Perinatal DepressionNCT06000449
Center M: Digital Health Innovation Pilot
A study testing Center M and Treatment as Usual in people with Perinatal Depression, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Center M is a digital health solution to Perinatal Depression (PD) which provides an alternative to Mindfulness Based Cognitive Therapy - Perinatal Depression (MBCT-PD). Center M shifts treatment to a telehealth model, reduces the number of sessions, and transitions home practice materials to a digital format. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- Center M and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently pregnant
- Age 18-50 years
- Fluent in English
- Available and able to attend online group scheduled meetings
Who cannot join
- Current or past enrollment in a mindfulness-based intervention group
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Center M is a digital health solution to Perinatal Depression (PD) which provides an alternative to Mindfulness Based Cognitive Therapy - Perinatal Depression (MBCT-PD). Center M shifts treatment to a telehealth model, reduces the number of sessions, and transitions home practice materials to a digital format. This study will include a clinical trial in which participants will be randomized to the Center M treatment with smartphone app delivery of homework compared to treatment as usual (TAU).
- Conditions
- Perinatal Depression
- Being tested
- Center M, Treatment as Usual
- Keywords
- Maternal Mental Health, Telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Center MBehavioural
Digital mental health platform. Screening and prevention activities will be provided through the Center M platform, telehealth group mindfulness sessions, and digitally delivered home practice materials.
Treatment as UsualBehavioural
Paper screening and PD handout.
| Study group | Role | What they receive |
|---|---|---|
| Center M | Experimental | This intervention will include digital PD screening as well as four weekly one-hour group telehealth Mindfulness Cognitive Behavioral Therapy sessions and digitally delivered home practice materials for skill building between online group sessions. Receives: Behavioral: Center M |
| Treatment as Usual (TAU) | Active comparator | This arm will receive the current standard of care, which includes a paper-based PD screening and a PD educational handout. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening Rate
Rates of PD screening in Center M and TAU groups.
Measured: 6 weeks postpartum
PD Symptoms at baseline
PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
Measured: Initial screening pre-intervention
PD Symptoms post intervention
PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
Measured: Two weeks post intervention
PD Symptoms post intervention
PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
Measured: Four weeks post intervention
PD Symptoms postpartum
PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
Measured: Six weeks postpartum
Secondary outcomes (1)
Participant Satisfaction
Participant satisfaction with PD care measured by The Client Satisfaction Questionnaire - 8 (CSQ-8).
Measured: Six weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start15 Feb 2024
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
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.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ellen Tilden, Oregon Health and Science University
- Investigators
- Ellen Tilden, PhD, CNM, FACNM, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000449
- Sponsor's protocol ID
- STUDY00026642
- Other IDs
- 1R41MH134692
- Status last verified
- Oct 2025
- First submitted
- 14 Aug 2023
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared with IRB #17203 (MBCT-PD Feasibility) #19166 (The Roo Study on Mom and Baby Well-Being) #18579 (Prenatal Environment and Child Health), #19004 (Maternal Well-Being Study) or #20186 (Parents Engaging Infants Study or PENGuIN). This is included in the consent form. Data will be linked between studies using non-HIPAA based participant identification numbers. Any research staff transferring data will be included on all of the study IRB protocols.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Center M: Digital Health Innovation Pilot
- ClinicalTrials.gov ID
- NCT06000449
- Acronym / sponsor ID
- STUDY00026642
- Conditions
- Perinatal Depression
- Keywords
- Maternal Mental Health, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 21 Aug 2023 (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.
Center M is a digital health solution to Perinatal Depression (PD) which provides an alternative to Mindfulness Based Cognitive Therapy - Perinatal Depression (MBCT-PD). Center M shifts treatment to a telehealth model, reduces the number of sessions, and transitions home practice materials to a digital format. This study will include a clinical trial in which participants will be randomized to the Center M treatment with smartphone app delivery of homework compared to treatment as usual (TAU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Center M | Experimental | Behavioral: Center MThis intervention will include digital PD screening as well as four weekly one-hour group telehealth Mindfulness Cognitive Behavioral Therapy sessions and digitally delivered home practice materials for skill building between online group sessions. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as UsualThis arm will receive the current standard of care, which includes a paper-based PD screening and a PD educational handout. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Currently pregnant
- Age 18-50 years
- Fluent in English
- Available and able to attend online group scheduled meetings
Key exclusion criteria (1 listed)
- Current or past enrollment in a mindfulness-based intervention group
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 MDigital mental health platform. Screening and prevention activities will be provided through the Center M platform, telehealth group mindfulness sessions, and digitally delivered home practice materials. | Behavioural | Center M |
| Treatment as UsualPaper screening and PD handout. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Screening Rate
Time frame: 6 weeks postpartum
Rates of PD screening in Center M and TAU groups.
PD Symptoms at baseline
Time frame: Initial screening pre-intervention
PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
PD Symptoms post intervention
Time frame: Two weeks post intervention
PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
PD Symptoms post intervention
Time frame: Four weeks post intervention
PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
PD Symptoms postpartum
Time frame: Six weeks postpartum
PD symptom severity measured by two validated depression screening instruments, The Center for Epidemiologic Studies Depression - Revised (CESD-R) and The Edinburgh Postnatal Depression Scale (EPDS).
1 secondary outcome
Participant Satisfaction
Time frame: Six weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared with IRB #17203 (MBCT-PD Feasibility) #19166 (The Roo Study on Mom and Baby Well-Being) #18579 (Prenatal Environment and Child Health), #19004 (Maternal Well-Being Study) or #20186 (Parents Engaging Infants Study or PENGuIN). This is included in the consent form. Data will be linked between studies using non-HIPAA based participant identification numbers. Any research staff transferring data will be included on all of the study IRB protocols.
Related trials for Perinatal Depression
Recruiting
Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents
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e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
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Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
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. This study is not recruiting at the moment.
Ellen Tilden, PhD, CNM, FACNM principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Center M and Treatment as Usual in people with Perinatal Depression, run by Oregon Health and Science University at 1 site in United States.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Screening Rate (time frame: 6 weeks postpartum). The study lists 5 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 9 Oct 2025.