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Recruiting NCT06511479

Jackson Heart Study Women's Hypertension Study

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MIND-BP, BOOST.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 18 years — 99 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral 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
  • Behavioral 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) person

Primary outcome measures

  • Change in Systolic Blood Pressure [Time frame: Baseline, Month 6]
Secondary outcome measures (9)
  • Perceived Stress Scale (PSS-10) Score at Baseline [Time frame: Baseline]
  • Perceived Stress Scale (PSS-10) Score at Month 3 [Time frame: Month 3]
  • Perceived Stress Scale (PSS-10) Score at Month 6 [Time frame: Month 6]
  • Center for Epidemiological Studies Depression (CES-D) Score at Baseline [Time frame: Baseline]
  • Center for Epidemiological Studies Depression (CES-D) Score at Month 3 [Time frame: Month 3]
  • Center for Epidemiological Studies Depression (CES-D) Score at Month 6 [Time frame: Month 6]
  • Number of Participants with Uncontrolled Hypertension at Baseline [Time frame: Baseline]
  • Number of Participants with Uncontrolled Hypertension at Month 3 [Time frame: Month 3]
  • Number of Participants with Uncontrolled Hypertension at Month 6 [Time frame: Month 6]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Mississippi Medical Center — Jackson

Identifiers

NCT: NCT06511479 · 23-00717 · R01MD016402

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