Home › NCT06849869

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

Collaborative Care Model for Perinatal Depression Support Services -- Population-Level Equity-Centered Systems Change (COMPASS-PLUS): A Hybrid Type 2 Cluster Randomized Trial

Who can join

Ages 18 and older · Women

Inclusion Criteria:

* all pregnant and postpartum people receiving care at participating sites, who reach a gestational age of 20 or more weeks
* age \> 17 years

Exclusion Criteria:

* age \< 18 years
* all pregnant and postpartum people receiving care at participating sites, who do not reach a gestational age of 20 or more weeks

About the study

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.

What is being tested

• COMPASS+ (behavioral)

Sponsor: Women and Infants Hospital of Rhode Island · Participants: 14,820 · Started: Jun 3, 2024

Contact the study team

• Emily Miller, MD · Phone: 401- 274-1100

Official record on ClinicalTrials.gov — NCT06849869

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.