Extract

Background and study aims For many women, pregnancy is a positive experience. However, for some, pregnancy can intensify existing areas of anxiety and introduce new areas of concern. For example, women have reported becoming more worried about the support available to them and feeling anxious about their pregnancy, birth and parenting. These feelings can have a considerable impact on the woman and her developing foetus. Babies of mothers who have had higher than average levels of anxiety during pregnancy have more problems in their emotional, behavioural and cognitive development. These same women are also at an increased risk of postnatal anxiety and depression, both of which make it challenging for the mother to provide care for her baby, and can interfere with the formation of a secure emotional bond between mother and infant. Despite the fact that anxiety is common during pregnancy and may have adverse consequences for the mother and her baby, there is very little research into the best and most acceptable ways of helping women. However, a guided self-help intervention designed to help parents prepare for the emotional aspects of parenting has recently been tested in Australia and shown to reduce anxiety in expectant mothers. In order to reach the greatest number of women in an effective and cost effective fashion, we plan to adapt this intervention to be delivered to women with elevated anxiety by midwives in the context of routine antenatal care in the UK. In order to do this, we will first trial the intervention with a small group of women and gain feedback from them in order to understand what modifications are needed. The findings from this phase will be used to guide the final refinement of a brief psychological intervention to reduce anxiety in pregnant women which will then be tested for feasibility and acceptability in a randomised controlled trial. Our primary aims are therefore to develop a brief, widely deliverable intervention to improve symptoms of anxiety in pregnant women and to test its feasibility and acceptability to pregnant women and their partners in a randomised controlled trial. What does the study involve? The programme involves attending three group sessions led by midwives. The sessions will be in the evening at three-week intervals. Each session will last about 1.5 hours and will take place at Queen Charlotte’s and Chelsea Hospital, London. We would like to involve partners as well where this is possible, but are very happy for women to come on their own if not. In these sessions participants will receive information about stress and anxiety during pregnancy, and will learn a variety of techniques and strategies to help with these feelings. Participants will also receive a workbook called ‘Towards Parenthood’, which includes details of the information and techniques. Participants will be asked to complete some questionnaires at the beginning and end of the study so we have an idea of how they are getting on. After participants have completed the group session we would like to talk to them about their experiences of the group intervention and being in the study. We are interested in getting feedback on all aspects of the programme and the research. This discussion will take about 30 - 60 minutes. What are the possible benefits and disadvantages of taking part? We are in the early stages of this research and therefore we cannot say with certainty that taking part will be of benefit to participants. However, the programme has been used in research studies previously and parents have found it helpful. It has been shown to reduce stress and anxiety in expectant parents. The disadvantages of taking part are likely to be small. Participants will need to put aside time for the group sessions (about 1.5 hours), which will be in the evening, and the follow up discussion (about 30 - 60 minutes). The midwives and researchers are experienced and specially trained for the study, and if during the sessions or discussions participants were to feel uncomfortable or distressed for any reason, they would respond sensitively and only continue if the participant was happy to do so. Where is the study run from? Participants will be recruited from Queen Charlotte's and Chelsea Hospital, London. The group intervention will also take place at this location. When is the study starting and how long is it expected to run for? October 2014 to November 2016 Who is funding the study? NIHR Research for Patient Benefit (RfPB) (UK) Who is the main contact? Dr Paul Ramchandani [email protected]

Inclusion criteria

• Topic: Mental Health, Reproductive health and childbirth; Subtopic: Anxiety, Reproductive Health and Childb (all Subtopics); Disease: Anxiety, Reproductive Health & Childbirth

Links

• isrctn
• ictrp