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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| Case Western Reserve University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | The Mindfulness-Based Stress Reduction intervention includes eight 2.5-hour weekly group sessions and an all-day retreat. |
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| Stress Management Education | Active Comparator | The Stress Management Education intervention includes eight 2.5-hour weekly group sessions and an all-day retreat. |
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| AHA Recommended Self-Care | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction | Behavioral | Patients are randomized to an intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Fresco, Ph.D. | Kent State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| W.O. Walker Building | Cleveland | Ohio | 44106 | United States | ||
| University of Pennsylvania Perelman School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24127622 | Background | 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. | |
| 35694435 | Derived | 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. |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Stress Management Education | Behavioral | Patients are randomized to an intervention |
|
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| American Heart Association Recommended Self-Care | Other | All Patients receive AHA Recommended Self-Care |
|
| Week 0, Week 8, Week 60 |
| 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 |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| D004191 |
| Behavioral Disciplines and Activities |