Mindfulness Training for Pregnancy-Related Hypertension
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Lifespan
Disqualifiers: Multiple gestations, Severe depression, Psychosis, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?Hypertensive disorders of pregnancy (HDP) are the most common medical condition affecting pregnancy and a leading cause of maternal morbidity and mortality in the Unites States. HDP also increase lifetime cardiac disease risk in women and infants. Current interventions to prevent HDP are limited, and interventions that do not include medications are minimally effective at preventing HDP. Mindfulness interventions hold promise as a intervention to prevent HDP that does not require pregnant women to take medications. Past research shows that mindfulness interventions reduce blood pressure in adults with hypertension and pre-hypertension. However, past studies of mindfulness interventions for pregnant women have not allowed women at risk for HDP to participate. The preliminary study of prenatal mindfulness training for women at risk for HDP demonstrated benefit on maternal blood pressure and fetal growth. However, the mechanisms explaining effects of prenatal mindfulness training on risk for HDP are unknown. Building upon these promising preliminary findings, the proposed clinical trial will measure daily experiences of stress, physiological reactivity to stress, and interpersonal processes before and after prenatal mindfulness training. The investigators hypothesize that mindfulness training will impact these processes, which may lead to improved maternal cardiovascular parameters and reduced risk for HDP. N=150 pregnant women at risk for HDP will be randomized to an 8-week phone-delivered mindfulness intervention or usual care. For every participant, we will measure maternal cardiovascular parameters (24-hour blood pressure and uterine artery resistance values by ultrasound Doppler) before and after the 8-week period. All participants will complete surveys of daily experiences for 2 weeks before and after the 8-week period to evaluate mechanisms of mindfulness training on maternal cardiovascular parameters. Daily experiences will be measured using surveys delivered via smartphone-app, ambient audio sampling, and wearable wrist-worn biosensor monitoring (heart rate and heart rate variability).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on mindfulness training as an additional intervention, so it's best to discuss your medications with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Mindfulness training for pregnancy-related hypertension?
Research shows that mindfulness training can help reduce stress, anxiety, and depression in pregnant women, which are factors that can contribute to high blood pressure. While the studies focus on mental health benefits, these improvements may indirectly support better blood pressure management during pregnancy.
12345Is mindfulness training safe for pregnant women?
Mindfulness training is considered safe and acceptable for pregnant women, helping to reduce stress, anxiety, and depression without any reported safety concerns.
14678How does mindfulness training differ from other treatments for pregnancy-related hypertension?
Mindfulness training is unique because it focuses on reducing stress and improving mental well-being through meditation and awareness practices, which can indirectly help manage high blood pressure during pregnancy. Unlike medications, it does not involve taking drugs and instead aims to lower stress hormones like cortisol, which may contribute to hypertension.
147910Eligibility Criteria
This trial is for English-speaking pregnant women under 20 weeks' gestation, with blood pressure below 140/90, and at moderate to high risk for hypertensive disorders. It's not for those with multiple pregnancies, severe depression or psychosis, or who regularly practice mind-body activities like yoga or meditation.Inclusion Criteria
You are at risk for developing high blood pressure during pregnancy.
English speaking
You are less than 20 weeks pregnant when you join the study.
+2 more
Exclusion Criteria
I am currently experiencing severe depression or psychosis.
Multiple gestations
You regularly practice activities that involve the mind and body, like yoga or meditation, at least once a week.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Measurement of maternal cardiovascular parameters and completion of surveys of daily experiences
2 weeks
1 visit (in-person), daily surveys (virtual)
Treatment
Participants receive an 8-week phone-delivered mindfulness intervention or usual care
8 weeks
Weekly phone sessions
Post-Treatment Assessment
Re-assessment of maternal cardiovascular parameters and completion of surveys of daily experiences
2 weeks
1 visit (in-person), daily surveys (virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if mindfulness training can prevent hypertension during pregnancy without medication. Participants will either receive an 8-week phone-delivered mindfulness intervention or usual care. The effects on maternal blood pressure and stress-related parameters will be measured using surveys and biosensors.
2Treatment groups
Experimental Treatment
Group I: Treatment as usualExperimental Treatment1 Intervention
Prenatal care
Group II: Mindfulness trainingExperimental Treatment1 Intervention
Phone-delivered mindfulness training
Mindfulness training is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Headspace for:
- Stress reduction
- Anxiety management
- Depression management
🇺🇸 Approved in United States as Headspace for:
- Stress reduction
- Anxiety management
- Depression management
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Women's Medicine CollaborativeProvidence, RI
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Who Is Running the Clinical Trial?
LifespanLead Sponsor
References
Mindful pregnancy and childbirth: effects of a mindfulness-based intervention on women's psychological distress and well-being in the perinatal period. [2018]This pilot study explored the effects of an 8-week mindfulness-based cognitive therapy group on pregnant women. Participants reported a decline in measures of depression, stress and anxiety; with these improvements continuing into the postnatal period. Increases in mindfulness and self-compassion scores were also observed over time. Themes identified from interviews describing the experience of participants were: 'stop and think', 'prior experience or expectations', 'embracing the present', 'acceptance' and 'shared experience'. Childbirth preparation classes might benefit from incorporating training in mindfulness.
