Enhanced Doula Support for Postpartum Depression
(UNITE Trial)
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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Standard Doula Support
Participants receive standard Medicaid doula support throughout pregnancy and postpartum.
Follow-up
Participants are monitored for effectiveness of doula support, including assessments of perinatal depressive and anxiety symptoms, and other secondary outcomes.
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
Participants with Medicaid insurance will receive standard Medicaid doula support only.
Participants with Medicaid insurance will receive an enhanced doula support, which adds more visits starting earlier in pregnancy, more frequent visits near the due date, several extended home visits in the first two months postpartum, and continued check-ins through the first year after birth.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
National Institute of Nursing Research (NINR)
Collaborator
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 ...
2.
womensmentalhealth.org
womensmentalhealth.org/posts/improved-mental-health-outcomes-with-doula-support/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, ...
4.
nursing.ceconnection.com
nursing.ceconnection.com/files/TheDoulasRoleinReducingPostpartumDepressionANarrativeReview-1778521450368.pdf;jsessionid=756A2CDCC78D124275CE4360EB693272THE 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) ...
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 ...
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