Mindfulness & Mechanisms Study
Primary Purpose
Hypertension in Pregnancy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness training
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension in Pregnancy focused on measuring mindfulness, pregnancy, blood pressure, ecological momentary assessment
Eligibility Criteria
Inclusion Criteria:
- Singleton pregnancy
- English speaking
- less than 20 weeks' gestation at enrollment
- Blood pressure < 140/90
- Moderate to high risk for hypertensive disorders of pregnancy
Exclusion Criteria:
- Multiple gestations
- current severe depression or psychosis
- ongoing mind-body practice (e.g., yoga, meditation, mindfulness => once a week).
Sites / Locations
- Women's Medicine CollaborativeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Mindfulness training
Treatment as usual
Arm Description
Phone-delivered mindfulness training
Prenatal care
Outcomes
Primary Outcome Measures
Perceived stress and mood responses to momentary stress
Ecological momentary assessment surveys will query for maternal mood and perceived stress throughout the day.
Secondary Outcome Measures
Heart rate response to momentary stress
Perceived and received support in response to momentary stress
Ecological momentary assessment and audio recording will be used to measure perceived and received social support and loneliness throughout the day.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04626245
Brief Title
Mindfulness & Mechanisms Study
Official Title
Mindfulness & Daily Experiences Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lifespan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
Hypertensive disorders of pregnancy (HDP) are the most common medical conditions in pregnancy and a leading cause of maternal morbidity and mortality in the United States. HDP are also associated with significant financial costs to the US healthcare system; $2.18 billion is spent on treatment of affected mothers and infants in the first year after delivery. Women exposed to HDP are at increased lifetime risk for cardiovascular disease, dementia, and all-cause mortality. Current interventions to prevent HDP are limited and do not target underlying mechanisms of disease. Mindfulness training (MT) holds tremendous promise as a mind-body intervention to prevent HDP. MT is effective at reducing blood pressure in non-pregnant patients with pre-hypertension and hypertension and has proven more effective at blood pressure reduction than other stress management interventions. Results from the pilot RCT were the first to indicate that prenatal phone-delivered MT is feasible and had a medium to large effect on cardiovascular parameters in women at risk for HDP. However, the mechanisms through which prenatal MT affects cardiovascular parameters are not yet understood.
MT teaches participants to "attend and respond in a non-judgmental way to ordinary, everyday experiences." Theory and available evidence indicate that MT elicits relaxation, decreases stress biomarkers and autonomic activation, and decreases loneliness --- dynamic processes that may serve as pathways to improved cardiovascular parameters in women at risk for HDP. The proposed RCT will harness subjective and objective ecological momentary assessment (EMA) methodologies (in vivo repeated assessments) in combination with wearable biosensor technology to capture rich epochs of ecologically-valid psychological, physiological, and interpersonal processes through which MT may lead to improved maternal cardiovascular parameters. Pregnant women at risk for HDP will be randomized to an 8-week phone-delivered MT intervention or usual care. For every participant, the research team will measure maternal cardiovascular parameters (24-hour blood pressure and uterine artery resistance values by ultrasound Doppler) before and after the RCT. All participants will complete EMA for 2 weeks 'bursts' before and after the RCT to evaluate mechanisms of MT on cardiovascular parameters. EMA will include smartphone-app based experience sampling of psychological processes; smartphone-app based ambient audio sampling (i.e. the Electronically Activated Recorder [EAR] method) and wearable wrist-worn biosensor monitoring of physiological responses (heart rate and heart rate variability) to everyday experiences. Results will provide new insights into 1) effects of MT on cardiovascular parameters in pregnancy, 2) pathophysiological mechanisms of HDP, and 3) targets for new HDP prevention strategies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy
Keywords
mindfulness, pregnancy, blood pressure, ecological momentary assessment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to a mindfulness training condition or treatment as usual.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness training
Arm Type
Experimental
Arm Description
Phone-delivered mindfulness training
Arm Title
Treatment as usual
Arm Type
Other
Arm Description
Prenatal care
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness training
Intervention Description
Phone-delivered brief mindfulness training based on principles of MBSR
Primary Outcome Measure Information:
Title
Perceived stress and mood responses to momentary stress
Description
Ecological momentary assessment surveys will query for maternal mood and perceived stress throughout the day.
Time Frame
Before and after the intervention, approximately 3 months
Secondary Outcome Measure Information:
Title
Heart rate response to momentary stress
Time Frame
Before and after the intervention, approximately 3 months
Title
Perceived and received support in response to momentary stress
Description
Ecological momentary assessment and audio recording will be used to measure perceived and received social support and loneliness throughout the day.
Time Frame
Before and after the intervention, approximately 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Singleton pregnancy
English speaking
less than 20 weeks' gestation at enrollment
Blood pressure < 140/90
Moderate to high risk for hypertensive disorders of pregnancy
Exclusion Criteria:
Multiple gestations
current severe depression or psychosis
ongoing mind-body practice (e.g., yoga, meditation, mindfulness => once a week).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret H Bublitz, PhD
Phone
4017937884
Email
margaret_bublitz@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Martin, BA
Phone
401-793-7010
Email
smartin8@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret H Bublitz
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Medicine Collaborative
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Martin, BA
Phone
401-793-7010
Email
smartin8@lifespan.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Mindfulness & Mechanisms Study
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