Sustainability of Blood Pressure Reduction Through Adapted Mindfulness Training: The MB-BP Study

A 2023 World Health Organization report revealed that elevated blood pressure (BP) may be the primary modifiable driver of mortality worldwide, accountable for one in five deaths.¹ In the United States, 46% of adults have hypertension, and of them, fewer than 25% have their hypertension controlled.^2,3 After decades of improvement, hypertension control in the United States declined in recent years despite availability of effective lifestyle and medication treatments.^2,3 Consequently, we need to either enhance adherence to evidence-based approaches, or consider innovative programs. The Mindfulness-Based Blood Pressure Reduction (MB-BP) program offers the potential of both. MB-BP is an adapted mindfulness training that teaches participants mindfulness skills such as self-awareness, attention control and emotion regulation, and then directs those skills towards participants’ relationships with major factors that influence BP, such as diet, physical activity, alcohol consumption and antihypertensive medication adherence.^4–6 MB-BP demonstrated clinically-relevant reductions in systolic blood pressure (SBP), with associations found in a single-group trial replicated in a statistically-powered randomized controlled trial (RCT).^4,6 However, the longest reported follow-up to date is one year. The aim was to assess associations of the MB-BP program participation with clinic-assessed SBP at two years follow-up, which is available in the single-arm stage one⁷ clinical trial.

Methods

Detailed methods are described elsewhere.⁴ Briefly, the sample included adults primarily recruited from Rhode Island and Massachusetts, who: (1) had elevated clinic BP (SBP≥120 mmHg or diastolic BP (DBP) ≥80 mmHg) regardless of whether they were prescribed antihypertensive medications; and (2) communicated in English. The study protocol was approved by the institutional review board at Brown University (protocol #1412001171). Participants provided informed consent.

All participants were scheduled to receive MB-BP, consisting of eight weekly 2.5 h mindfulness sessions adapted for elevated BP, plus a 7.5-hour retreat.^4,6 Key adaptions include: personalized feedback and education about hypertension risk factors; mindfulness training of participants in relationship to hypertension risk factors; and behavior change support.^4,6

Unattended clinic BP was assessed at baseline, 3, 6, 12 and 24 months using a calibrated Omron HEM-705CPN automated BP monitor (Lake Forest, IL) with established validity.^8,9 At each assessment, three BP readings were obtained, and the mean of the second and third readings was used for analyses.¹⁰

Statistical analyses were performed on all participants regardless of the extent of MB-BP intervention completion. Analyses utilized mixed-effects regression models with random intercepts. Models estimated the change in BP from baseline through two-year follow-up (including three, six, and 12-month follow-up), accounting for correlation between data collection points. A priori analysis subgroups, detailed elsewhere,⁴ included: (1) baseline SBP ≥140 mmHg vs. 120–139 mmHg and (2) tertile of formal home mindfulness practice duration throughout the 8-week MB-BP program. Multiple imputation with fully conditional specification was used to account for missing data in primary analyses. All analyses were conducted using SAS 9.4 (Cary, NC).

Results

Participants were 61% female, predominantly Non-Hispanic White race/ethnicity (96%), well-educated (92% with college degree), with mean age of 60 (range 26–83) years, and mean baseline SBP of 139.4 mmHg. Antihypertensive medication was used by 60.4% of participants. Detailed demographics are elsewhere.⁴ Of the 48 participants enrolled, 34 (71%) completed two-year assessments. Multiple imputation and complete case analyses showed similar findings (Table 1). There was a 5.3 mmHg reduction in SBP from baseline to two-year follow-up (p=0.03; Figure 1A, Table 1). Using a priori selected subgroups, sizable effects were seen in participants with SBP≥140 mmHg (14.7 mmHg drop from baseline to two-year follow-up; n=23; p<0.0001), while effects were not present in participants with SBP<140 mmHg (1.6 mmHg increase from baseline; n=25; p=0.65). Participants in the highest tertile of mindfulness practice (median=18.0 h per week, interquartile range: 13.5–27.0 h) showed a 9.7 mmHg (n=14; p=0.01) reduction from baseline to two years, while those in the lowest tertile (median=0.0 h per week; interquartile range=0.0–2.3 h) demonstrated a 4.0 mmHg (n=15; p=0.51) reduction (Figure 1B). Secondary analyses on DBP showed changes from 80.4 mmHg at baseline to 79.0 mmHg at two-years follow-up (p=0.39) (Table 1). Among participants with SBP≥140mmHg, DBP lowered by 5.1 mmHg at two years (p=0.04; Table 1).

Table 1.

Associations of MB-BP program with systolic and diastolic blood pressure at 3, 6, 12, and 24 months follow-up. Findings show complete case and multiple imputation analyses.

