Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440596
Status:
COMPLETED
Last Update Posted:
2020-11-09
First Post:
2007-02-26
Brief Title:
Mindfulness Based Stress Reduction for High Blood Pressure
Sponsor:
Kent State University
Organization:
Kent State University
Study Overview
Official Title:
Mindfulness Based Stress Reduction for High Blood Pressure
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nearly 60 million adults in the United States have high blood pressure BP in the pre-hypertension SBP 120-139 or DBP 80-89 Hypertension is estimated to account for 1 in 8 deaths in the world and in the US the direct and indirect costs of high BP are estimated to reach 597 billion in 2005 JNC-7 guidelines recommend lifestyle modifications for prehypertension followed by antihypertensive medication if BP progresses to Stage I hypertension Mindfulness-based Stress Reduction MBSR is an increasingly popular practice that has been purported to alleviate stress and treat certain health conditions Some stress management therapies and one meditation therapy eg Transcendental Meditation have shown promise in reducing elevated BP but MBSR has not been evaluated as a treatment for high BP When added to lifestyle modification advice MBSR may be an appropriate complementary treatment for prehypertension However prior to a large randomized clinical trial of MBSR for prehypertension andor hypertension pilot data is necessary to provide preliminary evidence of a treatment effect and to evaluate feasibility This feasibility randomized clinical trial of MBSR for unmedicated prehypertension will provide preliminary evidence to support a larger randomized clinical trial by evaluating the feasibility and safety of MBSR as a complementary treatment for high BP and by documenting any treatment effect Sixty patients with unmedicated BP in the range of SBP 120-139 mm Hg or DBP 80-89 mm Hg will be randomly assigned to MBSR or a progressive muscle relaxation control condition All patients will receive lifestyle modification advice Patients will complete 8 weeks of MBSR delivered in a group format by an experienced psychologist trained in MBSR or 8 weeks of progressive muscle relaxation training matched for therapist contact and homework Patients BP will be assessed prior to randomization and following treatment by researchers blind to treatment assignment Accrual rates acceptance of randomization treatment adherence treatment fidelity and patient satisfaction with treatment will be evaluated
Detailed Description:
See brief summary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None