PDA for Antidepressant Use in Pregnancy

NCT ID: NCT03632863

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 462 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-18
• Study Completion Date: 2025-04-30

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.

Detailed Description

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.

Conditions

Pregnancy; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Electronic Patient Decision Aid

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

Group Type: EXPERIMENTAL

Electronic Patient Decision Aid

Intervention Type: 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.

Standard Resource Sheet

Intervention Type: 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.

Standard Resource Sheet

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

Group Type: SHAM_COMPARATOR

Standard Resource Sheet

Intervention Type: 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.

Interventions

Electronic Patient Decision Aid

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.

Intervention Type: BEHAVIORAL

Standard Resource Sheet

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Women aged ≥ 18 years old; and

2. Diagnosed with major depressive disorder (current or in remission); and

3. Planning conception in the next 12 months or < 30 weeks gestational age; and

4. Deciding whether to start or continue a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) in pregnancy; and

5. Have moderate-to-high decisional conflict regarding the decision to start or continue an SSRI/SNRI in pregnancy; and

6. Live in Canada

Exclusion Criteria

1. Have had alcohol or substance use disorder in prior 12 months; or

2. Have active suicide ideation or psychosis; or

3. Have past/current major obstetrical or fetal complications; or

4. Are unable to complete relevant study procedures online; or

5. Are unable to complete study procedures in English

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Simone Vigod

Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Vigod, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

Women's College Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

2018-0069-B

Identifier Type: -

Identifier Source: org_study_id