Mindfulness Training for Pregnancy-Related Hypertension

Overseen By Susan Martin, BA

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Lifespan

Disqualifiers: Multiple gestations, Severe depression, Psychosis, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

150 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 4 6 7 8}

How 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. ^{1 4 7 9 10}

Research Team

Margaret H Bublitz

Principal Investigator

The Miriam Hospital

Eligibility 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.

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.

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

Treatment Details

Interventions

• Mindfulness training

Trial Overview 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.

Participant Groups

Group I: Treatment as usual Experimental Treatment 1 Intervention

Prenatal care

Group II: Mindfulness training Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Lifespan

Lead Sponsor

Trials

43

Recruited

41,100+

Findings from Research

An 8-week mindfulness-based cognitive therapy program for pregnant women led to significant reductions in depression, stress, and anxiety, with benefits extending into the postnatal period.

Participants also showed increased mindfulness and self-compassion, suggesting that incorporating mindfulness training into childbirth preparation classes could enhance emotional well-being during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindful pregnancy and childbirth: effects of a mindfulness-based intervention on women's psychological distress and well-being in the perinatal period. Dunn, C., Hanieh, E., Roberts, R., et al.[2018]

The Mindfulness-Based Childbirth and Parenting Program (MBCP) significantly reduced perceived stress and depressive symptoms in first-time pregnant women at risk of perinatal depression, compared to a Lamaze childbirth class, with 197 participants involved in the study.

MBCP also increased positive states of mind and self-reported mindfulness, suggesting that enhancing mindfulness may be a key mechanism in reducing stress and depression during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Lönnberg, G., Jonas, W., Unternaehrer, E., et al.[2021]

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]

Mindfulness interventions during pregnancy have been shown to significantly reduce stress, anxiety, and depression, based on a review of 13 randomized clinical trials involving pregnant women.

While mindfulness also showed potential improvements in emotional regulation and mindfulness levels, the studies varied widely in their methods and none specifically assessed sleep quality, indicating a need for more focused research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness interventions during pregnancy: A narrative review. Lucena, L., Frange, C., Pinto, ACA., et al.[2021]

A pilot study involving 48 women found that both a mindfulness intervention and a pregnancy support program effectively reduced perceived stress, with the mindfulness group showing greater improvement in present moment awareness.

Participants in the mindfulness program reported enhanced self-acceptance and stress management skills, suggesting that mindfulness may help women become less reliant on external support for their well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness on maternal stress, depressive symptoms and awareness of present moment experience: A pilot randomised trial. Beattie, J., Hall, H., Biro, MA., et al.[2018]

A study involving 64 pregnant women practicing prenatal meditation showed that their infants had higher cord blood cortisol levels, indicating a positive health status for the newborns.

Infants from the meditation group exhibited better temperament at five months old, suggesting that prenatal meditation positively influences infant behavior and health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal meditation influences infant behaviors. Chan, KP.[2022]

An eight-week mindfulness-based stress reduction (MBSR) program significantly decreased stress, anxiety, and depression in 60 women with unwanted pregnancies, as measured by the DASS-21 questionnaire (P = 0.0).

In contrast, the control group showed no significant changes in their mental health scores, highlighting the efficacy of MBSR as a supportive strategy for mental health during unplanned pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of mindfulness-based stress reduction (MBSR) on stress, anxiety and depression due to unwanted pregnancy: a randomized clinical trial. Nejad, FK., Shahraki, KA., Nejad, PS., et al.[2022]

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 study involving 117 first-time pregnant women found that mindfulness-based interventions significantly reduced pregnancy stress levels compared to a control group, with a notable statistical difference (P = 0.047).

The intervention also positively influenced the hypothalamic-pituitary-adrenal (HPA) axis function, as indicated by significant increases in cortisol-related indicators in the mindfulness group (Delta value P = 0.01 and AUCM value P = 0.031).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness training on pregnancy stress and the hypothalamic-pituitary-adrenal axis in women in China: A multicenter randomized controlled trial. Wang, S., Zhang, C., Sun, M., et al.[2023]

Mindfulness-based interventions during pregnancy have been shown to effectively reduce prenatal stress, which is important for maternal and fetal health.

While these interventions showed significant improvements in managing gestational diabetes-related outcomes, their effects on other pregnancy complications like preterm birth and preeclampsia were mixed or inconclusive, highlighting the need for more robust studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mindfulness-Based Interventions on Cardiometabolic-Related Adverse Pregnancy Outcomes: A Systematic Review. Root, AL., Crossley, NP., Heck, JL., et al.[2023]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Mindful pregnancy and childbirth: effects of a mindfulness-based intervention on women's psychological distress and well-being in the perinatal period. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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]

3. 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]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness interventions during pregnancy: A narrative review. [2021]

5. Scotland pubmed.ncbi.nlm.nih.gov

Effects of mindfulness on maternal stress, depressive symptoms and awareness of present moment experience: A pilot randomised trial. [2018]

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

Prenatal meditation influences infant behaviors. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

The influence of mindfulness-based stress reduction (MBSR) on stress, anxiety and depression due to unwanted pregnancy: a randomized clinical trial. [2022]

8. 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]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness training on pregnancy stress and the hypothalamic-pituitary-adrenal axis in women in China: A multicenter randomized controlled trial. [2023]

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

Effects of Mindfulness-Based Interventions on Cardiometabolic-Related Adverse Pregnancy Outcomes: A Systematic Review. [2023]