CBT for Postpartum Depression and Infant Emotion Regulation (NCT05269732) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
CBT for Postpartum Depression and Infant Emotion Regulation
Canada172 participantsStarted 2022-06-17
Plain-language summary
The primary objective of this study is to determine if online group cognitive behavioral therapy (CBT) for maternal postpartum depression (PPD) added to treatment as usual (TAU) leads to greater improvements in infant emotion regulation (ER) than maternal receipt of TAU alone immediately post-treatment, 6 and 30 months later. This study will also aim to determine what mechanisms PPD treatment leads to changes in infant ER.
Who can participate
Age range
18 Years – 99 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* women 18 years of age or older
* understand and speak English (so that they can participate in the CBT group and complete study measures)
* live in Ontario (the primary WHCC catchment area)
* have an EPDS score of 10 or more
* meets diagnostic criteria for comorbid psychiatric conditions.
* Infants must be between 4-12 months old at enrollment.
Exclusion Criteria:
* bipolar disorder
* a current psychotic disorder
* substance or alcohol use disorder
* antisocial or borderline personality disorder.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying both my depression and my baby's emotional development at the same time — can you help me understand whether that dual focus would be a good fit for where I am right now, or whether treating my depression first through another route makes more sense?
2Since this study is no longer actively enrolling, is there any way to find out if a waitlist exists, or are there similar CBT-based programs for postpartum depression that I could access right now?
3The trial is measuring infant temperament and emotion regulation as key outcomes — what does that mean practically, and should I be concerned about how my postpartum depression might already be affecting my baby's emotional development?
4CBT is a talk-therapy approach, not a medication — given my specific situation, do you think a therapy-based treatment like this would be sufficient on its own, or might I also need to consider medication for postpartum depression?
5This trial is listed as 'Phase NA,' which typically means it's a behavioral or psychological study rather than a drug trial — does that change what we know about its safety, and what should I realistically expect in terms of time commitment if something like this were available to me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Infant Temperament
Timeframe: Enrollment, 9 weeks and 6 months
2
Infant emotion regulation
Timeframe: Enrollment, 9 weeks and 6 months
3
Maternal Depression
Timeframe: Enrollment, 9 weeks, 6 and 30 months later
4
Maternal Anxiety
Timeframe: Enrollment, 9 weeks, 6 and 30 months later