Stress Management for High Blood Pressure
1 other identifier
interventional
141
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2015
CompletedFirst Posted
Study publicly available on registry
February 25, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedAugust 13, 2019
August 1, 2019
4.1 years
January 21, 2015
August 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Week 0, Week 4, Week 8, Week 34, and Week 60
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.
Week 0, Week 4, Week 8, Week 34, and Week 60
Secondary Outcomes (2)
Change in 24-hour Ambulatory Systolic Blood Pressure
Week 0, Week 8, Week 60
Change in 24-hour Ambulatory Diastolic Blood Pressure
Week 0, Week 8, Week 60
Study Arms (3)
Mindfulness-Based Stress Reduction
EXPERIMENTALThe Mindfulness-Based Stress Reduction intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.
Stress Management Education
ACTIVE COMPARATORThe Stress Management Education intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.
AHA Recommended Self-Care
OTHERAll 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.
Interventions
Patients are randomized to an intervention
Patients are randomized to an intervention
All Patients receive AHA Recommended Self-Care
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kent State Universitylead
- University of Pennsylvaniacollaborator
- Case Western Reserve Universitycollaborator
Study Sites (2)
W.O. Walker Building
Cleveland, Ohio, 44106, United States
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Related Publications (2)
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.
PMID: 24127622BACKGROUNDChin 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.
PMID: 35694435DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David M Fresco, Ph.D.
Kent State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 21, 2015
First Posted
February 25, 2015
Study Start
May 1, 2015
Primary Completion
May 31, 2019
Study Completion
May 31, 2020
Last Updated
August 13, 2019
Record last verified: 2019-08