Enhanced Doula Support for Postpartum Depression

(UNITE Trial)

Age: < 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a randomized controlled trial comparing two models of doula support for pregnant individuals enrolled in Medicaid: an enhanced doula support model, in which support starts earlier in pregnancy, occurs more frequently, and continues through the first year after birth, versus the standard doula care currently covered by Medicaid in Florida.

The study also builds the doula workforce needed to sustain this model of care, training doulas to become eligible to bill Medicaid for their services.

The primary goal is to determine whether the enhanced doula model results in significantly lower rates of perinatal depressive and anxiety symptoms compared to standard doula support, while gathering data on real-world implementation. The study also evaluates the effectiveness of Medicaid-covered doula services more broadly, with findings intended to inform state-level policy on Medicaid reimbursement and the extension of doula services into the postpartum period.

Are You a Good Fit for This Trial?

This trial is for pregnant people enrolled in Medicaid who are interested in receiving doula support during pregnancy, birth, and after delivery. There are no detailed exclusions listed.

Inclusion Criteria

I am currently 14 to 28 weeks pregnant.
Resides in North Central Florida
I am between 15 and 49 years old.
See 1 more

Exclusion Criteria

Severe physical or mental health conditions that interfere with participation

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced Doula Support Model
  • Standard Medicaid Doula Support

Trial Overview

The study compares two types of doula care: an enhanced model with earlier, more frequent, and longer-lasting support versus the standard Medicaid-covered doula services. Participants are randomly assigned to one group or the other.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Standard Medicaid Doula SupportExperimental Treatment1 Intervention
Group II: Enhanced Doula SupportActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+