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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
~780

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
877 Previous Clinical Trials
2,595,893 Total Patients Enrolled
12 Trials studying Postpartum Depression
2,992 Patients Enrolled for Postpartum Depression
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,333 Previous Clinical Trials
25,747,191 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my profile align with the criteria for this experiment?

"Individuals with postpartum depression aged between 18 and 99 are eligible for this trial, which looks to recruit 167 participants."

Answered by AI

Are new participants being recruited to this clinical trial currently?

"Affirmative. According to clinicaltrials.gov, this trial - first posted on March 28th 2022 - is actively recruiting prospects. There are 167 participants sought from a single medical centre."

Answered by AI

What is the cap on the number of participants in this research trial?

"Absolutely, the information on clinicaltrials.gov clearly indicates that this trial is actively seeking participants. It was first posted in March 28th 2022 and has been modified as recently as November 17th 2022. This study requires 167 volunteers to be enrolled at a single site for its success."

Answered by AI

What is the primary purpose of this research endeavor?

"This 6-month study will primarily assess participant's scores on the Edinburgh Postnatal Depression Scale (EPDS). Secondary outcomes include examination of The Postpartum Bonding Questionnaire (PBQ), Healthcare Resource Utilization Questionnaire, and Parenting Stress Index (PSI-SF) as continuous or dichotomous values. PBQ has a 0 to 5 score scale with higher numbers indicating more difficulties; while PSI-SF is an 36 item parent self-report measure that evaluates overall stress levels in parenting roles. Lastly, HRUQ focuses on public health care payer resource consumption which can be utilized to calculate corresponding unit costs"

Answered by AI

Is the age requirement for participation in this medical research restricted to those under 50 years old?

"Patients aged 18 to 99 are the only individuals who meet the criteria for this clinical trial. There are 196 studies available specifically for those under 18 and 967 tailored towards seniors over 65."

Answered by AI
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~56 spots leftby Mar 2025