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Collaborative Care Model for Perinatal Wellness Support Services - Population-Level Equity-Centered Systems Change

NCT06849869 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14820

Last updated 2026-04-20

No results posted yet for this study

Summary

The collaborative care model (CCM) is a health services intervention that integrates mental health care in primary care settings. The goal of this study is to adapt the CCM to the perinatal care context, including community co-designed adaptations to enhance health equity (COMPASS+). The main objectives of the study are to:

1. Evaluate the effect of COMPASS+ on depression symptom outcomes. Specifically we will evaluate population-level depression symptom trajectories and the prevalence of suicidal ideation among. We will also measure rates of depression response and remission for those who have elevated screen scores (i.e., PHQ9 ≥ 10)
2. Adapt, optimize, and evaluate COMPASS+ implementation strategies to the unique context of perinatal care and evaluate implementation outcomes. The RE-AIM framework will be used to evaluate implementation outcomes (acceptability, appropriateness, feasibility, and fidelity). We hypothesize that variability in effectiveness outcomes will be attributable to variability in fidelity to the implementation strategies or in implementation outcomes.
3. Identify the effect of COMPASS+ on perinatal depression and implementation outcomes across racial and ethnic subgroups.

Conditions

  • Perinatal Mental Health

Interventions

BEHAVIORAL

COMPASS+

COMPASS+ is centered around the integration of a care manager (a licensed mental health clinician) who provides mental health supports (e.g. short-term therapy) and symptom monitoring to perinatal patients. The care manager works closely with the patient and obstetric clinician to create a treatment plan based on the patient's preferences and needs. The care manager also utilizes a care registry to send monthly mental health screeners to patients and track their symptoms. The care manger meets weekly with the obstetric clinician and a consulting psychiatrist to review and modify treatment plans as needed. The care manager services are available throughout pregnancy and up to one year postpartum.

Sponsors & Collaborators

  • Brown University

    collaborator OTHER

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06849869 on ClinicalTrials.gov