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Cognitive Behavioral Therapy
Cognitive Behavioural Therapy for Postpartum Depression
N/A
Recruiting
Led By Ryan Van Lieshout, MD, PHD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Infants must be between 4-12 months old at enrollment
Meets diagnostic criteria for comorbid psychiatric conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will study whether online group CBT for maternal postpartum depression leads to greater improvements in infant emotion regulation than treatment as usual.
Who is the study for?
This trial is for English-speaking women over 18 living in Ontario with postpartum depression, as indicated by an EPDS score of at least 10. Their infants should be aged between 4-8 months. Women with bipolar disorder, current psychotic disorders, substance abuse issues, or certain personality disorders cannot participate.Check my eligibility
What is being tested?
The study tests if adding online group cognitive behavioral therapy (CBT) to the usual treatment helps improve how babies manage their emotions better than just the usual treatment alone. The effects will be checked right after and six months post-treatment.See study design
What are the potential side effects?
Since this trial involves psychological therapy rather than medication, typical side effects associated with drugs are not expected. However, participants may experience emotional discomfort discussing personal topics during CBT sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My infant is between 4 to 12 months old.
Select...
I have been diagnosed with a mental health condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Infant Temperament
Infant emotion regulation
Maternal Anxiety
+1 moreSecondary outcome measures
Brain-to-brain Synchrony (fNIRS)
Epigenetic Analyses
Parent-Child Early Relational Assessment (PCERA)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment (9-week online CBT group)Experimental Treatment1 Intervention
Participants assigned to the treatment group will continue to receive any healthcare they might already be receiving (e.g. family doctor, midwife, Obstetrician/Gynecologist, etc.) and participate in a 9-week group Cognitive Behavioral Therapy (CBT) intervention for Postpartum Depression (PPD) delivered via Zoom by two trained psychologists, social workers, nurses, and/or psychiatrists.
Group II: Control (treatment as usual)Active Control1 Intervention
The control group will receive standard postnatal care from their obstetrician, midwife, and/or family physician
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Group Cognitive Behavioural Therapy (CBT)
2020
N/A
~160
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
881 Previous Clinical Trials
2,597,714 Total Patients Enrolled
12 Trials studying Postpartum Depression
3,015 Patients Enrolled for Postpartum Depression
Ryan Van Lieshout, MD, PHDPrincipal InvestigatorMcmaster
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a mental health condition.You are experiencing symptoms of depression, as indicated by a scoring test called EPDS, with a score of 10 or higher.I am a woman aged 18 or older.My infant is between 4 to 12 months old.I have been diagnosed with a mental health condition.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (9-week online CBT group)
- Group 2: Control (treatment as usual)
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.
What criteria must individuals meet to join this research project?
"In order to participate in this research trial, potential candidates must suffer from depression and range between 18-99 years old. A total of 172 patients need to be enrolled for the study's completion."
Answered by AI
What is the participation size of this investigation?
"Affirmative. Records available on clinicaltrials.gov state that this medical study, which was initially posted in June 17th 2022, is actively seeking participants. 172 volunteers are sought from 1 hospital location(s)."
Answered by AI
Does this study still accept enrollees?
"Affirmative. According to clinicaltrials.gov, this experiment is still searching for participants after being first posted on June 17th 2022 and most recently updated on July 28th 2022. The research team have set a goal of recruiting 172 people at 1 site."
Answered by AI
Is the age of 20+ an eligibility criterion for this medical research?
"This clinical trial has a narrow range of inclusion criteria, recruiting participants between the ages 18-99. For those under 18 or over 65, there are 197 and 970 trials respectively that may better suit their needs."
Answered by AI
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