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NCT Number: NCT06511479

Jackson Heart Study Women's Hypertension 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location status: Recruiting

Location contact

April P. Carson, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIND-BP

Behavioral

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.

BOOST

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tanya Spruill, PhD

CONTACT

[email protected]

646-923-0626

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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