Mindfulness Based Stress Reduction for High Blood Pressure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by National Center for Complementary and Alternative Medicine (NCCAM).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00440596
First received: February 26, 2007
Last updated: May 18, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Mindfulness based stress reduction
Behavioral: Progressive Muscle Relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Based Stress Reduction for High Blood Pressure

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • SBP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • DBP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: September 2006
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MBSR
Mindfulness based stress reduction
Behavioral: Mindfulness based stress reduction
8 weeks group MBSR
Active Comparator: PMR
Progressive Muscle Relaxation
Behavioral: Progressive Muscle Relaxation
8 weeks PMR in group format

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • prehypertension
  • 30-60 years of age

Exclusion Criteria:

  • normal BP
  • hypertension
  • pregnancy
  • smoking
  • use of antihypertensive medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440596

Contacts
Contact: Joel W Hughes, Ph.D 330-672-7721 jhughes1@kent.edu
Contact: David Fresco, Ph.D. 330-672-4049 dfresco@kent.edu

Locations
United States, Ohio
Summa Health System Recruiting
Akron, Ohio, United States, 44304
Contact: Richard Josephson, MD    330-253-8195    josephsonr@akcardio.com   
Principal Investigator: Josephson Richard, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Joel W Hughes, Ph.D. Kent State University
  More Information

No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joel W. Hughes, PhD, Kent State University
ClinicalTrials.gov Identifier: NCT00440596     History of Changes
Other Study ID Numbers: R21 AT002698-01A2, 0760
Study First Received: February 26, 2007
Last Updated: May 18, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014