The ACTonHEART study: Rationale and design of a randomized controlled clinical trial comparing a brief intervention based on Acceptance and Commitment Therapy to usual secondary prevention care of coronary heart disease

Health and Quality of Life Outcomes

Volumn 12, Issue 1, 2014, Pages

  Spatola, Chiara A M ^a,b   Manzoni, Gian M ^a,b   Castelnuovo, Gianluca ^a,b   Malfatto, Gabriella ^a   Facchini, Mario ^a   Goodwin, Christina L ^c   Baruffi, Matteo ^a   Molinari, Enrico ^a,b  

^a ISTITUTO AUXOLOGICO ITALIANO   (Italy)

^b UNIVERSITÀ CATTOLICA DEL SACRO CUORE   (Italy)

^c OHIO STATE UNIVERSITY   (United States)

Author keywords

Acceptance and Commitment Therapy; Adherence; Behavior modification; Ischemic heart disease; Modifiable cardiovascular risk factors; Psychological well being; Quality of life; Randomized clinical trial

Indexed keywords

ACCEPTANCE AND COMMITMENT THERAPY; ADULT; AGED; ARTICLE; CARDIAC PATIENT; CARDIOVASCULAR RISK; CONTROLLED STUDY; EATING HABIT; EXERCISE; FOLLOW UP; HEALTH BEHAVIOR; HUMAN; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MEDICATION COMPLIANCE; MIDDLE AGED; MINDFULNESS; PROSPECTIVE STUDY; PSYCHOLOGICAL WELL BEING; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SECONDARY PREVENTION; SMOKING; YOUNG ADULT;

ACCEPTANCE AND COMMITMENT THERAPY; ADOLESCENT; ADULT; AGED; CORONARY DISEASE; FEMALE; FOLLOW-UP STUDIES; HEALTH STATUS; HUMANS; ITALY; MALE; MIDDLE AGED; PATIENT COMPLIANCE; PRIMARY HEALTH CARE; PSYCHOMETRICS; QUALITY OF LIFE; RESEARCH DESIGN; RISK FACTORS; SECONDARY PREVENTION; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84896724950     PISSN: None     EISSN: 14777525     Source Type: Journal    
DOI: 10.1186/1477-7525-12-22     Document Type: Article

References (80)

