Patient Decision Aid for Antidepressant Use During Pregnancy

Overseen By Simone Vigod, MD, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Women's College Hospital

Must be taking: SSRIs, SNRIs

Disqualifiers: Substance use, Suicide ideation, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

462 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Simone Vigod

Principal Investigator

Women's College Hospital

Are You a Good Fit for This Trial?

This trial is for women over 18 in Canada who are pregnant or planning to conceive within a year, diagnosed with depression, and deciding whether to start or continue SSRI/SNRI antidepressants. It's not for those with active suicidal thoughts, psychosis, substance abuse issues in the last year, major obstetrical/fetal complications, or inability to complete procedures online/in English.

Exclusion Criteria

I cannot complete study tasks online.

I am currently experiencing thoughts of harming myself or have psychosis.

Are unable to complete study procedures in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Baseline Assessment

Participants are randomized to either the online PDA or control condition and complete baseline questionnaires

1 week

Online

Intervention

Participants access the online PDA or standard resources and complete questionnaires at various time points

Throughout pregnancy and up to 1 year postpartum (up to 21 months)

Online

Follow-up

Participants are monitored for postpartum depression and other outcomes through online questionnaires

12 months postpartum

Online

What Are the Treatments Tested in This Trial?

Interventions

• Electronic Patient Decision Aid
• Standard Resource Sheet

Trial Overview The study tests an online patient decision aid (PDA) designed to help pregnant women make informed choices about using antidepressants during pregnancy. The PDA will be compared against standard resources through a randomized controlled trial to see if it improves decision-making satisfaction.

How Is the Trial Designed?

Group I: Electronic Patient Decision Aid Experimental Treatment 2 Interventions

Participants login to a website where they access the interactive PDA as well as access standard published information and resources.

Group II: Standard Resource Sheet Placebo Group 1 Intervention

Participants login to a website where they access standard published information and resources.

Who Is Running the Clinical Trial?

Women's College Hospital

Lead Sponsor

Trials

108

Recruited

43,700+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+