Design and baseline data from the Management of Sadness and Anxiety in Cardiology (MOSAIC) randomized controlled trial

Contemporary Clinical Trials

Volumn 36, Issue 2, 2013, Pages 488-501

  Huffman, Jeff C ^a,b   Beach, Scott R ^a,b   Suarez, Laura ^a,b   Mastromauro, Carol A ^a,b   DuBois, Christina M ^a,b   Celano, Christopher M ^a,b   Rollman, Bruce L ^c   Januzzi, James L ^a,b  

^a HARVARD MEDICAL SCHOOL   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

Author keywords

Anxiety; Arrhythmia; Collaborative care; Coronary artery disease; Depression; Heart failure

Indexed keywords

AMFEBUTAMONE; BUSPIRONE; CITALOPRAM; CLONAZEPAM; DIAZEPAM; DULOXETINE; ESCITALOPRAM; FLUOXETINE; LORAZEPAM; MIRTAZAPINE; PAROXETINE; SERTRALINE; VENLAFAXINE;

ACUTE CORONARY SYNDROME; ADULT; ARTICLE; CARDIAC PATIENT; CARDIOLOGY; CONTROLLED STUDY; DEPRESSION; FEMALE; FUNCTIONAL ASSESSMENT; GENERALIZED ANXIETY DISORDER; HEART ARRHYTHMIA; HEART FAILURE; HOSPITAL READMISSION; HUMAN; MAJOR CLINICAL STUDY; MALE; MENTAL HEALTH; OUTCOME ASSESSMENT; PANIC; PATIENT CARE; PROSPECTIVE STUDY; PSYCHOLOGICAL ASPECT; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SHORT FORM 12; SINGLE BLIND PROCEDURE;

ANXIETY; ARRHYTHMIA; COLLABORATIVE CARE; CORONARY ARTERY DISEASE; DEPRESSION; HEART FAILURE;

ACUTE CORONARY SYNDROME; ANTI-ANXIETY AGENTS; ANTIDEPRESSIVE AGENTS; ANXIETY DISORDERS; ARRHYTHMIAS, CARDIAC; COOPERATIVE BEHAVIOR; DEPRESSION; HEART DISEASES; HEART FAILURE; HUMANS; PANIC DISORDER; PATIENT CARE TEAM; PSYCHOTHERAPY; QUALITY OF LIFE; TREATMENT OUTCOME;

EID: 84885439860     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2013.09.012     Document Type: Article

References (89)

