Recruiting

Hypertension Study

Sponsor:

NYU Langone Health

Code:

NCT06511479

Conditions

Hypertension

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MIND-BP

BOOST

Study Details

Brief summary:

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.

Conditions

Hypertension

Study ID

NCT06511479

Start date

Nov 18, 2024

Status verified date

Feb, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: MIND-BP

Participants who are randomly assigned to receive the MIND-BP program, a virtually delivered mindfulness training group.

experimental: BOOST

Participants who are randomly assigned to receive the BOOST program, a virtually delivered mindfulness training group.

Interventions

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.

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.

Primary outcome measure

  • Change in Systolic Blood Pressure [ Time Frame: Baseline, Month 6 ]

Central Contacts and Locations

Central contacts

Tanya Spruill, PhD

646-923-0626Tanya.spruill@nyulangone.org

Locations

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Principal Investigator:

April P. Carson, PhD

More Information

Sponsor

NYU Langone Health

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-02-25.