Assessing the effectiveness of enhanced psychological care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): study protocol for a pilot cluster randomised controlled trial
详细信息 查看全文
- 作者：Suzanne H. Richards ; Chris Dickens ; Rob Anderson ; David A. Richards…
- 关键词：Depression ; Coronary heart disease ; Multimorbidity ; Behavioural activation ; Mental health care coordination ; Cardiac rehabilitation ; Randomised controlled trial ; Qualitative interviews
- 刊名：Trials
- 出版年：2016
- 出版时间：December 2016
- 年：2016
- 卷：17
- 期：1
- 全文大小：733 KB
- 参考文献：1.Thombs BD, Ziegelstein RC, Pilote L, Dozois DJ, Beck AT, Dobson KS, et al. Somatic symptom overlap in Beck Depression Inventory-II scores following myocardial infarction. Br J Psychiatry. 2010;197(1):61–6. doi:10.1192/bjp.bp.109.076596 .PubMedCentral CrossRef PubMed
2.Connerney I, Shapiro PA, McLaughlin JS, Bagiella E, Sloan RP. Relation between depression after coronary artery bypass surgery and 12-month outcome: a prospective study. Lancet. 2001;358(9295):1766–71. doi:10.1016/S0140-6736(01)06803-9 .CrossRef PubMed
3.Lesperance F, Frasure-Smith N, Juneau M, Theroux P. Depression and 1-year prognosis in unstable angina. Arch Intern Med. 2000;160(9):1354–60.CrossRef PubMed
4.Rutledge T, Reis VA, Linke SE, Greenberg BH, Mills PJ. Depression in heart failure a meta-analytic review of prevalence, intervention effects, and associations with clinical outcomes. J Am Coll Cardiol. 2006;48(8):1527–37. doi:10.1016/j.jacc.2006.06.055 .CrossRef PubMed
5.Singleton N, Bumpstead R, O’Brien M, Lee A, Meltzer H. Psychiatric morbidity among adults living in private households, 2000. London: HMSO2001 Feb–May. Report No.: 0954-0261 Contract No.: 1-2.
6.Rugulies R. Depression as a predictor for coronary heart disease. a review and meta-analysis. Am J Prev Med. 2002;23(1):51–61.CrossRef PubMed
7.Wulsin LR, Singal BM. Do depressive symptoms increase the risk for the onset of coronary disease? A systematic quantitative review. Psychosom Med. 2003;65(2):201–10.CrossRef PubMed
8.Dickens C, McGowan L, Percival C, Douglas J, Tomenson B, Cotter L, et al. Association between depressive episode before first myocardial infarction and worse cardiac failure following infarction. Psychosomatics. 2005;46(6):523-8. doi:http://dx.doi.org/10.1176/appi.psy.46.6.523 .
9.Leung YW, Flora DB, Gravely S, Irvine J, Carney RM, Grace SL. The impact of premorbid and postmorbid depression onset on mortality and cardiac morbidity among patients with coronary heart disease: meta-analysis. Psychosom Med. 2012;74(8):786–801.PubMedCentral CrossRef PubMed
10.Dickens CM, Percival C, McGowan L, Douglas J, Tomenson B, Cotter L, et al. The risk factors for depression in first myocardial infarction patients. Psychol Med. 2004;34(6):1083–92.CrossRef PubMed
11.Dickens C, McGowan L, Percival C, Tomenson B, Cotter L, Heagerty A, et al. Negative illness perceptions are associated with new-onset depression following myocardial infarction. Gen Hosp Psychiatry. 2008;30(5):414–20.CrossRef PubMed
12.Dickens C. Depression in people with coronary heart disease: prognostic significance and mechanisms. Curr Cardiol Rep. 2015;17(10):1–10. doi:10.1007/s11886-015-0640-6 .CrossRef
13.Dickens CM, McGowan L, Percival C, Tomenson B, Cotter L, Heagerty A, et al. Contribution of depression and anxiety to impaired health-related quality of life following first myocardial infarction. Br J Psychiatry. 2006;189:367–72. doi:10.1192/bjp.bp.105.018234 .CrossRef PubMed
14.Dickens C, Cherrington A, McGowan L. Depression and health-related quality of life in people with coronary heart disease: a systematic review. Eur J Cardiovasc Nurs. 2012;11(3):265–75. doi:10.1177/1474515111430928 .CrossRef PubMed
15.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(6):802–13. doi:10.1097/01.psy.0000146332.53619.b2 .CrossRef PubMed
16.Nicholson A, Kuper H, Hemingway H. Depression as an aetiologic and prognostic factor in coronary heart disease: a meta-analysis of 6362 events among 146 538 participants in 54 observational studies. Eur Heart J. 2006;27(23):2763–74.CrossRef PubMed
