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Mindfulness Based Stress Reduction for High Blood Pressure

Mindfulness Based Stress Reduction for High Blood Pressure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00440596
Enrollment
56
Registered
2007-02-27
Start date
2006-09-30
Completion date
2009-07-31
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

Nearly 60 million adults in the United States have high blood pressure (BP) in the pre-hypertension (SBP 120-139 or DBP 80-89). Hypertension is estimated to account for 1 in 8 deaths in the world, and in the US the direct and indirect costs of high BP are estimated to reach $59.7 billion in 2005. JNC-7 guidelines recommend lifestyle modifications for prehypertension, followed by antihypertensive medication if BP progresses to Stage I hypertension. Mindfulness-based Stress Reduction (MBSR) is an increasingly popular practice that has been purported to alleviate stress and treat certain health conditions. Some stress management therapies and one meditation therapy (e.g., Transcendental Meditation) have shown promise in reducing elevated BP, but MBSR has not been evaluated as a treatment for high BP. When added to lifestyle modification advice, MBSR may be an appropriate complementary treatment for prehypertension. However, prior to a large randomized clinical trial of MBSR for prehypertension and/or hypertension, pilot data is necessary to provide preliminary evidence of a treatment effect and to evaluate feasibility. This feasibility randomized clinical trial of MBSR for unmedicated prehypertension will provide preliminary evidence to support a larger randomized clinical trial by evaluating the feasibility and safety of MBSR as a complementary treatment for high BP and by documenting any treatment effect. Sixty patients with unmedicated BP in the range of SBP 120-139 mm Hg or DBP 80-89 mm Hg will be randomly assigned to MBSR or a progressive muscle relaxation control condition. All patients will receive lifestyle modification advice. Patients will complete 8 weeks of MBSR delivered in a group format by an experienced psychologist trained in MBSR or 8 weeks of progressive muscle relaxation training matched for therapist contact and homework. Patients BP will be assessed prior to randomization and following treatment by researchers blind to treatment assignment. Accrual rates, acceptance of randomization, treatment adherence, treatment fidelity, and patient satisfaction with treatment will be evaluated.

Detailed description

See brief summary

Interventions

BEHAVIORALMindfulness based stress reduction

8 weeks group MBSR

BEHAVIORALProgressive Muscle Relaxation

8 weeks PMR in group format

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Kent State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* prehypertension * 30-60 years of age

Exclusion criteria

* normal BP * hypertension * pregnancy * smoking * use of antihypertensive medication

Design outcomes

Primary

MeasureTime frameDescription
SBP12 weeks
DBP12 weeksClinic BP

Countries

United States

Participant flow

Recruitment details

248 Assessed for eligibility 192 excluded

Pre-assignment details

181 did not meet inclusion criteria 11 did not consent to participate

Participants by arm

ArmCount
MBSR
Mindfulness based stress reduction
28
Progressive Muscle Relaxation
Progressive Muscle Relaxation 8 weeks group treatment
28
Total56

Baseline characteristics

CharacteristicProgressive Muscle RelaxationMBSRTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
28 Participants28 Participants56 Participants
Age, Continuous49.5 years
STANDARD_DEVIATION 7.2
51.2 years
STANDARD_DEVIATION 5.8
50.3 years
STANDARD_DEVIATION 7.2
Region of Enrollment
United States
28 participants28 participants56 participants
Sex: Female, Male
Female
15 Participants17 Participants32 Participants
Sex: Female, Male
Male
13 Participants11 Participants24 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 280 / 28
serious
Total, serious adverse events
0 / 280 / 28

Outcome results

Primary

DBP

Clinic BP

Time frame: 12 weeks

ArmMeasureValue (MEAN)Dispersion
MBSRDBP77.3 mm HgStandard Deviation 4.8
Progressive Muscle RelaxationDBP78.3 mm HgStandard Deviation 6.1
Primary

SBP

Time frame: 12 weeks

Population: 56 participatns intent to treat

ArmMeasureValue (MEAN)Dispersion
MBSRSBP130.2 mm HgStandard Deviation 6.3
Progressive Muscle RelaxationSBP128.8 mm HgStandard Deviation 6.3

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026