Hypertension Analysis of stress Reduction using Mindfulness meditatiON and Yoga (The HARMONY Study): Study protocol of a randomised control trial

BMJ Open

Volumn 2, Issue 2, 2012, Pages

  Blom, Kimberly ^a   How, Maxine ^a   Dai, Monica ^b   Baker, Brian ^c   Irvine, Jane ^d   Abbey, Susan ^c   Abramson, Beth L ^e   Myers, Martin ^a   Perkins, Nancy ^a   Tobe, Sheldon W ^a  

^a SUNNYBROOK RESEARCH INSTITUTE   (Canada)

^b QUEEN S UNIVERSITY   (Canada)

^c UNIVERSITY HEALTH NETWORK   (Canada)

^d YORK UNIVERSITY   (Canada)

^e ST MICHAEL'S HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

CHOLESTEROL; CREATININE; ELECTROLYTE; GLUCOSE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; TRIACYLGLYCEROL;

ADULT; AGED; ARTICLE; BLOOD PRESSURE MONITORING; BLOOD PRESSURE REGULATION; COGNITIVE THERAPY; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; FEMALE; GROUP THERAPY; HUMAN; HYPERTENSION; LIFESTYLE MODIFICATION; MAJOR CLINICAL STUDY; MALE; MEDITATION; MINDFULNESS BASED STRESS REDUCTION THERAPY; OUTCOME ASSESSMENT; PILOT STUDY; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RELAXATION TRAINING; STRESS; SYSTOLIC BLOOD PRESSURE; TREATMENT OUTCOME; YOGA;

EID: 84860912525     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2012-000848     Document Type: Article

References (81)

