MOMS Intervention for Prenatal Stress
(MOMSPlacenta Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of the Incarnate Word
Disqualifiers: Military dependent daughters, VA beneficiaries
No Placebo Group
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.
12345Is 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.
678910How 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.
16111213Eligibility 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
+1 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: MOMS InterventionExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Joint Base San AntonioSan Antonio, TX
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Who Is Running the Clinical Trial?
University of the Incarnate WordLead Sponsor
Uniformed Services University of the Health SciencesCollaborator
Brooke Army Medical CenterCollaborator
59th Medical WingCollaborator
References
Process Evaluation of a Stress Management Program for Low-Income Pregnant Women: The SMART Moms/Mamás LÍSTAS Project. [2021]Background. The SMART Moms/Mamás LÍSTAS Project was a randomized control trial that tested the efficacy of a prenatal stress management program in reducing stress and cortisol levels among low-income women. The current study is a process evaluation of the stress management program (intervention arm of the original randomized controlled trial) and assessed whether implementation fidelity factors (i.e., intervention delivery, receipt, and enactment) were associated with lower stress (perceived stress, salivary cortisol), improved negative and positive mood states (Positive and Negative Affect Schedule), and increased confidence to use relaxation and coping skills. Method. Fifty-five low-income pregnant women (71% Latina, 76% annual income <$20,000) attended weekly group-based sessions over an 8-week period in which a clinically trained researcher taught relaxation and coping skills. Process evaluation measures were obtained via participant self-report and videotaped class sessions that were coded for delivery, receipt, and enactment of the intervention to determine which implementation factors were associated with changes in program outcomes (stress, mood, confidence) over the 8-week period. Results. Women in stress management showed a significant reduction in their stress and cortisol levels (p < .001), improvements in negative and positive mood states (p < .001) and were more confident in using relaxation and coping skills postintervention (74%). The implementation factors of delivery (i.e., instructor adherence to intervention content; p = .03) and enactment (i.e., participant use of intervention skills; p = .02) were most associated with improvements in program outcomes. Conclusion. These findings highlight that implementation factors should be considered when delivering stress management interventions in underserved communities.
The Efficacy of Provider-Based Prenatal Interventions to Reduce Maternal Stress: A Systematic Review. [2023]Exposure to stress during the prenatal period is often associated with adverse maternal and neonatal health outcomes and is increasing in prevalence in the United States. Health care providers play a crucial role in addressing and mitigating this stress, but there is a lack of consensus regarding effective interventions. This review evaluates the effectiveness of prenatal provider-based interventions that reduce stress for pregnant people, especially those who are disproportionately affected by stress.
Fetal response to abbreviated relaxation techniques. A randomized controlled study. [2011]stress during pregnancy can have adverse effects on the course of pregnancy and on fetal development. There are few studies investigating the outcome of stress reduction interventions on maternal well-being and obstetric outcome.
The Effects of a Mindfulness-Based Intervention on Mental Health Outcomes in Pregnant Woman: A Systematic Review and Meta-Analysis. [2023]Pregnancy stress, anxiety, and depression increase the risk of short-term and long-term health problems for the mother and fetus. Mindfulness-based intervention (MBI) is one of the most popular, nonpharmacological interventions used to treat mental health problems. The results of prior research indicate MBI has a less consistent effect on mental health problems in pregnant women.
Mind-body interventions on stress management in pregnant women: A systematic review and meta-analysis of randomized controlled trials. [2021]To quantify the effect of mind-body interventions on stress in pregnant women.
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]Stress and mental disorders in pregnancy can adversely affect the developing fetus. Women with a preconception history of mental disorders or of psychosocial vulnerabilities are at increased risk of experiencing perinatal stress or mental health problems. Mindfulness-Based-Stress-Reduction (MBSR) is an acceptable intervention for pregnant women and has a growing evidence-base with meta-analyses consistently pointing to reductions in symptoms of stress, anxiety and depression. This study protocol aim to address the need for a wider array of evidence-based and non-pharmacological options during pregnancy to reduce stress and improve mental health in a psychosocially highly vulnerable group of women.
