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Mindfulness Based Stress Reduction for High Blood Pressure

NCT ID: NCT00440596

Last Updated: 2020-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-07-31

Brief Summary

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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. Accrual rates, acceptance of randomization, treatment adherence, treatment fidelity, and patient satisfaction with treatment will be evaluated.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindfulness based stress reduction

Mindfulness based stress reduction

Group Type EXPERIMENTAL

Mindfulness based stress reduction

Intervention Type BEHAVIORAL

8 weeks group MBSR

Progressive Muscle Relaxation

Progressive Muscle Relaxation

Group Type ACTIVE_COMPARATOR

Progressive Muscle Relaxation

Intervention Type BEHAVIORAL

8 weeks PMR in group format

Interventions

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Mindfulness based stress reduction

8 weeks group MBSR

Intervention Type BEHAVIORAL

Progressive Muscle Relaxation

8 weeks PMR in group format

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* prehypertension
* 30-60 years of age

Exclusion Criteria

* normal BP
* hypertension
* pregnancy
* smoking
* use of antihypertensive medication
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Kent State University

OTHER

Sponsor Role lead

Responsible Party

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Joel Hughes

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joel W Hughes, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kent State University

Locations

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Summa Health System

Akron, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24127622 (View on PubMed)

Other Identifiers

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R21AT002698-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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