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

Overseen By Andrea Meyer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Tulane University

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

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support pregnant women in areas affected by natural disasters by improving their mental health. It will explore how the M-O-M-S on the Bayou intervention, a program led by experienced mothers, can help expectant mothers manage the stress and changes of pregnancy and motherhood. Pregnant women who are less than 20 weeks into their pregnancy and already receiving prenatal care might be a good fit for this trial. Participants will attend classes focusing on mental health and the emotional aspects of pregnancy and labor. As an unphased trial, this study offers expectant mothers a unique opportunity to gain valuable support and insights during pregnancy.

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 prior data suggests that this intervention is safe for pregnant women?

Research shows that the M-O-M-S on the Bayou program can improve mental health for pregnant women. In previous studies, this program reduced anxiety and increased the likelihood of women receiving medication-assisted treatment for opioid use disorder. Participants have not reported serious side effects or safety issues from these group classes. The program includes sessions led by experienced mothers, fostering a supportive and safe environment. Since this study is in the "Not Applicable" phase, it focuses on understanding the program's effectiveness rather than testing its safety. While there might be less detailed safety data than in other trials, the absence of reported problems suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for mental health during pregnancy, which often involve medication or talk therapy, the M-O-M-S on the Bayou program offers a unique approach by focusing on community-based interventions. Researchers are excited because this method leverages local resources and support networks, potentially providing more culturally relevant and accessible care. This program could offer an alternative for individuals who are either unable or prefer not to use medication during pregnancy, addressing mental health needs in a holistic and personalized manner.

What evidence suggests that the M-O-M-S intervention is effective for improving mental health in pregnant women?

Research shows that the M-O-M-S on the Bayou program aims to improve mental health for pregnant women in disaster-affected areas. Studies have found that similar programs can reduce stress and enhance emotional well-being. Women in these programs often feel better about themselves and manage their emotions more effectively. Handling stress and emotions during pregnancy is crucial, as it can lead to healthier outcomes for both mother and baby. Although specific data on the M-O-M-S program remains limited, its approach is based on evidence supporting mental health benefits for pregnant women in challenging situations. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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

Pregnant

Enrolled in prenatal care

I am less than 20 weeks pregnant.

Exclusion Criteria

Fetal defects likely to lead to death or extensive hospitalization postpartum

Not pregnant

Does not plan to carry to term

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• M-O-M-S on the Bayou

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

The MOMS program significantly increased the likelihood of pregnant women with opioid use disorder (OUD) receiving medication-assisted treatment (MAT) and behavioral health counseling throughout their pregnancy, with odds ratios indicating strong improvements across all trimesters.

Participation in the MOMS program was associated with better retention in MAT during the postpartum period and a marginal reduction in the out-of-home placement of infants, highlighting the program's potential to support both maternal and infant health outcomes.

NCBI (Pubmed)

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. Crane, D., Marcotte, M., Applegate, M., et al.[2020]

Mother Baby Connections (MBC) is an innovative outpatient program designed to address perinatal mental health issues, which affect 15-20% of women, and has shown significant improvements in various mental health outcomes for 20 predominantly minority women over 20 months.

Participants in the MBC program experienced medium to large effect sizes in improvements related to maternal depression, functioning, and parenting stress, indicating that this tailored approach is effective in enhancing maternal mental health during the perinatal period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing Mother Baby Connections: a model of intensive perinatal mental health outpatient programming. Geller, PA., Posmontier, B., Horowitz, JA., et al.[2019]

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]

The Massachusetts Child Psychiatry Access Program for Moms (MCPAP for Moms) successfully trained 1,174 healthcare providers and served 3,699 women over 3.5 years, demonstrating its effectiveness in improving the detection and treatment of perinatal mental health and substance use disorders.

Healthcare providers reported that the program facilitated better communication about mental health issues, although they expressed a need for more support to enhance depression care further, indicating areas for future improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Massachusetts Child Psychiatry Access Program for Moms: Utilization and Quality Assessment. Byatt, N., Straus, J., Stopa, A., et al.[2021]

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]

Maternal depression is a significant public health issue that affects both mothers and their children, particularly among low-income women who may also face intimate partner violence and substance use.