	Baseline		3 Months			6 Months			12 Months			24 Months
	BP	95% CI	BP	95% CI	P	BP	95% CI	P	BP	95% CI	P	BP	95% CI	P
Systolic Blood Pressure
Complete Case Analyses
120<SBP<140 mmHg	129.7	127.2, 132.2	131.4	125.7, 137.0	0.50	132.7	126.0, 139.3	0.40	130.7	125.9, 135.5	0.69	131.2	123.4, 138.9	0.63
SBP≥140 mmHg	151.2	145.9, 156.4	131.2	122.7, 139.7	<.0001	138.7	130.6, 146.8	0.003	136.5	129.8, 143.1	0.0002	134.0	125.8, 142.3	0.0002
All Participants	139.4	135.4, 143.4	131.3	126.6, 136.0	0.002	135.3	130.3, 140.3	0.12	133.2	129.3, 137.1	0.008	132.4	126.9, 137.8	0.04
Multiple Imputation Analyses
120<SBP<140 mmHg	129.7	127.2, 132.2	131.5	126.0, 136.9	0.49	133.1	126.7, 139.5	0.29	130.9	126.3, 135.4	0.65	131.3	124.6, 138.0	0.65
SBP≥140 mmHg	151.2	145.9, 156.4	131.3	123.6, 139.0	<.0001	137.8	130.4, 145.1	0.0004	136.0	130.1, 141.9	<.0001	136.5	129.3, 143.6	<.0001
All Participants	139.4	135.4, 143.4	131.4	126.7, 136.1	0.001	135.5	130.4, 140.5	0.09	133.0	129.1, 136.8	0.005	134.1	129.2, 139.0	0.03
Diastolic Blood Pressure
Complete Case Analyses
120<SBP<140 mmHg	77.9	74.8, 81.0	79.2	76.1, 82.3	0.46	79.4	76.0, 82.8	0.6	79.2	75.3, 83.1	0.52	79.9	74.7, 85.1	0.61
SBP≥140 mmHg	83.1	79.1, 87.0	76.9	71.5, 82.3	0.008	77.7	74.6, 80.9	0.02	79.6	74.3, 84.9	0.21	77.9	72.9, 82.8	0.049
All Participants	80.4	77.9, 82.9	78.2	75.3, 81.0	0.10	78.7	76.4, 80.9	0.22	79.4	76.3, 82.4	0.54	79.1	75.5, 82.6	0.55
Multiple Imputation Analyses
120<SBP<140 mmHg	77.9	74.8, 81.0	79.1	76.1, 82.1	0.47	79.1	75.9, 82.2	0.53	79.1	75.4, 82.8	0.48	79.7	75.3, 84.1	0.43
SBP≥140 mmHg	83.1	79.1, 87.0	76.8	72.0, 81.6	0.007	77.8	74.9, 80.8	0.01	79.4	74.6, 84.1	0.14	78.1	73.7, 82.5	0.04
All Participants	80.4	77.9, 82.9	78.2	75.5, 81.0	0.10	78.3	76.1, 80.5	0.17	79.5	76.5, 82.5	0.45	79.0	75.8, 82.3	0.39

Figure 1.

Changes in SBP from baseline through two-years follow-up after MB-BP program: (A) for all participants, and stratified by baseline SBP; (B) stratified by tertile of mindfulness practice duration. P-values represent comparison of SBP at two-years versus baseline, utilizing multiple imputation. Error bars represent standard error of the mean. N=48.

Discussion

Findings showed that MB-BP was associated with a reduction in SBP that persisted after two years. Effect sizes were larger in participants with higher SBP (SBP>140 mmHg) at baseline or greater home mindfulness practice duration.

Strengths of the study included considerably longer-term follow-up of two years, double that of any prior clinical trial evaluating the effect of mindfulness training on BP.^4,6 Additionally, the MB-BP program, while rooted in the evidence-based Mindfulness-Based Stress Reduction (MBSR), was modified to apply its tools to the management of risk factors for hypertension.

Limitations encompass being a single-arm trial, which leads to uncertainty if results were influenced by factors such as regression to the mean or the Hawthorne effect. To address these limitations, we performed an RCT in 201 participants, which demonstrated that MB-BP significantly outperformed the control group at 6 months follow-up, supporting the hypothesis of a causal relationship between the MB-BP intervention and improved SBP.^5,6 Furthermore, the 29% loss to follow-up by two years led to missing data. We lessened the potential biases using multiple imputation, which showed similar findings to complete case analyses. The high percentage of well-educated Non-Hispanic White participants reduced generalizability. Future studies should study whether this program can foster health promotion in more diverse and underserved populations.⁶ Finally, the field would be served by independent research groups attempting to replicate or extend the MB-BP findings. In conclusion, this study provided initial evidence of durable effects for the MB-BP program reducing BP.