Improving mental health support for pregnant and postpartum individuals
Collaborative Care Model for Perinatal Depression Support Services -- Population-Level Equity-Centered Systems Change (COMPASS-PLUS): A Hybrid Type 2 Cluster Randomized Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14820 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Women and Infants Hospital of Rhode Island Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06849869 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant and postpartum individuals aged 18 and older receiving care at participating sites.
Not a fit: Patients under 18 years of age will not be eligible for this study and therefore may not receive its benefits.
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 performed: Previous studies have shown the effectiveness of the collaborative care model in improving depression outcomes, but its application in perinatal care is relatively novel.
Eligibility criteria
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 this trial is running
Providence, Rhode Island
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.