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NCT06849869 · ClinicalTrials.gov registry record · NA
Collaborative Care Model for Perinatal Wellness Support Services - Population-Level Equity-Centered Systems Change
A NA study of Perinatal Mental Health, sponsored by Women and Infants Hospital of Rhode Island.
- Recruiting
- Registry status
- NA
- Development phase
- 14,820
- Enrollment target
- 1
- Study location
NCT06849869: Recruiting NA study of Perinatal Mental Health, sponsored by Women and Infants Hospital of Rhode Island.
NCT06849869 is a NA study of Perinatal Mental Health that is actively recruiting participants, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 14,820 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (956% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06849869, a NA study of Perinatal Mental Health, is actively recruiting participants, sponsored by Women and Infants Hospital of Rhode Island.
- RECRUITING
- Registry status
- NA
- Development phase
- 14,820 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Depression symptom trajectories will be measured using the PHQ9 PHQ9 scores will be collected by the perinatal practice in each trimester and again postpartum for all pregnant and postpartum people receiving prenatal care. PHQ9 scores will also be collected by the care manager every 30 days for those referred to the COMPASS+ program until one year postpartum. Each of these scores will be entered into the trajectory analysis.
Conditions Studied
Interventions
- BEHAVIORAL COMPASS+
Study Locations (1)
Rhode Island
- Women and Infants Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,820 participants |
| Start Date | 2025-02-24 |
| Est. Completion | 2028-06 |
| Phase | NA |
What NCT06849869 shows while recruiting
NCT06849869 is an interventional study that assigns participants to a tested intervention. Its 14,820 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (956% higher).
The record links to 1 condition, with Perinatal Mental Health appearing as the primary indexed condition, and to 1 intervention - of which COMPASS+ is the first listed.
NCT06849869 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT06849869 about?
NCT06849869 is a clinical study titled "Collaborative Care Model for Perinatal Wellness Support Services - Population-Level Equity-Centered Systems Change". 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 object...
What is the current status of trial NCT06849869?
This trial is currently recruiting. It is a NA study. The enrollment target is 14,820 participants. The study started on 2025-02-24. Estimated completion is 2028-06.
What conditions does trial NCT06849869 study?
This clinical trial studies the following conditions: Perinatal Mental Health.
What interventions are being tested in trial NCT06849869?
The interventions under investigation include: COMPASS+ (BEHAVIORAL).
Who is sponsoring clinical trial NCT06849869?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06849869 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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