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Perinatal Mental HealthCOMPASS+NCT06849869

Collaborative Care Model for Perinatal Wellness Support Services - Population-Level Equity-Centered Systems Change

A study testing COMPASS+ in people with Perinatal Mental Health, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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+). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Perinatal Mental Health
What is being tested?
COMPASS+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14,820 participants
Where
1 siteUnited States
Study dates
3 Jun 2024to 30 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • all pregnant and postpartum people receiving care at participating sites, who reach a gestational age of 20 or more weeks
  • age > 17 years

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emily Miller, MD contact

401- 274-1100

emmiller@wihri.org

Andrea Chu contact

andrea_chu@brown.edu

United States1 site, 1 recruiting
  • Women and Infants Hospital

    Providence, Rhode Island, 02906

    Emily Miller, MD, 401-274-1100, emmiller@wihri.org

    Recruiting

Other trials in United States

About this study

Official title: Collaborative Care Model for Perinatal Depression Support Services -- Population-Level Equity-Centered Systems Change (COMPASS-PLUS): A Hybrid Type 2 Cluster Randomized 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.
Read the detailed description

One in five women experiences perinatal depression (PD), defined as an episode of major depressive disorder, during pregnancy or postpartum. PD can have devastating consequences for the individual, family, and community. In its most extreme form, PD can lead directly to suicide, a leading contributor to maternal mortality (MM). Untreated PD also indirectly contributes to severe maternal morbidity (SMM) and MM via associated behavioral risk factors. Despite evidence-based recommendations for PD, only 3-5% of women with PD will achieve remission of their depressive symptoms. Gaps in addressing social determinants of mental health (SDoMH), including structural racism and discrimination, contribute to the lack of success in treating PD, particularly among pregnant and postpartum individuals. Our team has identified marked racial disparities in both screening for PD and in its actual treatment.

In contrast to the existing, but failing, systems for PD care, the collaborative care model (CCM) is an established integrated supportive care intervention built on four equity-centered core principles: 1) patient-centered team care, 2) population-based care, 3) measurement-optimized treatment, and 4) evidence-based care. In primary care settings, over 80 randomized trials have demonstrated the efficacy of the CCM for improving depression outcomes. However, CCM is not broadly utilized in obstetric care. There are two major reasons for this gap from evidence to practice. The first is the lack of rigorous and generalizable evidence to support the impact of the perinatal CCM (pCCM) on population-level depression outcomes. Second, substantive differences between obstetric and primary care, which occur at the patient, provider, and system-levels, require tailored implementation strategies for pCCM.

Our prior formative research generated an optimized package of strategies for effectively implementing pCCM within diverse perinatal care settings through COMPASS (Collaborative Care Model for Perinatal Depression Support Services). We demonstrated that COMPASS improves the steps necessary for PD care, including screening and recommending treatment for PD. Moreover, our research has demonstrated that COMPASS reduces racial disparities in the steps required for PD care. Nonetheless the small samples sizes of the available studies preclude robust analyses of impact on the racial and ethnic disparities in PD outcomes. The lack of a rigorous approach to identifying and addressing SDoMH renders even the successes of COMPASS inadequate.

The critical need to equitably and adequately care for mental health conditions in pregnancy and postpartum informs the creation of COMPASS-PLUS (Collaborative Care Model for Perinatal Depression Support Services - Population-Level Equity-Centered Systems Change) (herein referred to as COMPASS+). COMPASS+ is built upon the foundations of COMPASS and embeds an anti-racist approach to addressing SDoMH via 1) a health equity advocate and 2) race and ethnicity-centered support groups for pregnancy and postpartum people, irrespective of any identified mental health needs. We propose a multi-site hybrid type 2 implementation effectiveness stepped wedge cluster randomized trial to test our central hypothesis that COMPASS+ is more effective and equitable than standard care for PD outcomes. To test this hypothesis, six diversely structured clinics across Rhode Island will be randomized to receive COMPASS+ or usual care to address the following specific aims:

Aim 1: Evaluate the effect of COMPASS+ on depression symptom severity and rate of depression response and remission. We hypothesize that implementing COMPASS+ will improve Patient Health Questionnaire 9 (PHQ9) scores (primary outcome) and reduce suicidal ideation across the study population. We hypothesize that implementing COMPASS+ will increase depression response (50% reduction in PHQ9 compared to baseline) and depression remission (PHQ9 ≤ 9) among those with PD.

