M-O-M-S on the Bayou Program for Mental Health in Pregnancy

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Tulane University

Disqualifiers: Under 18, Non-English/Spanish, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to help pregnant women in disaster-affected areas by providing classes led by experienced mothers. These classes offer emotional support to reduce anxiety and depression, promoting healthier pregnancies.

Do I need to stop my current medications for this trial?

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 M-O-M-S on the Bayou treatment for mental health in pregnancy?

The PRogram In Support of Moms (PRISM) study suggests that integrating mental health and obstetric care can effectively address perinatal depression, and the Michigan Clinical Consultation and Care Program showed significant decreases in anxiety and depression among pregnant individuals. These findings support the potential effectiveness of similar integrated mental health treatments like M-O-M-S on the Bayou. ^{1 2 3 4 5}

How is the M-O-M-S on the Bayou treatment different from other treatments for mental health in pregnancy?

The M-O-M-S on the Bayou treatment is unique because it integrates behavioral health and prenatal care with social support, creating a comprehensive care model for pregnant women. This approach is particularly effective for those with opioid use disorder, as it increases the likelihood of receiving medication-assisted treatment and behavioral health counseling throughout pregnancy and postpartum. ^{6 7 8 9 10}

Research Team

Eligibility Criteria

This trial is for pregnant women under 20 weeks' gestation, enrolled in prenatal care, and living in areas affected by a natural disaster. Participants must be over 18 and plan to carry to term and stay in the study area throughout pregnancy. They should speak English or Spanish.

Inclusion Criteria

I am less than 20 weeks pregnant.

Pregnant

Enrolled in prenatal care

Exclusion Criteria

Not pregnant

Does not plan to carry to term

Does not plan to remain in the study area through pregnancy

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 6 group meetings every other week, focusing on decreasing pregnancy concerns and building coping skills through supportive relationships.

12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for mental health outcomes and intervention effectiveness after the treatment phase.

4 weeks

Treatment Details

Interventions

• M-O-M-S on the Bayou (Behavioral Intervention)

Trial Overview The 'M-O-M-S on the Bayou' intervention aims to improve mental health among pregnant women post-disaster. It includes classes on cognitive changes during pregnancy, relationship shifts, and preparing mentally for labor led by experienced mothers.

Participant Groups

Group I: MOMS on the Bayou Intervention Group Experimental Treatment 1 Intervention

Participants complete intervention protocol.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

James Zanewicz

Tulane University

Chief Medical Officer

MD from Tulane University

Elaine Hamm

Tulane University

Chief Executive Officer since 2022

PhD in Microbiology from the University of Oklahoma

Findings from Research

The 'Mindful Moms' intervention, a 12-week program using prenatal yoga and goal-setting, was found to be feasible and acceptable for pregnant women experiencing depressive symptoms, with positive feedback from participants.

Participants in the 'Mindful Moms' program showed significant reductions in depressive symptoms, anxiety, and perceived stress, suggesting its potential effectiveness in improving mental health during pregnancy, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Effects of "Mindful Moms": A Mindful Physical Activity Intervention for Pregnant Women with Depression. Kinser, PA., Thacker, LR., Rider, A., et al.[2023]

In a study of 192 women receiving care at an integrated Obstetric Mental Health Clinic over a decade, about 72% reported reduced depression symptoms by their first follow-up visit, indicating the clinic's effectiveness in addressing perinatal depression.

Women with higher initial depression levels showed the most significant improvement, and the clinic was perceived positively by both patients and obstetric team members, highlighting the benefits of integrated mental health services in improving access and care during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression Outcomes From a Fully Integrated Obstetric Mental Health Clinic: A 10-Year Examination. Goedde, D., Zidack, A., Li, YH., et al.[2021]

Integrating mental health care with primary health services and addressing social needs through community partnerships can significantly improve women's health, especially during reproductive years.

Utilizing the engagement of women during pregnancy as a 'window of opportunity' allows healthcare providers to address mental health issues and promote positive behavior changes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting Women Where They Are: Integration of Care As the Foundation of Treatment for At-Risk Pregnant and Postpartum Women. Thomas, M., Hutchison, M., Castro, G., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

The PRogram In Support of Moms (PRISM): study protocol for a cluster randomized controlled trial of two active interventions addressing perinatal depression in obstetric settings. [2023]

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

Feasibility, Acceptability, and Preliminary Effects of "Mindful Moms": A Mindful Physical Activity Intervention for Pregnant Women with Depression. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of the Michigan Clinical Consultation and Care Program: An Evidence-Based Approach to Perinatal Mental Healthcare. [2023]

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

Massachusetts Child Psychiatry Access Program for Moms: Utilization and Quality Assessment. [2021]

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

Introducing Mother Baby Connections: a model of intensive perinatal mental health outpatient programming. [2019]

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

A statewide quality improvement (QI) initiative for better health outcomes and family stability among pregnant women with opioid use disorder (OUD) and their infants. [2020]

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

Depression Outcomes From a Fully Integrated Obstetric Mental Health Clinic: A 10-Year Examination. [2021]

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

Meeting Women Where They Are: Integration of Care As the Foundation of Treatment for At-Risk Pregnant and Postpartum Women. [2018]

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

A model for maternal depression. [2021]

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

A multifaceted intervention strategy for reducing substance use in high-risk women. [2019]