1. Cobb SL, Brown DJ, Davis LL. Effective interventions for lifestyle change after myocardial infarction or coronary artery revascularization. J Am Acad Nurse Pract 2006, 18(1):31-39. 10.1111/j.1745-7599.2006.00096.x, 16403210.
2. Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA 1998, 280(23):2001-2007. 10.1001/jama.280.23.2001, 9863851.
3. Held C, Iqbal R, Lear SA, Rosengren A, Islam S, Mathew J, Yusuf S. Physical activity levels, ownership of goods promoting sedentary behaviour and risk of myocardial infarction: results of the INTERHEART study. Eur Heart J 2012, 33(4):452-466. 10.1093/eurheartj/ehr432, 22238330.
4. Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L, INTERHEART Study Investigators Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet 2004, 364(9438):937-952. 10.1016/S0140-6736(04)17018-9, 15364185, INTERHEART Study Investigators.
5. Janssen V, Gucht VD, Dusseldorp E, Maes S. Lifestyle modification programmes for patients with coronary heart disease: a systematic review and meta-analysis of randomized controlled trials. Eur J Prev Cardiol 2013, 20(4):620-640. 10.1177/2047487312462824, 23022703.
6. Bolman C, de Vries H, van Breukelen G. A minimal-contact intervention for cardiac inpatients: long-term effects on smoking cessation. Prev Med 2002, 35(2):181-192. 10.1006/pmed.2002.1036, 12200104.
7. Dorneleas E. Psychotherapy with cardiac patients: Behavioral cardiology in practice 2008, Washington, DC: American Psychological Association.
8. Hajek P, Taylor TZ, Mills P. Brief intervention during hospital admission to help patients to give up smoking after myocardial infarction and bypass surgery: randomised controlled trial. BMJ 2002, 324(7329):87-89. 10.1136/bmj.324.7329.87, 64504, 11786452.
9. Aldana SG, Greenlaw R, Salberg A, Merrill RM, Hager R, Jorgensen RB. The effects of an intensive lifestyle modification program on carotid artery intima-media thickness: a randomized trial. Am J Health Promot 2007, 21(6):510-516. 10.4278/0890-1171-21.6.510, 17674638.
10. Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svardsudd K. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). Arch Intern Med 2011, 171(2):134-140.
11. Lisspers J, Sundin O, Hofman-Bang C, Nordlander R, Nygren A, Ryden L, Ohman A. Behavioral effects of a comprehensive, multifactorial program for lifestyle change after percutaneous transluminal coronary angioplasty: a prospective, randomized controlled study. J Psychosom Res 1999, 46(2):143-154. 10.1016/S0022-3999(98)00074-9, 10098823.
12. Pischke CR, Scherwitz L, Weidner G, Ornish D. Long-term effects of lifestyle changes on well-being and cardiac variables among coronary heart disease patients. Health Psychol 2008, 27(5):584-592.
13. Toobert DJ, Glasgow RE, Radcliffe JL. Physiologic and related behavioral outcomes from the Women's Lifestyle Heart Trial. Ann Behav Med 2000, 22(1):1-9. 10.1007/BF02895162, 10892523.
14. Giannuzzi P, Saner H, Bjornstad H, Fioretti P, Mendes M, Cohen-Solal A, Dugmore L, Hambrecht R, Hellemans I, McGee H, Perk J, Vanhees L, Veress G, Working Group on Cardiac Rehabilitation and Exercise Physiology of the European Society of Cardiology Secondary prevention through cardiac rehabilitation: position paper of the Working Group on Cardiac Rehabilitation and Exercise Physiology of the European Society of Cardiology. Eur Heart J 2003, 24(13):1273-1278. 10.1016/S0195-668X(03)00198-2, 12831822, Working Group on Cardiac Rehabilitation and Exercise Physiology of the European Society of Cardiology.
15. Hayes SC, Strosahl K, Wilson KG. Acceptance and commitment therapy: an experiential approach to behavior change 1999, New York, NY: Guilford.
16. Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther 2006, 44(1):1-25. 10.1016/j.brat.2005.06.006, 16300724.
17. Powers MB, Zum Vorde Sive Vording MB, Emmelkamp PM. Acceptance and commitment therapy: a meta-analytic review. Psychother Psychosom 2009, 78(2):73-80. 10.1159/000190790, 19142046.
18. Prevedini AB, Presti G, Rabitti E, Miselli G, Moderato P. Acceptance and commitment therapy (ACT): the foundation of the therapeutic model and an overview of its contribution to the treatment of patients with chronic physical diseases. G Ital Med Lav Ergon 2011, 33(1 Suppl A):A53-A63.
