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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new online tool called the Electronic Patient Decision Aid, designed to help pregnant women make informed decisions about using antidepressants. The researchers aim to determine if this decision aid can better support women in understanding their options and making choices that align with their personal values. Participants will either use this interactive tool or receive standard information to compare outcomes. Women in Canada diagnosed with major depressive disorder and facing decisions about antidepressant use during pregnancy might be a good fit, especially if they struggle with making these decisions. As an unphased trial, this study offers participants the chance to contribute to research that could enhance decision-making tools for pregnant women facing similar challenges.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It focuses on helping you decide whether to start or continue antidepressants during pregnancy.

What prior data suggests that this patient decision aid is safe for use during pregnancy?

Research has shown that the electronic Patient Decision Aid (PDA) for using antidepressants during pregnancy has been tested for safety and effectiveness. In earlier studies, participants expressed satisfaction with the PDA. These studies examined participant engagement and adherence to trial guidelines. No major negative effects resulted from using the PDA. The tool aims to help women make informed choices about using antidepressants while pregnant.

Overall, the PDA supports decision-making and is considered safe. It helps reduce the stress and confusion often associated with these important health decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Decision Aid (PDA) for antidepressant use during pregnancy because it empowers pregnant individuals by providing interactive, personalized information. Unlike the standard resource sheets, which offer general published information, this electronic tool is designed to actively engage users in their decision-making process. By offering tailored guidance and resources, the PDA aims to help users make informed choices that align with their personal values and health needs. This approach could potentially improve outcomes and satisfaction for those managing depression during pregnancy.

What evidence suggests that this decision aid is effective for antidepressant use during pregnancy?

This trial will compare the effectiveness of an electronic Patient Decision Aid (PDA) with a Standard Resource Sheet for pregnant women considering antidepressant use. Research has shown that an electronic PDA can help pregnant women make better decisions about using antidepressants. In past studies, this tool reduced uncertainty, helping women feel more confident and satisfied with their choices. Participants reported a high satisfaction rate, with an average score of 4.2 out of 5. The PDA proved more effective than standard care in general healthcare settings for addressing these concerns. This suggests the tool can be a valuable resource for those facing difficult decisions about using antidepressants during pregnancy. ^{2 3 5 6 7}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02308592

Patient Decision Aid for Antidepressant Use in Pregnancy 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 ...

2. bmcmedinformdecismak.biomedcentral.com bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-022-01870-1

The development of a patient decision aid to reduce ... We developed a web-based PDA for people deciding whether to start or continue antidepressant use for depression in pregnancy.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032718328611

A patient decision aid for antidepressant use in pregnancy Pilot results suggest that the tool is acceptable and reduces decisional conflict more than clinical care alone in a non-specialist setting.

4. bjgpopen.org bjgpopen.org/content/3/4/bjgpopen19x101666

Patient decision aids for antidepressant use in pregnancy Results Fifty-one women were recruited with a follow-up rate of 90.2% at 4 weeks. The PDA received good overall satisfaction ratings (mean 4.2/5). Analysis of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4770694/

A patient decision aid for antidepressant use in pregnancy The primary outcomes of the pilot study are feasibility of recruitment and retention, acceptability of the intervention, and adherence to the trial protocol.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02492009

Patient Decision Aid for Antidepressant Use in Pregnancy The proposed study is a pilot randomized controlled trial (RCT) of an electronic patient decision aid (PDA) for antidepressant use in pregnancy.

7. psychiatryadvisor.com psychiatryadvisor.com/home/depression-advisor/evaluation-of-online-patient-decision-aid-for-antidepressants-in-pregnancy-is-feasible/

Feasibility of Online Patient Decision Aid for ... Online tools designed to reduce decisional conflict among women deciding on use of antidepressants in pregnancy can be feasibly evaluated ...