Jackson Heart Study Women's Hypertension Study

NYU Langone Health

Status: Enrolling

Conditions: Hypertension

Treatments: Behavioral: MIND-BP; Behavioral: BOOST

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06511479

23-00717

R01MD016402 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

MIND-BP

Experimental group

Description:

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

Treatment:

Behavioral: MIND-BP

BOOST

Experimental group

Description:

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

Treatment:

Behavioral: BOOST