PDA for Antidepressant Use in Pregnancy

Randomized Controlled Trial of an Electronic Patient Decision Aid (PDA) for Antidepressant Medication Use in Pregnancy

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.

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.

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

The electronic PDA is an interactive website with 3 main sections: Review of depression treatment options (non-pharmacological and pharmacological) along with their respective risks and benefits. Interactive "values clarification" exercises to help women determine which risks and benefits are most important to them. 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.

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.

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

DCS consists of 16 items each rated 1-5 where scores ≥ 25 represent delayed and ineffective decisions.

EPDS is a 10-item self-report scale. Each item is scored 0-3 with scores >12 being predictive of a diagnosis of depression.

STAI is a 40-item self-report scale with good discriminate validity in perinatal populations. Each item is scored 1-4 with scores >48 being predictive of an anxiety disorder diagnosis.

SF-12 is a 12-item survey used to estimate the quality-adjusted life year (QALY) which incorporates both length of life and quality of life into a single measure. The measure includes a physical component summary and a mental component summary score. It is scored 0-100 with higher scores indicating better physical and mental health.

Data generated by the website to inform how participants interact with the PDA: 1) proportion of participants who login to the PDA; 2) timing from enrollment to first login; 3) total number of PDA logins; 4) number of logins between each study time point; 5) proportion of participants who completed the PDA; 6) timing of enrollment to first completion of PDA; 7) number of logins required prior to first completion of PDA; 8) total number of PDA completions; 9) number of PDA completions between each study time point; 10) mean (SD) number of pages viewed per login; 11) whether or not each page was viewed; 12) whether or not each page was viewed between study time points; 13) whether or not each interactive tag was interacted with; 14) whether each interactive tag was interacted with between study time points

1) direct medical costs; 2) indirect medical costs; 3) productivity loss due to patient and family work absence

ICQ is a 27-item questionnaire with each item scored 1-7. Higher scores indicate higher parental perceptions of difficult infant temperament.

ASQ-3 is a 30-item instrument that screens for child development from 1 to 60 months. Items are scored as 0, 5 or 10 points. Higher scores indicate that the child is doing well.

The PSI-SF is a 36-item measure consisting of 3 subscales (parental distress, dysfunction in parent-child relations, difficult child). Each item is scored 1-5 with higher scores indicating higher levels of parenting stress. PSI reports subscales separately and also reports a total measure.

DAS is a self-report measure of relationship adjustment. An abbreviated version of this scale consisting of only the dyadic consensus subscale will be used. Each item is scored 0-5 with higher scores indicating a higher level of agreement amongst couples.

Schizophrenia and other psychotic disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)

Obsessive-compulsive and related disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)

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