HypertensionHARMONYNCT00825526
HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga)
A study testing Mindfulness Based Stress Reduction (MBSR) Therapy in people with Hypertension, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Mindfulness Based Stress Reduction (MBSR) Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2008to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20 to 75 years
- Hypertension by ABPM at baseline (daytime > 135/85 mmHg or 24-hour ABPM > 130/80 mmHg)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University Health Network
Toronto, Ontario, M5G 2N2
About this study
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
- Being tested
- Mindfulness Based Stress Reduction (MBSR) Therapy
- Keywords
- Mindfulness Based Stress Reduction (MBSR), Stress Reduction, hypertension, high blood pressure, ambulatory blood pressure monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction (MBSR) TherapyBehavioural
Also called stress reduction therapy, Jon Kabat-Zinn, mindfulness meditation
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
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention, MBSR therapy | Experimental | Group that receives Mindfulness Based Stress Reduction Therapy immediately after randomization Receives: 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 Receives: Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 24 weeks
The effect of MBSR on ambulatory blood pressure by gender
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJul 2008
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Sheldon Tobe, Sunnybrook Health Sciences Centre
- Investigators
- Sheldon Tobe, MD, FRCP(C), Principal investigator, Sunnybrook Health Sciences CentreBrian Baker, ChB, MB, Study chair, University Health Network, TorontoJane Irvine, D.Phil., C. Psych., Study chair, York UniversitySusan Abbey, MD, FRCP(C), Study chair, University Health Network, TorontoBeth Abramson, MD, FRCPC, FACC, Study chair, Unity Health TorontoMartin Myers, MD, FRCPC, Study chair, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825526
- Sponsor's protocol ID
- NA 6349
- Acronym
- HARMONY
- Status last verified
- May 2012
- First submitted
- 19 Jan 2009
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24038797Blom 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.
PubMed 22396225
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga)
- ClinicalTrials.gov ID
- NCT00825526
- Acronym / sponsor ID
- HARMONY / NA 6349
- Conditions
- Hypertension
- Keywords
- Mindfulness Based Stress Reduction (MBSR), Stress Reduction, hypertension, high blood pressure, ambulatory blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Jul 2008
- Primary completion
- Mar 2012 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intervention, MBSR therapy | Experimental | Behavioral: Mindfulness Based Stress Reduction (MBSR) TherapyGroup that receives Mindfulness Based Stress Reduction Therapy immediately after randomization |
| Delayed Treatment Arm, MBSR Therapy | Active comparator | Behavioral: Mindfulness Based Stress Reduction (MBSR) TherapyGroup that receives Mindfulness Based Stress Reduction Therapy within 3 months of randomization |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 20 to 75 years
- Hypertension by ABPM at baseline (daytime > 135/85 mmHg or 24-hour ABPM > 130/80 mmHg)
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) TherapyAlso: stress reduction therapy, Jon Kabat-Zinn, mindfulness meditationThe 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 | Behavioural | Delayed Treatment Arm, MBSR Therapy, Early Intervention, MBSR therapy |
Primary outcome
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.
Time frame: 12 weeks
4 secondary outcomes
Changes in 24 hour ambulatory systolic and diastolic blood pressure at the end of the treatment assessment period compared to the beginning.
Time frame: 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.
Time frame: 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
Time frame: 24 weeks
The effect of MBSR on ambulatory blood pressure by gender
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
- Derived from this study: PubMed 24038797Blom 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.
- Derived from this study: PubMed 22396225Blom 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.
- Overview of MBSR programLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheldon Tobe, MD, FRCP(C) principal investigator
Sunnybrook Health Sciences Centre
Brian Baker, ChB, MB study chair
University Health Network, Toronto
Jane Irvine, D.Phil., C. Psych. study chair
York University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction (MBSR) Therapy in people with Hypertension, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00825526, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.