Center M: Digital Health Innovation Pilot

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 Overview

• Status: Completed
• Conditions: Perinatal Depression
• Intervention / Treatment: Behavioral: Center M; Behavioral: Treatment as Usual

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Currently pregnant
• Age 18-50 years
• Fluent in English
• Available and able to attend online group scheduled meetings

Exclusion Criteria:

• Current or past enrollment in a mindfulness-based intervention group

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Center M; 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.	Behavioral: Center M; 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.
Active Comparator: Treatment as Usual (TAU); This arm will receive the current standard of care, which includes a paper-based PD screening and a PD educational handout.	Behavioral: Treatment as Usual; Paper screening and PD handout.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening Rate	Rates of PD screening in Center M and TAU groups.	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).	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).	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).	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).	Six weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Satisfaction	Participant satisfaction with PD care measured by The Client Satisfaction Questionnaire - 8 (CSQ-8).	Six weeks postpartum

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Ellen Tilden, PhD, CNM, FACNM, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): June 15, 2025
• Study Completion (Actual): June 15, 2025

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: October 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Telehealth; Maternal Mental Health
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Therapeutics
• Other Study ID Numbers: STUDY00026642; 1R41MH134692 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: Data for specific participants who need to be linked across studies will be deidentified and transferred. Data is only accessible on an individual user basis by Principal Investigators. Any research staff transferring data will be included on all of the study IRB protocols.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No