Enjoy Your Bump - Implementation Study

Antenatal Depression Clinical Trial

Official title: On-line Cognitive Behavioural Therapy Intervention in Pregnancy 'Enjoy Your Bump': an Antenatal Intervention for Perinatal Anxiety

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Antenatal Depression
• Depression

• NCT number: NCT04700501
• Study type: Interventional
• Source: University of Edinburgh
• Status: Completed
• Phase: N/A
• Start date: January 5, 2021
• Completion date: February 8, 2022