed for use by pregnant women with chronic PNMH problems like elevated anxiety, mild depressive symptoms or high levels of self-reported stress. It also addresses specific concerns that women have during pregnancy, is the only pregnancy specific on-line CBT tool available and teaches CBT-based life skills in a fun and low-jargon way.

This implementation study will be open to any pregnant women in NHS Lothian who are experiencing mild or moderate symptoms of anxiety or depression. All pregnant women have access to an antenatal booking appointment with the community midwife following a positive pregnancy test. Women receive routine antenatal appointments during other stages of pregnancy and can participate in the study at any time point up to 32 weeks of pregnancy. During the booking appointment women are routinely asked two mental health questions:

1. During the past month has the participant often been bothered by feeling down, depressed or hopeless?"
2. During the past month has the participant often been bothered by having little interest or pleasure in doing things?"

If participants answer yes to either of these questions, the midwife can direct them to the online Enjoy Your Bump study website to gain further information about the study.

Information about this study will also be displayed in maternity waiting rooms in hospitals and on-line websites and women can self refer to participate.

Following completion of three baseline questionnaires, the participants will be provided with a link to the Enjoy Your Bump website. It can be completed using a tablet, smart phone, computer or kindle and is delivered as a modular intervention.

Women are asked to complete 5 'core' modules. There are additional optional modules and support materials the women can access to support their journey through the programme. The modules are supported by completion of 'worksheets' which can be accessed electronically. EYB is unique, as it is tailored to include specific issues relevant to pregnancy. At approximately 36 weeks gestation (after completion of the modules) the participants will be asked to complete 3 short questionnaires either by phone or by an email link to the study website. As part of routine practice all women receive a 6-12 week community follow up appointment by a health care professional. During this appointment the EPDS questionnaire is collected to assess postnatal mental Health.

Eligibility criteria: Inclusion Criteria:

* Age 16 or over,
* Capacity to give informed consent to participate in the study,
* Mild to moderate chronic Perinatal mental health (PMH) problems Score ≥3 on PHQ- 2,
* 8-32 week gestation

Exclusion Criteria:

* Severe Perinatal mental health problem - schizophrenia, bipolar disorder,
* Substance abuse/dependence,
* Active risk of self-harm,
* Insufficient English language to engage with intervention,
* No access to the internet

Primary outcomes:
measure: To measure any change from baseline mental health scores when the General Anxiety Disorder-7 (GAD-7) is repeated on completion of the course, or at 36 weeks' gestation.
timeFrame: Through study completion, up to 1 year
measure: To measure any change from baseline mental health scores when the Patient Health Questionnaire -8 (PHQ-8) is repeated on completion of the course, or at 36 weeks' gestation.
timeFrame: Through study completion, up to 1 year
measure: To measure any change from baseline mental health scores when the Edinburgh Postnatal Depression Score is repeated on completion of the course, or at 36 weeks' gestation.
timeFrame: Through study completion, up to 1 year
Secondary outcomes:
measure: To measure the post-natal Edinburgh Postnatal Depression Scale (EPDS) scores when taken at 6-12 weeks by NHS Health Visitors.
timeFrame: Through study completion, up to 1 year
measure: To measure the number of participants consented into the study.
timeFrame: Through study completion, up to 1 year
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh, Queens Medical Research Facility
Study officials:
affiliation: University of Edinburgh
name: Professor R Reynolds
role: PRINCIPAL_INVESTIGATOR
References:
citation: Antenatal and postnatal mental health: clinical management and service guidance. National Institute of Health and Clinical Excellence (NICE) guidelines [CG192] Published date: December 2014
citation: Saving Lives, Improving Mothers' Care. Lessons learned to inform future maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2009-2012
citation: Bauer A, Parsonage M, Knapp M, Lemmi V, Adelaja B. The costs of perinatal mental health problems. London School of Economics and Political Science. 2014.
citation: Heron J, O'Connor TG, Evans J, Golding J, Glover V; ALSPAC Study Team. The course of anxiety and depression through pregnancy and the postpartum in a community sample. J Affect Disord. 2004 May;80(1):65-73. doi: 10.1016/j.jad.2003.08.004.
citation: Evans J, Heron J, Francomb H, Oke S, Golding J. Cohort study of depressed mood during pregnancy and after childbirth. BMJ. 2001 Aug 4;323(7307):257-60. doi: 10.1136/bmj.323.7307.257.
citation: Ashford MT, Olander EK, Ayers S. Computer- or web-based interventions for perinatal mental health: A systematic review. J Affect Disord. 2016 Jun;197:134-46. doi: 10.1016/j.jad.2016.02.057. Epub 2016 Mar 9.
citation: Lee EW, Denison FC, Hor K, Reynolds RM. Web-based interventions for prevention and treatment of perinatal mood disorders: a systematic review. BMC Pregnancy Childbirth. 2016 Feb 29;16:38. doi: 10.1186/s12884-016-0831-1.