Clinical trial NCT03632863: PDA for Antidepressant Use in Pregnancy
Official title: Randomized Controlled Trial of an Electronic Patient Decision Aid (PDA) for Antidepressant Medication Use in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Depression
Keywords: Pregnancy
Depression
Antidepressant Use
Decision Aid
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-08-16
Enrollment: 462
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Postpartum depression as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (SCID-I)
timeFrame: 3 months postpartum
Secondary outcomes:
measure: Postpartum depression as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
timeFrame: 12 months postpartum
measure: Maternal knowledge of depression, postpartum depression and antidepressant use during pregnancy
timeFrame: baseline and 4 weeks
measure: Decisional conflict as measured by the Decisional Conflict Scale (DCS)
timeFrame: throughout pregnancy (up to 9 months)
measure: Maternal depression as measured by the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: throughout pregnancy and up to 1 year postpartum (up to 21 months)
measure: Maternal anxiety as measured by the Spielberger State-Trait Anxiety Inventory (STAI)
timeFrame: throughout pregnancy and up to 1 year postpartum (up to 21 months)
measure: Maternal quality of life as measured by the 12-item Short Form (SF-12) Health Survey
timeFrame: throughout pregnancy and up to 1 year postpartum (up to 21 months)
measure: Study website metrics to inform if patterns of PDA use are predictive of clinical outcomes
timeFrame: throughout pregnancy (up to 9 months)
measure: Health service utilization
timeFrame: throughout pregnancy and up to 1 year postpartum (up to 21 months)
measure: Pregnancy complications and neonatal outcomes
timeFrame: 1 month postpartum
measure: Infant Outcomes as measured by the Infant Characteristics Questionnaire (ICQ)
timeFrame: 3-12 months after birth
measure: Child Development as measured by the Ages and Stages Questionnaire (ASQ-3)
timeFrame: 3-12 months after birth
measure: Parenting stress measured by the Parenting Stress Index (PSI) short form
timeFrame: 1 month postpartum to 1 year postpartum
measure: Partner relationship outcomes measured by the Dyadic Adjustment Scale (DAS)
timeFrame: throughout pregnancy and up to 1 year postpartum (up to 21 months)
measure: Bipolar disorder as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
timeFrame: 3 months and 12 months postpartum
measure: Schizophrenia and other psychotic disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
timeFrame: 3 months and 12 months postpartum
measure: Anxiety disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
timeFrame: 3 months and 12 months postpartum
measure: Obsessive-compulsive and related disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
timeFrame: 3 months and 12 months postpartum
measure: Feeding and eating disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
timeFrame: 3 months and 12 months postpartum
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Simone Vigod, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: