Mindfulness for Cardiovascular Disease Risk

Overseen By Micheline R Anderson, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Lifespan

Disqualifiers: Multiple gestations, Chronic hypertension, Suicidality, Psychosis, others

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

Compensation: Varies

Number of Visits: 2

40 Participants Needed

Trial Summary

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 might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of prenatal mindfulness training for cardiovascular disease risk?

Research shows that mindfulness training can help reduce stress and improve mental health, which may indirectly benefit heart health. For example, a study found that online mindfulness training improved exercise capacity and reduced blood pressure in heart disease patients, suggesting potential benefits for cardiovascular health. ^{1 2 3 4 5}

Is mindfulness training generally safe for humans?

Research on mindfulness training, including prenatal mindfulness, suggests it is generally safe for humans. While the study of adverse effects is limited, no significant safety concerns have been reported in the available studies. ^{3 5 6 7 8}

How does prenatal mindfulness training differ from other treatments for cardiovascular disease risk?

Prenatal mindfulness training is unique because it focuses on reducing stress and inflammation through mental exercises, rather than using medication. This approach may help lower inflammation levels, which is linked to better cardiovascular health, by promoting relaxation and mental well-being during pregnancy. ^{3 9 10 11 12}

What is the purpose of this trial?

Prenatal Mindfulness training (MT) shows promise as a preventive intervention against hypertensive disorders of pregnancy (HDP) and may reduce risk for offspring cardiovascular disease (CVD). One proposed mechanism of MT to reduced CVD risk is improved self-regulation following stress. Perhaps the most crucial contributor to the development of self-regulation in the first year is the psychophysiological coregulatory relationship between mother and infant. However, this self-and co-regulation among women exposed to prenatal MT has not been studied and has yet to be examined in relation to CVD risk. The goal of this proposed project is to evaluate maternal-infant physiological reactivity to and recovery from stress at 6 months postpartum following prenatal MT, and to examine the relationship between these maternal infant stress responses and maternal-infant CVD risk at 12 months postpartum. Using a lab-based stress paradigm and well-validated biomarkers of mother and infant CVD risk, the investigators will assess respiratory sinus arrhythmia and heart rate at 6 months postpartum for 40 mother-infant dyads who have completed either prenatal MT or a usual care arm of an RCT examining MT for women at risk for HDP. The investigators will compare maternal, infant, and dyadic stress responses by treatment arm. Then, cardiac stress responses will be examined as predictors of maternal and infant biomarkers of CVD risk at 12 months postpartum.

Eligibility Criteria

This trial is for mothers and infants who were part of a previous study on mindfulness during pregnancy. Participants must be over 18, speak English, not currently pregnant, and have been at 'moderate' to 'high' risk for preeclampsia but normotensive when they enrolled in the earlier study.

Inclusion Criteria

For the current research study: Participants will be individuals from the parent RCT who have consented to be contacted for future research in the parent study and are not pregnant during the mentored research study procedures

Exclusion Criteria

For the parent RCT study: active suicidality or psychosis

For the parent RCT study: multiple gestations

I have long-term high blood pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Mindfulness Training

Participants undergo mindfulness training during pregnancy to prevent hypertensive disorders

Duration not specified

Postpartum Stress Reactivity Assessment

Maternal-infant physiological reactivity to stress is assessed using the Still Face Paradigm at 6 months postpartum

Single session

1 visit (in-person)

Follow-up

Maternal and infant cardiovascular risk is measured at 12 months postpartum

Single assessment

1 visit (in-person)

Treatment Details

Interventions

• Prenatal Mindfulness training

Trial Overview The trial examines how prenatal mindfulness training affects stress responses in mothers and their infants at 6 months postpartum. It also looks into whether these stress responses can predict cardiovascular disease risk one year after birth.

Participant Groups

Group I: Follow-up to Mindfulness RCT Using Still Face Paradigm Experimental Treatment 1 Intervention

Postpartum people who participated in either a mindfulness arm or TAU during an RCT examining prenatal mindfulness for pregnant people at risk for hypertensive disorders of pregnancy and their infants at 6 months of age will attend one session in which they are consented and prepared for the Still Face Paradigm (application of electrodes and RSA monitors, placement of video equipment). The SFP consists of a sequence of three, 2-minute episodes in which the parent and the infant are seated about one meter away from each other. During the first episode, the parent is free to play with the infant as they would at home. During the "still-face" episode (SF), the parent maintains a neutral face and is told not to touch or interact with the infant. The third episode is a resumption of play sometimes referred to as the "reunion" episode.

Who Is Running the Clinical Trial?

Lifespan

Lead Sponsor

Trials

43

Recruited

41,100+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Findings from Research

A 12-month follow-up study involving 324 patients with heart disease showed that online mindfulness training led to a small but significant improvement in exercise capacity, with participants walking an average of 17.9 meters further in a 6-minute test compared to usual care.

Mindfulness training also resulted in favorable long-term effects on systolic blood pressure, mental functioning, and depressive symptoms, suggesting it could be a beneficial addition to standard clinical care for heart disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online mindfulness as a promising method to improve exercise capacity in heart disease: 12-month follow-up of a randomized controlled trial. Gotink, RA., Younge, JO., Wery, MF., et al.[2019]

In a 21-day mindfulness-based intervention with 82 participants, 87% reported at least one momentary adverse effect during meditation, primarily anxiety, indicating that mindfulness practice can sometimes lead to temporary increases in anxiety.

Despite these momentary effects, 25% of participants experienced sustained adverse effects in daily life after the intervention, but these were not linked to the momentary effects during meditation, suggesting that increased awareness of internal states may contribute to these post-intervention challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. Aizik-Reebs, A., Shoham, A., Bernstein, A.[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]

References

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

Online mindfulness as a promising method to improve exercise capacity in heart disease: 12-month follow-up of a randomized controlled trial. [2019]

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

Mindfulness-Based Childbirth and Parenting Education: Promoting Family Mindfulness During the Perinatal Period. [2022]

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

The Impact of Mindfulness Treatment on Maternal Inflammation and Fetal Neurodevelopment Among Participants with Histories of Hypertensive Disorders. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The Effects of MBSR Programme on Prenatal Comfort and Fetal Health Anxiety in Pregnant Women. [2023]

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

Effect of prenatal mindfulness training on depressive symptom severity through 18-months postpartum: A latent profile analysis. [2020]

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

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Randomised controlled pilot trial of mindfulness training for stress reduction during pregnancy. [2022]

8. 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]

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

Effects of a Mindfulness-Based Parental Reflection Intervention on Pregnancy-Related Distress: A Pilot Study. [2023]

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

Potential benefits of mindfulness during pregnancy on maternal autonomic nervous system function and infant development. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The effectiveness of mindfulness-based interventions on self-efficacy and fear of childbirth in pregnant women: A systematic review and meta-analyses. [2023]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Effect of a mindfulness-based pilot intervention on maternal-fetal bonding. [2020]