Recruiting

Observational Study

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT06849869

Conditions

Perinatal Mental Health

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

COMPASS+

Study Details

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.

Conditions

Perinatal Mental Health

Study ID

NCT06849869

Start date

Jun 3, 2024

Status verified date

Feb, 2026

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Jan 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

14820 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: COMPASS+

COMPASS+ services are embedded into the perinatal practice. COMPASS+ includes mental health support services and monitoring by a behavioral health care manager, a patient registry to track participant response to treatment, and weekly team huddles supervised by a perinatal psychiatrist to discussed new participants in the program or individuals who are not symptomatically improving. Patients are eligible for referral to COMPASS+ during pregnancy through one year postpartum.

no intervention: Usual care

Perinatal care practices support the mental health needs of patients providing usual care workflows at their clinic (e.g. screening for depression and anxiety symptoms in each trimester and postpartum, referring patients to community resources)

Interventions

COMPASS+

COMPASS+ is centered around the integration of a care manager (a licensed mental health clinician) who provides mental health supports (e.g. short-term therapy) and symptom monitoring to perinatal patients. The care manager works closely with the patient and obstetric clinician to create a treatment plan based on the patient's preferences and needs. The care manager also utilizes a care registry to send monthly mental health screeners to patients and track their symptoms. The care manger meets weekly with the obstetric clinician and a consulting psychiatrist to review and modify treatment plans as needed. The care manager services are available throughout pregnancy and up to one year postpartum.

Primary outcome measure

  • Patient Health Questionnaire-9 (PHQ9) trajectories [ Time Frame: enrollment in prenatal care through end of one year postpartum ]

Central Contacts and Locations

Central contacts

Emily Miller, MD

401- 274-1100emmiller@wihri.org

Andrea Chu

andrea_chu@brown.edu

Locations

Women and Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

Emily Miller, MD

401-274-1100emmiller@wihri.org

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

Aug 13, 2026

Last verified

Feb, 2026

Keywords

  • health services interventions
  • mental health
  • collaborative care model
  • compass+
  • perinatal care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2026-08-13.