A patient decision aid for antidepressant use in pregnancy: Pilot randomized controlled trial
Abstract
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.
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Formulation assists in choosing which medication, psychosocial or lifestyle approaches to treatment and care a person might need or expect, as well as identifying individuals at risk of suicide.
“Formulation assists in choosing which medication, psychosocial or lifestyle approaches to treatment and care a person might need or expect, as well as identifying individuals at risk of suicide. 604”
From Time for united action on depression: a Lancet–World Psychiatric Association Commission (2022) · cites this paper as [604]
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- Authors
- Vigod, S. N., Hussain-Shamsy, N., Stewart, D. E., Grigoriadis, S., Metcalfe, K., Oberlander, T. F., Schram, C., Taylor, V. H., & Dennis, C.-L.
- Affiliations
- University of Toronto (CA)
- University Health Network (CA)
- Sunnybrook Health Science Centre (CA)
- University of British Columbia (CA)
- St. Michael's Hospital (CA)
- Corresponding author
- Vigod, Simone N.
- ORCID
- Venue
- Journal of Affective Disorders
- Publisher
- Elsevier BV
- Published
- 2019-05
- Volume
- 251
- Pages
- 91-99
- ISSN
- 0165-0327 (ISSN-L)
- OpenAlex
- W2922399840
- Cited by
- 42
- References
- 29
- Citations by year
- 2026: 3 · 2025: 6 · 2024: 6 · 2023: 5 · 2022: 14 · 2021: 5 · 2020: 3
- FWCI
- 7.49
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Affective Disorders (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Canadian Institutes of Health Research
- Topics
- Health Sciences › Health Professions › General Health Professions › Patient-Provider Communication in Healthcare
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Maternal Mental Health During Pregnancy and Postpartum
- Keywords
- antidepressant use in pregnancy, patient decision aids, online decision support, decisional conflict, maternal mental health, preconception care, feasibility, Decisional Conflict Scale, maternal depression
- MeSH terms
- Adult, Antidepressive Agents, Canada, Conflict, Psychological, Decision Making, Decision Support Techniques, Major Depressive Disorder, Double-Blind Method, Female, Humans, Patient Participation, Pilot Projects, Pregnancy, Pregnancy Complications, Young Adult
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