PDA for Antidepressant Use in Pregnancy

Women's College Hospital

Status: Active, not recruiting

Conditions: Depression; Pregnancy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03632863

2018-0069-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 574 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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574 participants in 2 patient groups

Electronic Patient Decision Aid

Experimental group

Description:

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

Treatment:

Behavioral: Electronic Patient Decision Aid

Behavioral: Standard Resource Sheet

Standard Resource Sheet

Sham Comparator group

Description:

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

Treatment:

Behavioral: Standard Resource Sheet