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Electronic Patient Decision Aid for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Women's College Hospital, Toronto, CanadaDepression+1 MoreElectronic Patient Decision Aid - Behavioral
Eligibility
18+
Female
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Study Summary

This trial will assess whether an online patient decision aid can help women with depression make decisions about antidepressant use during pregnancy.

Eligible Conditions
  • Depression
  • Pregnancy

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires
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Study Objectives

1 Primary · 18 Secondary · Reporting Duration: 3-12 months after birth

1 month postpartum
Pregnancy complications and neonatal outcomes
Year 1
Parenting stress measured by the Parenting Stress Index (PSI) short form
12 months postpartum
Postpartum depression as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Month 12
Anxiety disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Bipolar disorder as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
Feeding and eating 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)
Schizophrenia and other psychotic disorders as diagnosed by the Structured Clinical Interview for DSM-5 (SCID-I)
3 months postpartum
Postpartum depression as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (SCID-I)
3-12 months after birth
Child Development as measured by the Ages and Stages Questionnaire (ASQ-3)
Infant Outcomes as measured by the Infant Characteristics Questionnaire (ICQ)
baseline and 4 weeks
Maternal knowledge of depression, postpartum depression and antidepressant use during pregnancy
Month 9
Decisional conflict as measured by the Decisional Conflict Scale (DCS)
Study website metrics to inform if patterns of PDA use are predictive of clinical outcomes
Year 1
Health service utilization
Maternal anxiety as measured by the Spielberger State-Trait Anxiety Inventory (STAI)
Maternal depression as measured by the Edinburgh Postnatal Depression Scale (EPDS)
Maternal quality of life as measured by the 12-item Short Form (SF-12) Health Survey
Partner relationship outcomes measured by the Dyadic Adjustment Scale (DAS)

Trial Safety

Safety Progress

1 of 3

Similar Trials

3
Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires
1
Decision aid
1
Patient Decision Aid

Trial Design

2 Treatment Groups

Electronic Patient Decision Aid
1 of 2
Standard Resource Sheet
1 of 2

Experimental Treatment

Non-Treatment Group

574 Total Participants · 2 Treatment Groups

Primary Treatment: Electronic Patient Decision Aid · Has Placebo Group · N/A

Electronic Patient Decision AidExperimental Group · 2 Interventions: Electronic Patient Decision Aid, Standard Resource Sheet · Intervention Types: Behavioral, Behavioral
Standard Resource Sheet
Behavioral
ShamComparator Group · 1 Intervention: Standard Resource Sheet · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electronic Patient Decision Aid
2015
N/A
~100
Standard Resource Sheet
2015
N/A
~160

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3-12 months after birth

Who is running the clinical trial?

Women's College HospitalLead Sponsor
93 Previous Clinical Trials
36,388 Total Patients Enrolled
11 Trials studying Depression
2,211 Patients Enrolled for Depression
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,246 Previous Clinical Trials
24,677,554 Total Patients Enrolled
43 Trials studying Depression
3,272,890 Patients Enrolled for Depression
Simone Vigod, MD, MScPrincipal InvestigatorWomen's College Hospital
3 Previous Clinical Trials
336 Total Patients Enrolled
2 Trials studying Depression
256 Patients Enrolled for Depression

Eligibility Criteria

Age 18+ · Female Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with depression, either currently or in the past.
This study is not about deciding whether or not to take certain antidepressants (SSRIs or SNRIs) during pregnancy.
You are unsure or have difficulty deciding whether to take a certain type of medication (SSRI/SNRI) during pregnancy.
References

Frequently Asked Questions

How many people have been accepted into the experiment?

"Affirmative. Clinicaltrials.gov records indicate that this trial, established on October 18th 2018, is actively looking for participants. The investigation requires 574 subjects from a single medical centre to take part in the research." - Anonymous Online Contributor

Unverified Answer

Is enrollment currently open for this experiment?

"The information hosted on clinicaltrials.gov confirms that this medical research is actively recruiting patients; it was first posted in October 2018 and the latest update occurred on February 4th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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