Mindfulness & Mechanisms Study

NCT04626245 | Active Not Recruiting DMC

• 1 other identifier: 1679889-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hypertension in Pregnancy

Keywords

mindfulness; pregnancy; blood pressure; ecological momentary assessment

Outcome Measures

Primary Outcomes (1)

• Perceived stress and mood responses to momentary stress

  Ecological momentary assessment surveys will query for maternal mood and perceived stress throughout the day.

  Before and after the intervention, approximately 3 months

Secondary Outcomes (2)

• Heart rate response to momentary stress

  Before and after the intervention, approximately 3 months

• Perceived and received support in response to momentary stress

  Before and after the intervention, approximately 3 months

Study Arms (2)

Mindfulness training

EXPERIMENTAL

Phone-delivered mindfulness training

Behavioral: Mindfulness training

Treatment as usual

OTHER

Prenatal care

Behavioral: Mindfulness training

Interventions

Mindfulness training BEHAVIORAL

Phone-delivered brief mindfulness training based on principles of MBSR

Mindfulness training; Treatment as usual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy
• English speaking
• less than 20 weeks' gestation at enrollment
• Blood pressure \< 140/90
• Moderate to high risk for hypertensive disorders of pregnancy

You may not qualify if:

• Multiple gestations
• current severe depression or psychosis
• ongoing mind-body practice (e.g., yoga, meditation, mindfulness =\> once a week).

Sponsors & Collaborators

• Lifespan: lead

Study Sites (1)

Women's Medicine Collaborative

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Margaret H Bublitz

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: Participants will be randomized to a mindfulness training condition or treatment as usual.

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 12, 2020
• Study Start: June 13, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)