Mindfulness Based Stress Reduction for High Blood Pressure

• ClinicalTrials.gov Identifier: NCT00440596
• Recruitment Status: Completed
• First Posted: February 27, 2007
• Results First Posted: November 9, 2020
• Last Update Posted: November 9, 2020
• Sponsor: Kent State University
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Joel Hughes, Kent State University

Tracking Information

• First Submitted Date: February 26, 2007
• First Posted Date: February 27, 2007
• Results First Submitted Date: June 22, 2011
• Results First Posted Date: November 9, 2020
• Last Update Posted Date: November 9, 2020
• Study Start Date: September 2006
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 5, 2020)

• SBP [ Time Frame: 12 weeks ]
• DBP [ Time Frame: 12 weeks ]
  Clinic BP

Original Primary Outcome Measures (submitted: February 26, 2007)

• SBP
• DBP

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mindfulness Based Stress Reduction for High Blood Pressure
• Official Title: Mindfulness Based Stress Reduction for High Blood Pressure
• 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.
• Detailed Description: See brief summary
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

• Behavioral: Mindfulness based stress reduction
  8 weeks group MBSR
• Behavioral: Progressive Muscle Relaxation
  8 weeks PMR in group format

Study Arms

• Experimental: Mindfulness based stress reduction
  Mindfulness based stress reduction
  Intervention: Behavioral: Mindfulness based stress reduction
• Active Comparator: Progressive Muscle Relaxation
  Progressive Muscle Relaxation
  Intervention: Behavioral: Progressive Muscle Relaxation

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 5, 2020): 56
• Original Enrollment (submitted: February 26, 2007): 84
• Actual Study Completion Date: July 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• prehypertension
• 30-60 years of age

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00440596
• Other Study ID Numbers: R21AT002698-01A2( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Joel Hughes, Kent State University
• Original Responsible Party: Not Provided
• Current Study Sponsor: Kent State University
• Original Study Sponsor: National Center for Complementary and Integrative Health (NCCIH)
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Joel W Hughes, Ph.D.; Kent State University

• PRS Account: Kent State University
• Verification Date: November 2020