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Purpose <p>Decisions about whether to use antidepressant medication in pregnancy can be complex for patients. When decisional conflict is high, this can negatively impact on decision-making and resultant clinical outcomes. We evaluated an electronic patient decision aid (PDA) around antidepressant use in pregnancy for its ability to improve patients’ decision-making experience and the clinical outcomes associated with their decisions.</p> Methods <p>This parallel-group trial (2018–2025) randomized preconception and pregnant Canadian participants with depression in a 1:1 ratio to an electronic PDA plus standard resources or standard resource control. Groups were compared on decisional conflict (measured using the Decisional Conflict Scale, DCS) at 4 weeks post-randomization. Those who were pregnant/became pregnant were evaluated for postpartum depression (PPD) at 3 months postpartum using the Structured Clinical Interview for DSM-5.</p> Results <p>Of <i>n</i> = 462 participants, <i>n</i> = 231 (mean age 32.4 +/- 4.0 years. 48.3% pregnant at baseline) were randomized to the PDA and <i>n</i> = 231 (mean age 32.5 +/- 4.2 years. 48.1% pregnant at baseline) to control. Between baseline and 4-weeks post-randomization, mean (SD) DCS score decreased from 48.3 (13.1) to 33.9 (14.9) in the PDA condition and 47.9 (14.5) to 40.1 (17.0) in controls, an adjusted mean difference of -6.34 (95%CI -8.92 to -3.79). PPD at 3 months postpartum was present in 7 (6.0%) PDA and 15 (12.9%) control participants, an absolute risk difference of -6.9% (95% CI -14.4% to 0.5%).</p> Conclusions <p>Compared to standard resources alone, our PDA plus standard resources significantly reduced decisional conflict about the decision of whether or not to use antidepressant medication in pregnancy. PPD rates at 3 months postpartum were non-significantly lower in the PDA group as well. These results support dissemination of the PDA, and the evaluation of its utility with a wider audience.</p>

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A randomized controlled trial of an electronic patient decision aid (PDA) for decision-making around antidepressant use in pregnancy

  • 期刊论文

  • 发表日期：

    2026年1月29日

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  • Simone N. Vigod,
  • Cindy-Lee Dennis,
  • Sophie Grigoriadis,
  • Kelly Metcalfe,
  • Tim F. Oberlander,
  • Maria Michalowska,
  • Aysha Butt,
  • Antara Chatterjee,
  • Claire DeOliveira,
  • Wanrudee Isaranuwatchai,
  • Yutong Lu,
  • Janet Parsons,
  • Donna E. Stewart,
  • Kevin E. Thorpe

摘要

Purpose

Decisions about whether to use antidepressant medication in pregnancy can be complex for patients. When decisional conflict is high, this can negatively impact on decision-making and resultant clinical outcomes. We evaluated an electronic patient decision aid (PDA) around antidepressant use in pregnancy for its ability to improve patients’ decision-making experience and the clinical outcomes associated with their decisions.

Methods

This parallel-group trial (2018–2025) randomized preconception and pregnant Canadian participants with depression in a 1:1 ratio to an electronic PDA plus standard resources or standard resource control. Groups were compared on decisional conflict (measured using the Decisional Conflict Scale, DCS) at 4 weeks post-randomization. Those who were pregnant/became pregnant were evaluated for postpartum depression (PPD) at 3 months postpartum using the Structured Clinical Interview for DSM-5.

Results

Of n = 462 participants, n = 231 (mean age 32.4 +/- 4.0 years. 48.3% pregnant at baseline) were randomized to the PDA and n = 231 (mean age 32.5 +/- 4.2 years. 48.1% pregnant at baseline) to control. Between baseline and 4-weeks post-randomization, mean (SD) DCS score decreased from 48.3 (13.1) to 33.9 (14.9) in the PDA condition and 47.9 (14.5) to 40.1 (17.0) in controls, an adjusted mean difference of -6.34 (95%CI -8.92 to -3.79). PPD at 3 months postpartum was present in 7 (6.0%) PDA and 15 (12.9%) control participants, an absolute risk difference of -6.9% (95% CI -14.4% to 0.5%).

Conclusions

Compared to standard resources alone, our PDA plus standard resources significantly reduced decisional conflict about the decision of whether or not to use antidepressant medication in pregnancy. PPD rates at 3 months postpartum were non-significantly lower in the PDA group as well. These results support dissemination of the PDA, and the evaluation of its utility with a wider audience.