Jackson Heart Study Women's Hypertension Study

February 23, 2026 updated by: NYU Langone Health

Telephone-based Mindfulness Training to Reduce Blood Pressure in Black Women With Hypertension in the Jackson Heart Study

High blood pressure is a powerful risk factor for heart disease. Black women are more likely to have high blood pressure than white women or Hispanic women. Even when they are aware they have high blood pressure, many people struggle to keep their blood pressure controlled. Research shows a connection between life stress and high blood pressure and heart disease outcomes. Mindfulness training programs can help people regulate their emotions and cope with stress. Research shows that mindfulness programs can also lower blood pressure. This study will compare two programs: MIND-BP, a Zoom-based mindfulness training group; and BOOST, a Zoom-based support group. The aims of the study are to test if the MIND-BP program leads to greater reductions in blood pressure, stress and depressive symptoms than the BOOST program in Black women with high blood pressure who are participating in the Jackson Heart Study. The primary outcome measure is 6-month change in systolic blood pressure. The secondary outcome measures are 6-month changes in perceived stress and depressive symptoms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Principal Investigator:
          • April P. Carson, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female participant in Jackson Heart Study
  • Willing to be randomized and comply with all aspects of protocol
  • Willing to be audio-recorded during group sessions.

Exclusion Criteria:

  • Positive cognitive screen (MMSE <19)
  • Severe depressive symptoms (CES-D ≥16)
  • Pregnant or planning to become pregnant in the next 6 months
  • Current participation in another trial
  • Arm circumference >45 cm and <22 cm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MIND-BP
Participants who are randomly assigned to receive the MIND-BP program, a virtually delivered mindfulness training group.
Behavioral: MIND-BP
8-week program delivered to small groups by a trained facilitator using Zoom/Webex. Each session is one hour long and includes a check-in period, teaching on the week's topic, group discussion, a skill-building exercise and home practice assignment. Participants receive a workbook of all session content, audio guides for home practice, and practice logs. At the start of the program, the stress response and its importance for hypertension and cardiovascular disease is discussed, and the rationale for the mindfulness and cognitive skills to be taught are explained. Weekly sessions focus on learning and practicing skills.
Experimental: BOOST
Participants who are randomly assigned to receive the BOOST program, a virtually delivered mindfulness training group.
Behavioral: BOOST
The BOOST program is designed to control for attention, credibility, and expectation of benefit. To parallel MIND-BP, the BOOST program will be delivered in 8 weekly group sessions via Zoom/Webex and led by a trained facilitator. Each weekly BOOST session will be 1 hour long and comprised of a check-in period, introduction of the week's topic, and group discussion. Didactic information, skill-building instruction and home practice are not included. Weekly BOOST session topics include: (1) personal experience of hypertension; (2) personal experience of stress; (3) personal experience of mood-related challenges; (4) personal experience of social relationships; (5) concerns related to hypertension treatment; (6) concerns about other health problems; (7) personal experience related to healthcare; and (8) review of the BOOST experience.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure
Time Frame: Baseline, Month 6
Change in average systolic blood pressure (SBP) from 7 consecutive days of home blood pressure monitoring.
Baseline, Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale (PSS-10) Score at Baseline
Time Frame: Baseline
The 10-item Perceived Stress Scale (PSS-10) is a validated measure of perceived stress that assesses the degree to which situations in one's life are appraised as overwhelming, uncontrollable, and unpredictable over the last month. Items are rated on a 5-point scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 40; higher total scores indicate greater perceived stress.
Baseline
Perceived Stress Scale (PSS-10) Score at Month 3
Time Frame: Month 3
The 10-item Perceived Stress Scale (PSS-10) is a validated measure of perceived stress that assesses the degree to which situations in one's life are appraised as overwhelming, uncontrollable, and unpredictable over the last month. Items are rated on a 5-point scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 40; higher total scores indicate greater perceived stress.
Month 3
Perceived Stress Scale (PSS-10) Score at Month 6
Time Frame: Month 6
The 10-item Perceived Stress Scale (PSS-10) is a validated measure of perceived stress that assesses the degree to which situations in one's life are appraised as overwhelming, uncontrollable, and unpredictable over the last month. Items are rated on a 5-point scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 40; higher total scores indicate greater perceived stress.
Month 6
Center for Epidemiological Studies Depression (CES-D) Score at Baseline
Time Frame: Baseline
20-item assessment of the frequency of depressive symptoms during the prior week. Items are rated on a 4-point scale. The total score is the sum of responses and ranges from 0 to 60; higher total scores indicate greater frequency of depressive symptoms.
Baseline
Center for Epidemiological Studies Depression (CES-D) Score at Month 3
Time Frame: Month 3
20-item assessment of the frequency of depressive symptoms during the prior week. Items are rated on a 4-point scale. The total score is the sum of responses and ranges from 0 to 60; higher total scores indicate greater frequency of depressive symptoms.
Month 3
Center for Epidemiological Studies Depression (CES-D) Score at Month 6
Time Frame: Month 6
20-item assessment of the frequency of depressive symptoms during the prior week. Items are rated on a 4-point scale. The total score is the sum of responses and ranges from 0 to 60; higher total scores indicate greater frequency of depressive symptoms.
Month 6
Number of Participants with Uncontrolled Hypertension at Baseline
Time Frame: Baseline
Uncontrolled hypertension will be defined (using average blood pressure from 7 consecutive days of home blood pressure monitoring at each point) as mean SBP ≥130 mmHg or mean diastolic BP (DBP) ≥80 mmHg, as recommended in the 2017 American College of Cardiology/American Heart Association Guideline.
Baseline
Number of Participants with Uncontrolled Hypertension at Month 3
Time Frame: Month 3
Uncontrolled hypertension will be defined (using average blood pressure from 7 consecutive days of home blood pressure monitoring at each point) as mean SBP ≥130 mmHg or mean diastolic BP (DBP) ≥80 mmHg, as recommended in the 2017 American College of Cardiology/American Heart Association Guideline.
Month 3
Number of Participants with Uncontrolled Hypertension at Month 6
Time Frame: Month 6
Uncontrolled hypertension will be defined (using average blood pressure from 7 consecutive days of home blood pressure monitoring at each point) as mean SBP ≥130 mmHg or mean diastolic BP (DBP) ≥80 mmHg, as recommended in the 2017 American College of Cardiology/American Heart Association Guideline.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tanya Spruill, PhD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-00717
  • R01MD016402 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified participant data from the final research dataset used in the published manuscript will be shared immediately following publication with no end date. The data will be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose; the data are permitted to be used to achieve aims in the approved protocol. A data use agreement will be established between the investigator and the University of Mississippi Medical Center. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose will be permitted to access the data; the data are permitted to be used to achieve aims in the approved protocol. A data use agreement will be established between the investigator and the University of Mississippi Medical Center.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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