PDA for Antidepressant Use in Pregnancy

NCT03632863 | Completed

• 1 other identifier: 2018-0069-B
• Study Type: interventional
• Target: 462
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Depression

Keywords

Pregnancy; Depression; Antidepressant Use; Decision Aid

Outcome Measures

Primary Outcomes (1)

• Postpartum depression as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (SCID-I)

  The depression module will be used to indicate presence of postpartum depression.

  3 months postpartum

Secondary Outcomes (18)

• Postpartum depression as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)

  12 months postpartum

• Maternal knowledge of depression, postpartum depression and antidepressant use during pregnancy

  baseline and 4 weeks

• Decisional conflict as measured by the Decisional Conflict Scale (DCS)

  throughout pregnancy (up to 9 months)

• Maternal depression as measured by the Edinburgh Postnatal Depression Scale (EPDS)

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

• Maternal anxiety as measured by the Spielberger State-Trait Anxiety Inventory (STAI)

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

Study Arms (2)

Electronic Patient Decision Aid

EXPERIMENTAL

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

Behavioral: Electronic Patient Decision Aid; Behavioral: Standard Resource Sheet

Standard Resource Sheet

SHAM COMPARATOR

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

Behavioral: Standard Resource Sheet

Interventions

Electronic Patient Decision Aid BEHAVIORAL

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.

Electronic Patient Decision Aid

Standard Resource Sheet BEHAVIORAL

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.

Electronic Patient Decision Aid; Standard Resource Sheet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≥ 18 years old; and
• Diagnosed with major depressive disorder (current or in remission); and
• Planning conception in the next 12 months or \< 30 weeks gestational age; and
• Deciding whether to start or continue a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) in pregnancy; and
• Have moderate-to-high decisional conflict regarding the decision to start or continue an SSRI/SNRI in pregnancy; and
• Live in Canada

You may not qualify if:

• Have had alcohol or substance use disorder in prior 12 months; or
• Have active suicide ideation or psychosis; or
• Have past/current major obstetrical or fetal complications; or
• Are unable to complete relevant study procedures online; or
• Are unable to complete study procedures in English

Sponsors & Collaborators

• Women's College Hospital: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S1B2, Canada

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Simone Vigod, MD, MSc

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 16, 2018
• Study Start: October 18, 2018
• Primary Completion: July 31, 2024
• Study Completion: April 30, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)