COMPASS+ for Perinatal Mental Health

(COMPASS+ Trial)

Overseen By Emily Miller, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Women and Infants Hospital of Rhode Island

Disqualifiers: Age < 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Enrollment in prenatal care through end of one year postpartum

14820 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the purpose of this trial?

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

This trial is for individuals experiencing mental health challenges during the perinatal period, which includes pregnancy and the first year after giving birth. The study aims to include a diverse population to assess the effectiveness of COMPASS+ across different racial and ethnic groups.

Inclusion Criteria

All pregnant and postpartum people receiving care at participating sites

I am older than 17 years.

Exclusion Criteria

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of COMPASS+ services, including mental health support and monitoring by a behavioral health care manager

12-13 months

Weekly team huddles

Treatment

Participants receive mental health support services and monitoring by a behavioral health care manager, with PHQ9 scores collected every 4 weeks

Enrollment in prenatal care through end of one year postpartum

Follow-up

Participants are monitored for depression symptom response and remission, and suicidal ideation using PHQ9 scores

Enrollment in prenatal care through end of one year postpartum

Treatment Details

Interventions

• COMPASS+

Trial Overview COMPASS+ is being tested as an adaptation of the collaborative care model specifically for perinatal mental health. It integrates mental healthcare into primary care settings with a focus on improving depression symptoms, reducing suicidal ideation, and achieving equity in healthcare outcomes.

Participant Groups

Group I: COMPASS+ Experimental Treatment 1 Intervention

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.

Group II: Usual care Active Control 1 Intervention

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)

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+