What is the clinical evidence from this study?

Study design: Other. Population: Hypertension or prehypertension (n=48). Intervention: Mindfulness-Based Blood Pressure Reduction (MB-BP). Primary outcome: Change in clinic-assessed systolic blood pressure (SBP) at 1 year (MD -6.1 mmHg, p=0.008).

November 27, 2019Open Access

Mindfulness-Based Blood Pressure Reduction (MB-BP): Stage 1 single-arm clinical trial

Key Result

The Mindfulness-Based Blood Pressure Reduction (MB-BP) program reduced mean systolic blood pressure by 6.1 mmHg at one year follow-up in participants with elevated blood pressure.

Structured PICO

Does the Mindfulness-Based Blood Pressure Reduction (MB-BP) program improve self-regulation and reduce systolic blood pressure in adults with prehypertension or hypertension?

Population

48 adults with prehypertension or hypertension (mean age 60, 61% female) were enrolled in a single-arm trial of a mindfulness-based blood pressure reduction program and followed for one year.

Intervention

Mindfulness-Based Blood Pressure Reduction (MB-BP) program: orientation session, eight 2.5-hour weekly group sessions, and a 7.5-hour one-day session. Includes homework practicing mindfulness skills for ≥45 min/day, 6 days/week. Directed towards modifiable determinants of blood pressure (diet, physical activity, medication adherence, alcohol consumption, stress).

Outcome

Acceptability, feasibility, and self-regulation outcomes (attention control via Sustained Attention to Response Task, emotion regulation via Difficulties in Emotion Regulation Score, and self-awareness via Multidimensional Assessment of Interoceptive Awareness) at one-year follow-up.surrogate

A customized Mindfulness-Based Blood Pressure Reduction program is feasible, acceptable, and associated with significant reductions in systolic blood pressure at one year, particularly among patients with uncontrolled Stage 2 hypertension.

Main Result

Mean Difference: -6.1

p-value: p=0.008

Limitations

Single-arm design without a control group
Small sample size
Predominantly white and highly educated sample limits generalizability
Self-selection bias in participant recruitment

Abstract

BACKGROUND AND OBJECTIVES: Impacts of mindfulness-based programs on blood pressure remain equivocal, possibly because the programs are not adapted to engage with determinants of hypertension, or due to floor effects. Primary objectives were to create a customized Mindfulness-Based Blood Pressure Reduction (MB-BP) program, and to evaluate acceptability, feasibility, and effects on hypothesized proximal self-regulation mechanisms. Secondary outcomes included modifiable determinants of blood pressure (BP), and clinic-assessed systolic blood pressure (SBP). METHODS: This was a Stage 1 single-arm trial with one year follow-up. Focus groups and in-depth interviews were performed to evaluate acceptability and feasibility. Self-regulation outcomes, and determinants of BP, were assessed using validated questionnaires or objective assessments. The MB-BP curriculum was adapted from Mindfulness-Based Stress Reduction to direct participants' mindfulness skills towards modifiable determinants of blood pressure. RESULTS: Acceptability and feasibility findings showed that of 53 eligible participants, 48 enrolled (91%). Of these, 43 (90%) attended at least 7 of the 10 MB-BP classes; 43 were followed to one year (90%). Focus groups (n = 19) and semi-structured interviews (n = 10) showed all participants viewed the delivery modality favorably, and identified logistic considerations concerning program access as barriers. A priori selected primary self-regulation outcomes showed improvements at one-year follow-up vs. baseline, including attention control (Sustained Attention to Response Task correct no-go score, p<0.001), emotion regulation (Difficulties in Emotion Regulation Score, p = 0.02), and self-awareness (Multidimensional Assessment of Interoceptive Awareness, p<0.001). Several determinants of hypertension were improved in participants not adhering to American Heart Association guidelines at baseline, including physical activity (p = 0.02), Dietary Approaches to Stop Hypertension-consistent diet (p<0.001), and alcohol consumption (p<0.001). Findings demonstrated mean 6.1 mmHg reduction in SBP (p = 0.008) at one year follow-up; effects were most pronounced in Stage 2 uncontrolled hypertensives (SBP≥140 mmHg), showing 15.1 mmHg reduction (p<0.001). CONCLUSION: MB-BP has good acceptability and feasibility, and may engage with self-regulation and behavioral determinants of hypertension.

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