Mindfulness Based Stress Reduction for High Blood Pressure
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.
Description
See brief summary
Status: Recruiting (N/A). Started on September 1st, 2006.
Enrollment: 84 subjects
Study Type: Interventional
Study Design:
- Treatment
- Randomized
- Single Blind (Outcomes Assessor)
- Active Control
- Factorial Assignment
- Safety/Efficacy Study
Conditions:
Interventions:
- Behavioral: Mindfulness based stress reduction
- Behavioral: Progressive Muscle Relaxation
Eligibility
- Gender
Both
- Mininum Age
30 Years
- Maximum Age
60 Years
- Healthy Volunteers
Accepts Healthy Volunteers
Resources
Source: National Center for Complementary and Alternative Medicine (NCCAM)
Authority: United States: Federal Government
Locations
-
Summa Health System
Akron
Ohio
44304
United States
Officials
Joel W Hughes, Ph.D. (Principal Investigator, Kent State University)
Sponsors
National Center for Complementary and Alternative Medicine (NCCAM) (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- May 1st, 2009
- First Received
- May 18th, 2009
- Last Changed
- May 18th, 2009
Information obtained from ClinicalTrials.gov on May 19, 2009. Link to the current ClinicalTrials.gov record.
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