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Behavioral Intervention

Online Group CBT for Postpartum Depression

N/A
Waitlist Available
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
18 years of age or older
Baby under 12 months of age at recruitment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing whether a group CBT intervention, delivered online by trained Peer facilitators, is helpful for postpartum depression.

Who is the study for?
This trial is for mothers in Ontario who are over 18, speak English fluently, and have a baby under one year old. They should be feeling depressed after giving birth but not suffering from bipolar, psychotic disorders, substance abuse or borderline personality disorder.Check my eligibility
What is being tested?
The study tests if online group Cognitive Behavioural Therapy (CBT) led by peers can help with postpartum depression. Mothers will either receive this 9-week CBT program or continue regular new mother care to see which helps more.See study design
What are the potential side effects?
Since the intervention involves therapy rather than medication, there may not be direct side effects like with drugs; however, discussing emotional issues could potentially cause discomfort or emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My baby is under 12 months old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Edinburgh Postnatal Depression Scale (EPDS)
MINI International Neuropsychiatric Interview
Secondary outcome measures
EQ-5D-5L
GAD-7
Healthcare Resource Utilization Questionnaire
+3 more
Other outcome measures
Adherence Checklist
CBT Skills Questionnaire (CBTSQ)
Client Satisfaction Questionnaire (CSQ-8)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Experimental, interventionExperimental Treatment1 Intervention
The immediate intervention group will receive an online 9 week CBT intervention led by trained peers who have themselves recovered from postpartum depression. The CBT group will be two hours long, weekly and involves teaching and practice of core CBT skills. Core cognitive skills including thought records and cognitive restructuring are introduced and practiced from week 1. Behavioural techniques are introduced at week 2 and continue throughout the group, including behavioural activation, relaxation techniques, sleep strategies, exercise and goal setting. Each participant will receive a professionally design CBT manual to facilitate learning. Participants in the intervention group may also receive typical care or treatment as usual for new mothers.
Group II: Arm 2: Control GroupActive Control1 Intervention
The control group will receive treatment as usual (TAU) or typical care available for postpartum depression in participant's home communities, via participant's family doctor, mental health services, midwifery services, etc. Subjects in the control group will receive a list of resources where participants may seek treatment and will receive a monthly email encouraging them to seek treatment if symptoms worsen, including thoughts of self harm or harm to participant's child. Participants will also receive a copy of the Canadian Practice Guidelines for the treatment of PPD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioural Therapy (CBT)
2017
N/A
~970

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
891 Previous Clinical Trials
2,605,275 Total Patients Enrolled
12 Trials studying Postpartum Depression
2,996 Patients Enrolled for Postpartum Depression
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,348 Previous Clinical Trials
26,454,434 Total Patients Enrolled
4 Trials studying Postpartum Depression
997 Patients Enrolled for Postpartum Depression
Ryan Van Lieshout, MD PhDPrincipal InvestigatorMcMaster University

Media Library

CBT (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05044455 — N/A
Postpartum Depression Research Study Groups: Arm 1: Experimental, intervention, Arm 2: Control Group
Postpartum Depression Clinical Trial 2023: CBT Highlights & Side Effects. Trial Name: NCT05044455 — N/A
CBT (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05044455 — N/A
~60 spots leftby Jun 2025
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