HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga)

NCT00825526 | Completed

• 1 other identifier: NA 6349
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if Mindfulness Based Stress Reduction (MBSR) is an effective intervention for lowering blood pressure in early unmedicated hypertensives.

Conditions

Hypertension

Keywords

Mindfulness Based Stress Reduction (MBSR); Stress Reduction; hypertension; high blood pressure; ambulatory blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the difference in 24-hour systolic and diastolic blood pressure between the treatment and wait-list group for the 12-week primary assessment period.

  12 weeks

Secondary Outcomes (4)

• Changes in 24 hour ambulatory systolic and diastolic blood pressure at the end of the treatment assessment period compared to the beginning.

  12 weeks

• Between and within group comparisons of MBSR on blood pressure at different times of the day including daytime, night time and work time.

  24 weeks

• The proportion of patients achieving blood pressure targets (24-hour ABPM<130/80 mmHg, daytime ABPM<135/85 mmHg) at the end of the Primary Outcome period

  24 weeks

• The effect of MBSR on ambulatory blood pressure by gender

  24 weeks

Study Arms (2)

Early Intervention, MBSR therapy

EXPERIMENTAL

Group that receives Mindfulness Based Stress Reduction Therapy immediately after randomization

Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy

Delayed Treatment Arm, MBSR Therapy

ACTIVE COMPARATOR

Group that receives Mindfulness Based Stress Reduction Therapy within 3 months of randomization

Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy

Interventions

Mindfulness Based Stress Reduction (MBSR) Therapy BEHAVIORAL

The objectives of MBSR therapy are to 1) understand their personal response to stress and 2) develop techniques to change the way these patients respond and cope with stress

Also known as: stress reduction therapy, Jon Kabat-Zinn, mindfulness meditation

Delayed Treatment Arm, MBSR Therapy; Early Intervention, MBSR therapy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 to 75 years
• Hypertension by ABPM at baseline (daytime \> 135/85 mmHg or 24-hour ABPM \> 130/80 mmHg)

You may not qualify if:

• Use of antihypertensive within 6 months of the screening ABPM.
• Screening office BP \> 180/100 and ABPM \> 160/100 mmHg.
• Diabetes
• Secondary hypertension
• Renal disease (GFR \< 60 ml/min or overt nephropathy)
• History of heart attack
• Stroke or TIA or
• Re-vascularization procedure.
• Active malignant disease (except non-melanoma skin cancer)
• Epileptic seizure 6 months before the screening visit.
• Congestive heart failure
• Severe liver disease
• Pregnancy or lactation period
• Participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit.
• Planned elective surgery during the study period except for cataract surgery

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• University Health Network, Toronto: collaborator

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (2)

• Blom K, Baker B, How M, Dai M, Irvine J, Abbey S, Abramson BL, Myers MG, Kiss A, Perkins NJ, Tobe SW. Hypertension analysis of stress reduction using mindfulness meditation and yoga: results from the HARMONY randomized controlled trial. Am J Hypertens. 2014 Jan;27(1):122-9. doi: 10.1093/ajh/hpt134. Epub 2013 Sep 14.

  PMID: 24038797 DERIVED

• Blom K, How M, Dai M, Baker B, Irvine J, Abbey S, Abramson BL, Myers M, Perkins N, Tobe SW. Hypertension Analysis of stress Reduction using Mindfulness meditatiON and Yoga (The HARMONY Study): study protocol of a randomised control trial. BMJ Open. 2012 Mar 5;2(2):e000848. doi: 10.1136/bmjopen-2012-000848. Print 2012.

  PMID: 22396225 DERIVED

Related Links

• Overview of MBSR program

MeSH Terms

Conditions

Hypertension

Interventions

Mindfulness-Based Stress Reduction; Therapeutics; Mindfulness

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sheldon Tobe, MD, FRCP(C)

  Sunnybrook Health Science Centre

  PRINCIPAL INVESTIGATOR

• Brian Baker, ChB, MB

  University Health Network, Toronto

  STUDY CHAIR

• Jane Irvine, D.Phil., C. Psych.

  York University

  STUDY CHAIR

• Susan Abbey, MD, FRCP(C)

  University Health Network, Toronto

  STUDY CHAIR

• Beth Abramson, MD, FRCPC, FACC

  Unity Health Toronto

  STUDY CHAIR

• Martin Myers, MD, FRCPC

  Sunnybrook Health Science Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 19, 2009
• First Posted: January 21, 2009
• Study Start: July 1, 2008
• Primary Completion: March 1, 2012
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

CA (2)