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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called COMPASS+ to improve mental health care for pregnant and postpartum individuals. It aims to determine if this approach can better manage depression symptoms and reduce suicidal thoughts compared to standard care. The trial will also assess the approach's effectiveness across different racial and ethnic groups. Pregnant individuals or those who recently had a baby and are receiving care at a participating site may qualify for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance mental health care for diverse populations.

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 prior data suggests that the COMPASS+ model is safe for perinatal mental health care?

Research has shown that the COMPASS+ program is designed to help with depression during and after pregnancy. It provides mental health support, regular check-ins with health managers, and team meetings with a psychiatrist. Past participants found this type of care manageable. The program includes talking therapies and, if needed, medications tailored to each person.

No specific reports of major safety concerns have emerged with COMPASS+. The focus on support and monitoring helps catch any issues early. This careful approach ensures that treatments can be adjusted as needed, making the program safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for perinatal mental health, which often involves general screenings and community referrals, COMPASS+ offers a more integrated approach. This program embeds mental health services directly into perinatal care, providing continuous support through a dedicated behavioral health care manager. Researchers are excited because COMPASS+ includes a patient registry and regular team meetings supervised by a perinatal psychiatrist, ensuring personalized and responsive care. This proactive and coordinated approach aims to address mental health issues more effectively during and after pregnancy, potentially improving outcomes for new mothers.

What evidence suggests that COMPASS+ is effective for perinatal mental health?

Research has shown that the COMPASS+ program, available to participants in this trial, can help treat depression during and after pregnancy. Studies indicate that the approach used in COMPASS+ improves depression and reduces disparities in healthcare access. This method combines mental health support with regular medical care, offering services like medication and therapy. The program aims to improve the well-being of women with depression through personalized treatment and regular check-ins. Early results suggest that these strategies can lead to better mental health outcomes for many women. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7491613/

Perinatal mental health: a review of progress and challenges Recent systematic reviews report a pre‐valence of 15‐20% for antenatal and 10% for postnatal anxiety disorders21, 22, with higher rates in LMIC versus HIC ...

2. policycentermmh.org policycentermmh.org/app/uploads/2024/05/NorthwesternMedicine-ACollaborativeCareModelforPerinatalDepressionSupportServicesCOMPASSOverview-1.pdf

A Collaborative Care Model for Perinatal Depression ... Thus, we anticipate that COMPASS not only improves clinical outcomes for all women, but also reduces disparities in mental health care experienced by this ...

3. nm.org nm.org/conditions-and-care-areas/womens-health/obgyn/obstetrics/postnatal-care/compass

Compass Program The COMPASS Program offers support and care for perinatal depression, including personalized treatment options such as medication and talk therapy.

4. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2023.01427

Integrating Mental Health In Perinatal Care: Perspectives ... Some estimates suggest that up to 40 percent of people experience mental health complications, mainly depression or anxiety, during or after ...

5. jpbs.hapres.com jpbs.hapres.com/SwitchArticles.aspx?cid=1569&direction=right

Disparities in Utilization and Delivery Outcomes for Women ... Perinatal mood and anxiety disorders (PMAD), which include depression and/or anxiety in the year before and/or after delivery, are common ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5957550/

Consensus Bundle on Maternal Mental Health Maternal depression and anxiety are associated with adverse perinatal outcomes, including an increased risk of poor adherence to medical care, poor ...

7. saferbirth.org saferbirth.org/psbs/perinatal-mental-health-conditions/

Perinatal Mental Health Conditions | AIM Perinatal mental health conditions refer to mood, anxiety, and anxiety-related disorders that occur during pregnancy or within one year of delivery.

8. psnet.ahrq.gov psnet.ahrq.gov/perspective/maternal-safety-and-perinatal-mental-health

Maternal Safety and Perinatal Mental Health | PSNet This piece focuses on perinatal mental health and efforts to improve maternal safety.