MOMS Intervention for Prenatal Stress

(MOMSPlacenta Trial)

Overseen By Karen L Weis, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of the Incarnate Word

Disqualifiers: Military dependent daughters, VA beneficiaries

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

Compensation: Varies

Number of Visits: 16

Duration: 32 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Explore the associations of prenatal maternal anxiety to placental histologic findings, and the pro-inflammatory, anti-inflammatory, and immunoregulatory cells found in the placenta and determine the effect of maternal anxiety on the association between placental molecular changes on pregnancy and birth and infant outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the MOMS Intervention treatment for prenatal stress?

Research from the SMART Moms/Mamás LÍSTAS Project shows that a stress management program significantly reduced stress and cortisol levels (a stress hormone) in low-income pregnant women, improved their mood, and increased their confidence in using relaxation and coping skills. ^{1 2 3 4 5}

Is the MOMS Intervention for Prenatal Stress safe for humans?

Mindfulness-Based Stress Reduction (MBSR), which is similar to the MOMS Intervention, is considered safe for pregnant women and has been shown to reduce stress, anxiety, and depression without the use of medication. ^{6 7 8 9 10}

How does the MOMS Intervention for Prenatal Stress differ from other treatments for prenatal stress?

The MOMS Intervention is unique because it focuses on teaching relaxation and coping skills through weekly group sessions, specifically targeting low-income pregnant women to reduce stress and cortisol levels. This approach is distinct from other treatments as it emphasizes skill-building and confidence in using these techniques, rather than relying on medication or individual therapy. ^{1 6 11 12 13}

Research Team

Karen L Weis, PhD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

This trial is for pregnant women who are active duty or DoD beneficiaries, at least 18 years old, receiving prenatal care at SAMMC, and speak English. It aims to understand how anxiety during pregnancy affects the placenta and baby's health.

Inclusion Criteria

Receiving prenatal care at SAMMC

All Active Duty and DoD beneficiary gravid women

English speaking

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the M-O-M-S intervention or routine prenatal care, with multiple psychosocial measures and blood collections at specified gestational weeks

32 weeks

Multiple visits at 16, 24, 28, and 32 weeks gestation

Follow-up

Participants are monitored for safety and effectiveness after treatment, with placental and serum analysis

4 weeks

Treatment Details

Interventions

• MOMS Intervention

Trial Overview The study is examining the MOMS Intervention to see if it can reveal links between maternal anxiety and changes in the placenta. It also looks at how these changes might influence both pregnancy outcomes and infant health.

Participant Groups

Group I: MOMS Intervention Experimental Treatment 1 Intervention

Women that are currently in the Mentors Offering Maternal Support (M-O-M-S) research program as well as pregnant women entering prenatal care in the first trimester, who are not in the M-O-M-S program may participate in the study. Arms Assigned Interventions Experimental: M-O-M-S Intervention M-O-M-S intervention is 10, 1 hour prenatal mentored support groups No Intervention: Routine Prenatal Care Routine prenatal care in accordance with the Department of Defense Pregnancy Guidelines

Who Is Running the Clinical Trial?

University of the Incarnate Word

Lead Sponsor

Trials

18

Recruited

2,500+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

59th Medical Wing

Collaborator

Trials

42

Recruited

12,700+

Findings from Research

The SMART Moms/Mamás LÍSTAS Project demonstrated that an 8-week prenatal stress management program significantly reduced stress and cortisol levels in 55 low-income pregnant women, with improvements in both negative and positive mood states.

Key implementation factors, such as the instructor's adherence to the intervention and participants' use of relaxation skills, were strongly associated with the program's success, emphasizing the importance of delivery fidelity in stress management interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process Evaluation of a Stress Management Program for Low-Income Pregnant Women: The SMART Moms/Mamás LÍSTAS Project. Urizar, GG., Caliboso, M., Gearhart, C., et al.[2021]

Provider-based stress-reducing interventions during pregnancy, such as skills-building, mindfulness, behavioral therapy, and group support, can improve mood and reduce stress among pregnant individuals, particularly those from marginalized communities.

