NCT03632863

PDA for Antidepressant Use in Pregnancy

Randomized Controlled Trial of an Electronic Patient Decision Aid (PDA) for Antidepressant Medication Use in Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 462 (actual)
• Sponsor: Women's College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A parallel group randomized controlled trial (RCT) will be conducted. Eligible and consenting women with depression will be randomized in a 1:1 ratio to either online PDA or a control condition comprising an online set of publicly available standard resources. The study will be stratified by preconception vs. pregnant, and by province. The study is based at Women's College Hospital (Toronto) but participants will be recruited from across Canada, as the online intervention does not require any in-person study visits. Participants will be recruited via social media (ex. Facebook, Twitter, mommy/baby blogs) and by provider referrals. Participants will be given a series of online questionnaires with various measures collected at baseline, 4 weeks post-randomization, in each trimester of pregnancy, and at 1, 3, 6 and 12 months postpartum. Participants who are planning pregnancy will enter the longer-term (pregnancy and postpartum) follow-up phase once they become pregnant; those who do not conceive by one year post-randomization will be sent a final set of questionnaires and exit the study. A process evaluation will also be conducted to gain insights around trial conduct, and perspectives on potential for (or barriers to) scale-up. This, along with the planned economic evaluation, will inform clinical and policy decisions around adopting the PDA into real-world practice.

Conditions

• Pregnancy
• Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-18
• Primary completion: 2024-07-31
• Completion: 2025-04-30
• First posted: 2018-08-16
• Last updated: 2025-05-28

Locations

1 site across 1 country: Canada