516 Participants NeededMy employer runs this trial

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 trial tests whether an enhanced doula support model can more effectively reduce postpartum depression and anxiety compared to standard Medicaid-covered care. Enhanced support involves more frequent and earlier visits during pregnancy, with continued support through the first year after birth. The researchers aim to determine if this model can improve mental health outcomes and potentially influence Medicaid policy for doula services. The trial seeks pregnant individuals, between 14 and 28 weeks along, who are eligible for Medicaid and living in North Central Florida. As an unphased trial, it offers a unique opportunity to contribute to research that could shape future Medicaid policies and improve support for new mothers.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that having a doula is generally safe and well-received by pregnant individuals. Studies have found that women with doula support are less likely to experience postpartum depression and anxiety. This support includes ongoing emotional and educational help, which improves mental health for new mothers.

Overall, strong evidence indicates that having a doula can boost social support, lower stress, and enhance the birth experience. These positive effects suggest that having a doula is likely safe and helpful for those in the trial.12345

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Doula Support model because it offers a more comprehensive approach to tackling postpartum depression. Unlike standard Medicaid doula support, which provides limited visits, this enhanced model includes more frequent and earlier visits during pregnancy, extended home visits postpartum, and continuous check-ins throughout the first year after birth. This increased and sustained support could lead to better mental health outcomes for new mothers, offering a proactive and long-term approach to postpartum care.

What evidence suggests that this trial's treatments could be effective for postpartum depression?

Studies have shown that having a doula can greatly benefit mental health. Women who receive continuous emotional and educational support from doulas often experience lower rates of postpartum depression and anxiety. Research indicates that this support not only improves mental health but also boosts self-confidence and reduces stress. In this trial, participants will join either the Enhanced Doula Support Model or the Standard Medicaid Doula Support. The Enhanced Doula Support Model, which includes more frequent visits starting earlier in pregnancy and continuing after birth, is expected to further decrease stress and anxiety. Overall, these findings suggest that enhanced doula support could lead to better mental health outcomes for new mothers.34567

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enhanced Doula Support

Participants receive enhanced doula support starting earlier in pregnancy, with more frequent visits near the due date, extended home visits in the first two months postpartum, and continued check-ins through the first year after birth.

Approximately 18 months (from early pregnancy to 1 year postpartum)
Multiple visits in-person and/or virtually

Standard Doula Support

Participants receive standard Medicaid doula support throughout pregnancy and postpartum.

Approximately 18 months (from early pregnancy to 1 year postpartum)
Standard frequency of visits as per Medicaid guidelines

Follow-up

Participants are monitored for effectiveness of doula support, including assessments of perinatal depressive and anxiety symptoms, and other secondary outcomes.

1 year postpartum
Surveys at five time points from pregnancy through one year postpartum

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+

Citations

The Effect of Doulas on Maternal and Birth Outcomes - PMC

The studies in this review indicated that doula guidance in perinatal care was associated with positive delivery outcomes including reduced ...

Improved Mental Health Outcomes Associated with Doula ...

Women receiving doula support show significantly lower rates of postpartum depression and anxiety. Continuous emotional and educational support from doulas ...

Doula Care and Health Outcomes: A Systematic Review

This systematic review found that doula support was most consistently associated with improved maternal anxiety and breastfeeding initiation, ...

THE DOULA'S ROLE IN REDUCING POSTPARTUM ...

• Doula support improves labor management and birth outcomes (Marudo et al., 2023;. Sobczak et al., 2023). • Doula support enhances self-efficacy (Ramey ...

Deconstructing Maternal Burdens: Doulas and the ...

The primary goal is to determine whether the enhanced doula model results in significantly lower rates of perinatal depressive and anxiety ...

National Helpline for Mental Health, Drug, Alcohol Issues

SAMHSA's National Helpline is a free, confidential, 24/7, 365-day-a-year treatment referral and information service (in English and Spanish) ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41770830/

The Doula's Role in Reducing Postpartum Depression

Women receiving doula support had lower odds of developing PPD or postpartum anxiety. Outcomes for women who had doula participation during and ...