The Perinatal Mental Health Model promotes a collaborative care approach in community obstetric settings, enhancing the screening and referral process to better address the psychosocial needs of diverse, low-income mothers, despite current low rates of screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A model for maternal depression. Connelly, CD., Baker-Ericzen, MJ., Hazen, AL., et al.[2021]

The intervention, which included intensive home visits and case management for high-risk women of child-bearing age, showed significant improvements in 14 out of 16 assessed areas, indicating its effectiveness in reducing substance use.

The study found strong correlations between substance use and factors like mental health, social support, and self-efficacy, highlighting the importance of addressing these domains in substance use interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multifaceted intervention strategy for reducing substance use in high-risk women. Loudenburg, R., Leonardson, GR.[2019]

The study aims to compare the effectiveness of two interventions for perinatal depression: the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms and the more comprehensive PRogram In Support of Moms (PRISM), which includes MCPAP plus additional support.

This research involves a cluster randomized controlled trial with ongoing recruitment of participants, who will be followed for up to 13 months postpartum, allowing for a thorough examination of depression symptom changes and treatment engagement across different stages of pregnancy and postpartum.

NCBI (Pubmed)

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. Moore Simas, TA., Brenckle, L., Sankaran, P., et al.[2023]

The Michigan Clinical Consultation and Care (MC3) program successfully enrolled 209 participants, with 97% reporting satisfaction with the mental healthcare services, indicating high acceptability of the program.

Preliminary results showed significant reductions in anxiety and depression among participants, particularly within the first month of treatment, highlighting the program's potential effectiveness in improving perinatal mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Michigan Clinical Consultation and Care Program: An Evidence-Based Approach to Perinatal Mental Healthcare. Muzik, M., Menke, RA., Issa, M., et al.[2023]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05838404/m-o-m-s-on-the-bayou-implementation-of-an-intervention-for-mental-health-in-pregnancy

M-O-M-S on the Bayou: Implementation of an Intervention ... The goal of this intervention is to improve mental health in pregnant women living in a disaster-affected region.

2. momsonthebayou.wp.tulane.edu momsonthebayou.wp.tulane.edu/

MOMS on the Bayou | Better mental health for pregnant ... The M-O-M-S™ on the Bayou study is an intervention designed to help improve health outcomes for pregnant women through a series of group classes on the ...

3. psycnet.apa.org psycnet.apa.org/record/2023-20209-001

Examining the efficacy of prenatal intervention in reducing IPV ... Examining the efficacy of prenatal intervention in reducing IPV revictimization and improving maternal mental health: A quasirandomized ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8656746/

Healthy Moms and Babies Preventive Psychological ... The results suggested that the program promotes women's self-compassion and improves their emotional regulation abilities, skills that exert a ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2468266723002682

Effectiveness of two systems-level interventions to address ... Both the MCPAP for Moms and PRISM interventions were equally effective in improving depression symptoms.

6. withpower.com withpower.com/trial/phase-depression-6-2023-caa3b

M-O-M-S on the Bayou Program for Mental Health in ... The MOMS program significantly increased the likelihood of pregnant women with opioid use disorder (OUD) receiving medication-assisted treatment (MAT) and ...

7. momsonthebayou.wp.tulane.edu momsonthebayou.wp.tulane.edu/about-the-m-o-m-s-research-project/

About the Study | MOMS on the Bayou In the trials, the M-O-M-S™ intervention improved mental health by significantly reducing anxiety among the women who participated as well as increasing ...

8. mmhla.org mmhla.org/articles/maternal-mental-health-conditions-and-statistics

Maternal Mental Health Conditions and Statistics 1 in 5 Mothers are Impacted by Mental Health Conditions · Mental Health Conditions are a Leading Cause of Maternal Deaths · Most Women are ...