PDA for Antidepressant Use in Pregnancy

  • STATUS
    Recruiting
  • End date
    Apr 21, 2023
  • participants needed
    574
  • sponsor
    Women's College Hospital
Updated on 21 March 2022
remission
norepinephrine
depressive disorder
antidepressants
depressed mood
selective serotonin reuptake inhibitors
major depressive disorder

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.

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.

Details
Condition Pregnancy, Depression
Treatment Electronic Patient Decision Aid, Standard Resource Sheet
Clinical Study IdentifierNCT03632863
SponsorWomen's College Hospital
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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