PDA for Antidepressant Use in Pregnancy
Primary Purpose
Pregnancy, Depression
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Electronic Patient Decision Aid
Standard Resource Sheet
Sponsored by

About this trial
This is an interventional health services research trial for Pregnancy focused on measuring Pregnancy, Depression, Antidepressant Use, Decision Aid
Eligibility Criteria
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
Sites / Locations
- Women's College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Electronic Patient Decision Aid
Standard Resource Sheet
Arm Description
Participants login to a website where they access the interactive PDA as well as access standard published information and resources.
Participants login to a website where they access standard published information and resources.
Outcomes
Primary Outcome Measures
Postpartum depression as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (SCID-I)
The depression module will be used to indicate presence of postpartum depression.
Secondary Outcome Measures
Postpartum depression as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
The depression module will be used to indicate presence of postpartum depression.
Maternal knowledge of depression, postpartum depression and antidepressant use during pregnancy
True/false knowledge questionnaire.
Decisional conflict as measured by the Decisional Conflict Scale (DCS)
DCS consists of 16 items each rated 1-5 where scores ≥ 25 represent delayed and ineffective decisions.
Maternal depression as measured by the Edinburgh Postnatal Depression Scale (EPDS)
EPDS is a 10-item self-report scale. Each item is scored 0-3 with scores >12 being predictive of a diagnosis of depression.
Maternal anxiety as measured by the Spielberger State-Trait Anxiety Inventory (STAI)
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.
Maternal quality of life as measured by the 12-item Short Form (SF-12) Health Survey
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.
Study website metrics to inform if patterns of PDA use are predictive of clinical outcomes
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
Health service utilization
1) direct medical costs; 2) indirect medical costs; 3) productivity loss due to patient and family work absence
Pregnancy complications and neonatal outcomes
Self-reported pregnancy complications and neonatal infant characteristics
Infant Outcomes as measured by the Infant Characteristics Questionnaire (ICQ)
ICQ is a 27-item questionnaire with each item scored 1-7. Higher scores indicate higher parental perceptions of difficult infant temperament.
Child Development as measured by the Ages and Stages Questionnaire (ASQ-3)
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.
Parenting stress measured by the Parenting Stress Index (PSI) short form
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.
Partner relationship outcomes measured by the Dyadic Adjustment Scale (DAS)
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.
Bipolar disorder as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
The bipolar disorders module will be used.
Schizophrenia and other psychotic disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
The schizophrenia and other psychotic disorders module will be used.
Anxiety disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
The anxiety disorders module will be used.
Obsessive-compulsive and related disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
The obsessive-compulsive and related disorders module will be used.
Feeding and eating disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
The feeding and eating disorders module will be used.
Full Information
NCT ID
NCT03632863
First Posted
July 31, 2018
Last Updated
October 24, 2023
Sponsor
Women's College Hospital
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT03632863
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women's College Hospital
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Depression
Keywords
Pregnancy, Depression, Antidepressant Use, Decision Aid
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
574 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electronic Patient Decision Aid
Arm Type
Experimental
Arm Description
Participants login to a website where they access the interactive PDA as well as access standard published information and resources.
Arm Title
Standard Resource Sheet
Arm Type
Sham Comparator
Arm Description
Participants login to a website where they access standard published information and resources.
Intervention Type
Behavioral
Intervention Name(s)
Electronic Patient Decision Aid
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Resource Sheet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postpartum depression as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (SCID-I)
Description
The depression module will be used to indicate presence of postpartum depression.
Time Frame
3 months postpartum
Secondary Outcome Measure Information:
Title
Postpartum depression as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Description
The depression module will be used to indicate presence of postpartum depression.
Time Frame
12 months postpartum
Title
Maternal knowledge of depression, postpartum depression and antidepressant use during pregnancy
Description
True/false knowledge questionnaire.
Time Frame
baseline and 4 weeks
Title
Decisional conflict as measured by the Decisional Conflict Scale (DCS)
Description
DCS consists of 16 items each rated 1-5 where scores ≥ 25 represent delayed and ineffective decisions.
Time Frame
throughout pregnancy (up to 9 months)
Title
Maternal depression as measured by the Edinburgh Postnatal Depression Scale (EPDS)
Description
EPDS is a 10-item self-report scale. Each item is scored 0-3 with scores >12 being predictive of a diagnosis of depression.
Time Frame
throughout pregnancy and up to 1 year postpartum (up to 21 months)
Title
Maternal anxiety as measured by the Spielberger State-Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
throughout pregnancy and up to 1 year postpartum (up to 21 months)
Title
Maternal quality of life as measured by the 12-item Short Form (SF-12) Health Survey
Description
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.
Time Frame
throughout pregnancy and up to 1 year postpartum (up to 21 months)
Title
Study website metrics to inform if patterns of PDA use are predictive of clinical outcomes
Description
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
Time Frame
throughout pregnancy (up to 9 months)
Title
Health service utilization
Description
1) direct medical costs; 2) indirect medical costs; 3) productivity loss due to patient and family work absence
Time Frame
throughout pregnancy and up to 1 year postpartum (up to 21 months)
Title
Pregnancy complications and neonatal outcomes
Description
Self-reported pregnancy complications and neonatal infant characteristics
Time Frame
1 month postpartum
Title
Infant Outcomes as measured by the Infant Characteristics Questionnaire (ICQ)
Description
ICQ is a 27-item questionnaire with each item scored 1-7. Higher scores indicate higher parental perceptions of difficult infant temperament.
Time Frame
3-12 months after birth
Title
Child Development as measured by the Ages and Stages Questionnaire (ASQ-3)
Description
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.
Time Frame
3-12 months after birth
Title
Parenting stress measured by the Parenting Stress Index (PSI) short form
Description
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.
Time Frame
1 month postpartum to 1 year postpartum
Title
Partner relationship outcomes measured by the Dyadic Adjustment Scale (DAS)
Description
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.
Time Frame
throughout pregnancy and up to 1 year postpartum (up to 21 months)
Title
Bipolar disorder as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Description
The bipolar disorders module will be used.
Time Frame
3 months and 12 months postpartum
Title
Schizophrenia and other psychotic disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Description
The schizophrenia and other psychotic disorders module will be used.
Time Frame
3 months and 12 months postpartum
Title
Anxiety disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Description
The anxiety disorders module will be used.
Time Frame
3 months and 12 months postpartum
Title
Obsessive-compulsive and related disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Description
The obsessive-compulsive and related disorders module will be used.
Time Frame
3 months and 12 months postpartum
Title
Feeding and eating disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Description
The feeding and eating disorders module will be used.
Time Frame
3 months and 12 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone Vigod, MD, MSc
Organizational Affiliation
Women's College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S1B2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PDA for Antidepressant Use in Pregnancy
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