Clinical trial NCT06511479: Jackson Heart Study Women's Hypertension Study
Official title: Telephone-based Mindfulness Training to Reduce Blood Pressure in Black Women With Hypertension in the Jackson Heart Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-07-22
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Perceived Stress Scale (PSS-10) Score at Baseline
timeFrame: Baseline
measure: Perceived Stress Scale (PSS-10) Score at Month 3
timeFrame: Month 3
measure: Perceived Stress Scale (PSS-10) Score at Month 6
timeFrame: Month 6
measure: Center for Epidemiological Studies Depression (CES-D) Score at Baseline
timeFrame: Baseline
measure: Center for Epidemiological Studies Depression (CES-D) Score at Month 3
timeFrame: Month 3
measure: Center for Epidemiological Studies Depression (CES-D) Score at Month 6
timeFrame: Month 6
measure: Number of Participants with Uncontrolled Hypertension at Baseline
timeFrame: Baseline
measure: Number of Participants with Uncontrolled Hypertension at Month 3
timeFrame: Month 3
measure: Number of Participants with Uncontrolled Hypertension at Month 6
timeFrame: Month 6
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: NYU Langone Health
name: Tanya Spruill, PhD
role: PRINCIPAL_INVESTIGATOR
References: