Jackson Heart Study Women's Hypertension Study
- Conditions
- Hypertension
- Interventions
- Behavioral: MIND-BPBehavioral: BOOST
- Registration Number
- NCT06511479
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MIND-BP MIND-BP Participants who are randomly assigned to receive the MIND-BP program, a virtually delivered mindfulness training group. BOOST BOOST Participants who are randomly assigned to receive the BOOST program, a virtually delivered mindfulness training group.
- Primary Outcome Measures
Name Time Method Change in Systolic Blood Pressure Baseline, Month 6 Change in average systolic blood pressure (SBP) from 7 consecutive days of home blood pressure monitoring.
- Secondary Outcome Measures
Name Time Method Perceived Stress Scale (PSS-10) Score at Month 3 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.
Center for Epidemiological Studies Depression (CES-D) Score at Month 3 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.
Number of Participants with Uncontrolled Hypertension at Month 6 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.
Center for Epidemiological Studies Depression (CES-D) Score at Baseline 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.
Center for Epidemiological Studies Depression (CES-D) Score at Month 6 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.
Number of Participants with Uncontrolled Hypertension at Baseline 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.
Number of Participants with Uncontrolled Hypertension at Month 3 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.
Perceived Stress Scale (PSS-10) Score at Baseline 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.
Perceived Stress Scale (PSS-10) Score at Month 6 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.
Trial Locations
- Locations (1)
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States