PDA for Antidepressant Use in Pregnancy

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
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.
Epistemonikos ID: 04d5207ecb6aa1363d4503610da778ec68f49020
First added on: May 21, 2024