17.van Melle JP, de Jonge P, Spijkerman TA, Tijssen JG, Ormel J, van Veldhuisen DJ, et al. Prognostic association of depression following myocardial infarction with mortality and cardiovascular events: a meta-analysis. Psychosom Med. 2004;66(6):814–22. doi:10.1097/01.psy.0000146294.82810.9c .CrossRef PubMed
18.Meijer A, Conradi HJ, Bos EH, Thombs BD, van Melle JP, de Jonge P. Prognostic association of depression following myocardial infarction with mortality and cardiovascular events: a meta-analysis of 25 years of research. Gen Hosp Psychiatry. 2011;33(3):203–16.CrossRef PubMed
19.Dickens C, Katon W, Blakemore A, Khara A, McGowan L, Tomenson B, et al. Does depression predict the use of urgent and unscheduled care by people with long term conditions? A systematic review with meta-analysis. J Psychosom Res. 2012;73(5):334–42. doi:10.1016/j.jpsychores.2012.08.018 .CrossRef PubMed
20.Frasure-Smith N, Lesperance F, Gravel G, Masson A, Juneau M, Talajic M, et al. Depression and health-care costs during the first year following myocardial infarction. J Psychosom Res. 2000;48(4-5):471–8.CrossRef PubMed
21.Rutledge T, Vaccarino V, Johnson BD, Bittner V, Olson MB, Linke SE, et al. Depression and cardiovascular health care costs among women with suspected myocardial ischemia: prospective results from the WISE (Women’s Ischemia Syndrome Evaluation) Study. J Am Coll Cardiol. 2009;53(2):176–83.PubMedCentral CrossRef PubMed
22.de Jonge P, van den Brink RH, Spijkerman TA, Ormel J. Only incident depressive episodes after myocardial infarction are associated with new cardiovascular events. J Am Coll Cardiol. 2006;48(11):2204–8. doi:10.1016/j.jacc.2006.06.077 .CrossRef PubMed
23.Dickens C, McGowan L, Percival C, Tomenson B, Cotter L, Heagerty A, et al. New onset depression following myocardial infarction predicts cardiac mortality. Psychosom Med. 2008;70(4):450–5. doi:10.1097/PSY.0b013e31816a74de .CrossRef PubMed
24.Parker GB, Hilton TM, Walsh WF, Owen CA, Heruc GA, Olley A et al. Timing is everything: the onset of depression and acute coronary syndrome outcome. Biological Psychiatry. 2008;.64(8):pp. doi:10.1016/j.biopsych.2008.05.021 18602090.
25.NICE commissioning guides. Cardiac rehabilitation services. London 2013 01 November 2013.
26.British Association for Cardiovascular Prevention and Rehabilitation. The BACPR standards and core components for cardiovascular disease prevention and rehabilitation 2012. London, UK: British Cardiovascular Society ; 2012.
27.NACR. National Audit of Cardiac Rehabilitation: 2012. London, UK: British Heart Foundation; 2012.
28.Dickens C, McGowan L, Percival C, Tomenson B, Cotter L, Heagerty A, et al. Depression is a risk factor for mortality after myocardial infarction: fact or artifact? J Am Coll Cardiol. 2007;49(18):1834–40. doi:10.1016/j.jacc.2007.01.075 .CrossRef PubMed
29.National Collaborating Centre for Mental Health. Depression in adults with a chronic physical health problem (NICE Clinical Guideline 91). London: National Institute for Health and Clinical Excellence; 2009.
30.National Collaborating Centre for Mental Health. Depression: the treatment and management of depression in adults (NICE Clinical Guideline 90). London: National Institute for Health and Clinical Excellence; 2009. Report No.: 9781849360999 (pbk.).
31.National Collaborating Centre for Mental Health. Common mental disorders: the NICE guidance on identification and pathways to care (NICE Guideline 123). London: National Institute for Health and Clinical Excellence; 2009. Report No.: 9781849360999 (pbk.).
32.Bird A. We need to talk: the case for psychological therapy on the NHS. UK: Mental Health Foundation; 2006.
33.DeRubeis RJ, Hollon SD, Amsterdam JD, Shelton RC, Young PR, Salomon RM, et al. Cognitive therapy vs medications in the treatment of moderate to severe depression. Arch Gen Psychiatry. 2005;62(4):409–16.CrossRef PubMed
34.Barnes M, Sherlock S, Thomas L, Kessler D, Kuyken W, Owen-Smith A, et al. No pain, no gain: depressed clients’ experiences of cognitive behavioural therapy. Br J Clin Psychol. 2013;52(4):347–64. doi:10.1111/bjc.12021 .CrossRef PubMed
35.Layard R. The case for psychological treatment centres. Br Med J. 2006;332(7548):1030–2.CrossRef
36.London School of Economics. The Depression Report. A new deal for depression and anxiety disorders. London: London School for Economics; 2006.