Aim 2: To 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.

Aim 3: Identify the effect of COMPASS+ on perinatal depression and implementation outcomes across racial and ethnic subgroups. We hypothesize that COMPASS+ will reduce Latinx and Black versus White disparities in COMPASS+ reach and in the aforementioned PD outcomes. A subset of women (n=30) will undergo qualitative interviews regarding their experiences with COMPASS+ to evaluate racial and ethnic differences in acceptability and accessibility, using the RE-AIM framework.

The expected outcome of this project is to generate the empiric evidence needed to understand the effect of the CCM in general, and COMPASS+ specifically, on PD-related outcomes. We will generate an optimized package of successful implementation strategies for COMPASS+ to promote broad dissemination. Findings from this trial will be broadly applicable to women throughout the United States who face challenges in receiving adequate mental health care. Moreover, our results will have a substantial impact on identifying and addressing the critical factors that contribute to racial and ethnic disparities in PD-related outcomes.

Being tested
COMPASS+
Keywords
health services interventions, mental health, collaborative care model, compass+, perinatal care
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COMPASS+Behavioural

    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.

Study groups in NCT06849869
Study groupRoleWhat they receive
COMPASS+ExperimentalCOMPASS+ 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.
Receives: Behavioral: COMPASS+
Usual careNo interventionPerinatal 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Health Questionnaire-9 (PHQ9) trajectories

    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.

    Measured: enrollment in prenatal care through end of one year postpartum

Secondary outcomes (7)
  1. Suicidal ideation as assessed by the PHQ9

    Suicidal ideation is defined as a PHQ-9 question 9 score > 0

    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

    Measured: enrollment in prenatal care through end of one year postpartum

  2. Depression symptom response: Number of participants with a PHQ9≥10 who achieve a 50% reduction in PHQ9

    Among participants who have an elevated screen for depression (i.e., PHQ-9≥10), the proportion of participants who achieve response (50% reduction in PHQ-9 compared to baseline) in their depression symptoms.

    Measured: enrollment in prenatal care through end of one year postpartum

  3. Depression symptom remission: Number of participants with a PHQ9≥10 who achieve a PHQ9<10

    Among participants who have an elevated screen for depression (i.e., PHQ-9≥10), the proportion of participants who achieve remission (PHQ-9 < 10) in their depression symptoms.

    Measured: enrollment in prenatal care through end of one year postpartum

  4. Acceptability measured by the Acceptability of Intervention Measure (AIM)

    The AIM will be completed by clinician champions and clinic stakeholders within each practice

    Measured: early implementation (1-2 months), mid-implementation (6-7 months), and sustainment (12-13 months)

  5. Appropriateness measured using the Intervention Appropriateness Measure (IAM)

    The IAM will be completed by clinician champions and clinic stakeholders within each practice

    Measured: early implementation (1-2 months), mid-implementation (6-7 months), and sustainment (12-13 months)

  6. Feasibility measured using the Feasibility of Intervention Measure (FIM)

    The FIM will be completed by clinician champions and clinic stakeholders within each practice

    Measured: early implementation (1-2 months), mid-implementation (6-7 months), and sustainment (12-13 months)

  7. Maintenance measured using the Clinical Sustainability Assessment Tool (CSAT)

    The CSAT will be completed by the MPIs, clinician champions, and clinic stakeholders within each practice

    Measured: 12-13 months after implementation at each site

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2025
  2. Study start3 Jun 2024
  3. Primary completion30 Jan 2029 (estimated)
  4. Study completion30 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Single group
Model description
randomized stepped wedge design
Masking
None (open label)
Enrolment
14,820 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06849869
Sponsor's protocol ID
2100211
Other IDs
R01NR021126
Acronym
COMPASS+
Status last verified
Feb 2026
First submitted
19 Feb 2025
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing COMPASS+ in people with Perinatal Mental Health, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emily Miller, MD (401- 274-1100, emmiller@wihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire-9 (PHQ9) trajectories (time frame: enrollment in prenatal care through end of one year postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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