Center M Randomized Trial

NCT07304895 | Not Yet Recruiting

• 1 other identifier: STUDY00029027
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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

Keywords

mindfulness based cognitive therapy

Outcome Measures

Primary Outcomes (2)

• Change in EPDS scores (baseline to 6 weeks)

  Measured by the Edinburgh Postnatal Depression Scale (EPDS). EPDS is scored on a scale from 0 to 30 with higher scores representing more symptoms of depression.

  Difference between baseline and 6 weeks postpartum

• Change in PHQ scores (baseline to 6 weeks)

  Measured by the Patient Health Questionnaire (PHQ-9). PHQ-9 is scored on a scale from 0 to 27 with higher scores representing more symptoms of depression.

  Difference between baseline and 6 weeks postpartum

Secondary Outcomes (4)

• Change in EPDS scores (baseline to 3 months)

  Difference between baseline and 3 months postpartum

• Change in PHQ scores (baseline to 3 months)

  Difference between baseline and 3 months postpartum

• Change in Mindfulness

  Compared between baseline and following the 4 week intervention, between 30 and 38 weeks of gestation.

• Change in Emotional Regulation

  Compared between baseline and following the 4 week intervention, between 30 and 38 weeks of gestation.

Study Arms (2)

Center M

EXPERIMENTAL

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.

Behavioral: Center M

Treatment as Usual (TAU)

NO INTERVENTION

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 BEHAVIORAL

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.

Also known as: Mindfulness Based Cognitive Therapy - Perinatal Depression

Center M

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• John & Tami Marick Foundation: collaborator
• Oregon Health and Science University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be masked to the PI, Co-I's, consultants, and anyone directly collecting or analyzing study data. Primary prenatal care providers will also be masked to subject assignment. Participant and interventionist masking is not possible due to the nature of the intervention arm. The research coordinator(s), research assistants needing to communicate with research participants about group activities (e.g., responding to logistical emails), and volunteers who support the research coordinator or research assistants with communications regarding groups will also be unmasked. Participants will be randomized by the research coordinator or designated research assistant after eligibility determination and study consent.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized 1:1 into the Center M intervention or Treatment as Usual (TAU)

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 26, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12