Stress Management for High Blood Pressure

Prehypertension Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02371317
• Other study ID #: KentSU
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2015
• Est. completion date: May 31, 2020

Study information

• Verified date: August 2019
• Source: Kent State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 141
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Prehypertension

Intervention

Behavioral:
• Mindfulness-Based Stress Reduction
Patients are randomized to an intervention
• Stress Management Education
Patients are randomized to an intervention

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

Locations

Country	Name	City	State
United States	W.O. Walker Building	Cleveland	Ohio
United States	University of Pennsylvania Perelman School of Medicine	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Kent State University	Case Western Reserve University, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Week 0, Week 8, Week 60
Secondary	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.	Week 0, Week 8, Week 60