Rationale and design of a randomized clinical trial comparing stress reduction treatment to usual cardiac care: The reducing vulnerability to implantable cardioverter defibrillator shock-treated ventricular arrhythmias (RISTA) trial

Psychosomatic Medicine

Volumn 72, Issue 2, 2010, Pages 172-177

  Donahue, Rebecca G ^a   Lampert, Rachel ^a   Dornelas, Ellen ^c   Clemow, Lynn ^b   Burg, Matthew M ^a,b  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Och Spine at New York Presbyterian Hospitals   (United States)

^c HARTFORD HOSPITAL   (United States)

Author keywords

Arrhythmia; Implantable cardioverter defibrillator; Randomized clinical trial; Stress; Treatment

Indexed keywords

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVULSIVE THERAPY; CORONARY CARE UNIT; DEFIBRILLATOR; ELECTROCARDIOGRAPHY MONITORING; FOLLOW UP; HEART VENTRICLE ARRHYTHMIA; HOSPITALIZATION; HUMAN; LABORATORY TEST; MAJOR CLINICAL STUDY; MENTAL STRESS; MULTICENTER STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL;

EID: 77649164317     PISSN: 00333174     EISSN: 15347796     Source Type: Journal    
DOI: 10.1097/PSY.0b013e3181c932d4     Document Type: Article

References (46)

1. Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y. Heart Disease and Stroke Statistics 2009 Update: A Report From the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2009;119:e21-e181.
2. The AVID Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. The Antiarrhythmics versus Implantable Defi-brillators (AVID) Investigators. N Engl J Med 1997;337:1576-1583
3. Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H, Levine JH, Saksena S, Waldo AL, Wilber D, Brown MW, Heo M. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibril-lator Implantation Trial Investigators. N Engl J Med 1996;335:1933-1940
4. Greenberg H, Case RB, Moss AJ, Brown MW, Carroll ER, Andrews ML. Analysis of mortality events in the multicenter automatic defibrillator implantation trial (MADIT-II). J Am Coll Cardiol 2004;43:1459-1465
5. Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Doman-ski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352:225-237
6. Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346:877-883
7. McClellan MB, Tunis SR. Medicare coverage of ICDs. N Engl J Med 2005;352:222-224
8. Tung R, Zimetbaum P, Josephson ME. A critical appraisal of implantable cardioverter-defibrillator therapy for the prevention of sudden cardiac death. J Am Coll Cardiol 2008;52:1111-1121
9. Hegel MT, Griegel LE, Black C, Goulden L, Ozahowski T. Anxiety and depression in patients receiving implanted cardioverter-defibrillators: a longitudinal investigation. Int J Psychiat Med 1997;27:57-69.
10. Sears SF Jr, Conti JB. Quality of life and psychological functioning of ICD patients. Heart 2002;87:488-493
11. Mark DB, Anstrom KJ, Sun JL, Clapp-Channing NE, Tsiatis AA, Davidson-Ray L, Lee KL, Bardy GH. Quality of life with defibrillator therapy or amiodarone in heart failure. N Eng J Med 2008;359:999-1008.
12. Irvine J, Dorian P, Baker B, O'Brien BJ, Roberts R, Gent M, Newman D, Connolly SJ. Quality of life in the Canadian Implantable Defibrillator Study (CIDS). Am Heart J 2002;144:282-289
13. Schron EB, Exner DV, Yao Q, Jenkins LS, Steinberg JS, Cook JR, Kutalek SP, Friedman PL, Bubien RS, Page RL, Powell J. Quality of life in the antiarrhythmics versus implantable defibrillators trial: impact of therapy and influence of adverse symptoms and defibrillator shocks. Circulation 2002;105:589-594
14. Wallace RL, Sears SF Jr, Lewis TS, Griffis JT, Curtis A, Conti JB. Predictors of quality of life in long-term recipients of implantable car-dioverter defibrillators. J Cardiopulm Rehabil 2002;22:278-281
15. Dunbar SB, Kimble LP, Jenkins LS, Hawthorne M, Dudley W, Slem-mons M, Langberg JJ. Association of mood disturbance and arrhythmia events in patients after cardioverter defibrillator implantation. Depress Anxiety 1999;9:163-168
16. Pacifico A, Hohnloser SH, Williams JH, Tao B, Saksena S, Henry PD, Prystowsky EN. Prevention of implantable-defibrillator shocks by treatment with sotalol. d,l-Sotalol Implantable Cardioverter-Defibrillator Study Group. N Engl J Med 1999;340:1855-1862
17. Wilson JS, Podrid PJ. Side effects from amiodarone. Am Heart J 1991; 121:158-171
18. Lampert R, Jain D, Burg MM, Batsford WP, McPherson CA. Destabilizing effects of mental stress on ventricular arrhythmias in patients with implantable cardioverter-defibrillators. Circulation 2000;101:158-164
19. Lampert R, Shusterman V, Burg MM, Lee FA, Earley C, Goldberg A, McPherson CA, Batsford WP, Soufer R. Effects of psychologic stress on repolarization and relationship to autonomic and hemodynamic factors. J Cardiovasc Electrophysiol 2005;16:372-377
20. Stopper M, Joska T, Burg MM, Batsford WP, McPherson CA, Jain D, Lampert R. Electrophysiologic characteristics of anger-triggered arrhythmias. Heart Rhythm 2007;4:268-273
21. Burg MM, Lampert R, Joska T, Batsford W, Jain D. Psychological traits and emotion-triggering of ICD shock-terminated arrhythmias. Psycho-som Med 2004;66:898-902.
22. Lampert R, Joska T, Burg MM, Batsford WP, McPherson CA, Jain D. Emotional and physical precipitants of ventricular arrhythmia. Circulation 2002;106:1800-1805
23. Linden W, Phillips MJ, Leclerc J. Psychological treatment of cardiac patients: a meta-analysis. Eur Heart J 2007;28:2972-2984
24. Blumenthal JA, Babyak M, Wei J, O'Connor C, Waugh R, Eisenstein E, Mark D, Sherwood A, Woodley PS, Irwin RJ, Reed G. Usefulness of psychosocial treatment of mental stress-induced myocardial ischemia in men. Am J Cardiol 2002;89:164-168
25. Frizelle DJ, Lewin RJ, Kaye G, Hargreaves C, Hasney K, Beaumont N, Moniz-Cook E. Cognitive-behavioural rehabilitation programme for patients with an implanted cardioverter defibrillator: a pilot study. Br J Health Psychol 2004;9:381-392
26. Kohn CS, Petrucci RJ, Baessler C, Soto DM, Movsowitz C. The effect of psychological intervention on patients' long-term adjustment to the ICD: a prospective study. PACE 2000;23:450-456
27. Chevalier P, Cottraux J, Mollard E, Sai N, Brun S, Burri H, Restier L, Adeleine P. Prevention of implantable defibrillator shocks by cognitive behavioral therapy: a pilot trial. Am Heart J 2006;151:191.
28. Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med 2007;357:2657-2665
29. Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc 1975;23: 433-441
30. Conigrave KM, Hall WD. The AUDIT questionnaire: choosing a cut-off score. Addiction 1995;90:1349-1356
31. Spielberger CD. Manual for the State-Trait Personality Inventory. Palo Alto, CA: Consulting Psychologists; 1983.
32. Spielberger CD, Johnson EH, Russell SF, Crane RJ, Jacobs GA, Worden TJ. The experience and expression of anger: construction and validation of an anger expression scale. In: Chesney M, Rosenman R, editors. Anger and Hostility in Cardiovascular and Behavioral Disorders. New York: McGraw-Hill; 1995.
33. Barefoot JC, Dodge KA, Peterson BL, Dahlstrom WG, Williams RB Jr. The Cook-Medley hostility scale: item content and ability to predict survival. Psychosom Med 1989;51:46-57.
34. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992; 30:473-483
35. Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Appl Psych Meas 1977;1:385-401.
36. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiat Scand 1983;67:361-370
37. Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale: An updated literature review. J Psychosom Res 2002;52:69-77.
38. Mitchell PH, Powell L, Blumenthal J, Norten J, Ironson G, Pitula CR, Froelicher ES, Czajkowski S, Youngblood M, Huber M, Berkman LF. A short social support measure for patients recovering from myocardial infarction: the ENRICHD Social Support Inventory. J Cardiopulm Rehab 2003;23:398-403.
39. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav 1983;24:385-396
40. Ong L, Linden W, Young S. Stress management: what is it? J Psychosom Res 2004;56:133-137
41. Blumenthal JA, Jiang W, Babyak MA, Krantz DS, Frid DJ, Coleman RE, Waugh R, Hanson M, Appelbaum M, O'Connor C, Morris JJ. Stress management and exercise training in cardiac patients with myocardial ischemia. Effects on prognosis and evaluation of mechanisms. Arch Intern Med 1997;157:2213-2223
42. Blumenthal JA, Sherwood A, Babyak MA, Watkins LL, Waugh R, Georgiades A, Bacon SL, Hayano J, Coleman RE, Hinderliter A. Effects of exercise and stress management training on markers of cardiovascular risk in patients with ischemic heart disease: a randomized controlled trial. JAMA 2005;293:1626-1634
43. Friedman M, Thoresen CE, Gill JJ, Ulmer D, Powell LH, Price VA, Brown B, Thompson L, Rabin DD, Breall WS, et al. Alteration of type A behavior and its effect on cardiac recurrences in post myocardial infarction patients: summary results of the recurrent coronary prevention project. Am Heart J 1986;112:653-665
44. Gidron Y, Davidson K, Bata I. The short-term effects of a hostility-reduction intervention on male coronary heart disease patients. Health Psychol 1999;18:416-420
45. Mendes de Leon CF, Powell LH, Kaplan BH. Change in coronary-prone behaviors in the recurrent coronary prevention project. Psychosom Med 1991;53:407-419
46. Thoresen CE, Bracke P. Reducing coronary recurrences and coronary-prone behavior: a structured group treatment approach. In: Spira JL, editor. Group Therapy for Medically Ill Patients. New York: Guilford Publications; 1997.