19. Forman EM, Butryn ML, Juarascio AS, Bradley LE, Lowe MR, Herbert JD, Shaw JA. The mind your health project: a randomized controlled trial of an innovative behavioral treatment for obesity. Obesity (Silver Spring) 2013, 21(6):1119-1126. 10.1002/oby.20169, 3735809, 23666772.
20. Lillis J, Hayes SC, Bunting K, Masuda A. Teaching acceptance and mindfulness to improve the lives of the obese: a preliminary test of a theoretical model. Ann Behav Med 2009, 37(1):58-69. 10.1007/s12160-009-9083-x, 19252962.
21. Butryn ML, Forman E, Hoffman K, Shaw J, Juarascio A. A pilot study of acceptance and commitment therapy for promotion of physical activity. J Phys Act Health 2011, 8(4):516-522.
22. Gifford E, Kohlenberg B, Hayes SC, Antonuccio D, Piasecki M, Rasmussen-Hall M, Palm KM. Acceptance-based treatment for smoking cessation. Behav Ther 2004, 35:689-705.
23. Gregg JA, Callaghan GM, Hayes SC, Glenn-Lawson JL. Improving diabetes self-management through acceptance, mindfulness, and values: a randomized controlled trial. J Consult Clin Psychol 2007, 75(2):336-343.
24. Lundgren T, Dahl J, Melin L, Kies B. Evaluation of acceptance and commitment therapy for drug refractory epilepsy: a randomized controlled trial in South Africa-a pilot study. Epilepsia 2006, 47(12):2173-2179. 10.1111/j.1528-1167.2006.00892.x, 17201719.
25. Lundgren T, Dahl J, Yardi N, Melin L. Acceptance and Commitment Therapy and yoga for drug-refractory epilepsy: a randomized controlled trial. Epilepsy Behav 2008, 13(1):102-108. 10.1016/j.yebeh.2008.02.009, 18343200.
26. Nordin L, Rorsman I. Cognitive behavioural therapy in multiple sclerosis: a randomized controlled pilot study of acceptance and commitment therapy. J Rehabil Med 2012, 44(1):87-90. 10.2340/16501977-0898, 22234322.
27. Dahl J, Wilson KG, Nilsson A. Acceptance and commitment therapy and the treatment of persons at risk for long-term disability resulting from stress and pain symptoms: a preliminary randomized trial., 35, 785-802. Behav Ther 2004, 35:785-802.
28. Moitra E, Herbert JD, Forman EM. Acceptance-based behavior therapy to promote HIV medication adherence. AIDS Care 2011, 23(12):1660-1667. 10.1080/09540121.2011.579945, 21732897.
29. Goodwin CL, Forman EM, Herbert JD, Butryn ML, Ledley GS. A pilot study examining the initial effectiveness of a brief acceptance-based behavior therapy for modifying diet and physical activity among cardiac patients. Behav Modif 2012, 36(2):199-217. 10.1177/0145445511427770, 22133992.
30. Hayes SC, Follette VM, Linehan MM. Mindfulness and acceptance: Expanding the cognitive-behavioral tradition 2004, New York, NY: Guilford.
31. Hayes SC, Wilson KG, Gifford EV, Follette VM, Strosahl K. Experimental avoidance and behavioral disorders: a functional dimensional approach to diagnosis and treatment. J Consult Clin Psychol 1996, 64(6):1152-1168.
32. Falk L, Bisogni C, Sobal J. Personal, social, and situational influences associated with dietary experiences of participants in an intensive heart program. J Nutr Educ 2000, 32:251-260.
33. Forman E, Butryn ML, Hoffman K, Herbert JD. An open trial of an acceptance-based behavioral treatment for weight loss. Cogn Behav Prac 2009, 16:223-235.
34. Kearney MH, O'Sullivan J. Identity shifts as turning points in health behavior change. West J Nurs Res 2003, 25(2):134-152. 10.1177/0193945902250032, 12666640.
35. Brown RA, Lejuez CW, Kahler CW, Strong DR, Zvolensky MJ. Distress tolerance and early smoking lapse. Clin Psychol Rev 2005, 25(6):713-733. 10.1016/j.cpr.2005.05.003, 1839854, 16023275.
36. Vervoort SC, Grypdonck MH, de Grauwe A, Hoepelman AI, Borleffs JC. Adherence to HAART: processes explaining adherence behavior in acceptors and non-acceptors. AIDS Care 2009, 21(4):431-438. 10.1080/09540120802290381, 19266408.
37. Bunker SJ, Colquhoun DM, Esler MD, Hickie IB, Hunt D, Jelinek VM, Oldenburg BF, Peach HG, Ruth D, Tennant CC, Tonkin AM. "Stress" and coronary heart disease: psychosocial risk factors. Med J Aust 2003, 178(6):272-276.
38. Januzzi JL, Stern TA, Pasternak RC, DeSanctis RW. The influence of anxiety and depression on outcomes of patients with coronary artery disease. Arch Intern Med 2000, 160(13):1913-1921. 10.1001/archinte.160.13.1913, 10888966.
39. Rozanski A, Blumenthal JA, Kaplan J. Impact of psychological factors on the pathogenesis of cardiovascular disease and implications for therapy. Circulation 1999, 99(16):2192-2217. 10.1161/01.CIR.99.16.2192, 10217662.