1. Celano C.M., Huffman J.C. Depression and cardiac disease: a review. Cardiol Rev 2011, 19:130-142.
2. Rutledge T., Reis V.A., Linke S.E., Greenberg B.H., Mills P.J. Depression in heart failure a meta-analytic review of prevalence, intervention effects, and associations with clinical outcomes. J Am Coll Cardiol 2006, 48:1527-1537.
3. Barth J., Schumacher M., Herrmann-Lingen C. Depression as a risk factor for mortality in patients with coronary heart disease: a meta-analysis. Psychosom Med 2004, 66:802-813.
4. Cully J.A., Jimenez D.E., Ledoux T.A., Deswal A. Recognition and treatment of depression and anxiety symptoms in heart failure. Prim Care Companion J Clin Psychiatry 2009, 11:103-109.
5. Grace S.L., Abbey S.E., Irvine J., Shnek Z.M., Stewart D.E. Prospective examination of anxiety persistence and its relationship to cardiac symptoms and recurrent cardiac events. Psychother Psychosom 2004, 73:344-352.
6. Thrall G., Lip G.Y., Carroll D., Lane D. Depression, anxiety, and quality of life in patients with atrial fibrillation. Chest 2007, 132:1259-1264.
7. Bankier B., Januzzi J.L., Littman A.B. The high prevalence of multiple psychiatric disorders in stable outpatients with coronary heart disease. Psychosom Med 2004, 66:645-650.
8. Huffman J.C., Pollack M.H. Predicting panic disorder among patients with chest pain: an analysis of the literature. Psychosomatics 2003, 44:222-236.
9. Todaro J.F., Shen B.J., Raffa S.D., Tilkemeier P.L., Niaura R. Prevalence of anxiety disorders in men and women with established coronary heart disease. J Cardiopulm Rehabil Prev 2007, 27:86-91.
10. Tully P.J., Cosh S.M. Generalized anxiety disorder prevalence and comorbidity with depression in coronary heart disease: a meta analysis. J Health Psychol Jan 8 2013, [Epub ahead of print].
11. Huffman J.C., Pollack M.H., Stern T.A. Panic disorder and chest pain: mechanisms, morbidity, and management. Prim Care Companion J Clin Psychiatry 2002, 4:54-62.
12. Roest A.M., Zuidersma M., de Jonge P. Myocardial infarction and generalised anxiety disorder: 10-year follow-up. Br J Psychiatry 2012, 200:324-329.
13. Martens E.J., de Jonge P., Na B., Cohen B.E., Lett H., Whooley M.A. Scared to death? Generalized anxiety disorder and cardiovascular events in patients with stable coronary heart disease: the Heart and Soul Study. Arch Gen Psychiatry 2010, 67:750-758.
14. Phillips A.C., Batty G.D., Gale C.R., Deary I.J., Osborn D., MacIntyre K., et al. Generalized anxiety disorder, major depressive disorder, and their comorbidity as predictors of all-cause and cardiovascular mortality: the Vietnam experience study. Psychosom Med 2009, 71:395-403.
15. Frasure-Smith N., Lesperance F. Depression and anxiety as predictors of 2-year cardiac events in patients with stable coronary artery disease. Arch Gen Psychiatry 2008, 65:62-71.
16. Huffman J.C., Mastromauro C.A., Sowden G.A., Wittmann C.L., Rodman R., Januzzi J.L. A collaborative care depression management program for cardiac inpatients: depression characteristics and in-hospital outcomes. Psychosomatics 2011, 52:26-33.
17. Celano C.M., Mastromauro C.A., Lenihan E.C., Januzzi J.L., Rollman B.L., Huffman J.C. Association of baseline anxiety with depression persistence at 6months in patients with acute cardiac illness. Psychosom Med 2012, 74:93-99.
18. Watkins L.L., Koch G.G., Sherwood A., Blumenthal J.A., Davidson J.R., O'Connor C., et al. Association of anxiety and depression with all-cause mortality in individuals with coronary heart disease. J Am Heart Assoc 2013, 2:e000068.
19. Glassman A.H., O'Connor C.M., Califf R.M., Swedberg K., Schwartz P., Bigger J.T., et al. Sertraline treatment of major depression in patients with acute MI or unstable angina. JAMA 2002, 288:701-709.
20. Jiang W., O'Connor C., Silva S.G., Kuchibhatla M., Cuffe M.S., Callwood D.D., et al. Safety and efficacy of sertraline for depression in patients with CHF (SADHART-CHF): a randomized, double-blind, placebo-controlled trial of sertraline for major depression with congestive heart failure. Am Heart J 2008, 156:437-444.
21. Lesperance F., Frasure-Smith N., Koszycki D., Laliberte M.A., van Zyl L.T., Baker B., et al. Effects of citalopram and interpersonal psychotherapy on depression in patients with coronary artery disease: the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) trial. JAMA 2007, 297:367-379.
