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Trial record 2 of 18 for:    Recruiting, Not yet recruiting, Available Studies | "Prehypertension"

Stress Management for High Blood Pressure

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ClinicalTrials.gov Identifier: NCT02371317
Recruitment Status : Recruiting
First Posted : February 25, 2015
Last Update Posted : February 21, 2018
Sponsor:
Collaborators:
University of Pennsylvania
Case Western Reserve University
Information provided by (Responsible Party):
David M. Fresco, Kent State University

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.

Condition or disease Intervention/treatment Phase
Prehypertension Behavioral: Mindfulness-Based Stress Reduction Behavioral: Stress Management Education Other: American Heart Association Recommended Self-Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : May 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

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 Name: 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.
Behavioral: Stress Management Education
Patients are randomized to an intervention
Other Name: SME

Other: American Heart Association Recommended Self-Care
All Patients receive AHA Recommended Self-Care

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371317


Contacts
Contact: Rosa Heryak, BA 216-983-1050 serenitystudy@kent.edu

Locations
United States, Ohio
W.O. Walker Building Recruiting
Cleveland, Ohio, United States, 44106
Contact: Rosa Heryak    216-983-1050    serenitystudy@kent.edu   
Principal Investigator: David M Fresco, Ph.D.         
United States, Pennsylvania
University of Pennsylvania Perelman School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Vanessa Anyanso    215-573-0763    anyansov@pennmedicine.upenn.edu   
Principal Investigator: Jeffrey M Greeson, Ph.D.         
Sponsors and Collaborators
Kent State University
University of Pennsylvania
Case Western Reserve University
Investigators
Principal Investigator: David M Fresco, Ph.D. Kent State University

Publications:
Responsible Party: David M. Fresco, Professor, Kent State University
ClinicalTrials.gov Identifier: NCT02371317     History of Changes
Other Study ID Numbers: KentSU
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Keywords provided by David M. Fresco, Kent State University:
Randomized clinical trial
Early medical intervention
Intervention studies
Blood pressure
Stress Management

Additional relevant MeSH terms:
Prehypertension
Vascular Diseases
Cardiovascular Diseases