A pilot trial of a patient decision aid for antidepressant use in pregnancy
Antidepressant medications are recommended in pregnancy for some women, but many of these women find it difficult to decide whether or not to take them. We have created a web-based Patient Decision Aid (PDA) to help women who are considering this decision. We want to find out if using this decision aid will improve women’s satisfaction with the decision-making process. We are conducting a small pilot randomized controlled trial to see which study procedures are practical and can be used in a bigger trial in the future.
The study website can be found at: www.kcl.ac.uk/decisionaid
The interactive, electronic PDA has 3 main sections: (1) Evidence-based information about depression in pregnancy and each treatment option and procedure; (2) evidence-based information on the risks and benefits of both untreated depression and antidepressant treatment, integrated with a series of exercises to help women determine which risks and benefits are most important to them. This section also includes exercises to help women consider how their relationships with others (e.g. partners, friends, and providers) affects the decision-making process; and (3) a summary section that outlines the information reviewed and which benefits and risks they deemed most important.
Women are eligible to participate if they meet all of the following criteria: (a) are aged 18 or over; (b) are planning a pregnancy or are <30 weeks pregnant at enrolment; (c) they have been offered to start or continue an antidepressant as treatment for depression by their clinician and (d) they are finding it difficult to decide whether to take an antidepressant or not. Women will not be eligible if they insufficient English language proficiency, and if they have certain severe mental or obstetric illnesses.
The study is run by Professor Louise Howard’s group in the Section of Women’s Mental Health, King’s College London. We will recruit via: (a) GP practices in London; (b) mental health services in South London and Maudsley NHS Foundation Trust, including specialist perinatal mental health services; (c) maternity services in hospitals in South London; (d) websites providing information or support for pregnant women and (e) relevant clinicians nationally. PDAs are not used in standard NHS practice for making decisions about antidepressant use in pregnancy, so this is an ideal opportunity to evaluate the efficacy of a new PDA without depriving women of standard care.
The study is funded by the UK’s National Institute for Health Research (NIHR), via a research professorship to Professor Louise Howard. The study team includes Louise Howard, Hind Khalifeh, Ruth Brauer and Emma Molyneaux.
If you would like to find about more about the study please email firstname.lastname@example.org.