Randomized Controlled Trial of an Electronic Patient Decision Aid (PDA) for Antidepressant Medication Use in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 462
- 试验地点
- 2
- 主要终点
- Postpartum depression as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (SCID-I)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Postpartum depression as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (SCID-I)
时间窗: 3 months postpartum
The depression module will be used to indicate presence of postpartum depression.
次要结局
- Maternal depression as measured by the Edinburgh Postnatal Depression Scale (EPDS)(throughout pregnancy and up to 1 year postpartum (up to 21 months))
- Maternal quality of life as measured by the 12-item Short Form (SF-12) Health Survey(throughout pregnancy and up to 1 year postpartum (up to 21 months))
- Health service utilization(throughout pregnancy and up to 1 year postpartum (up to 21 months))
- Pregnancy complications and neonatal outcomes(1 month postpartum)
- Study website metrics to inform if patterns of PDA use are predictive of clinical outcomes(throughout pregnancy (up to 9 months))
- Anxiety disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)(3 months and 12 months postpartum)
- Feeding and eating disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)(3 months and 12 months postpartum)
- Postpartum depression as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)(12 months postpartum)
- Decisional conflict as measured by the Decisional Conflict Scale (DCS)(throughout pregnancy (up to 9 months))
- Infant Outcomes as measured by the Infant Characteristics Questionnaire (ICQ)(3-12 months after birth)
- Parenting stress measured by the Parenting Stress Index (PSI) short form(1 month postpartum to 1 year postpartum)
- Maternal knowledge of depression, postpartum depression and antidepressant use during pregnancy(baseline and 4 weeks)
- Maternal anxiety as measured by the Spielberger State-Trait Anxiety Inventory (STAI)(throughout pregnancy and up to 1 year postpartum (up to 21 months))
- Child Development as measured by the Ages and Stages Questionnaire (ASQ-3)(3-12 months after birth)
- Bipolar disorder as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)(3 months and 12 months postpartum)
- Schizophrenia and other psychotic disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)(3 months and 12 months postpartum)
- Obsessive-compulsive and related disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)(3 months and 12 months postpartum)
- Partner relationship outcomes measured by the Dyadic Adjustment Scale (DAS)(throughout pregnancy and up to 1 year postpartum (up to 21 months))
研究者
Simone Vigod
Psychiatrist
Women's College Hospital