Group Prenatal Care for Depression During Pregnancy

(EleVATE GC Trial)

Recruiting at 3 trial locations

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Multiple gestation, Major fetal anomaly, Serious medical/psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

390 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will provide high-quality, representative data on the capacity of Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care (EleVATE GC) to reduce perinatal depression, preterm birth, and low birthweight in African-American women. If findings from this study indicate that EleVATE GC is feasible and effective, this model could be implemented nationwide to help achieve mental and obstetric health parity for low-income women of color in the United States.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment EleVATE Group Care for depression during pregnancy?

Research suggests that group prenatal care, which combines medical care with education and support in a group setting, can help build social support among pregnant women and may reduce the risk of postpartum depression. This indicates that similar group care models could be beneficial for managing depression during pregnancy. ^{1 2 3 4 5}

How is the EleVATE Group Care treatment different from other treatments for depression during pregnancy?

EleVATE Group Care is unique because it combines prenatal care with group therapy sessions, providing both medical and emotional support in a community setting, which is different from traditional one-on-one therapy or medication-based treatments for depression during pregnancy. ^{3 6 7 8 9}

Eligibility Criteria

This trial is for African-American women who are pregnant, at high risk of postpartum depression, and under 18 weeks' gestation. They must be able to give informed consent, attend group prenatal visits, speak English or Spanish, and have a history that may increase their risk of depression. Women with multiple pregnancies or serious health issues are not eligible.

Inclusion Criteria

I am less than 18 weeks pregnant.

The fetus is considered to be a fetus at ≤16 weeks' gestation

I speak English or Spanish.

Exclusion Criteria

You are carrying more than one baby at the same time.

I have a serious health condition that requires more care than a group can provide.

The fetus has a significant abnormality.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Care

Participants receive either group or individual prenatal care to address depression, toxic stress, and equity

28-40 weeks

Regular prenatal visits

Postpartum Follow-up

Participants are monitored for perinatal depression, stress, and other outcomes postpartum

4-12 weeks

Postpartum visits

Treatment Details

Interventions

• EleVATE Group Care

Trial Overview The study tests EleVATE Group Care against Individual Prenatal Care to see if it can reduce perinatal depression and improve birth outcomes in low-income African-American women. Participants will either join the group care model or receive standard individual care.

Participant Groups

Group I: Group Prenatal Care Experimental Treatment 1 Intervention

Group prenatal care model

Group II: Individual Prenatal Care Active Control 1 Intervention

Individual prenatal care

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial on the Effect of Group Versus Individual Prenatal Care on Psychosocial Outcomes. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of March of Dimes Supportive Pregnancy Care on Social Support and Postpartum Depression. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Culturally relevant treatment services for perinatal depression in socio-economically disadvantaged women: the design of the MOMCare study. [2021]

4. Austria pubmed.ncbi.nlm.nih.gov

Perinatal depression screening practices in a large health system: identifying current state and assessing opportunities to provide more equitable care. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of cognitive behavioral therapy for perinatal depression adapted for women with low incomes. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Use of an educational intervention to increase screening for antenatal depression in an obstetrics and gynecology practice. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Perinatal depression: hiding in plain sight. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Perinatal depression care pathway for obstetric settings. [2020]

9. Scotland pubmed.ncbi.nlm.nih.gov

Midwives and women's views on using UK recommended depression case finding questions in antenatal care. [2022]