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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 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. The trial reports 1 study location across 1 state.

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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.

Conditions Studied

Interventions

  • BEHAVIORAL COMPASS+

Study Locations (1)

Rhode Island

  • Women and Infants Hospital - Providence

Trial Details

FieldValue
Enrollment Target 14,820 participants
Start Date 2025-02-24
Est. Completion 2028-06
Phase NA

What the Registry Record Tells You About NCT06849869

The ClinicalTrials.gov registry entry for NCT06849869 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 14,820 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Women and Infants Hospital of Rhode Island, which has 65 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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