Effects of a mindfulness based childbirth and parenting program on pregnant women's perceived stress and risk of perinatal depression-Results from a randomized controlled trial. [2021]The aim of this study was to test the efficacy of a Mindfulness-Based Childbirth and Parenting Program (MBCP) in reducing pregnant women's perceived stress and preventing perinatal depression compared to an active control condition.
Feasibility, Acceptability, and Preliminary Effects of "Mindful Moms": A Mindful Physical Activity Intervention for Pregnant Women with Depression. [2023]Nonpharmacological and accessible therapies that engage individuals in self-management are needed to address depressive symptoms in pregnancy. The 12-week "Mindful Moms" intervention was designed to empower pregnant women with depressive symptomatology to create personal goals and engage in mindful physical activity using prenatal yoga.
Mindfulness interventions during pregnancy: A narrative review. [2021]Pregnancy is a period of major transformations in a woman's life; increased stress, and mood and sleep disorders are frequent. This review evaluates mindfulness interventions during pregnancy and their ability to help manage stress, anxiety, depression, emotional regulation, level of mindfulness and sleep quality. A search of English language scientific literature relevant to mindfulness interventions for pregnant women was conducted using PubMed, Scopus and Web of Science, without restriction on publication date. Inclusion criteria were randomized clinical trials with pregnant women, using mindfulness as an intervention for at least three weeks, in one of our main areas of interest, and using only validated scales to measure outcomes. Two hundred and thirty studies were identified in our searches of research databases, and thirteen were included in our analysis. We found a large diversity of mindfulness programs, heterogeneity among the instruments used to evaluate outcomes, and inconsistency in the gestational periods used in the studies. Mindfulness interventions were beneficial for stress, anxiety and depression. Mindfulness was also effective when applied in pregnant women with a history of depression or experiencing depression. Considering emotional regulation and the level of mindfulness, there were signs of improvement, but more studies are needed. None of the studies evaluated sleep quality. Our review provides information about current mindfulness programs, an overview of the effects of mindfulness interventions, a description of the measurements used so far, and recommendations for developing high-quality mindfulness protocols for pregnant women.
Effects of mindfulness on maternal stress, depressive symptoms and awareness of present moment experience: A pilot randomised trial. [2018]To determine the feasibility and acceptability and measure the effects of a mindfulness intervention compared to a pregnancy support program on stress, depressive symptoms and awareness of present moment experience.
Prenatal meditation influences infant behaviors. [2022]Meditation is important in facilitating health. Pregnancy health has been shown to have significant consequences for infant behaviors. In view of limited studies on meditation and infant temperament, this study aims to explore the effects of prenatal meditation on these aspects. The conceptual framework was based on the postulation of positive relationships between prenatal meditation and infant health. A randomized control quantitative study was carried out at Obstetric Unit, Queen Elizabeth Hospital in Hong Kong. 64 pregnant Chinese women were recruited for intervention and 59 were for control. Outcome measures were cord blood cortisol, infant salivary cortisol, and Carey Infant Temperament Questionnaire. Cord blood cortisol level of babies was higher in the intervention group (p
The influence of mindfulness-based stress reduction (MBSR) on stress, anxiety and depression due to unwanted pregnancy: a randomized clinical trial. [2022]Individuals with unwanted pregnancies often experience high levels of anxiety, stress and depression that associated with maternal-neonatal outcomes. Mindfulness training is a safe and acceptable strategy to support mental health before parturition.
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.
Effectiveness of mindfulness training on pregnancy stress and the hypothalamic-pituitary-adrenal axis in women in China: A multicenter randomized controlled trial. [2023]In the past two decades, mindfulness-based intervention programs have gradually become popular.Many studies have confirmed that these programs can effectively alleviate prenatal stress and negative emotion.The mindfulness-based stress-buffering hypothesis suggests that mindfulness training can induce changes in the levels of the cortisol secreted by the HPA axis, thereby reducing stress susceptibility. However, to date, only a few high-quality evidence-based medical studies have analyzed the effect of the mindfulness-based intervention in a maternal population.Thus, this study investigated the effects of a mindfulness-based psychosomatic intervention on pregnancy stress and the HYPERLINK "javascript:;" hypothalamic-pituitary-adrenal (HPA) axis of pregnant Chinese women.
Effects of Mindfulness-Based Interventions on Cardiometabolic-Related Adverse Pregnancy Outcomes: A Systematic Review. [2023]Growing evidence suggests maternal stress contributes to the development of adverse pregnancy outcomes that are associated with cardiovascular and cardiometabolic risk in birthing persons. Mindfulness-based interventions may positively affect psychological stress in pregnancy and, in turn, reduce stress. However, few study authors have examined the effects of mindfulness-based interventions on adverse pregnancy outcomes that heighten cardiovascular risk.