PregnancyNCT03632863
PDA for Antidepressant Use in Pregnancy
A study testing Electronic Patient Decision Aid and Standard Resource Sheet in people with Pregnancy and Depression, run by Women's College Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Depression
- What is being tested?
- Electronic Patient Decision Aid and Standard Resource Sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 462 participants
- Where
- 1 siteCanada
- Study dates
- 18 Oct 2018to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy, Depression
- Being tested
- Electronic Patient Decision Aid, Standard Resource Sheet
- Keywords
- Pregnancy, Depression, Antidepressant Use, Decision Aid
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Patient Decision AidBehavioural
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.
Standard Resource SheetBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Patient Decision Aid | Experimental | Participants login to a website where they access the interactive PDA as well as access standard published information and resources. Receives: Behavioral: Electronic Patient Decision Aid; Behavioral: Standard Resource Sheet |
| Standard Resource Sheet | Sham comparator | Participants login to a website where they access standard published information and resources. Receives: Behavioral: Standard Resource Sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months postpartum
Secondary outcomes (18)
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.
Measured: 12 months postpartum
Maternal knowledge of depression, postpartum depression and antidepressant use during pregnancy
True/false knowledge questionnaire.
Measured: baseline and 4 weeks
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.
Measured: throughout pregnancy (up to 9 months)
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.
Measured: throughout pregnancy and up to 1 year postpartum (up to 21 months)
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.
Measured: 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
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.
Measured: throughout pregnancy and up to 1 year postpartum (up to 21 months)
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
Measured: throughout pregnancy (up to 9 months)
Health service utilization
- direct medical costs; 2) indirect medical costs; 3) productivity loss due to patient and family work absence
Measured: throughout pregnancy and up to 1 year postpartum (up to 21 months)
Pregnancy complications and neonatal outcomes
Self-reported pregnancy complications and neonatal infant characteristics
Measured: 1 month postpartum
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.
Measured: 3-12 months after birth
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.
Measured: 3-12 months after birth
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.
Measured: 1 month postpartum to 1 year postpartum
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.
Measured: throughout pregnancy and up to 1 year postpartum (up to 21 months)
Bipolar disorder as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
The bipolar disorders module will be used.
Measured: 3 months and 12 months postpartum
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.
Measured: 3 months and 12 months postpartum
Anxiety disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
The anxiety disorders module will be used.
Measured: 3 months and 12 months postpartum
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.
Measured: 3 months and 12 months postpartum
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.
Measured: 3 months and 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start18 Oct 2018
- Primary completion31 Jul 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Simone Vigod, Women's College Hospital
- Investigators
- Simone Vigod, MD, MSc, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632863
- Sponsor's protocol ID
- 2018-0069-B
- Status last verified
- May 2025
- First submitted
- 31 Jul 2018
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of an Electronic Patient Decision Aid (PDA) for Antidepressant Medication Use in Pregnancy
- ClinicalTrials.gov ID
- NCT03632863
- Acronym / sponsor ID
- 2018-0069-B
- Conditions
- Pregnancy, Depression
- Keywords
- Pregnancy, Depression, Antidepressant Use, Decision Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic Patient Decision Aid | Experimental | Behavioral: Electronic Patient Decision Aid, Behavioral: Standard Resource SheetParticipants login to a website where they access the interactive PDA as well as access standard published information and resources. |
| Standard Resource Sheet | Sham comparator | Behavioral: Standard Resource SheetParticipants login to a website where they access standard published information and resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Patient Decision AidThe electronic PDA is an interactive website with 3 main sections: 1. Review of depression treatment options (non-pharmacological and pharmacological) along with their respective risks and benefits. 2. Interactive "values clarification" exercises to help women determine which risks and benefits are most important to them. 3. 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. | Behavioural | Electronic Patient Decision Aid |
| Standard Resource SheetA 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. | Behavioural | Electronic Patient Decision Aid, Standard Resource Sheet |
Primary outcome
Postpartum depression as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (SCID-I)
Time frame: 3 months postpartum
The depression module will be used to indicate presence of postpartum depression.
18 secondary outcomes
Postpartum depression as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Time frame: 12 months postpartum
Maternal knowledge of depression, postpartum depression and antidepressant use during pregnancy
Time frame: baseline and 4 weeks
Decisional conflict as measured by the Decisional Conflict Scale (DCS)
Time frame: throughout pregnancy (up to 9 months)
Maternal depression as measured by the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: throughout pregnancy and up to 1 year postpartum (up to 21 months)
Maternal anxiety as measured by the Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: 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
Time frame: throughout pregnancy and up to 1 year postpartum (up to 21 months)
Study website metrics to inform if patterns of PDA use are predictive of clinical outcomes
Time frame: throughout pregnancy (up to 9 months)
Health service utilization
Time frame: throughout pregnancy and up to 1 year postpartum (up to 21 months)
Pregnancy complications and neonatal outcomes
Time frame: 1 month postpartum
Infant Outcomes as measured by the Infant Characteristics Questionnaire (ICQ)
Time frame: 3-12 months after birth
Child Development as measured by the Ages and Stages Questionnaire (ASQ-3)
Time frame: 3-12 months after birth
Parenting stress measured by the Parenting Stress Index (PSI) short form
Time frame: 1 month postpartum to 1 year postpartum
Partner relationship outcomes measured by the Dyadic Adjustment Scale (DAS)
Time frame: throughout pregnancy and up to 1 year postpartum (up to 21 months)
Bipolar disorder as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Time frame: 3 months and 12 months postpartum
Schizophrenia and other psychotic disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Time frame: 3 months and 12 months postpartum
Anxiety disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Time frame: 3 months and 12 months postpartum
Obsessive-compulsive and related disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Time frame: 3 months and 12 months postpartum
Feeding and eating disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Time frame: 3 months and 12 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Vigod, MD, MSc principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Patient Decision Aid and Standard Resource Sheet in people with Pregnancy and Depression, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum depression as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (SCID-I) (time frame: 3 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.