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

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.

NCT Number	NCT06849869
Lead Sponsor	Women and Infants Hospital of Rhode Island Collaborators: Brown University, National Institute of Nursing Research (NINR)
Conditions	Perinatal Mental Health
Enrollment	14,820 participants
Start Date	2024-06-03
Primary Completion	2029-01-30 (estimated)
Study Completion	2029-03-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-13