1. Rabi DM, Daskalopoulou SS, Padwal RS, et al. The 2011 Canadian hypertension education program recommendations for the management of hypertension: blood pressure measurement, diagnosis, assessment of risk, and therapy. Can J Cardiol 2011;27:415-33.
2. Chockalingam A, Campbell NR, Fodor JG. Worldwide epidemic of hypertension. Can J Cardiol 2006;22:553-5. (Pubitemid 44044209)
3. Vasan RS, Larson MG, Leip EP, et al. Assessment of frequency of progression to hypertension in non-hypertensive participants in the Framingham Heart Study: a cohort study. Lancet 2001;358:1682-6. (Pubitemid 33124327)
4. Julius S, Nesbitt S, Egan B, et al. Feasibility of treating prehypertension with an angiotensin-receptor blocker. N Engl J Med 2006;354:1685-97.
5. World Health Organization. Preventing chronic diseases: a vital investment. http://www.who.int/chp/chronic-disease-report/contents/en/index.html (accessed 27 Apr 2007).
6. Stamler J, Rose G, Stamler R, et al. INTERSALT study findings. Public health and medical care implications. Hypertension 1989;14:570-7. (Pubitemid 19270524)
7. Appel LJ. Lifestyle modification as a means to prevent and treat high blood pressure. J Am Soc Nephrol 2003;14:S99-102.
8. O'Donnell MJ, Xavier D, Liu L, et al. Risk factors for ischaemic and intracerebral haemorrhagic stroke in 22 countries (the INTERSTROKE study): a case-control study. Lancet 2010;376:112-23.
9. Canter PH, Ernst E. Insufficient evidence to conclude whether or not transcendental meditation decreases blood pressure: results of a systematic review of randomized clinical trials. J Hypertens 2004;22:2049-54. (Pubitemid 39463793)
10. Parati G, Steptoe A. Stress reduction and blood pressure control in hypertension: a role for transcendental meditation? J Hypertens 2004;22:2057-60. (Pubitemid 39463795)
11. Dickinson HO, Mason JM, Nicolson DJ, et al. Lifestyle interventions to reduce raised blood pressure: a systematic review of randomized controlled trials. J Hypertens 2006;24:215-33.
12. Manikonda JP, Stork S, Togel S, et al. Contemplative meditation reduces ambulatory blood pressure and stress-induced hypertension: a randomized pilot trial. J Hum Hypertens 2008;22:138-40.
13. Wenneberg SR, Schneider RH, Walton KG, et al. A controlled study of the effects of the transcendental meditation program on cardiovascular reactivity and ambulatory blood pressure. Int J Neurosci 1997;89:15-28. (Pubitemid 27204371)
14. Castillo-Richmond A, Schneider RH, Alexander CN, et al. Effects of stress reduction on carotid atherosclerosis in hypertensive African Americans. Stroke 2000;31:568-73. (Pubitemid 30131638)
15. Schneider RH, Staggers F, Alxander CN, et al. A randomised controlled trial of stress reduction for hypertension in older African Americans. Hypertension 1995;26:820-7.
16. Schneider RH, Alexander CN, Staggers F, et al. Long-term effects of stress reduction on mortality in persons > or = 55 years of age with systemic hypertension. Am J Cardiol 2005;95:1060-4. (Pubitemid 40544308)
17. Paul-Labrador M, Polk D, Dwyer JH, et al. Effects of a randomized controlled trial of transcendental meditation on components of the metabolic syndrome in subjects with coronary heart disease. Arch Intern Med 2006;166:1218-24. (Pubitemid 43877632)
18. Schneider RH, Alexander CN, Staggers F, et al. A randomized controlled trial of stress reduction in African Americans treated for hypertension for over one year. Am J Hypertens 2005;18:88-98. (Pubitemid 40187354)
19. Nidich SI, Rainforth MV, Haaga DA, et al. A randomized controlled trial on effects of the transcendental meditation program on blood pressure, psychological distress, and coping in young adults. Am J Hypertens 2009;22:1326-31.
20. Anderson JW, Liu C, Kryscio RJ. Blood pressure response to transcendental meditation: a meta-analysis. Am J Hypertens 2008;21:310-16. (Pubitemid 351323278)
21. Rainforth MV, Schneider RH, Nidich SI, et al. Stress reduction programs in patients with elevated blood pressure: a systematic review and meta-analysis. Curr Hypertens Rep 2007;9:520-8.
22. Beck AT. The current state of cognitive therapy: a 40-year retrospective. Arch Gen Psychiatry 2005;62:953-9. (Pubitemid 41248374)
23. Linden W, Lenz JW, Con AH. Individualized stress management for primary hypertension: a randomized trial. Arch Intern Med 2001;161:1071-80. (Pubitemid 32685533)
24. Kabat-Zinn J. Full Catastrophe Living: Using The Wisdom Of Your Body And Mind To Face Stress, Pain And Illness. New York: Delta, 1990.
25. Praissman S. Mindfulness-based stress reduction: a literature review and clinician's guide. J Am Acad Nurse Pract 2008;20:212-16.
26. Plews-Ogan M, Owens JE, Goodman M, et al. A pilot study evaluating mindfulness-based stress reduction and massage for the management of chronic pain. J Gen Intern Medicine 2005;20:1136-8. (Pubitemid 43115148)
27. Morone NE, Greco CM, Weiner DK. Mindfulness meditation for the treatment of chronic low back pain in older adults: a randomized controlled pilot study. Pain 2008;134:310-19.
