Award Title: The RAPID 2 study. Reducing Anxiety in Pregnancy: Intervention Development phase 2. A feasibility study of a midwife facilitated supportive intervention.
Funder: Health Education England

Abstract: Research aim and objectivesThe aim of the study is to test the feasibility of conducting a trial to examine the effectiveness of a midwife facilitated intervention for pregnant women with symptoms of mild to moderate anxiety. The study objectives are to:	To assess rates of participant eligibility, recruitment and retention 	To assess the recruitment procedures 	To estimate the standard deviation of the primary outcome measure to estimate the sample size for a definitive cluster trial 	To conduct a qualitative assessment of women's and facilitators' experiences 	To investigate participant-related and service-level factors potentially affecting outcomes 	To estimate the amount of unexplained variability in outcomes between trusts and participants 	To assess the relevance and acceptability of data collection and outcome measures 	To identify data collection tools for economic evaluationBackgroundEach year in the UK approximately 750,000 women use midwifery services, and 14% will experience symptoms of anxiety. Anxiety disorders are associated with postnatal depression, low birthweight, premature birth and developmental and behavioural problems in children. For women with mild-moderate anxiety, psychological support may help reduce anxiety and prevent an escalation of symptoms. However, services have not been developed or rigorously tested in pregnancy. Work conducted as a doctoral study included the design and developmental testing of a new intervention (RAPID 1). This was the first midwife-led intervention to be evaluated for this population of pregnant women and the first to included midwifery support workers as co-facilitators. The design followed the MRC framework and informed by psychological theory, systematic review evidence and expert and public involvement. RAPID 1 demonstrated the intervention could be integrated within routine maternity care and women considered that they benefitted from participating. MethodsA cluster RCT to test the feasibility of the intervention (RAPID 2) will be conducted in six NHS trusts. The aim is to recruit 70 nulliparous pregnant women with self-reported symptoms of mild-moderate anxiety. The intervention comprises:( a) One-to-one pre-group midwife meeting (b) Six facilitated group discussion sessions (c) Self-help materials. The intervention will be given to six to eight groups over a twelve-week period. Control group participants will receive usual maternity care. The primary outcome will be GAD-7 anxiety scores. Secondary outcomes include quality of life, social support and birth outcomes. Timelines for deliveryEthical approval will be sought in year 1. Recruitment (70 participants), intervention delivery (across 3 cluster sites) and data collection (baseline, baseline plus 14 weeks) will be completed in year 2. Data analysis, reporting and dissemination will be completed in year 3. Anticipated impact and dissemination Public involvement will assist with dissemination including co-presenting at conferences and social media briefings. Dissemination will include journal submissions, reports and briefings for health providers, commissioners, perinatal mental health and maternity networks. The study will contribute to the knowledge base for the care of women with anxiety in pregnancy and has potential to improve infant and maternal outcomes. The intervention will provide women with access to timely, effective support and provide an evidence-based, cost-effective intervention which can be integrated in maternity care structures.

Lay Abstract: Aim of the research: To conduct a small research study known as a 'feasibility study' to test a new approach to care for pregnant women with symptoms of mild to moderate anxiety. This approach will be supported by midwives and maternity support workers. The study (called RAPID 2) will find out how many women are interested and willing to take part and test all the steps in a later larger study. Background to the research: Each year around 750,000 UK pregnant women use midwifery services. Around 14% of women will experience symptoms of anxiety. Anxiety in pregnancy is linked to other problems for women and their babies. This includes postnatal depression, babies born early, of lower birthweight than expected and behaviour and development problems for children. For women with mild to moderate anxiety, psychological support may help reduce anxiety and prevent their symptoms becoming worse. It is important that any new services to support pregnant women with anxiety are tested thoroughly. Earlier stages of this work included designing a new approach to care for women with mild to moderate anxiety (RAPID 1 study). The design was based on psychological theory, a review of previous research and the opinions of service users and other experts. This approach to care consists of group sessions, individual midwife support and self-help materials. The RAPID 1 study found that this approach to care could work within maternity care and women felt that they had benefitted from taking part. Design and methods used: A feasibility study is a piece of research done before a main study to answer the question 'Can this study be done?'. The RAPID 2 feasibility study will be conducted in six NHS trusts. The aim is to recruit 70 first-time pregnant women with symptoms of mild to moderate anxiety. Women will be invited to attend six group sessions over 12 weeks, groups will be supported by a trained midwife and a midwifery support worker. Women will be able to discuss their experiences, provide and receive peer support and access midwifery support. Anxiety before and after taking part in the study will be measured by asking women to complete questionnaires about their symptoms. Anxiety symptoms for this group of women will be compared with a group who receive usual current maternity care. Testing this approach to care with a small group of pregnant women will help to plan a larger study. The study will identify how many women would need to be involved to draw overall conclusions, how willing women are to participate and how useful information can be collected and assessed. Patient and public involvement: This new approach to care was designed with advice from women who had experienced anxiety and women who had recent pregnancies. Women decided the format of the groups and the range of self-help materials. Refinements to the design have been made with input from women who recently accessed maternity care and women from minority ethnic groups. This led to changes in the way that participants are introduced and recruited to the study and the location of groups. An advisory panel of five women have agreed to support the study through the three-year process. They will meet at key stages to help with recruitment, interpreting the results and presenting the findings through social media and local networks. Dissemination: The study findings will be published in scientific journal papers and presented at international midwifery and perinatal mental health conferences. Written reports and social media briefings will be prepared for healthcare professionals, perinatal mental health networks, service user groups, maternal and mental health charities and Royal Colleges (GPs, Psychiatrists, Midwives).

Research Activity Codes: 6.1 PHARMACEUTICALS;7.1 INDIVIDUAL CARE NEEDS
Health Categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;MENTAL HEALTH