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

Recruiting now · Not applicable

Conditions studied: Perinatal Mental Health

In brief

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.

Key facts

Study ID

NCT06849869

Run by

Women and Infants Hospital of Rhode Island

People needed

14820

Starts

2024-06-03

Expected to finish

2028-06-30

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Women and Infants Hospital — Providence, Rhode Island, United States (enrolling)

Full record on ClinicalTrials.gov

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