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Stress Management for High Blood Pressure

Primary Purpose

Prehypertension

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Stress Management Education
American Heart Association Recommended Self-Care
Sponsored by
Kent State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prehypertension focused on measuring Randomized clinical trial, Early medical intervention, Intervention studies, Blood pressure, Stress Management

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • W.O. Walker Building
  • University of Pennsylvania Perelman School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Mindfulness-Based Stress Reduction

Stress Management Education

AHA Recommended Self-Care

Arm Description

The Mindfulness-Based Stress Reduction intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.

The Stress Management Education intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.

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.

Outcomes

Primary Outcome Measures

Change in Systolic Clinic Blood Pressure
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.
Change in Diastolic Clinic Blood Pressure
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.

Secondary Outcome Measures

Change in 24-hour Ambulatory Systolic Blood Pressure
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.
Change in 24-hour Ambulatory Diastolic Blood Pressure
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.

Full Information

First Posted
January 21, 2015
Last Updated
August 12, 2019
Sponsor
Kent State University
Collaborators
University of Pennsylvania, Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT02371317
Brief Title
Stress Management for High Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kent State University
Collaborators
University of Pennsylvania, Case Western Reserve University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension
Keywords
Randomized clinical trial, Early medical intervention, Intervention studies, Blood pressure, Stress Management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Experimental
Arm Description
The Mindfulness-Based Stress Reduction intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.
Arm Title
Stress Management Education
Arm Type
Active Comparator
Arm Description
The Stress Management Education intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.
Arm Title
AHA Recommended Self-Care
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Other Intervention Name(s)
MBSR
Intervention Description
Patients are randomized to an intervention
Intervention Type
Behavioral
Intervention Name(s)
Stress Management Education
Other Intervention Name(s)
SME
Intervention Description
Patients are randomized to an intervention
Intervention Type
Other
Intervention Name(s)
American Heart Association Recommended Self-Care
Intervention Description
All Patients receive AHA Recommended Self-Care
Primary Outcome Measure Information:
Title
Change in Systolic Clinic Blood Pressure
Description
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.
Time Frame
Week 0, Week 4, Week 8, Week 34, and Week 60
Title
Change in Diastolic Clinic Blood Pressure
Description
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.
Time Frame
Week 0, Week 4, Week 8, Week 34, and Week 60
Secondary Outcome Measure Information:
Title
Change in 24-hour Ambulatory Systolic Blood Pressure
Description
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.
Time Frame
Week 0, Week 8, Week 60
Title
Change in 24-hour Ambulatory Diastolic Blood Pressure
Description
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.
Time Frame
Week 0, Week 8, Week 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Fresco, Ph.D.
Organizational Affiliation
Kent State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
W.O. Walker Building
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Pennsylvania Perelman School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
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
background
PubMed Identifier
35694435
Citation
Chin GR, Greeson JM, Hughes JW, Fresco DM. Does Dispositional Mindfulness Predict Cardiovascular Reactivity to Emotional Stress in Prehypertension? Latent Growth Curve Analyses from the Serenity Study. Mindfulness (N Y). 2021 Nov;12(11):2624-2634. doi: 10.1007/s12671-021-01745-y. Epub 2021 Sep 18.
Results Reference
derived

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Stress Management for High Blood Pressure

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