About the study

Up to a quarter of women struggle with serious anxiety symptoms during pregnancy. These anxieties can be about the health of the baby, childbirth, and changes to the family. Anxiety problems are very distressing for mothers. Many women will not improve without treatment, with symptoms continuing postnatally and for some, leading to depression.  width=”1/2″]High anxiety during pregnancy is related to negative outcomes in childbirth and baby development. Babies of mothers who struggle with anxiety during pregnancy can have more problems with their emotions, behaviours and cognitive development. If the mother’s anxiety continues after the baby is born it can make it difficult for the mother to bond with the baby and provide the kind of care the baby needs. Together, the impact of untreated perinatal mental health problems cost over £8 billion each year in England.

Despite the fact that anxiety problems are more common during pregnancy and have many negative effects, there is a lack of high quality research about the best way to help mothers. In the NHS most mothers with antenatal anxiety (65%) are seen in primary mental health care (IAPT), but IAPT lacks treatments that specifically address antenatal anxiety.

We worked with experts-by-experience to develop a 5-session group intervention (CALM) that gives pregnant women tools to manage anxiety, particularly worries about pregnancy. The treatment is delivered by a healthcare and psychological worker pair. The CALM treatment includes partners or a close support and the group encourages peer support. In our feasibility study, we readily recruited women and their partners, who viewed the treatment positively. CALM reduced mothers’ anxiety. We are now undertaking a large trial to evaluate whether offering CALM together with usual treatment is as effective for pregnant women who have problems with anxiety, compared to usual treatment on its own. We will test whether CALM 1) improves anxiety in pregnant women during pregnancy; 2) has sustained benefits in the postnatal period, up to a year after the baby is born; 3) improves the relationship the parent has with the child and how the child develops and 4) is cost-effective for the NHS to deliver. We will also interview parents who completed CALM to see which parts helped them the most, and we will ask care providers about the best ways to ensure CALM fits within the NHS.

Over an 18-month-period, we will recruit 484 women to the trial from five sites, both urban and rural, that have people from different ethnic and income backgrounds. We will work with community connectors to help engage pregnant women from diverse backgrounds. We will deliver most of CALM online because our experts-by-experience told us they think this approach will improve parents’ participation. The NHS and research studies are now also successfully delivering many perinatal psychological treatments online. We will have a tablet loan library (and data) allowance for those who need this.

Our team has a lot of experience developing, testing, and getting perinatal mental health treatments into NHS services. We have expertise in trial design, service user involvement, health economics, child development, statistics, and process research.
This is the first large trial to test the effectiveness and long-term benefits of a group treatment for antenatal anxiety. It has the potential to make a real difference to women and families, and could be delivered widely across the NHS.

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