22. Compare A., Germani E., Proietti R., Janeway D. Clinical psychology and cardiovascular disease: an up-to-date clinical practice review for assessment and treatment of anxiety and depression. Clin Pract Epidemiol Ment Health 2011, 7:148-156.
23. Huffman J.C., Stern T.A. The use of benzodiazepines in the treatment of chest pain: a review of the literature. J Emerg Med 2003, 25:427-437.
24. Berkman L.F., Blumenthal J., Burg M., Carney R.M., Catellier D., Cowan M.J., et al. Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial. JAMA 2003, 289:3106-3116.
25. Freedland K.E., Skala J.A., Carney R.M., Rubin E.H., Lustman P.J., Davila-Roman V.G., et al. Treatment of depression after coronary artery bypass surgery: a randomized controlled trial. Arch Gen Psychiatry 2009, 66:387-396.
26. Fulop G., Strain J.J., Stettin G. Congestive heart failure and depression in older adults: clinical course and health services use 6months after hospitalization. Psychosomatics 2003, 44:367-373.
27. Ziegelstein R.C., Kim S.Y., Kao D., Fauerbach J.A., Thombs B.D., McCann U., et al. Can doctors and nurses recognize depression in patients hospitalized with an acute myocardial infarction in the absence of formal screening?. Psychosom Med 2005, 67:393-397.
28. Gilbody S., Bower P., Fletcher J., Richards D., Sutton A.J. Collaborative care for depression: a cumulative meta-analysis and review of longer-term outcomes. Arch Intern Med 2006, 166:2314-2321.
29. Davidson K.W., Rieckmann N., Clemow L., Schwartz J.E., Shimbo D., Medina V., et al. Enhanced depression care for patients with acute coronary syndrome and persistent depressive symptoms: coronary psychosocial evaluation studies randomized controlled trial. Arch Intern Med 2010, 170:600-608.
30. Katon W.J., Lin E.H., Von Korff M., Ciechanowski P., Ludman E.J., Young B., et al. Collaborative care for patients with depression and chronic illnesses. N Engl J Med 2010, 363:2611-2620.
31. Rollman B.L., Belnap B.H., LeMenager M.S., Mazumdar S., Schulberg H.C., Reynolds C.F. The Bypassing the Blues treatment protocol: stepped collaborative care for treating post-CABG depression. Psychosom Med 2009, 71:217-230.
32. Huffman J.C., Mastromauro C.A., Sowden G., Fricchione G.L., Healy B.C., Januzzi J.L. Impact of a depression care management program for hospitalized cardiac patients. Circ Cardiovasc Qual Outcomes 2011, 4:198-205.
33. Rollman B.L., Belnap B.H., Mazumdar S., Houck P.R., Zhu F., Gardner W., et al. A randomized trial to improve the quality of treatment for panic and generalized anxiety disorders in primary care. Arch Gen Psychiatry 2005, 62:1332-1341.
34. Roy-Byrne P.P., Craske M.G., Stein M.B., Sullivan G., Bystritsky A., Katon W., et al. A randomized effectiveness trial of cognitive-behavioral therapy and medication for primary care panic disorder. Arch Gen Psychiatry 2005, 62:290-298.
35. Roy-Byrne P., Craske M.G., Sullivan G., Rose R.D., Edlund M.J., Lang A.J., et al. Delivery of evidence-based treatment for multiple anxiety disorders in primary care: a randomized controlled trial. JAMA 2010, 303:1921-1928.
36. Burg M.M., Lesperance F., Rieckmann N., Clemow L., Skotzko C., Davidson K.W. Treating persistent depressive symptoms in post-ACS patients: the project COPES phase-I randomized controlled trial. Contemp Clin Trials 2008, 29:231-240.
37. Kathol R.G., Wenzel R.P. Natural history of symptoms of depression and anxiety during inpatient treatment on general medicine wards. J Gen Intern Med 1992, 7:287-293.
38. Lesperance F., Frasure-Smith N., Laliberte M.A., White M., Lafontaine S., Calderone A., et al. An open-label study of nefazodone treatment of major depression in patients with congestive heart failure. Can J Psychiatry 2003, 48:695-701.
39. Ware J., Kosinski M., Keller S.D. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996, 34:220-233.
40. Strik J.J., Honig A., Lousberg R., Lousberg A.H., Cheriex E.C., Tuynman-Qua H.G., et al. Efficacy and safety of fluoxetine in the treatment of patients with major depression after first myocardial infarction: findings from a double-blind, placebo-controlled trial. Psychosom Med 2000, 62:783-789.
41. Weisz G., Moses J.W., Teirstein P.S., Holmes D.R., Raizner A.E., Satler L.F., et al. Safety of sirolimus-eluting stenting and its effect on restenosis in patients with unstable angina pectoris (a SIRIUS substudy). Am J Cardiol 2007, 99:1044-1050.
42. Carney R.M., Freedland K.E. Depression, mortality, and medical morbidity in patients with coronary heart disease. Biol Psychiatry 2003, 54:241-247.
