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eMBC for Postpartum Depression and Anxiety (eMBC Trial)
N/A
Waitlist Available
Led By Renu Gupta, MD
Research Sponsored by Women's College Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4, 8, and 12 weeks post randomization
Awards & highlights
eMBC Trial Summary
This trial is testing whether it's feasible to use a model of care called measurement based care (MBC) to treat perinatal depression and anxiety. In MBC, patients' psychiatric symptoms are routinely tracked and reviewed together by a patient and their doctor to better manage symptoms. The trial will use electronic MBC (eMBC), where patients can enter their symptoms into their electronic medical records before their appointment. The study will evaluate the feasibility of recruitment and retention for a future efficacy trial, and acceptability and adherence to a trial protocol.
Who is the study for?
This trial is for individuals aged 18 or older who are currently pregnant or have a child under one year old, experiencing depression and anxiety. They must be able to consent, read, and speak English. It's not suitable for those with active suicidal thoughts, substance abuse issues, past/current mania or psychosis.Check my eligibility
What is being tested?
The eMBC Intervention is being tested to manage symptoms of perinatal depression and anxiety. Patients will track their psychiatric symptoms electronically before appointments for review with their doctor. The study aims to test the feasibility of this approach.See study design
What are the potential side effects?
Since this trial involves tracking symptoms rather than medication or invasive procedures, direct side effects from interventions aren't expected; however, discussing mental health may cause emotional discomfort.
eMBC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
eMBC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of the trial protocol: Adherence
Feasibility of the trial protocol: Participant Acceptability
Feasibility of the trial protocol: Provider Acceptability
+1 moreSecondary outcome measures
Clinical outcomes - antidepressant side effects
Clinical outcomes - anxiety symptoms
Clinical outcomes - clinician-assessed depression symptoms
+3 moreOther outcome measures
Co-variates: Participants
Co-variates: Providers
eMBC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: eMBC InterventionExperimental Treatment1 Intervention
Participants in the intervention arm are followed by their RLS psychiatrists during the study at clinically appropriate intervals with the addition of eMBC.
Group II: Care As UsualActive Control1 Intervention
Participants in the control condition are followed by their RLS psychiatrists during the study as per usual care.
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Who is running the clinical trial?
Women's College HospitalLead Sponsor
100 Previous Clinical Trials
38,761 Total Patients Enrolled
2 Trials studying Postpartum Depression
286 Patients Enrolled for Postpartum Depression
Renu Gupta, MDPrincipal InvestigatorWomen's College Hospital
4 Previous Clinical Trials
111 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your EPDS score is greater than 12 upon enrollment.I am 18 years old or older.I am unable to give consent for participation on my own.I cannot read or speak English.You are either expecting a child or have recently had one, and you reside in the same household.I have become a parent through birth, adoption, or surrogacy.You are currently struggling with thoughts of self-harm, drug or alcohol addiction.
Research Study Groups:
This trial has the following groups:- Group 1: Care As Usual
- Group 2: eMBC Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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