28. Esmer G, Blum J, Rulf J, et al. Mindfulness-based stress reduction for failed back surgery syndrome: a randomized controlled trial. J Am Osteopath Assoc 2010;110:646-52.
29. Rosenzweig S, Greeson JM, Reibel DK, et al. Mindfulness-based stress reduction for chronic pain conditions: variation in treatment outcomes and role of home meditation practice. J Psychosom Res 2010;68:29-36.
30. Shapiro SL, Schwartz GE, Bonner G. Effects of mindfulness-based stress reduction on medical and premedical students. J Behav Med 1998;21:581-99. (Pubitemid 29024650)
31. Astin JA. Stress reduction through mindfulness meditation. Effects psychological symptomatology, sense control, spiritual experiences. Psychother Psychosom 1997;66:97-106. (Pubitemid 27117336)
32. Kabat-Zinn J, Massion AO, Kristeller J, et al. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry 1992;149:936-43.
33. Vieten C, Astin J. Effects of a mindfulness-based intervention during pregnancy on prenatal stress and mood: results of a pilot study. Arch Women's Ment Health 2008;11:67-74. (Pubitemid 351339495)
34. Vollestad J, Sivertsen B, Nielsen GH. Mindfulness-based stress reduction for patients with anxiety disorders: evaluation in a randomized controlled trial. Behav Res Ther 2011;49:281-8.
35. Barnhofer T, Duggan D, Crane C, et al. Effects of meditation on frontal alpha-asymmetry in previously suicidal individuals. Neuroreport 2007;18:709-12. (Pubitemid 46608520)
36. Kenny MA, Williams JM. Treatment-resistant depressed patients show a good response to mindfulness-based cognitive therapy. Behav Res Ther 2007;45:617-25. (Pubitemid 46135524)
37. Kingston J, Chadwick P, Meron D, et al. A pilot randomized control trial investigating the effect of mindfulness practice on pain tolerance, psychological well-being, and physiological activity. J Psychosom Res 2007;62:297-300. (Pubitemid 46282750)
38. Grossman P, Tiefenthaler-Gilmer U, Raysz A, et al. Mindfulness training as an intervention for fibromyalgia: evidence of postintervention and 3-year follow-up benefits in well-being. Psychother Psychosom 2007;76:226-33. (Pubitemid 46933368)
39. Sephton SE, Salmon P, Weissbecker I, et al. Mindfulness meditation alleviates depressive symptoms in women with fibromyalgia: results of a randomized clinical trial. Arthritis Rheum 2007;57:77-85.
40. Schmidt S, Grossman P, Schwarzer B, et al. Treating fibromyalgia with mindfulness-based stress reduction: results from a 3-armed randomized controlled trial. Pain 2011;152:361-9.
41. Kristeller JL, Hallett CB. An exploratory study of a meditation-based intervention for binge eating disorder. J Health Psychol 1999;4:357-63. (Pubitemid 29349552)
42. Kabat-Zinn J, Wheeler E, Light T, et al. Influence of a mindfulness meditation-based stress reduction intervention on rates of skin clearing in patients with moderate to severe psoriasis undergoing phototherapy (UVB) and photochemotherapy (PUVA). Psychosom Med 1998;60:625-32. (Pubitemid 28453029)
43. Carlson LE, Speca M, Faris P, et al. One year pre-post intervention follow-up of psychological, immune, endocrine and blood pressure outcomes of mindfulness-based stress reduction (MBSR) in breast and prostate cancer outpatients. Brain Behav Immun 2007;21:1038-49. (Pubitemid 47496126)
44. Carlson LE, Speca M, Patel KD, et al. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress and levels of cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin in breast and prostate cancer outpatients. Psychoneuroendocrinology 2004;29:448-74. (Pubitemid 38121602)
45. Carlson LE, Speca M, Patel KD, et al. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosom Med 2003;65:571-81. (Pubitemid 36900252)
46. Henderson VP, Clemow L, Massion AO, et al. The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: a randomized trial. Breast Cancer Res Treat 2012;131:99-109.
47. Lengacher CA, Johnson-Mallard V, Barta M, et al. Feasibility of a mindfulness-based stress reduction program for early-stage breast cancer survivors. J Holist Nurs 2011;29:107-17.
48. Lengacher CA, Johnson-Mallard V, Post-White J, et al. Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psychooncology 2009;18:1261-72.
49. Ledesma D, Kumano H. Mindfulness-based stress reduction and cancer: a meta-analysis. Psychooncology 2009;18:571-9.
50. Matchim Y, Armer JM, Stewart BR. Mindfulness-based stress reduction among breast cancer survivors: a literature review and discussion. Oncol Nurs Forum 2011;38:E61-71.
51. Matchim Y, Armer JM, Stewart BR. Effects of mindfulness-based stress reduction (MBSR) on health among breast cancer survivors. West J Nurs Res 2011;33:996-1016.
52. Matousek RH, Dobkin PL. Weathering storms: a cohort study of how participation in a mindfulness-based stress reduction program benefits women after breast cancer treatment. Curr Oncol 2010;17:62-70.
53. Smith JE, Richardson J, Hoffman C, et al. Mindfulness-based stress reduction as supportive therapy in cancer care: systematic review. J Adv Nurs 2005;52:315-27. (Pubitemid 41475412)
