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

Collaborative Care Model for Perinatal Depression Support Services -- Population-Level Equity-Centered Systems Change (COMPASS-PLUS): A Hybrid Type 2 Cluster Randomized Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests COMPASS+, a program that adds mental health care to care during and after pregnancy. It looks at how well the program helps with depression and how its results differ across racial and ethnic groups. It is for people age 18 or older at study care sites whose pregnancy reaches at least 20 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are pregnant or have given birth and receive care at a study site.
  • Your pregnancy reaches or reached at least 20 weeks.
  • You are age 18 or older.

Who can't join

  • You are younger than 18.
  • Your pregnancy does not or did not reach 20 weeks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

RI