Clinical trial NCT02371317: Stress Management for High Blood Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prehypertension
Keywords: Randomized clinical trial
Early medical intervention
Intervention studies
Blood pressure
Stress Management
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Case Western Reserve University
First posted: 2015-02-25
Enrollment: 141
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Systolic Clinic Blood Pressure
timeFrame: Week 0, Week 4, Week 8, Week 34, and Week 60
measure: Change in Diastolic Clinic Blood Pressure
timeFrame: Week 0, Week 4, Week 8, Week 34, and Week 60
Secondary outcomes:
measure: Change in 24-hour Ambulatory Systolic Blood Pressure
timeFrame: Week 0, Week 8, Week 60
measure: Change in 24-hour Ambulatory Diastolic Blood Pressure
timeFrame: Week 0, Week 8, Week 60
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: W.O. Walker Building
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman School of Medicine
state: Pennsylvania
Study officials:
affiliation: Kent State University
name: David M Fresco, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.