40. Barnes-Holmes D, Cochrane A, Barnes-Holmes Y, Stewart I. " Offer it up" and psychological acceptance: empirical evidence for your grandmother's wisdom. Ir Psychol 2004, 31:72-78.
41. Bond FW, Bunce D. Mediators of change in emotion-focused and problem-focused worksite stress management interventions. J Occup Health Psychol 2000, 5(1):156-163.
42. Bond FW, Bunce D. The role of acceptance and job control in mental health, job satisfaction, and work performance. J Appl Psychol 2003, 88(6):1057-1067.
43. Chawla N, Ostafin B. Experiential avoidance as a functional dimensional approach to psychopathology: an empirical review. J Clin Psychol 2007, 63(9):871-890. 10.1002/jclp.20400, 17674402.
44. Donaldson-Feilder EJ, Bond FW. The relative importance of psychological acceptance and emotional intelligence to workplace well-being, 32(2), 187-203. Br J Guidance Couns 2004, 32(2):187-203.
45. Gaudiano BA. Evaluating acceptance and commitment therapy: an analysis of a recent critique. Int J Behav Cons Ther 2011, 7:55-67.
46. Ost LG. Efficacy of the third wave of behavioral therapies: a systematic review and meta-analysis. Behav Res Ther 2008, 46(3):296-321. 10.1016/j.brat.2007.12.005, 18258216.
47. Ruiz FJ. A review of acceptance and commitment therapy (ACT) empirical evidence: correlational, experimental psychopathology, component and outcome studies. Int J Psychol Psychol Ther 2010, 1:125-162.
48. Fledderus M, Bohlmeijer ET, Pieterse ME. Does experiential avoidance mediate the effects of maladaptive coping styles on psychopathology and mental health?. Behav Modif 2010, 34(6):503-519. 10.1177/0145445510378379, 20660354.
49. Kashdan TB, Barrios V, Forsyth JP, Steger MF. Experiential avoidance as a generalized psychological vulnerability: comparisons with coping and emotion regulation strategies. Behav Res Ther 2006, 44(9):1301-1320. 10.1016/j.brat.2005.10.003, 16321362.
50. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, Medical Research Council Guidance Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008, 337:a1655. 10.1136/bmj.a1655, 2769032, 18824488, Medical Research Council Guidance.
51. Giannuzzi P, Temporelli PL, Marchioli R, Maggioni AP, Balestroni G, Ceci V, Chieffo C, Gattone M, Griffo R, Schweiger C, Tavazzi L, Urbinati S, Valagussa F, Vanuzzo D, GOSPEL Investigators Global secondary prevention strategies to limit event recurrence after myocardial infarction: results of the GOSPEL study, a multicenter, randomized controlled trial from the Italian Cardiac Rehabilitation Network. Arch Intern Med 2008, 168(20):2194-2204. 10.1001/archinte.168.20.2194, 19001195, GOSPEL Investigators.
52. Cardaciotto L, Herbert JD, Forman EM, Moitra E, Farrow V. The assessment of present-moment awareness and acceptance: the Philadelphia Mindfulness Scale. Assessment 2008, 15(2):204-223.
53. McGorrian C, Yusuf S, Islam S, Jung H, Rangarajan S, Avezum A, Prabhakaran D, Almahmeed W, Rumboldt Z, Budaj A, Dans AL, Gerstein HC, Teo K, Anand SS, INTERHEART Investigators Estimating modifiable coronary heart disease risk in multiple regions of the world: the INTERHEART Modifiable Risk Score. Eur Heart J 2011, 32(5):581-589. 10.1093/eurheartj/ehq448, 21177699, INTERHEART Investigators.
54. AmericanPsychologicalAssociation A DSM-IV-TR, Manuale diagnostico e statistico dei disturbi mentali - Text Revision 2001, Milano: Masson, AmericanPsychologicalAssociation A.
55. Dupuy HJ. The Psychological general Well-Being (PGWB) Index. Assessment of Quality of Life in clinical trials of cardiovascular therapies 1984, 170-183. New York: Le Jacq Publishing, Wenger NK, Mattson ME, Furberg CD, Elinson J.
56. Grossi E, Mosconi P, Groth N, Niero M, Apolone G. Il Questionario Psychological General Well Being. Questionario per la valutazione dello stato generale di benessere psicologico. Versione Italiana 2002, Milano: Istituto di ricerche farmacologiche "Mario Negri".
57. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30(6):473-483. 10.1097/00005650-199206000-00002, 1593914.
58. Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol 1998, 51(11):1025-1036. 10.1016/S0895-4356(98)00094-8, 9817120.
59. Ware JE, Kosinski M, Bayliss MS, McHorney CA, Rogers WH, Raczek A. Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Med Care 1995, 33(4 Suppl):AS264-AS279.
