Mindfulness Based Stress Reduction for High Blood Pressure
Primary Purpose
Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness based stress reduction
Progressive Muscle Relaxation
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- prehypertension
- 30-60 years of age
Exclusion Criteria:
- normal BP
- hypertension
- pregnancy
- smoking
- use of antihypertensive medication
Sites / Locations
- Summa Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness based stress reduction
Progressive Muscle Relaxation
Arm Description
Mindfulness based stress reduction
Progressive Muscle Relaxation
Outcomes
Primary Outcome Measures
SBP
DBP
Clinic BP
Secondary Outcome Measures
Full Information
NCT ID
NCT00440596
First Posted
February 26, 2007
Last Updated
November 5, 2020
Sponsor
Kent State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00440596
Brief Title
Mindfulness Based Stress Reduction for High Blood Pressure
Official Title
Mindfulness Based Stress Reduction for High Blood Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kent State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness based stress reduction
Arm Type
Experimental
Arm Description
Mindfulness based stress reduction
Arm Title
Progressive Muscle Relaxation
Arm Type
Active Comparator
Arm Description
Progressive Muscle Relaxation
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based stress reduction
Intervention Description
8 weeks group MBSR
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation
Intervention Description
8 weeks PMR in group format
Primary Outcome Measure Information:
Title
SBP
Time Frame
12 weeks
Title
DBP
Description
Clinic BP
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
prehypertension
30-60 years of age
Exclusion Criteria:
normal BP
hypertension
pregnancy
smoking
use of antihypertensive medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel W Hughes, Ph.D.
Organizational Affiliation
Kent State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24127622
Citation
Hughes JW, Fresco DM, Myerscough R, van Dulmen MH, Carlson LE, Josephson R. Randomized controlled trial of mindfulness-based stress reduction for prehypertension. Psychosom Med. 2013 Oct;75(8):721-8. doi: 10.1097/PSY.0b013e3182a3e4e5.
Results Reference
derived
Learn more about this trial
Mindfulness Based Stress Reduction for High Blood Pressure
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