MIND-BP vs BOOST for High Blood Pressure

Overseen By Tanya Spruill, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Cognitive impairment, Severe depression, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

300 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment BOOST, MIND-BP for high blood pressure?

The research suggests that using a combination of treatments, like in the study with telmisartan and amlodipine, can help quickly and effectively lower blood pressure, which might indicate that BOOST and MIND-BP could also be effective when used together. ^{1 2 3 4 5}

How does the MIND-BP treatment for high blood pressure differ from other treatments?

MIND-BP is unique because it combines psychotherapy with biofeedback alongside traditional blood pressure medications, which can enhance the effectiveness of the medication, improve mental well-being, and encourage a more active role in the treatment process, leading to a better quality of life. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Tanya Spruill, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for Black women with high blood pressure who are part of the Jackson Heart Study. It's designed to help those struggling to control their blood pressure, possibly due to life stress. Participants will need access to Zoom for online group sessions.

Inclusion Criteria

Willing to be audio-recorded during group sessions

I am a female participant in the Jackson Heart Study.

I am willing to follow all study requirements.

Exclusion Criteria

Current participation in another trial

Pregnant or planning to become pregnant in the next 6 months

My arm circumference is between 22 cm and 45 cm.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the MIND-BP or BOOST program, both delivered virtually, to assess changes in blood pressure, stress, and depressive symptoms

6 months

Follow-up

Participants are monitored for changes in systolic blood pressure, perceived stress, and depressive symptoms

6 months

Treatment Details

Interventions

• BOOST
• MIND-BP

Trial Overview The study compares two Zoom-based programs: MIND-BP, a mindfulness training group aimed at lowering blood pressure by managing emotions and stress; and BOOST, a support group. The goal is to see if MIND-BP can better reduce blood pressure, stress, and depression over six months.

Participant Groups

Group I: MIND-BP Experimental Treatment 1 Intervention

Participants who are randomly assigned to receive the MIND-BP program, a virtually delivered mindfulness training group.

Group II: BOOST Experimental Treatment 1 Intervention

Participants who are randomly assigned to receive the BOOST program, a virtually delivered mindfulness training group.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

References

1. India pubmed.ncbi.nlm.nih.gov

Early combination therapy with telmisartan plus amlodipine for rapid achievement of blood pressure goals. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Improvement in Hypertension Control Among Adults Seen in Federally Qualified Health Center Clinics in the Stroke Belt: Implementing a Program with a Dashboard and Process Metrics. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Blood pressure targets in subjects with type 2 diabetes mellitus/impaired fasting glucose: observations from traditional and bayesian random-effects meta-analyses of randomized trials. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility and impact of multidisciplinary training of an evidence-based intervention within a pediatric psychiatry consultation service. [2014]

5. Netherlands pubmed.ncbi.nlm.nih.gov

PERson-centredness in Hypertension management using Information Technology: a randomized controlled trial in primary care. [2023]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The efficacy of psychotherapy with biofeedback in the rehabilitation of hypertension patients]. [2009]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The treatment with antihypertensive and nootropic preparations of hypertension patients working under neuroemotional stress]. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Circulatory and plasma catecholamine responses to mental stress in young subjects with two different types of hypertension. [2017]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Cognitive functions and emotional state of post stroke patients on antihypertensive therapy]. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Cardiovascular reactivity in patients with essential or renal hypertension under standardized mental stress. [2021]