Online tools designed to reduce decisional conflict among women deciding on use of antidepressants in pregnancy can be feasibly evaluated and were found to be an acceptable intervention, according to a study published in the Journal of Affective Disorders.
The investigators of this pilot study sought to assess the feasibility of a randomized control trial protocol to evaluate an online patient decision aid (PDA) for women weighing whether or not to use antidepressant medications in pregnancy. The study included 96 preconception or pregnant women aged at least 18 years with a major depressive disorder who were recruited in Canada from both a specialist setting (n=51) and nonspecialist settings (n=45). The participants all reported moderate to high decisional conflict about antidepressants in pregnancy with a Decisional Conflict Scale score of at least 25 (range 0-100). The women were randomly assigned to use either the web-based PDA tool or a control tool for accessing publicly available resources and knowledge regarding antidepressants and pregnancy. After the 4-week study period, participants continued to receive care from their respective healthcare providers and completed follow-up to discuss their decision. Primary outcomes included feasibility, acceptability, and adherence to trial protocol; secondary outcomes were decisional conflict, depression, anxiety, and knowledge.
Of the total sample, 88.5% completed maternal outcome questionnaires after 4 weeks, and 91.3% of women assigned to the PDA had accessed the tool. The participants reported positive views of the tool, and women recruited from a nonspecialist setting vs a specialist setting were more likely to report that the PDA provided additional information not covered in a physician consultation (77.8% vs 25.0%) and that it increased their knowledge of antidepressants and pregnancy (83.3% vs 68.8%). The mean Decisional Conflict Scale score decreased by 19.9 points in the PDA group compared with 13.3 points in the control group (adjusted mean difference [MD] 7.01; 95% CI, -14.3 to 0.30). For PDA users in nonspecialist settings, their Decisional Conflict Scale scores decreased more than the controls (25.5 points vs 10.5 points; adjusted MD -15.1; 95% CI, -25.6 to -4.55). In the specialist setting, the Decisional Conflict Scale score decreased for both the PDA and control groups, but there was no meaningful difference between them.
A primary limitation to the study was the homogeneous nature of the recruited participants who were highly educated women from high-income households.
The researchers indicate that evaluating online PDA for antidepressant use in pregnancy using a randomized control trial protocol with nationwide recruitment is feasible. They conclude that in a nonspecialist setting, this tool was more effective for reducing decisional conflict than clinical care alone. Future studies should evaluate the PDA’s long-term impact on maternal and pediatric clinical outcomes.
Several authors declare affiliations with pharmaceutical companies. Please refer to the reference for a full list of disclosures.
Vigod SN, Hussain-Shamsy N, Stewart DE, et al. A patient decision aid for antidepressant use in pregnancy: pilot randomized controlled trial [published online March 18, 2019]. J Affect Disord. doi: 10.1016/j.jad.2019.01.051