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Telephone Support for Postpartum Depression

N/A
Waitlist Available
Led By Sylvana Côté
Research Sponsored by St. Justine's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pregnant women (12-25 weeks' gestation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (between gestational weeks 12-25) , 3 and 6 months postpartum
Awards & highlights

Study Summary

This trial will compare an online/telephone parenting course to the same course without telephone support, in order to evaluate the effectiveness of the intervention in improving mental health outcomes for parents.

Who is the study for?
This trial is for French-speaking pregnant women between 12-25 weeks' gestation who are at risk of postpartum depression, with mild to moderate depressive symptoms. Women with severe depression, psychosis, or substance abuse issues cannot participate.Check my eligibility
What is being tested?
The study tests the Parents & Babies program's effectiveness in preventing postpartum depression when accompanied by telephone support versus without it. The intervention includes a distance learning course during pregnancy.See study design
What are the potential side effects?
Since this trial involves educational material and phone support rather than medication, there are no typical drug side effects; however, participants may experience emotional discomfort discussing personal topics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am pregnant and between 12 to 25 weeks along.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (between gestational weeks 12-25) , 3 and 6 months postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (between gestational weeks 12-25) , 3 and 6 months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline at 3 month postpartum depressive symptoms: The Edinburgh Perinatal/Postnatal Depression Scale (EPDS)
Secondary outcome measures
Anxiety related to pregnancy: Pregnancy-specific anxiety scale (PRAQ-R2)
Change from 3 months post-partum at 6 month post partum child social, emotional and cognitive development: Ages and stages questionnaire 3rd edition (ASQ-3)
Change from baseline in Generalized Anxiety Disorder questionnaire (GAD-7) score
+14 more
Other outcome measures
Health Service Utilization and Cost of Care Questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive-Behavioral Therapy (CBT) and interpersonal counseling with telephone support.Experimental Treatment1 Intervention
The experimental group will receive an online cognitive behavioural intervention with weekly telephone support
Group II: Access to an online cognitive behavioural intervention without telephone supportActive Control1 Intervention
The control group will receive a fully automated version of the virtual intervention without telephone support
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telephone support
2015
N/A
~30

Find a Location

Who is running the clinical trial?

Hewitt FoundationUNKNOWN
1 Previous Clinical Trials
1,238 Total Patients Enrolled
Canadian Medical AssociationUNKNOWN
St. Justine FoundationUNKNOWN

Media Library

Telephone support Clinical Trial Eligibility Overview. Trial Name: NCT05110456 — N/A
Postpartum Depression Research Study Groups: Cognitive-Behavioral Therapy (CBT) and interpersonal counseling with telephone support., Access to an online cognitive behavioural intervention without telephone support
Postpartum Depression Clinical Trial 2023: Telephone support Highlights & Side Effects. Trial Name: NCT05110456 — N/A
Telephone support 2023 Treatment Timeline for Medical Study. Trial Name: NCT05110456 — N/A
~31 spots leftby Aug 2024
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