Jackson Heart Study Women's Hypertension Study
Telephone-based Mindfulness Training to Reduce Blood Pressure in Black Women With Hypertension in the Jackson Heart Study
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Nov 2024
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2024
CompletedFirst Posted
Study publicly available on registry
July 22, 2024
CompletedStudy Start
First participant enrolled
November 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
February 25, 2026
February 1, 2026
2.5 years
July 16, 2024
February 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Systolic Blood Pressure
Change in average systolic blood pressure (SBP) from 7 consecutive days of home blood pressure monitoring.
Baseline, Month 6
Secondary Outcomes (9)
Perceived Stress Scale (PSS-10) Score at Baseline
Baseline
Perceived Stress Scale (PSS-10) Score at Month 3
Month 3
Perceived Stress Scale (PSS-10) Score at Month 6
Month 6
Center for Epidemiological Studies Depression (CES-D) Score at Baseline
Baseline
Center for Epidemiological Studies Depression (CES-D) Score at Month 3
Month 3
- +4 more secondary outcomes
Study Arms (2)
MIND-BP
EXPERIMENTALParticipants who are randomly assigned to receive the MIND-BP program, a virtually delivered mindfulness training group.
BOOST
EXPERIMENTALParticipants who are randomly assigned to receive the BOOST program, a virtually delivered mindfulness training group.
Interventions
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 for the mindfulness and cognitive skills to be taught are explained. Weekly sessions focus on learning and practicing skills.
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) personal experience of hypertension; (2) personal experience of stress; (3) personal experience of mood-related challenges; (4) personal experience of social relationships; (5) concerns related to hypertension treatment; (6) concerns about other health problems; (7) personal experience related to healthcare; and (8) review of the BOOST experience.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tanya Spruill, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2024
First Posted
July 22, 2024
Study Start
November 18, 2024
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
May 30, 2027
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Immediately following publication. No end date.
- Access Criteria
- Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose will be permitted to access the data; the data are permitted to be used to achieve aims in the approved protocol. A data use agreement will be established between the investigator and the University of Mississippi Medical Center.
The de-identified participant data from the final research dataset used in the published manuscript will be shared immediately following publication with no end date. The data will be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose; the data are permitted to be used to achieve aims in the approved protocol. A data use agreement will be established between the investigator and the University of Mississippi Medical Center. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.