Center M: Digital Health Innovation Pilot

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06000449

Enrollment

116

Registered

2023-08-21

Start date

2024-02-15

Completion date

2025-06-15

Last updated

2025-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perinatal Depression

Keywords

Maternal Mental Health, Telehealth

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).

Interventions

BEHAVIORALCenter 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.

BEHAVIORALTreatment as Usual

Paper screening and PD handout.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Screening Rate	6 weeks postpartum	Rates of PD screening in Center M and TAU groups.
PD Symptoms at baseline	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	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 postpartum	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).

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026