Recruiting

Center MCenter M Randomized Trial

Sponsor:

Oregon Health and Science University

Code:

NCT07304895

Conditions

Perinatal Depression

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Center M

Study Details

Brief 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.

Conditions

Perinatal Depression

Study ID

NCT07304895

Start date

Jan 15, 2026

Status verified date

Oct, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Center M

In addition to standard prenatal care, participants will participate in Center M sessions, which are weekly one-hour digital group sessions led by a therapist. Each group will include 3-6 participants. The Center M session structure aligns with mindfulness-based cognitive therapy by including mental well-being, core mindfulness and cognitive behavioral therapy skills, in-session practice of skills, and home practice skills. Center M content teaches skills that increase capability for effectively navigating general life stress and the unique stresses of pregnancy and parenting.

no intervention: Treatment as Usual (TAU)

Those randomized to TAU will receive prenatal care as it is standardly delivered in their provider's clinical setting, including perinatal screenings and related educational handouts. Participants will be able to engage in any services recommended by their primary prenatal provider or that they voluntarily initiate, including mental health treatment. Participants will not be proscribed from engaging in other recommended interventions or care.

Interventions

Center M

Primary outcome measure

Change in EPDS scores (baseline to 6 weeks) [ Time Frame: Difference between baseline and 6 weeks postpartum ]
Change in PHQ scores (baseline to 6 weeks) [ Time Frame: Difference between baseline and 6 weeks postpartum ]

Central Contacts and Locations

Central contacts

Ellen Tilden, PhD, CNM, FACNM

503-418-2036 tildene@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

More Information

Sponsor

Oregon Health and Science University

Last update posted

Nov 12, 2026

Last verified

Oct, 2026

Keywords

mindfulness based cognitive therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.