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

What this Trial Is About

Perinatal depression affects about one in five women during pregnancy or after childbirth, leading to serious consequences including maternal mortality and severe maternal morbidity. This research evaluates the Collaborative Care Model adapted for perinatal care, called COMPASS+, which integrates mental health support into pregnancy and postpartum care. The study aims to assess how COMPASS+ impacts depression symptoms, suicidal thoughts, and racial disparities in mental health outcomes among pregnant and postpartum individuals. The study compares COMPASS+, which includes a licensed mental health care manager providing therapy, symptom monitoring, and treatment planning alongside obstetric clinicians and psychiatrists, to usual care that offers standard depression and anxiety screenings with community referrals. COMPASS+ services are provided from pregnancy through one year postpartum, with care managers using registries to track patient progress and meet weekly with care teams. The trial uses a randomized stepped wedge design across six clinics to test effectiveness and equity in real-world settings. Participants will be monitored from prenatal care enrollment through one year postpartum, with assessments including depression symptom tracking via the Patient Health Questionnaire-9, suicidal ideation rates, and depression response and remission rates. Implementation outcomes such as acceptability, appropriateness, feasibility, and sustainability of COMPASS+ are also evaluated at early, mid, and sustained time points. The study includes qualitative interviews with a subset of women to explore experiences across racial and ethnic groups, with the entire participation lasting until one year postpartum.

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