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

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}

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

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

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+

Findings from Research

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 '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 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]

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]

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 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]

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]

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]