Center M: Digital Health Innovation Pilot

NCT06000449 | Completed

• 2 other identifiers: STUDY000266421R41MH134692
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Maternal Mental Health; Telehealth

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Participant Satisfaction

  Six weeks postpartum

Study Arms (2)

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.

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.

Behavioral: Treatment as Usual

Interventions

Center M BEHAVIORAL

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.

Center M

Treatment as Usual BEHAVIORAL

Paper screening and PD handout.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Ellen Tilden, PhD, CNM, FACNM

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: February 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)