22 Mar 2022

Anxiety is common in the perinatal period. Up to 40% of pregnant women and new mothers experience high levels of anxiety (Fairbrother et al., 2017) with multiple significant adverse consequences for these women, their unborn child, children and partners, including reduced responsivity to babies (Stein et al., 2012), impairments in childhood development, and a two-fold increase in risk of a child developing psychological disorders (O'Donnell et al., 2014).   

Maternity anxiety

Project aim

The purpose of this randomised controlled trial is to determine whether pregnant women with high levels of repetitive negative thinking who complete an early online web-based intervention, RELAX, alongside receiving usual care, have a significant reduction in anxiety later in the perinatal period compared to those who receive usual care alone.

How the study will work

Women will be approached in person by members of the trial team to discuss the study at their 16-week midwife appointment and other relevant routine appointments. They will provide women with the study information sheet, answer questions and ask them to register their interest and complete the screening form on the RELAX platform if they would like to take part. The trial team will provide eligible women with more information verbally about the study by telephone and women wishing to continue in the study will be randomised and complete their baseline assessment online and be randomised either to the treatment as usual group (n=134) or the RELAX intervention group (n=134).

The intervention group will complete 12x25 minute sessions over four weeks and the usual care group will continue with their normal midwifery care, or regular health visitor contact. Participants in the RELAX intervention will listen to short, ambigious scenarios (covering everyday life and pregnancy tailored) that can be interpreted in both negative and positive ways. Through the platforrm, participants will learn to resolve the scenarios positively and imagine themselves in the positive outcome. All sessions will be completed at home on participants' personal computers, tablets or laptops. They will have assessments to complete at four intervals from joining the trial (16-28 weeks gestation) to follow up (12-24 weeks post birth).

Our collaborators

The research team will collaborate with healthcare staff at Guy’s and St Thomas’, King’s College Hospital and South London and Maudsley NHS Foundation Trusts, as well as University of Warwick and University of New South Wales.

Potential benefits of the project

Online interventions have the potential to increase access to reduce anxiety in women in the perinatal period, who may experience multiple practical barriers to attending therapy in a clinical setting. The intervention has the potential to reduce perinatal anxiety and improve women’s mental health in the short-term, and thus enhance their ability to cope with and navigate the challenges of pregnancy and caring for a new baby. In the longer term, postpartum access to specialist mental health services may be reduced for women receiving the intervention.

How patients and the public are involved in the research

Patients and the public have been involved in the design of the study and are continuing to be involved throughout the project. We have a fully costed PPI lead (co-applicant) who will liaise with the research team, Maternity Voices Partnerships (MVP), Parents and Children Together (PACT) and PPI members throughout the project. Our PPI lead, for example will convene workshops with women with lived experience of perinatal anxiety to guide the development of the materials used in the intervention. We will have a PPI advisory group who will refine materials on the basis of online feedback and contribute to blogs, recruitment strategies and the dissemination of research findings.

We will also tailor King's College London's Diversity and Inclusion strategy to this project, as well as upholding a PPI strategy and offering ongoing PPI support and training. We will seek to include Black, Asian and Minority Ethnic (BAME) service users and women with multiple social disadvantages to help us understand their experiences, consider how we can reflect these within our intervention, and how we can engage other women with similar experiences.

We also have three women with lived experience of perinatal anxiety on our Trial Steering Committee, as well as midwives, and perinatal mental-health clinicians. This group will meet seven times throughout the project.  

The study is funded by the NIHR from February 2022 to July 2025. It was adopted by ARC South London Executive in February 2022.