Center M: Digital Health Innovation Pilot

Oregon Health and Science University116 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

116

Conditions

Perinatal Depression

Interventions

Center MBEHAVIORAL

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 UsualBEHAVIORAL

Paper screening and PD handout.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Screening Rate

Rates of PD screening in Center M and TAU groups.

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: Six weeks postpartum

Secondary Outcomes

Participant Satisfaction

Participant satisfaction with PD care measured by The Client Satisfaction Questionnaire - 8 (CSQ-8).

Time frame: Six weeks postpartum

Data from ClinicalTrials.gov

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