43. Beck A.T., Steer R.A. BDI, Beck depression inventory: manual 1987, Psychological Corp.; Harcourt Brace Jovanovich, San Antonio, Tex. New York.
44. Davidson K.W., Bigger J.T., Burg M.M., Carney R.M., Chaplin W.F., Czajkowski S., et al. Centralized, stepped, patient preference-based treatment for patients with post-acute coronary syndrome depression: CODIACS vanguard randomized controlled trial. JAMA Intern Med 2013, 1-8.
45. Rollman B.L., Belnap B.H., LeMenager M.S., Mazumdar S., Houck P.R., Counihan P.J., et al. Telephone-delivered collaborative care for treating post-CABG depression: a randomized controlled trial. JAMA 2009, 302:2095-2103.
46. Elderon L., Smolderen K.G., Na B., Whooley M.A. Accuracy and prognostic value of American Heart Association: recommended depression screening in patients with coronary heart disease: data from the Heart and Soul Study. Circ Cardiovasc Qual Outcomes 2011, 4:533-540.
47. Whooley M.A., de Jonge P., Vittinghoff E., Otte C., Moos R., Carney R.M., et al. Depressive symptoms, health behaviors, and risk of cardiovascular events in patients with coronary heart disease. JAMA 2008, 300:2379-2388.
48. Beach S.R., Januzzi J.L., Mastromauro C.A., Healy B.C., Beale E.E., Celano C.M., et al. Patient Health Questionnaire-9 score and adverse cardiac outcomes in patients hospitalized for acute cardiac disease. J Psychosom Res 2013, (in press).
49. Spitzer R.L., Kroenke K., Williams J.B. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA 1999, 282:1737-1744.
50. Pinninti N.R., Madison H., Musser E., Rissmiller D. MINI International Neuropsychiatric Schedule: clinical utility and patient acceptance. Eur Psychiatry 2003, 18:361-364.
51. Mayfield D., McLeod G., Hall P. The CAGE questionnaire: validation of a new alcoholism screening instrument. Am J Psychiatry 1974, 131:1121-1123.
52. Kroenke K., Spitzer R.L., Williams J.B. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care 2003, 41:1284-1292.
53. Kroenke K., Spitzer R.L., Williams J.B., Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics 2009, 50:613-621.
54. Means-Christensen A.J., Sherbourne C.D., Roy-Byrne P.P., Craske M.G., Stein M.B. Using five questions to screen for five common mental disorders in primary care: diagnostic accuracy of the Anxiety and Depression Detector. Gen Hosp Psychiatry 2006, 28:108-118.
55. Honig A., Kuyper A.M., Schene A.H., van Melle J.P., de Jonge P., Tulner D.M., et al. Treatment of post-myocardial infarction depressive disorder: a randomized, placebo-controlled trial with mirtazapine. Psychosom Med 2007, 69:606-613.
56. Rigotti N.A., Thorndike A.N., Regan S., McKool K., Pasternak R.C., Chang Y., et al. Bupropion for smokers hospitalized with acute cardiovascular disease. Am J Med 2006, 119:1080-1087.
57. Katon W.J. Clinical practice. Panic disorder. N Engl J Med 2006, 354:2360-2367.
58. Sudak D.M. Cognitive behavioral therapy for depression. Psychiatr Clin North Am 2012, 35:99-110.
59. Hofmann S.G., Smits J.A. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry 2008, 69:621-632.
60. Bjelland I., Dahl A.A., Haug T.T., Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res 2002, 52:69-77.
61. Shear K., Belnap B.H., Mazumdar S., Houck P., Rollman B.L. Generalized anxiety disorder severity scale (GADSS): a preliminary validation study. Depress Anxiety 2006, 23:77-82.
62. Shear M.K., Rucci P., Williams J., Frank E., Grochocinski V., Vander Bilt J., et al. Reliability and validity of the Panic Disorder Severity Scale: replication and extension. J Psychiatr Res 2001, 35:293-296.
63. Freedland K.E., Mohr D.C., Davidson K.W., Schwartz J.E. Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions. Psychosom Med 2011, 73:323-335.
64. Practice guideline for the treatment of patients with panic disorder. Work Group on Panic Disorder. American Psychiatric Association. Am J Psychiatry 1998, 155:1-34.
65. Australian and New Zealand clinical practice guidelines for the treatment of panic disorder and agoraphobia. Aust N Z J Psychiatry 2003, 37:641-656.
66. Fricchione G. Clinical practice. Generalized anxiety disorder. N Engl J Med 2004, 351:675-682.
67. Krumholz H.M., Peterson E.D., Ayanian J.Z., Chin M.H., DeBusk R.F., Goldman L., et al. Report of the National Heart, Lung, and Blood Institute working group on outcomes research in cardiovascular disease. Circulation 2005, 111:3158-3166.
68. Moser D.K., Yamokoski L., Sun J.L., Conway G.A., Hartman K.A., Graziano J.A., et al. Improvement in health-related quality of life after hospitalization predicts event-free survival in patients with advanced heart failure. J Card Fail 2009, 15:763-769.
