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PDA for Antidepressant Use in Pregnancy

NCT03632863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2025-05-28

No results posted yet for this study

Summary

Depression in pregnancy is common, affecting up to 10% of women and represents serious risk to mother and infant. Unfortunately, antidepressant medication, a first-line treatment for depression in pregnancy, also comes with risks, making this a complex decision. Clinical care appears to be insufficient for ensuring that women make decisions that are consistent with their own values and with which they feel satisfied. Patient decision support tools can address such barriers. We have created and piloted with positive results an online patient decision aid (PDA) that has the potential to improve the decision-making process for women regarding antidepressant use in pregnancy in conjunction with clinical care. The overall objective of this study is to conduct a Randomized Controlled Trial (RCT) to assess the efficacy of our PDA for antidepressant use in pregnancy.

Conditions

Interventions

BEHAVIORAL

Electronic Patient Decision Aid

The electronic PDA is an interactive website with 3 main sections: 1. Review of depression treatment options (non-pharmacological and pharmacological) along with their respective risks and benefits. 2. Interactive "values clarification" exercises to help women determine which risks and benefits are most important to them. 3. Exercises to help women consider how partners, family, providers and the social context impacts decision-making. A summary of how a woman feels about each option along with risks and benefits is generated which can be provided to treating clinicians for use in follow-up. A printable pdf with standard published information and resources is also included.

BEHAVIORAL

Standard Resource Sheet

A control group aims to isolate the PDA's effects from time and clinical care. Controls login to the study website and receive the same printable pdf as in the PDA so that they can access standard publicly available information/resources, even if they will not receive the PDA.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Women's College Hospital

    lead OTHER

Principal Investigators

  • Simone Vigod, MD, MSc · Women's College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-18
Primary Completion
2024-07-31
Completion
2025-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03632863 on ClinicalTrials.gov