Center M: Digital Health Innovation Pilot

NCT ID: NCT06000449

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2025-06-15

Brief Summary

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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).

Detailed Description

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Conditions

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Perinatal Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Center M

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type BEHAVIORAL

Paper screening and PD handout.

Interventions

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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.

Intervention Type BEHAVIORAL

Treatment as Usual

Paper screening and PD handout.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Ellen Tilden

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ellen Tilden, PhD, CNM, FACNM

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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1R41MH134692

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00026642

Identifier Type: -

Identifier Source: org_study_id

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