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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mindfulness training can prevent high blood pressure during pregnancy, targeting pregnant women at risk of complications from hypertension. Participants will either receive mindfulness sessions over the phone or continue with their usual prenatal care. The goal is to determine if mindfulness can improve heart health and reduce stress, potentially lowering the risk of pregnancy-related hypertension. Women with a single pregnancy, who are less than 20 weeks along, and at moderate to high risk for hypertension, are ideal candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance prenatal care for future mothers.

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 prior data suggests that mindfulness training is safe for pregnant women?

Research has shown that mindfulness training is safe and well-tolerated for pregnant women. Studies have found it reduces stress, anxiety, and depression without safety concerns. In healthy pregnant women, increased mindfulness was linked to lower blood pressure and improved heart health.

Additionally, mindfulness programs have successfully lowered blood pressure in individuals with hypertension. This evidence suggests that mindfulness training could be a safe option for pregnant women, particularly those at risk for high blood pressure issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for pregnancy-related hypertension, which often involve medications like methyldopa or labetalol, mindfulness training offers a non-pharmacological approach. Researchers are excited about this because it focuses on reducing stress and promoting relaxation through phone-delivered sessions. This method is not only convenient but also empowers expectant mothers to actively manage their condition without the potential side effects of medication. By integrating mindfulness techniques, it holds promise for improving both mental and physical well-being during pregnancy.

What evidence suggests that mindfulness training might be an effective treatment for pregnancy-related hypertension?

This trial will compare mindfulness training with treatment as usual for managing pregnancy-related hypertension. Research has shown that mindfulness training, which participants in this trial may receive, can help lower blood pressure in adults with high blood pressure, including pregnant women. Early studies with pregnant women at risk for high blood pressure-related issues have shown promising results. Specifically, these studies found that mindfulness training not only lowered the mother's blood pressure but also positively affected the baby's growth. While the exact reasons mindfulness helps are still being explored, it seems to reduce stress, which can improve heart health. Although some research has not found a significant impact on blood pressure or preeclampsia rates, the potential benefits make mindfulness a promising non-drug option for managing blood pressure during pregnancy. ^{1 2 3 5 6}

Who Is on the Research Team?

Margaret H Bublitz

Principal Investigator

The Miriam Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10288303/

Feasibility, acceptability, and preliminary effects of ... In healthy pregnant participants, higher trait levels of mindfulness were associated with lower blood pressure [18] and improvements in parasympathetic function ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03679117

NCT03679117 | Prenatal Mindfulness & Hypertension Study Mindfulness interventions hold great potential as a non-pharmacological approach to reduce stress and prevent the recurrence of hypertension in pregnant women ...

3. withpower.com withpower.com/trial/phase-hypertension-pregnancy-induced-2022-acf30

Mindfulness Training for Pregnancy-Related Hypertension The preliminary study of prenatal mindfulness training for women at risk for HDP demonstrated benefit on maternal blood pressure and fetal growth. However, the ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424002441

Protocol for a randomized controlled trial comparing phone ... Mindfulness training (MT) is effective at reducing blood pressure in non-pregnant patients with pre-hypertension and hypertension and has proven more effective ...

5. link.springer.com link.springer.com/article/10.1007/s12671-024-02337-2

Mindfulness and Cardiometabolic Health During Pregnancy Crovetto et al. (2021) reported no effects of the mindfulness intervention on blood pressure, as well as no effects on rates of preeclampsia or ...

6. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.028712

The MB‐BP Study: A Randomized Clinical Trial A mindfulness‐based program adapted for individuals with elevated BP showed clinically relevant reductions in systolic BP compared with enhanced usual care.