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Randomized Controlled Trial
. 2025 Apr 29;25(1):437.
doi: 10.1186/s12888-025-06876-3.

Electronic Measurement-based care (eMBC) for perinatal depression and anxiety: a pilot randomized controlled trial

Affiliations
Randomized Controlled Trial

Electronic Measurement-based care (eMBC) for perinatal depression and anxiety: a pilot randomized controlled trial

Neda Askari et al. BMC Psychiatry. .

Abstract

Background: As few as 20% of perinatal patients with depression or anxiety are treated to remission. Measurement-based care (MBC) improves patient outcomes but has not been evaluated for perinatal mental illness. We aimed to assess the feasibility of an MBC protocol in perinatal patients experiencing depression and/or anxiety symptoms.

Methods: In this pilot randomized controlled trial (RCT), perinatal people with Edinburgh Postnatal Depression Scale (EPDS) scores ≥ 13 were randomized 1:1 to (1) an electronic MBC (eMBC) intervention embedded in an electronic health record (EHR) that included scales assessing symptoms and functioning at each clinical visit or (2) usual care, for 12 weeks post-randomization. The primary outcome was feasibility (recruitment, acceptability, trial protocol adherence). While not powered to detect clinically significant differences on clinical outcomes, we also measured depressive and anxiety symptoms (Montgomery-Asberg Depression Rating Scale, MADRS; Hamilton Anxiety Scale, HAM-A).

Results: Of 42 participants (n = 21/arm), 32 (76.2%) completed follow-up questionnaires. At least one scale was completed in 87.5% of clinical encounters, but only 68.8% of encounters included documented participant-provider discussion of the results. Acceptability was good, with opportunities identified for improvement from participant and provider perspectives. At 12-weeks post-randomization, MADRS and HAM-A scores were non-signficantly lower in the eMBC group (mean differences: -1.10, 95%CI -7.81 to 5.61; -1.28, 95%CI -4.69 to 2.12).

Conclusions: The protocol evaluated in this study was feasible, which supports proceeding to a larger RCT to evaluate efficacy with minor modifications. If effective, an EHR-integrated eMBC intervention for perintal depression and anxiety could be implemented widely.

Trial registration: The trial was registered at www.

Clinicaltrials: gov (NCT04836585). Registration Date: 08/04/2021.

Keywords: Electronic measurement-based care; Measurement-based care; Perinatal anxiety; Perinatal depression; Perinatal mental health.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Approval for the study was obtained from the Research Ethics Board at Women’s College Hospital in Toronto, Ontario (Approval # 2020-0090-B) and the study was conducted in adherence with the Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects and Canada’s Tri-Council Policy Statement (TCPS 2): Ethical Conduct for Research Involving Humans. All study participants provided informed consent to participate. A dedicated research staff member conducted informed consent via telephone, secure video-visit, or in-person meetings. Consent for publication: Not applicable. Competing interests: SV reports royalties from UpToDate Inc for authorship of materials related to depression and pregnancy. RG reports royalties from UptoDate Inc. for authorship of an article related to Pseudocyesis. RL has received honoraria for ad hoc speaking or advising/consulting, or received research funds, from Abbvie, Asia-Pacific Economic Cooperation, Bausch, BC Leading Edge Foundation, Brain Canada, Canadian Institutes of Health Research, Canadian Network for Mood and Anxiety Treatments, Carnot, CB Solutions, Healthy Minds Canada, Janssen, Lundbeck, Michael Smith Foundation for Health Research, MITACS, Neurotorium, Ontario Brain Institute, Otsuka, Shanghai Mental Health Center, Vancouver Coastal Health Research Institute, Unity Health, and VGH-UBCH Foundation. The other authors indicated that they do not have competing interests to declare.

Figures

Fig. 1
Fig. 1
CONSORT diagram for eMBC for Perinatal Depression and Anxiety study

References

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