Mindfulness Based Stress Reduction for High Blood Pressure

NCT00440596 | Completed Results DMC

• 1 other identifier: R21AT002698-01A2
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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 $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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• SBP

  12 weeks

• DBP

  Clinic BP

  12 weeks

Study Arms (2)

Mindfulness based stress reduction

EXPERIMENTAL

Mindfulness based stress reduction

Behavioral: Mindfulness based stress reduction

Progressive Muscle Relaxation

ACTIVE COMPARATOR

Progressive Muscle Relaxation

Behavioral: Progressive Muscle Relaxation

Interventions

Mindfulness based stress reduction BEHAVIORAL

8 weeks group MBSR

Mindfulness based stress reduction

Progressive Muscle Relaxation BEHAVIORAL

8 weeks PMR in group format

Progressive Muscle Relaxation

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• prehypertension
• years of age

You may not qualify if:

• normal BP
• hypertension
• pregnancy
• smoking
• use of antihypertensive medication

Sponsors & Collaborators

• Kent State University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Summa Health System

Akron, Ohio, 44304, United States

Location

Related 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.

  PMID: 24127622 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Mindfulness-Based Stress Reduction; Autogenic Training

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Joel Hughes
• Organization: Kent State University

jhughes1@kent.edu

330-672-7721

Study Officials

• Joel W Hughes, Ph.D.

  Kent State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2007
• First Posted: February 27, 2007
• Study Start: September 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: November 9, 2020
• Results First Posted: November 9, 2020

Record last verified: 2020-11

Locations

US (1)