Jackson Heart Study Women's Hypertension Study

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Change in Systolic Blood Pressure [Срок оценки: Baseline, Month 6]

Вторичные конечные точки (9)

• Perceived Stress Scale (PSS-10) Score at Baseline [Срок оценки: Baseline]
• Perceived Stress Scale (PSS-10) Score at Month 3 [Срок оценки: Month 3]
• Perceived Stress Scale (PSS-10) Score at Month 6 [Срок оценки: Month 6]
• Center for Epidemiological Studies Depression (CES-D) Score at Baseline [Срок оценки: Baseline]
• Center for Epidemiological Studies Depression (CES-D) Score at Month 3 [Срок оценки: Month 3]
• Center for Epidemiological Studies Depression (CES-D) Score at Month 6 [Срок оценки: Month 6]
• Number of Participants with Uncontrolled Hypertension at Baseline [Срок оценки: Baseline]
• Number of Participants with Uncontrolled Hypertension at Month 3 [Срок оценки: Month 3]
• Number of Participants with Uncontrolled Hypertension at Month 6 [Срок оценки: Month 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Mississippi Medical Center — Jackson

Идентификаторы

NCT: NCT06511479 · 23-00717 · R01MD016402

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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