Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy

Brief Summary

Detailed Description

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 a 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 project is to inform the development of a larger, international RCT to assess the efficacy of our PDA for antidepressant use in pregnancy. To achieve this objective, we will assess the feasibility of our clinical trial protocol to evaluate the PDA and determine the preliminary effect size for a larger multi-site efficacy study. The primary outcome for this pilot study is the feasibility of conducting a large randomized controlled trial to evaluate the efficacy of the PDA. This includes feasibility (how well the trial protocol can be implemented), acceptability (usability and tolerability of the intervention) and adherence (the degree to which the trial protocol is followed). We hypothesize that our protocol will be feasible, that the PDA will have a high degree of acceptability, and that adherence to the protocol will be high.

Primary Outcomes

Secondary Outcomes

• PDA Acceptability Questionnaire(4 Weeks post-randomization)
• Edinburgh Postnatal Depression Scale(12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy), only for participants who are seeing specialty psychiatric services)
• Spielburg State-Trait Anxiety Inventory(12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy), only for participants who are seeing specialty psychiatric services)
• Self-reported satisfaction with the PDA by the participants(4 Weeks post-randomization)
• Decisional Conflict Scale(4 Weeks post-randomization)
• Knowledge about antidepressant treatment in pregnancy(4 Weeks post-randomization)
• Provider Perspective Survey(After all other participant data has been collected)
• Treatment Decision(s)(12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy), only for participants who are seeing specialty psychiatric services)
• Time between recruitment to first log-in to the study website(4 weeks post-randomization)
• Provider's perspective on the utility of the PDA in clinical practice(After all participant data has been collected)
• Study Website Usage(4 Weeks post-randomization)
• Number of participants who follow-up with their physician during the intended timeline(4 weeks post-randomization, only for participants who are seeing specialty psychiatric services)
• The rate of follow-up data collection(12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy), OR at 4 weeks post-randomization for women who are NOT seeing specialty perinatal psychiatry services)