Improving mental health support for pregnant and postpartum individuals
Official title: Collaborative Care Model for Perinatal Depression Support Services -- Population-Level Equity-Centered Systems Change (COMPASS-PLUS): A Hybrid Type 2 Cluster Randomized Trial
Run by Women and Infants Hospital of Rhode Island · NCT06849869 · Data updated 2026-11-12
This study is testing a new approach to mental health support for pregnant and new moms to see if it can help reduce feelings of depression and thoughts of self-harm.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 14820 (estimated) |
| Sponsor | Women and Infants Hospital of Rhode Island Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Status | Recruiting |
| Started | June 3, 2024 |
| Main results expected | January 30, 2029 |
| Study ends | March 30, 2029 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT06849869 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant and postpartum individuals aged 18 and older receiving care at participating sites.
✕Probably not a fit
Patients under 18 years of age will not be eligible for this study and therefore may not receive its benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to adapt the collaborative care model (CCM) to enhance perinatal mental health services, focusing on integrating mental health care into primary care settings. The intervention, known as COMPASS+, will be evaluated for its effectiveness in reducing depression symptoms and suicidal ideation among pregnant and postpartum individuals. The study will also assess the implementation of COMPASS+ using the RE-AIM framework to ensure it meets the unique needs of perinatal care. By addressing social determinants of mental health and promoting health equity, this approach seeks to improve outcomes for a population that often faces significant disparities in care.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce depression and improve mental health outcomes for pregnant and postpartum individuals.
How similar studies have gone: Previous studies have shown the effectiveness of the collaborative care model in improving depression outcomes, but its application in perinatal care is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Women and Infants Hospital
Providence, Rhode Island, United States Recruiting
Study contacts
- Study coordinator: Emily Miller, MD
- Email: emmiller@wihri.org
- Phone: 401- 274-1100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.