Stress Management for High Blood Pressure

August 12, 2019 updated by: David M. Fresco, Kent State University
The purpose of this research study is to examine the efficacy of two stress management interventions in reducing blood pressure (BP) in patients who have prehypertension (BP between 120/80 and 139/89). It is expected that participants will be better able to control their BP through reducing stress and increasing healthy lifestyle behaviors.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • W.O. Walker Building
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Perelman School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unmedicated high blood pressure (SBP of 120-139 or DBP of 80-89)
  • BMI in the range of 19-40
  • Interest in attempting to control blood pressure through lifestyle modification

Exclusion Criteria:

  • pacemakers
  • uncontrolled hypertension (SBP≥140 or DBP≥90)
  • atrial fibrillation
  • myocardial infarction (MI)
  • percutaneous transluminal coronary angioplasty (PTCA)
  • coronary artery bypass graft (CABG) within 6 months of enrollment
  • congestive heart failure
  • uncorrected primary valvular disease hypertrophic or restrictive cardiomyopathy
  • uncorrected thyroid heart disease
  • chronic kidney disease
  • persistent tachyarrhythmia
  • JNC risk category C (target organ damage, diabetes)
  • patients who are pregnant or plan to become pregnant within 9 months
  • patients who are lactating
  • patients unable to comply with assessment procedures
  • patients with alcohol or drug abuse within 12 months
  • patients who consume more than 21 alcoholic drinks per week
  • patients who are current smokers
  • patients who are unable to provide informed consent or who have dementia
  • patients with previous extensive meditation or yoga training
  • patients with blood pressure ≥140/90

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Based Stress Reduction
The Mindfulness-Based Stress Reduction intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.
Behavioral: Mindfulness-Based Stress Reduction
Patients are randomized to an intervention
Other Names:
  • MBSR
Other: American Heart Association Recommended Self-Care
All Patients receive AHA Recommended Self-Care
Active Comparator: Stress Management Education
The Stress Management Education intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.
Other: American Heart Association Recommended Self-Care
All Patients receive AHA Recommended Self-Care
Behavioral: Stress Management Education
Patients are randomized to an intervention
Other Names:
  • SME
Other: AHA Recommended Self-Care
All participants will receive the American Heart Association - Understanding and Controlling Your High Blood Pressure Brochure and information on the Dietary Approach to Stop Hypertension from the National Institutes of Health. These brochures describe ways that individuals can improve their lifestyle through better diet and exercise. Participants will get a chance to try and make healthy lifestyle changes on their own, using this information.
Other: American Heart Association Recommended Self-Care
All Patients receive AHA Recommended Self-Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Clinic Blood Pressure
Time Frame: Week 0, Week 4, Week 8, Week 34, and Week 60
All clinic blood pressure assessments will be completed in a quiet, climate controlled room according to American Heart Association guidelines. The mean of the three seated readings on the non- dominant arm will be averaged to define clinic blood pressure.
Week 0, Week 4, Week 8, Week 34, and Week 60
Change in Diastolic Clinic Blood Pressure
Time Frame: Week 0, Week 4, Week 8, Week 34, and Week 60
All clinic blood pressure assessments will be completed in a quiet, climate controlled room according to American Heart Association guidelines. The mean of the three seated readings on the non- dominant arm will be averaged to define clinic blood pressure.
Week 0, Week 4, Week 8, Week 34, and Week 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 24-hour Ambulatory Systolic Blood Pressure
Time Frame: Week 0, Week 8, Week 60
Participants will complete 24-hour Ambulatory Blood Pressure Monitoring with the Oscar 2 oscillometric blood pressure monitor. The Oscar will be programmed to take three blood pressure measurements per hour from 6 AM till 11 PM and two BP measurements per hour from 11 PM to 6 AM. During each reading, participants will be instructed to drop their arms to their sides as soon as they sense the cuff inflating, and to keep it relaxed and still until a few seconds after the deflation has finished. Ambulatory SBP and DBP will be derived by computing the mean of all valid readings obtained during waking hours and nighttime sleep.
Week 0, Week 8, Week 60
Change in 24-hour Ambulatory Diastolic Blood Pressure
Time Frame: Week 0, Week 8, Week 60
Participants will complete 24-hour Ambulatory Blood Pressure Monitoring with the Oscar 2 oscillometric blood pressure monitor. The Oscar will be programmed to take three blood pressure measurements per hour from 6 AM till 11 PM and two BP measurements per hour from 11 PM to 6 AM. During each reading, participants will be instructed to drop their arms to their sides as soon as they sense the cuff inflating, and to keep it relaxed and still until a few seconds after the deflation has finished. Ambulatory SBP and DBP will be derived by computing the mean of all valid readings obtained during waking hours and nighttime sleep.
Week 0, Week 8, Week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kent State University

Collaborators

University of Pennsylvania
Case Western Reserve University

Investigators

  • Principal Investigator: David M Fresco, Ph.D., Kent State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

May 31, 2019

Study Completion (Anticipated)

May 31, 2020

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KentSU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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