Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

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.

More Perinatal Mental Health trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment14820 (estimated)
SponsorWomen and Infants Hospital of Rhode Island
Academic / other
Locations1 site (Providence, Rhode Island)
StatusRecruiting
StartedJune 3, 2024
Main results expectedJanuary 30, 2029
Study endsMarch 30, 2029
Registry record updatedAugust 13, 2026
Trial IDNCT06849869 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

  • Women and Infants Hospital
    Providence, Rhode Island, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.