Trial reportTrials2016
A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial.
Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02308592 (Patient Decision Aid), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.
- Guidelines on treatment of perinatal depression with antidepressants: An international review.The Australian and New Zealand journal of psychiatry · 2018Pooled it
- Motherhood choice in multiple sclerosis (MoMS) - Pilot trial of web-based decision support.PloS one · 2026Trial
- Comparison of analog and digital patient decision aids for the treatment of depression: a scoping review.Frontiers in digital health · 2023Article
- NICE shared decision making guidelines and mental health: challenges for research, practice and implementation.BJPsych open · 2021Article
- Perinatal mental health around the world: priorities for research and service development in the USA.BJPsych international · 2020Article
- Decision-making about antidepressant medication use in pregnancy: a comparison between women making the decision in the preconception period versus in pregnancy.BMC psychiatry · 2020Article
- Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK.BJGP open · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 4 institutions in 2 countries.
Funding
Abstract
backgroundMany women with depression experience significant difficulty making a decision about whether or not to use antidepressant medication in pregnancy. Patient decision aids (PDAs) are tools that assist patients in making complex health decisions. PDAs can reduce decision-making difficulty and lead to better treatment outcomes. We describe the methods for a pilot randomized controlled trial of an interactive web-based PDA for women who are having difficulty deciding about antidepressant drug use in pregnancy. METHODS/
designThis is a pilot randomized controlled trial that aims to assess the feasibility of a larger, multi-center efficacy study. The PDA aims to help a woman: (1) understand why an antidepressant is being recommended, (2) be knowledgeable about potential benefits and risks of treatment and non-treatment with antidepressants, and (3) be clear about which benefits and risks are most important to her, with the goal of improving confidence in her decision-making. We include women aged 18 years or older who are: (1) planning a pregnancy or are pregnant (gestational age less than 30 weeks), (2) diagnosed with major depressive disorder, (3) deciding whether or not to use a selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) antidepressant in pregnancy, and (4) having at least moderate decision-making difficulty as per a Decisional Conflict Scale (DCS) Score ≥25. Participants are randomized to receive the PDA or an informational resource sheet via a secure website, and have access to the stated allocation until their final study follow-up. The primary outcomes of the pilot study are feasibility of recruitment and retention, acceptability of the intervention, and adherence to the trial protocol. The primary efficacy outcome is DCS score at 4 weeks post randomization, with secondary outcomes including depressive and anxiety symptoms. DISCUSSION: Our PDA represents a key opportunity to optimize the decision-making process for women around antidepressants in pregnancy, leading to effective decision-making and optimizing improved maternal and child outcomes related to depression in pregnancy. The electronic nature of the PDA will facilitate keeping it up-to-date, and allow for widespread dissemination after efficacy is demonstrated.
trial registrationThis trial is registered on ClinicalTrials.Gov under the identifier NCT02308592 (first registered: 2 December 2014).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.