CompletedNot Applicable

Online 1-Day CBT-Based Workshops for Preventing Postpartum Depression

Canada412 participantsStarted 2022-11-10

Plain-language summary

To conduct a randomized controlled trial (N=408) examining the impact of an online cognitive behavioural therapy (CBT)-based workshop on rates of postpartum depression (i.e., EPDS scores at 2-months postpartum) when added to treatment as usual (TAU) compared to TAU alone.

Who can participate

Age range

18 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: * 18 years of age or older * Currently residing in Ontario, Canada * Currently in 3rd trimester of pregnancy (28-36 weeks gestation) * EPDS score \>6 * Past history of major depressive disorder (determined using the Mini International Neuropsychiatric Interview (MINI) Exclusion Criteria: * positive score on the MINI for a current major depressive episode * positive score on the MINI subsections of bipolar, psychotic, 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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

EPDS score as a continuous outcome (Total EPDS) and an EPDS score of 13 or more at 2-months postpartum (T3) will serve as co-primary outcomes.

Timeframe: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)

Trial details

NCT IDNCT05753176

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-12

View on ClinicalTrials.gov More Postpartum Depression trials