60. Panagiotakos DB, Pitsavos C, Zampelas A, Chrysohoou C, Stefanadis C. The relationship between fish consumption and the risk of developing acute coronary syndromes among smokers: the CARDIO2000 case-control study. Nutr Metab Cardiovasc Dis 2005, 15(6):402-409. 10.1016/j.numecd.2005.04.003, 16314226.
61. Panagiotakos DB, Pitsavos C, Chrysohoou C, Stefanadis C. Hierarchical analysis of cardiovascular risk factors in relation to the development of acute coronary syndromes, in different parts of Greece: the CARDIO2000 study. Angiology 2008, 59(2):156-165. 10.1177/0003319707304576, 18388034.
62. Panagiotakos DB, Pitsavos C, Stefanadis C. Dietary patterns: a Mediterranean diet score and its relation to clinical and biological markers of cardiovascular disease risk. Nutr Metab Cardiovasc Dis 2006, 16(8):559-568. 10.1016/j.numecd.2005.08.006, 17126772.
63. Hu FB. Dietary pattern analysis: a new direction in nutritional epidemiology. Curr Opin Lipidol 2002, 13(1):3-9. 10.1097/00041433-200202000-00002, 11790957.
64. Quatromoni PA, Copenhafer DL, Demissie S, D'Agostino RB, O'Horo CE, Nam BH, Millen BE. The internal validity of a dietary pattern analysis. The Framingham Nutrition Studies. J Epidemiol Community Health 2002, 56(5):381-388. 10.1136/jech.56.5.381, 1732145, 11964437.
65. Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc 2003, 35(8):1381-1395. 10.1249/01.MSS.0000078924.61453.FB, 12900694.
66. Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich) 2008, 10(5):348-354. 10.1111/j.1751-7176.2008.07572.x, 2562622, 18453793.
67. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986, 24(1):67-74. 10.1097/00005650-198601000-00007, 3945130.
68. Fabbrini G, Abbruzzese G, Barone P, Antonini A, Tinazzi M, Castegnaro G, Rizzoli S, Morisky DE, Lessi P, Ceravolo R, On behalf of the REASON study group Adherence to anti-Parkinson drug therapy in the "REASON" sample of Italian patients with Parkinson's disease: the linguistic validation of the Italian version of the "Morisky Medical Adherence scale-8 items". Neurol Sci 2013, 34(11):2015-2022. On behalf of the REASON study group.
69. Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther 2011, 42(4):676-688. 10.1016/j.beth.2011.03.007, 22035996.
70. Pennato T, Berrocal C, Bernini O, Rivas T. Italian Version of the Acceptance and Action Questionnaire-II (AAQ-II): Dimensionality, Reliability, Convergent and Criterion Validity. J Psychopathol Behav Assess 2013, 35(4):552-563.
71. Cohen J. Statistical power analysis for the behavioral sciences 1998, Hillsdale, NY: Lawrence Earlbaum Associates, 2.
72. de Jong K, Moerbeek M, van der Leeden R. A priori power analysis in longitudinal three-level multilevel models: an example with therapist effects. Psychother Res 2010, 20(3):273-284. 10.1080/10503300903376320, 19946814.
73. Moerbeek M, Piersma AH, Slob W. A comparison of three methods for calculating confidence intervals for the benchmark dose. Risk Anal 2004, 24(1):31-40. 10.1111/j.0272-4332.2004.00409.x, 15027998.
74. Wampold BE, Serlin RC. The consequence of ignoring a nested factor on measures of effect size in analysis of variance. Psychol Methods 2000, 5(4):425-433.
75. Bauer DJ, Sterba SK, Hallfors DD. Evaluating group-based interventions when control participants are ungrouped. Multivariate Behav Res 2008, 43(2):210-236. 10.1080/00273170802034810, 2853949, 20396621.
76. Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J 1991, 121(1 Pt 2):293-298.
77. Hippisley-Cox J, Coupland C, Vinogradova Y, Robson J, Minhas R, Sheikh A, Brindle P. Predicting cardiovascular risk in England and Wales: prospective derivation and validation of QRISK2. BMJ 2008, 336(7659):1475-1482. 10.1136/bmj.39609.449676.25, 2440904, 18573856.
78. Linden W, Satin JR. Avoidable pitfalls in behavioral medicine outcome research. Ann Behav Med 2007, 33(2):143-147. 10.1007/BF02879895, 17447866.
79. Smith TW, Orleans CT, Jenkins CD. Prevention and health promotion: decades of progress, new challenges, and an emerging agenda. Health Psychol 2004, 23(2):126-131.
80. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT Group Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008, 148(4):295-309. 10.7326/0003-4819-148-4-200802190-00008, 18283207, CONSORT Group.