N/A
N=56
Mindfulness Based Stress Reduction for High Blood Pressure
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00440596 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: SBP — 130.2; 128.8 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness based stress reduction (Behavioral); Progressive Muscle Relaxation (Behavioral)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- Kent State University
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SBP |
130.2; 128.8 | — |
| PRIMARY DBP |
77.3; 78.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- prehypertension
- 30-60 years of age
Exclusion Criteria
- normal BP
- hypertension
- pregnancy
- smoking
- use of antihypertensive medication
Data sourced from ClinicalTrials.gov (NCT00440596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.