Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK.

Emma Molyneaux,Hind Khalifeh,Louise M Howard,Simone Vigod,Ruth Brauer

doi:10.3399/bjgpopen19x101666

Abstract

BackgroundDecision-making regarding antidepressant use in pregnancy is challenging, given the uncertain evidence base on the benefits and risks for women and their children. Patient decision aids (PDAs) can improve shared decision-making for complex health decisions but no evidence-based PDAs exist for antidepressant use in pregnancy.AimTo assess the feasibility of a full-scale randomised controlled trial (RCT) to evaluate the efficacy of an electronic PDA on antidepressant use in pregnancy.Design & settingA UK-based pilot parallel-group RCT.MethodThe study recruited women whose clinicians recommended an antidepressant for depression in a current or planned pregnancy, and who were uncertain about antidepressant use while pregnant. Women were recruited via clinician or self-referral, and randomised to online access to the PDA or online access to standard resource list, with primary follow-up at 4 weeks and longer-term follow-up. The primary outcome was protocol feasibility (recruitment target of 50 women and follow-up rate of 80%). Outcome measures for a future full-scale RCT included the decisional conflict scale (DCS).ResultsFifty-one women were recruited with a follow-up rate of 90.2% at 4 weeks. The PDA received good overall satisfaction ratings (mean 4.2/5). Analysis of covariance (ANCOVA) indicated a small improvement in decisional conflict at 4 weeks, accounting for baseline scores (DCS regression coefficient = -3.5, 95% confidence intervals [CI = -12.6 to 5.6]).ConclusionThis pilot RCT for an electronic PDA on antidepressant use in pregnancy showed that the study protocol was feasible, with high rates of participant satisfaction among those randomised to the PDA.

Highlights

Depression is one of the commonest morbidities of pregnancy, affecting around 10–15% of pregnant women.[1]
The study recruited women whose clinicians recommended an antidepressant for depression in a current or planned pregnancy, and who were uncertain about antidepressant use while pregnant
Analysis of covariance (ANCOVA) indicated a small improvement in decisional conflict at 4 weeks, accounting for baseline scores (DCS regression coefficient = -3.5, 95% confidence intervals [CI = -12.6 to 5.6]). This pilot randomised controlled trial (RCT) for an electronic Patient decision aids (PDAs) on antidepressant use in pregnancy showed that the study protocol was feasible, with high rates of participant satisfaction among those randomised to the PDA

Summary

Introduction

Depression is one of the commonest morbidities of pregnancy, affecting around 10–15% of pregnant women.[1] Untreated or incompletely treated depression is associated with potential adverse effects for mother and unborn child, including prematurity, childhood emotional and behavioural problems, and, rarely, maternal suicide.[1,2] Antidepressants are indicated for the treatment of moderate-to-severe depression in pregnancy when psychotherapy alone is unlikely to result in substantive improvements.[3] There is evidence that the proportion of women taking antidepressants during pregnancy has increased substantially in recent years;[4] for example from 2% in 1991–1992 to 13% in 2012–2016 in a two-g enerational study of young mothers in southwest England.[5]. Decision-m aking regarding antidepressant use in pregnancy is challenging, given the uncertain evidence base on the benefits and risks for women and their children. Patient decision aids (PDAs) can improve shared decision-m aking for complex health decisions but no evidence-based PDAs exist for antidepressant use in pregnancy

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Conclusion