A Mindfulness Application for Reducing Prenatal Stress. [2022]Up to 40% of patients report depression or anxiety symptoms in pregnancy; feelings of increased stress are nearly universal. Antepartum stress is linked to adverse outcomes including preterm birth, low birthweight, postpartum depression, and maternal self harm. Unfortunately, limited treatment options exist, and patients are often hesitant to initiate medications prenatally. Thus, the development of efficacious nonpharmacologic interventions is crucial. This pilot study investigated the feasibility and impact of an application (app)-based mindfulness practice, begun in the first trimester, on maternal stress and pregnancy outcomes.
Maternal stress exposures, reactions, and priorities for stress reduction among low-income, urban women. [2021]Maternal psychosocial stress has been associated with adverse maternal-child outcomes. Vulnerable women's experiences with stressors during pregnancy and their desires and priorities for appropriate and useful stress reduction interventions are not well understood.
The contribution of maternal stress to preterm birth: issues and considerations. [2023]Preterm birth represents the most significant problem in maternal-child health, with maternal stress identified as a variable of interest. The effects of maternal stress on risk of preterm birth may vary as a function of context. This article focuses on select key issues and questions highlighting the need to develop a better understanding of which particular subgroups of pregnant women may be especially vulnerable to the potentially detrimental effects of maternal stress, and under what circumstances and at which stages of gestation. Issues related to the characterization and assessment of maternal stress and candidate biologic mechanisms are addressed.
Antenatal interventions to reduce maternal distress: a systematic review and meta-analysis of randomised trials. [2018]Maternal distress can have adverse health outcomes for mothers and their children. Antenatal interventions may reduce maternal distress.
A randomized controlled trial of the effects of applied relaxation training on reducing anxiety and perceived stress in pregnant women. [2008]The purpose of this study was to investigate the effect of applied relaxation training on reducing anxiety and perceived stress among pregnant women. A randomized controlled trial with a prospective pretest-posttest experimental design was used. One hundred ten primigravid women (mean age = 23.8 years) in their second trimester (mean of gestational age = 17.8 weeks) were randomly assigned into experimental and control groups. The experimental group received routine prenatal care with applied relaxation training, and the control group received only routine prenatal care. State/trait anxiety was measured with the Spielberger State-Trait Anxiety Inventory, and perceived stress was measured with the Cohen Perceived Stress Scale. There were significant reductions in state/trait anxiety and perceived stress for the experimental group compared with the control group after the intervention. The findings suggest beneficial effects of relaxation on reducing anxiety and perceived stress in pregnant women. Teaching relaxation techniques could serve as a resource for improving maternal psychological health.
Investigating the effect of group counseling on family stress and anxiety of primiparous mothers during delivery. [2022]Family is considered as the first source of care and support for the mother. Family stress and anxiety can be transmitted to the pregnant mother and have negative effects on pregnancy, childbirth, postpartum, and even their fetus. Given that one of the policies of the World Health Organization is to emphasize "safe family is safe with mother" this study was aimed to determine the effect of group counseling on family stress and anxiety of primiparous mothers during delivery.
Impact of a prenatal cognitive-behavioral stress management intervention on salivary cortisol levels in low-income mothers and their infants. [2022]Recent findings suggest that elevated stress levels during the pre- and postpartum period are related to poor maternal and infant health outcomes; yet, few studies have prospectively examined the efficacy of stress management interventions on regulating stress levels among mothers and their infants. The current study examined whether a prenatal cognitive behavioral stress management (CBSM) intervention would be effective in regulating salivary cortisol (a biological marker of stress) and self-reported stress levels among mothers and their infants at six and 18 months postpartum, relative to two control groups. Our sample was comprised of predominantly Spanish-speaking, low-income women (80%; mean age=25±5 years) who were screened for depression during their second trimester of pregnancy (M=16±5 weeks of gestation). Women at high risk for depression [i.e., having either a past history of major depression or current elevated symptoms of depression (≥16 on CES-D)] were randomized to either a CBSM group (n=24) or a usual care (UC) group (n=33), while a low risk comparison (LRC) group (n=29) was comprised of women not meeting either depression criteria. ANCOVA analyses demonstrated that: (1) infants of women in the CBSM and LRC groups had significantly lower cortisol levels than infants of women in the UC group at six months postpartum (p