The review analyzed 23 studies and found that while the overall effectiveness of these interventions varies, group-based therapies that combine multiple approaches tend to be more beneficial in addressing maternal stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Provider-Based Prenatal Interventions to Reduce Maternal Stress: A Systematic Review. Moore, N., Abouhala, S., Maleki, P., et al.[2023]

The study involving 33 fetuses found that maternal relaxation techniques, particularly guided imagery (GI), positively influenced fetal behavior, with increased long-term heart rate variation compared to a control group.

Women practicing progressive muscle relaxation (PMR) exhibited more uterine activity than those using GI or the control group, suggesting that different relaxation methods may have varying effects on maternal and fetal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal response to abbreviated relaxation techniques. A randomized controlled study. Fink, NS., Urech, C., Isabel, F., et al.[2011]

Mindfulness-based interventions (MBIs) have a small but significant positive effect on mental health outcomes in pregnant women, particularly reducing stress and anxiety, based on a systematic review of 13 studies involving randomized controlled trials and quasi-experimental designs.

While MBIs showed moderate effects on stress (SMD = -0.59) and anxiety (SMD = -0.55), they did not have a significant impact on depression (SMD = -0.33), indicating that while MBIs can help with certain mental health issues during pregnancy, they may not be as effective for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of a Mindfulness-Based Intervention on Mental Health Outcomes in Pregnant Woman: A Systematic Review and Meta-Analysis. Sari, YP., Hsu, YY., Nguyen, TTB.[2023]

Mind-body interventions, including mindfulness, cognitive behavioral therapy, relaxation techniques, and yoga, significantly reduce stress in pregnant women, with a large effect size (SMD=-0.94) based on a systematic review of 28 studies involving 1944 participants.

These interventions not only lower antenatal stress but also help reduce anxiety and depression during pregnancy, suggesting they are safe and effective options for managing mental health in expectant mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-body interventions on stress management in pregnant women: A systematic review and meta-analysis of randomized controlled trials. Guo, P., Zhang, X., Liu, N., et al.[2021]

A study is underway involving 240 pregnant women with a history of mental disorders or psychosocial vulnerabilities to evaluate the effectiveness of an adapted Mindfulness-Based Stress Reduction (MBSR) program in improving mental wellbeing and reducing stress during pregnancy.

The primary goal is to assess mental wellbeing nine months after randomization, with secondary outcomes including anxiety, depression, and maternal attachment, highlighting the potential of MBSR as a non-pharmacological intervention for enhancing perinatal mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an adapted Mindfulness-Based Stress Reduction program on mental health, maternal bonding and birth outcomes in psychosocially vulnerable pregnant women: a study protocol for a randomized controlled trial in a Danish hospital-based outpatient setting. Skovbjerg, S., Sumbundu, A., Kolls, M., et al.[2023]

A pilot study involving 59 pregnant patients showed that using a mindfulness app significantly reduced perceived stress levels by an average of 6.3 points between the second and third trimesters, compared to a historical control group.

Despite limited adherence to the app, the findings suggest that prenatal mindfulness practices could be a valuable nonpharmacologic intervention for managing stress during pregnancy, offering a low-cost and accessible option for expectant mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mindfulness Application for Reducing Prenatal Stress. Porter, AC., Hunter, S., Noonan, K., et al.[2022]

A study involving 24 low-income, urban women revealed that they experience high levels of stress during pregnancy, primarily due to financial strain, exposure to violence, and feelings of isolation, which can negatively impact maternal and child health.

Participants expressed a strong desire for support through connections with other women to alleviate stress, highlighting the need for healthcare providers to facilitate these connections as part of prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal stress exposures, reactions, and priorities for stress reduction among low-income, urban women. Bloom, T., Glass, N., Curry, MA., et al.[2021]

Maternal stress is a significant factor that may increase the risk of preterm birth, but its effects can vary depending on the context and specific circumstances of the pregnancy.

