Patient Decision Aid for Antidepressant Use In Pregnancy
Research type
Research Study
Full title
An electronic patient decision aid for antidepressant use in pregnancy: a pilot randomized controlled trial
IRAS ID
166207
Contact name
Kieth Brennan
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Depression in pregnancy is common, affecting up to 10% of women and represents serious risk to mother and infant. Unfortunately, antidepressant medication, a first-line treatment for depression in pregnancy, also comes with risks, making this a complex decision. Clinical care appears to be insufficient for ensuring that women make decisions that are consistent with their own values and with which they feel satisfied. Patient decision support tools can address such barriers. We have created an electronic patient decision aid (PDA) that has the potential to improve the decision-making process for women regarding antidepressant use in pregnancy in conjunction with clinical care.
The overall objective of this project is to inform the development of a future international randomised controlled trial (RCT) to assess the efficacy of our PDA for antidepressant use in pregnancy. To achieve this objective, we will conduct a pilot RCT to assess to feasibility of our clinical trial protocol, to evaluate the PDA and to determine the preliminary effect size for a larger multi-site efficacy study. The pilot RCT will recruit women under the care of primary and secondary services in London(target N=50). Women will be eligible if they are considering starting or continuing antidepressants in pregnancy, and if they have moderate to high decisional conflict. They will be randomised to receive usual clinical care plus PDA or usual clinical care plus standard resource information. Key outcomes include feasibility of the trial protocol (in terms of recruitment and adherence) and the PDA’s acceptability to women. Findings will be used to inform a future definitive multicentre efficacy trial.
REC name
London - Queen Square Research Ethics Committee
REC reference
15/LO/0601
Date of REC Opinion
8 May 2015
REC opinion
Further Information Favourable Opinion