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NCT00440596 · ClinicalTrials.gov registry record · NA
Mindfulness Based Stress Reduction for High Blood Pressure
A NA study of Hypertension, sponsored by Kent State University.
- Completed
- Registry status
- NA
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT00440596 is a NA study of Hypertension that has completed, run by Kent State University. The registered enrollment target is 56 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00440596, a NA study of Hypertension, has completed, sponsored by Kent State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study 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 $59.7 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 (e.g., 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 and/or 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. Accrua
Conditions Studied
Interventions
- BEHAVIORAL Progressive Muscle Relaxation
- BEHAVIORAL Mindfulness based stress reduction
Study Locations (1)
Ohio
- Summa Health System - Akron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00440596
The ClinicalTrials.gov registry entry for NCT00440596 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (98% lower). The listed sponsor is Kent State University, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Progressive Muscle Relaxation is the first listed.
NCT00440596 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT00440596 about?
NCT00440596 is a clinical study titled "Mindfulness Based Stress Reduction for High Blood Pressure". 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 $59.7 billion in 2005. JN...
What is the current status of trial NCT00440596?
This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2006-09. Estimated completion is 2009-07.
What conditions does trial NCT00440596 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT00440596?
The interventions under investigation include: Progressive Muscle Relaxation (BEHAVIORAL), Mindfulness based stress reduction (BEHAVIORAL).
Who is sponsoring clinical trial NCT00440596?
This trial is sponsored by Kent State University, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00440596 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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