Healia Clinical Trials Information Database

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

Inclusion Criteria:

  • prehypertension

  • 30-60 years of age

Exclusion Criteria:

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.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


Advertisements

About | Privacy Policy | Business Solutions | Advertise | Contact | Add Healia to your site

©2012. Healia / Meredith Corporation  

Use of this site constitutes acceptance of our Terms of Service and Privacy Policy. All content on this Web site, including medical opinion and any other health-related information, is for informational purposes only and should not be used for a specific diagnosis or individual treatment plan for any situation. Use of this site and the information contained herein does not create a doctor-patient relationship. Always seek the direct advice of your doctor in connection with any questions or issues you may have regarding your own health or the health of others.