NCT06849869 Collaborative Care Model for Perinatal Wellness Support Services - Population-Level Equity-Centered Systems Change
| NCT ID | NCT06849869 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Women and Infants Hospital of Rhode Island |
| Condition | Perinatal Mental Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 14,820 participants |
| Start Date | 2024-06-03 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 14,820 participants in total. It began in 2024-06-03 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06849869 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Perinatal Mental Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06849869 currently recruiting?
Yes, NCT06849869 is actively recruiting participants. Contact the research team at emmiller@wihri.org for enrollment information.
Where is the NCT06849869 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT06849869 clinical trial?
NCT06849869 is sponsored by Women and Infants Hospital of Rhode Island. The trial plans to enroll 14,820 participants.