54. Witek-Janusek L, Albuquerque K, Chroniak KR, et al. Effect of mindfulness based stress reduction on immune function, quality of life and coping in women newly diagnosed with early stage breast cancer. Brain Behav Immun 2008;22:969-81.
55. Birnie K, Garland SN, Carlson LE. Psychological benefits for cancer patients and their partners participating in mindfulness-based stress reduction (MBSR). Psychooncology 2010;19:1004-9.
56. Rosenzweig S, Reibel DK, Greeson JM, et al. Mindfulness-based stress reduction is associated with improved glycemic control in type 2 diabetes mellitus: a pilot study. Altern Ther Health Med 2007;13:36-8. (Pubitemid 351299603)
57. Baer RA. Mindfulness training as a clinical intervention: a conceptual and empirical review. Clin Psychol Sci Pract 2003;10:125-43. (Pubitemid 41288839)
58. Grossman P, Niemann L, Schmidt S, et al. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res 2004;57:35-43. (Pubitemid 38901093)
59. Bohlmeijer E, Prenger R, Taal E, et al. The effects of mindfulness-based stress reduction therapy on mental health of adults with a chronic medical disease: a meta-analysis. J Psychosom Res 2010;68:539-44.
60. Ditto B, Eclache M, Goldman N. Short-term autonomic and cardiovascular effects of mindfulness body scan meditation. Ann Behav Med 2006;32:227-34. (Pubitemid 44906937)
61. Barnes VA, Treiber FA, Davis H. Impact of transcendental meditation on cardiovascular function at rest and during acute stress in adolescents with high normal blood pressure. J Psychosom Res 2001;51:597-605. (Pubitemid 33048742)
62. Barnes VA, Davis HC, Murzynowski JB, et al. Impact of meditation on resting and ambulatory blood pressure and heart rate in youth. Psychosom Med 2004;66:909-14. (Pubitemid 39552876)
63. Van Wielingen LE, Carlson LE, Campbell TS. Mindfulness-based stress reduction (MBSR), blood pressure and psychological functioning in women with cancer. [abstract]. Psychosom Med 2007;69:A43.
64. Linden W, Moseley JV. The efficacy of behavioral treatments for hypertension. Appl Psychophysiol Biofeedback 2006;31:51-63. (Pubitemid 43863751)
65. Kingston T, Dooley B, Bates A, et al. Mindfulness-based cognitive therapy for residual depressive symptoms. Psychol Psychotherapy 2007;80:193-203. (Pubitemid 46975347)
66. Spielberger C, Jacobs G, Russel S, et al. Assessment of anger: the state-trait anger scale. In: Butcher J, Spielberger C, eds. Advances in Personality Assesment. Hillsdale, NJ: Lawrence Erlbaum Associates, 1983:112-89.
67. Bjelland I, Dahl AA, Haug TT, et al. The validity of the hospital anxiety and depression scale. An updated literature review. J Psychosom Res 2002;52:69-77. (Pubitemid 34192886)
68. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav 1983;24:385-96.
69. Rosengren A, Hawken S, Ounpuu S, et al. Association of psychosocial risk factors with risk of acute myocardial infarction in 11119 cases and 13648 controls from 52 countries (the INTERHEART study): case-control study. Lancet 2004;364:953-62. (Pubitemid 39208456)
70. Karasek R, Brisson C, Kawakami N, et al. The job content questionnaire (JCQ): an instrument for internationally comparative assessments of psychosocial job characteristics. J Occup Health Psychol 1998;3:322-55.
71. Baer RA, Smith GT, Lykins E, et al. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment 2008;15:329-42.
72. Evans C, Connell J, Barkham M, et al. Towards a standardised brief outcome measure: psychometric properties and utility of the COREOM. Br J Psychiatry 2002;180:51-60. (Pubitemid 34093626)
73. Lau MA, Bishop SR, Segal ZV, et al. The Toronto mindfulness scale: development and validation. J Clin Psychol 2006;62:1445-67. (Pubitemid 44862639)
74. Kabat-Zinn J, Lipworth L, Burney R. The clinical use of mindfulness meditation for the self-regulation of chronic pain. J Behav Med 1985;8:163-90. (Pubitemid 15023685)
75. Bishop SR. What do we really know about mindfulness-based stress reduction? Psychosom Med 2002;64:71-83. (Pubitemid 34137401)
76. Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry 1982;4:33-47. (Pubitemid 12088404)
77. Baker B, Paquette M, Szalai JP, et al. The influence of marital adjustment on 3-year left ventricular mass and ambulatory blood pressure in mild hypertension. Arch Intern Med 2000;160:3453-8.
78. Tobe SW, Kiss A, Sainsbury S, et al. The impact of job strain and marital cohesion on ambulatory blood pressure during 1 year: the double exposure study. Am J Hypertens 2007;20:148-53. (Pubitemid 46150018)
79. World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Seoul: From the 59th World Medical Association Assembly, 2008. http://www.wma.net/en/30publications/10policies/b3/17c.pdf (accessed 29 Dec 2011).
80. Health Canada. Int Conf Harmonization (ICH) Guidance E6. Good Clin Pract Consolidated Guidel, 1997. http://www.hc-sc.gc.ca/dhpmps/prodpharma/applic- demande/guide-ld/ich/efficac/e6-eng.php (accessed 29 Dec 2011).
81. Goverment of Canada. Panel Of Research Ethics. 2nd edn. Of Tri-Council Policy Statement: Ethical Conduct for research involving Humans, 2010. http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/ Default/ (accessed 29 Dec 2011).