A patient decision aid for antidepressant use in pregnancy: Pilot randomized controlled trial

BACKGROUND: Decisions about antidepressant use in pregnancy are complex. We performed a pilot randomized controlled trial assessing the feasibility of a trial protocol for an online patient decision aid (PDA) for women deciding about antidepressant use in pregnancy. METHODS: 96 preconception and pregnant Canadian women recruited from specialist (n = 51) and non-specialist (n = 45) settings with Decisional Conflict Scale (DCS, range 0-100) score of ≥25 signifying moderate-to-high decisional conflict were randomly allocated to either the PDA or a control condition that guided participants to publicly available resources for advice around antidepressants and pregnancy. Follow-up data were collected at 4 weeks post-randomization. RESULTS: About 88.9% of eligible participants consented to participate. Women's views of the tool were positive; 88.7% of participants provided follow-up data. At follow-up, mean DCS score had decreased by 19.9 points in the PDA group vs. 13.3 in controls (adjusted mean difference, MD, 7.01, 95% CI -14.3 to 0.30). In the non-specialist setting, DCS scores decreased more for PDA users (25.5 points) than controls (10.5 points; adjusted MD -15.1, 95% CI -25.6 to -4.55); the MD was negligible in the specialist setting. LIMITATIONS: The main limitation is the highly educated, high-income nature of our sample. CONCLUSIONS: Evaluation of an online PDA for antidepressant use in pregnancy with national recruitment is feasible. Pilot results suggest that the tool is acceptable and reduces decisional conflict more than clinical care alone in a non-specialist setting. Evaluation of the PDA's impact on longer-term maternal and child clinical outcomes is a key next step.