Center M Randomized Trial (NCT07304895) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Center M Randomized Trial
160 participantsStarted 2025-12
Plain-language summary
This is a randomized controlled trial with an intervention of Center M compared to treatment as usual. Center M consists of weekly digital one-hour group sessions led by a trained therapist aligned with mindfulness based cognitive therapy. Changes in perinatal depression symptoms will be compared between groups.
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:
* Currently pregnant at ≥ 12 weeks of gestation age (GA)
* ≤ 34 weeks GA at time of Center M intervention initiation
* Receiving prenatal care through the Center for Women's Health at Oregon Health \& Science University
* Able to fluently understand, speak and read English
* Available, able and willing to attend online group sessions
* Willing and able to receive home practice materials on an accessible smartphone, tablet or computer
* Residing in Oregon or Washington
* Willingness to participate in either randomization arm
Exclusion Criteria:
* Current or past enrollment in a formal mindfulness-based intervention group
* Score in the "severe" range on the Edinburgh Postnatal Depression Scale (EPDS) (≥ 20) or Patient History Questionnaire (PHQ-9) (≥ 20)
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
1
Change in EPDS scores (baseline to 6 weeks)
Timeframe: Difference between baseline and 6 weeks postpartum
2
Change in PHQ scores (baseline to 6 weeks)
Timeframe: Difference between baseline and 6 weeks postpartum