Perinatal DepressionNCT07304895
Center M Randomized Trial
A study testing Center M in people with Perinatal Depression, run by Oregon Health and Science University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- Center M
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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.
Read the detailed description
The study is a randomized control trial (RCT) with two parallel arms, 1) an intervention arm: Center M added to treatment as usual (TAU), defined as standard prenatal care, and 2) a control arm: TAU, again defined as standard prenatal care. As both groups will be obtaining services through the Center for Women's Health at OHSU, offered standard prenatal care is expected to be similar in both arms. 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.
The Center M intervention proceeds sequentially with weekly one-hour group sessions led by a trained, masters-level (or equivalent) therapist. Each group will include 3-6 participants. These sessions are conducted digitally via WebEx. Center M session structure aligns with mindfulness based cognitive therapy by including: 1) introduction of a core theme and rationale for how this theme relates to mental well-being (i.e., psychoeducation); 2) teaching core mindfulness (including an emphasis on self-compassion) and CBT skills; 3) facilitating in-session practice of skills (i.e., experiential learning); and 4) reviewing home practice of skills as well as barriers to practice. Sessions are focused on skill development, both through active engagement in practice during group sessions and individual home practice. Center M content teaches skills that increase capability for effectively navigating general life stress and the unique stresses of pregnancy and parenting. It is further designed to increase awareness of early warning signs of perinatal depression to allow for identification of the need for additional resources (including more intensive preventive intervention). The curriculum is designed to be a 'light touch', or minimum necessary intervention that still retains the capacity to prevent perinatal depression. Examples and summaries of the curriculum and accompanying handouts and homework are outlined below and full curriculum, handouts, and homework are available in the IRB documents. The Center M curriculum, handouts and homework follows the parent model MBCT curriculum, with alterations made in direct communication with Sona Dimidjian, PhD, and Sherryl Goodman, PhD, the developers of the parent model. The Center M adaptation has been accomplished with the support and involvement of Drs. Dimidjian and Goodman.
- Conditions
- Perinatal Depression
- Being tested
- Center M
- Keywords
- mindfulness based cognitive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Center MBehavioural
Also called Mindfulness Based Cognitive Therapy - Perinatal Depression
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Difference between baseline and 6 weeks postpartum
Secondary outcomes (4)
Change in EPDS scores (baseline to 3 months)
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.
Measured: Difference between baseline and 3 months postpartum
Change in PHQ scores (baseline to 3 months)
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.
Measured: Difference between baseline and 3 months postpartum
Change in Mindfulness
Measured by the Five Facet Mindfulness Questionnaire (FFMQ). Average total score can be between 1 and 5 with 5 representing the highest level of mindfulness.
Measured: Compared between baseline and following the 4 week intervention, between 30 and 38 weeks of gestation.
Change in Emotional Regulation
Measured by the Emotional Regulation Questionnaire (ERQ). It consists of two subscales, reappraisal and suppression. For the reappraisal subscale, scores can be between 6 and 42 with higher scores representing a more positive outcome. For the suppression subscale, scores can be between 4 and 28 with a higher score representing a worse outcome.
Measured: Compared between baseline and following the 4 week intervention, between 30 and 38 weeks of gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 into the Center M intervention or Treatment as Usual (TAU)
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- John & Tami Marick Foundation
- Responsible party
- Principal investigator, Ellen Tilden, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304895
- Sponsor's protocol ID
- STUDY00029027
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Center M Randomized Trial
- ClinicalTrials.gov ID
- NCT07304895
- Acronym / sponsor ID
- STUDY00029027
- Conditions
- Perinatal Depression
- Keywords
- mindfulness based cognitive therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- John & Tami Marick Foundation
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a randomized control trial (RCT) with two parallel arms, 1) an intervention arm: Center M added to treatment as usual (TAU), defined as standard prenatal care, and 2) a control arm: TAU, again defined as standard prenatal care. As both groups will be obtaining services through the Center for Women's Health at OHSU, offered standard prenatal care is expected to be similar in both arms. 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.
The Center M intervention proceeds sequentially with weekly one-hour group sessions led by a trained, masters-level (or equivalent) therapist. Each group will include 3-6 participants. These sessions are conducted digitally via WebEx. Center M session structure aligns with mindfulness based cognitive therapy by including: 1) introduction of a core theme and rationale for how this theme relates to mental well-being (i.e., psychoeducation); 2) teaching core mindfulness (including an emphasis on self-compassion) and CBT skills; 3) facilitating in-session practice of skills (i.e., experiential learning); and 4) reviewing home practice of skills as well as barriers to practice. Sessions are focused on skill development, both through active engagement in practice during group sessions and individual home practice. Center M content teaches skills that increase capability for effectively navigating general life stress and the unique stresses of pregnancy and parenting. It is further designed to increase awareness of early warning signs of perinatal depression to allow for identification of the need for additional resources (including more intensive preventive intervention). The curriculum is designed to be a 'light touch', or minimum necessary intervention that still retains the capacity to prevent perinatal depression. Examples and summaries of the curriculum and accompanying handouts and homework are outlined below and full curriculum, handouts, and homework are available in the IRB documents. The Center M curriculum, handouts and homework follows the parent model MBCT curriculum, with alterations made in direct communication with Sona Dimidjian, PhD, and Sherryl Goodman, PhD, the developers of the parent model. The Center M adaptation has been accomplished with the support and involvement of Drs. Dimidjian and Goodman.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 into the Center M intervention or Treatment as Usual (TAU)
| Arm | Type | Receives |
|---|---|---|
| Center M | Experimental | Behavioral: Center MIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Center MAlso: Mindfulness Based Cognitive Therapy - Perinatal DepressionIn 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. | Behavioural | Center M |
Primary outcome
Change in EPDS scores (baseline to 6 weeks)
Time frame: Difference between baseline and 6 weeks postpartum
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.
Change in PHQ scores (baseline to 6 weeks)
Time frame: Difference between baseline and 6 weeks postpartum
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.
4 secondary outcomes
Change in EPDS scores (baseline to 3 months)
Time frame: Difference between baseline and 3 months postpartum
Change in PHQ scores (baseline to 3 months)
Time frame: Difference between baseline and 3 months postpartum
Change in Mindfulness
Time frame: Compared between baseline and following the 4 week intervention, between 30 and 38 weeks of gestation.
Change in Emotional Regulation
Time frame: Compared between baseline and following the 4 week intervention, between 30 and 38 weeks of gestation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Center M in people with Perinatal Depression, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EPDS scores (baseline to 6 weeks) (time frame: Difference between baseline and 6 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.