There is a need for more research to identify which subgroups of pregnant women are particularly vulnerable to the negative impacts of stress, as well as to understand the biological mechanisms involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contribution of maternal stress to preterm birth: issues and considerations. Wadhwa, PD., Entringer, S., Buss, C., et al.[2023]

Preventive antenatal interventions do not significantly reduce maternal distress during pregnancy, as shown by a meta-analysis of six trials involving 2793 participants, which reported a negligible effect size.

In contrast, treatment interventions for women already experiencing or at risk of maternal distress demonstrated a significant reduction in distress, with a moderate effect size observed in three trials involving 270 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antenatal interventions to reduce maternal distress: a systematic review and meta-analysis of randomised trials. Fontein-Kuipers, YJ., Nieuwenhuijze, MJ., Ausems, M., et al.[2018]

A study involving 110 pregnant women showed that applied relaxation training significantly reduced anxiety and perceived stress compared to those who only received routine prenatal care.

The findings suggest that teaching relaxation techniques can be an effective way to improve the psychological health of pregnant women, highlighting the importance of mental well-being during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effects of applied relaxation training on reducing anxiety and perceived stress in pregnant women. Bastani, F., Hidarnia, A., Kazemnejad, A., et al.[2008]

A study involving 72 family members of pregnant women showed that group counseling significantly reduced perceived stress and anxiety levels among families of primiparous mothers during delivery, with p-values indicating strong statistical significance (p < 0.001).

The intervention demonstrated that cognitive group counseling effectively alleviated both hidden and obvious anxiety in families, suggesting that supporting family members can positively impact the well-being of pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the effect of group counseling on family stress and anxiety of primiparous mothers during delivery. Alaem, F., Jalali, A., Almasi, A., et al.[2022]

A prenatal cognitive behavioral stress management (CBSM) intervention effectively reduced salivary cortisol levels, a stress marker, in mothers and their infants at six and 18 months postpartum, compared to usual care.

Infants of mothers in the CBSM group had significantly lower cortisol levels than those in the usual care group at six months postpartum, indicating potential long-term health benefits from stress management during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a prenatal cognitive-behavioral stress management intervention on salivary cortisol levels in low-income mothers and their infants. Urizar, GG., Muñoz, RF.[2022]

References

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

Process Evaluation of a Stress Management Program for Low-Income Pregnant Women: The SMART Moms/Mamás LÍSTAS Project. [2021]

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

The Efficacy of Provider-Based Prenatal Interventions to Reduce Maternal Stress: A Systematic Review. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Fetal response to abbreviated relaxation techniques. A randomized controlled study. [2011]

4. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

The Effects of a Mindfulness-Based Intervention on Mental Health Outcomes in Pregnant Woman: A Systematic Review and Meta-Analysis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Mind-body interventions on stress management in pregnant women: A systematic review and meta-analysis of randomized controlled trials. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The effect of an adapted Mindfulness-Based Stress Reduction program on mental health, maternal bonding and birth outcomes in psychosocially vulnerable pregnant women: a study protocol for a randomized controlled trial in a Danish hospital-based outpatient setting. [2023]

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

A Mindfulness Application for Reducing Prenatal Stress. [2022]

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

Maternal stress exposures, reactions, and priorities for stress reduction among low-income, urban women. [2021]

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

The contribution of maternal stress to preterm birth: issues and considerations. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Antenatal interventions to reduce maternal distress: a systematic review and meta-analysis of randomised trials. [2018]

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

A randomized controlled trial of the effects of applied relaxation training on reducing anxiety and perceived stress in pregnant women. [2008]

12. England pubmed.ncbi.nlm.nih.gov

Investigating the effect of group counseling on family stress and anxiety of primiparous mothers during delivery. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Impact of a prenatal cognitive-behavioral stress management intervention on salivary cortisol levels in low-income mothers and their infants. [2022]