69. Konstam V., Salem D., Pouleur H., Kostis J., Gorkin L., Shumaker S., et al. Baseline quality of life as a predictor of mortality and hospitalization in 5,025 patients with congestive heart failure. SOLVD Investigations. Studies of Left Ventricular Dysfunction Investigators. Am J Cardiol 1996, 78:890-895.
70. O'Loughlin C., Murphy N.F., Conlon C., O'Donovan A., Ledwidge M., McDonald K. Quality of life predicts outcome in a heart failure disease management program. Int J Cardiol 2010, 139:60-67.
71. Zuluaga M.C., Guallar-Castillon P., Lopez-Garcia E., Banegas J.R., Conde-Herrera M., Olcoz-Chiva M., et al. Generic and disease-specific quality of life as a predictor of long-term mortality in heart failure. Eur J Heart Fail 2010, 12:1372-1378.
72. Katon W.J., Von Korff M., Lin E.H., Simon G., Ludman E., Russo J., et al. The Pathways Study: a randomized trial of collaborative care in patients with diabetes and depression. Arch Gen Psychiatry 2004, 61:1042-1049.
73. Doyle F., Conroy R., McGee H. Differential predictive value of depressive versus anxiety symptoms in the prediction of 8-year mortality after acute coronary syndrome. Psychosom Med 2012, 74:711-716.
74. Rothenbacher D., Hahmann H., Wusten B., Koenig W., Brenner H. Symptoms of anxiety and depression in patients with stable coronary heart disease: prognostic value and consideration of pathogenetic links. Eur J Cardiovasc Prev Rehabil 2007, 14:547-554.
75. Barlow D.H., Gorman J.M., Shear M.K., Woods S.W. Cognitive-behavioral therapy, imipramine, or their combination for panic disorder: a randomized controlled trial. JAMA 2000, 283:2529-2536.
76. Roy-Byrne P.P., Katon W., Cowley D.S., Russo J. A randomized effectiveness trial of collaborative care for patients with panic disorder in primary care. Arch Gen Psychiatry 2001, 58:869-876.
77. Spitzer R.L., Kroenke K., Williams J.B., Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006, 166:1092-1097.
78. Alonso J., Permanyer-Miralda G., Cascant P., Brotons C., Prieto L., Soler-Soler J. Measuring functional status of chronic coronary patients. Reliability, validity and responsiveness to clinical change of the reduced version of the Duke Activity Status Index (DASI). Eur Heart J 1997, 18:414-419.
79. Hsu J., Uratsu C., Truman A., Quesenberry C., McDonald K.M., Hlatky M.A., et al. Life after a ventricular arrhythmia. Am Heart J 2002, 144:404-412.
80. Parissis J.T., Nikolaou M., Birmpa D., Farmakis D., Paraskevaidis I., Bistola V., et al. Clinical and prognostic value of Duke's Activity Status Index along with plasma B-type natriuretic peptide levels in chronic heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. Am J Cardiol 2009, 103:73-75.
81. Erickson S.R., Ellis J.J., Kucukarslan S.N., Kline-Rogers E., Smith D.E., Eagle K.A. Satisfaction with current health status in patients with a history of acute coronary syndrome. Curr Med Res Opin 2009, 25(3):683-689.
82. Casey E., Hughes J.W., Waechter D., Josephson R., Rosneck J. Depression predicts failure to complete phase-II cardiac rehabilitation. J Behav Med 2008, 31:421-431.
83. Romanelli J., Fauerbach J.A., Bush D.E., Ziegelstein R.C. The significance of depression in older patients after myocardial infarction. J Am Geriatr Soc 2002, 50:817-822.
84. Yun L.W., Maravi M., Kobayashi J.S., Barton P.L., Davidson A.J. Antidepressant treatment improves adherence to antiretroviral therapy among depressed HIV-infected patients. J Acquir Immune Defic Syndr 2005, 38:432-438.
85. Ziegelstein R.C., Fauerbach J.A., Stevens S.S., Romanelli J., Richter D.P., Bush D.E. Patients with depression are less likely to follow recommendations to reduce cardiac risk during recovery from a myocardial infarction. Arch Intern Med 2000, 160:1818-1823.
86. Grypma L., Haverkamp R., Little S., Unutzer J. Taking an evidence-based model of depression care from research to practice: making lemonade out of depression. Gen Hosp Psychiatry 2006, 28:101-107.
87. Williams M.D., Jaeckels N., Rummans T.A., Somers K., Nesse R.E., Gorman R.S. Creating value in depression management. Qual Prim Care 2010, 18:327-333.
88. Lowe B., Decker O., Muller S., Brahler E., Schellberg D., Herzog W., et al. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care 2008, 46:266-274.
89. Swinson R.P. The GAD-7 scale was accurate for diagnosing generalised anxiety disorder. Evid Based Med 2006, 11:184.