37.Jacobson NS, Martell CR, Dimidjian S. Behavioral activation treatment for depression: returning to contextual roots. Clinical Psychology: Science and Practice. 2001;8(3):255–70. doi:10.1093/clipsy.8.3.255 .
38.Addis M, Martell C. Overcoming depression one step at a time: the new behavioral activation approach to getting your life back. Oakland, CA, US : New Harbinger Publications ; 2004.
39.Beck A, Rush AJ, Shaw B, Emery G. Cognitive therapy of depression: a treatment manual. The Guilford clinical psychology and psychotherapy series. New York: Guilford Press; 1979.
40.Ekers D, Richards D, McMillan D, Bland JM, Gilbody S. Behavioural activation delivered by the non-specialist: phase II randomised controlled trial. Br J Psychiatry. 2011;198(1):66–72. doi:10.1192/bjp.bp.110.079111 .CrossRef PubMed
41.Richards D. Behavioural activation. In: Bennett-Levy J, Richards D, Farrand P, Christensen H, Griffiths K, Kavanagh D, et al., editors. Oxford guide to low intensity CBT interventions. Oxford: Oxford University Press; 2010. p. 141–50.
42.Richards D, Farrand P, Chellingsworth M. National Curriculum for the Education of Psychological Wellbeing Practitioners (PWPS). Lancashire: British Association for Behavioural & Cognitive Psychotherapies; 2011.
43.Richards D, Whyte M. Reach Out: National programme educator materials to support the delivery of training for practitioners delivering low intensity interventions. London: Rethink, National Mental Health Development Unit, 2009.
44.Lespérance F, Frasure-Smith N, Koszycki D, Laliberté M, 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(4):367–79. doi:10.1001/jama.297.4.367 .CrossRef PubMed
45.Glassman AH, O’Connor CM, Califf RM, Swedberg K, Schwartz P, Bigger Jr JT, et al. Sertraline treatment of major depression in patients with acute MI or unstable angina. JAMA. 2002;288(6):701–9.CrossRef PubMed
46.van Melle JP, de Jonge P, Honig A, Schene AH, Kuyper AM, Crijns HJ, et al. Effects of antidepressant treatment following myocardial infarction. Br J Psychiatry. 2007;190:460–6.CrossRef PubMed
47.Whalley B, Rees K, Davies P, Bennett P, Ebrahim S, Liu Z, et al. Psychological interventions for coronary heart disease. Cochrane Database Syst Rev. 2011;8, CD002902. doi:10.1002/14651858.CD002902.pub3 .PubMed
48.Baumeister H, Hutter N, Bengel J. Psychological and pharmacological interventions for depression in patients with coronary artery disease. Cochrane Database Syst Rev. 2011;9, CD008012. doi:10.1002/14651858.CD008012.pub3 .PubMed
49.Berkman LF, Blumenthal J, Burg M, Carney RM, Catellier D, Cowan MJ, 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(23):3106–16.CrossRef PubMed
50.Whang W, Burg MM, Carney RM, Freedland KE, Bigger JT, Catellier D et al. Design and baseline data from the vanguard of the Comparison of Depression Interventions after Acute Coronary Syndrome (CODIACS) randomized controlled trial. Contemporary Clinical Trials. 2012;33(5):1003-10. doi:http://dx.doi.org/10.1016/j.cct.2012.05.005 .
51.Davidson KW, Bigger JT, Burg MM, Carney RM, Chaplin WF, Czajkowski S et al. Centralized, stepped, patient preference-based treatment for patients with post-acute coronary syndrome depression: CODIACS Vanguard Randomized Controlled Trial. Journal of the American Medical Association: Internal Medicine. 2013:1-8. doi:10.1001/jamainternmed.2013.915 .
52.Simmonds R, Tylee A, Walters P, Rose D. Patients’ perceptions of depression and coronary heart disease: a qualitative UPBEAT-UK study. BMC Fam Pract. 2013;14(1):38.PubMedCentral CrossRef PubMed
53.Cuijpers P, van Straten A, Warmerdam L. Behavioral activation treatments of depression: a meta-analysis. Clin Psychol Rev. 2007;27(3):318–26. doi:10.1016/j.cpr.2006.11.001 .CrossRef PubMed
54.Ekers D, Richards D, Gilbody S. A meta-analysis of randomized trials of behavioural treatment of depression. Psychol Med. 2008;38(5):611–23. doi:10.1017/S0033291707001614 .CrossRef PubMed
55.Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: new guidance: London, UK: Medical Research Council. 2008.
56.Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios L, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1.PubMedCentral CrossRef PubMed
57.Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12. doi:10.1111/j.2002.384.doc.x .CrossRef PubMed
58.Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–13.PubMedCentral CrossRef PubMed
59.Meader N, Mitchell AJ, Chew-Graham C, Goldberg D, Rizzo M, Bird V, et al. Case identification of depression in patients with chronic physical health problems: a diagnostic accuracy meta-analysis of 113 studies. Br J Gen Pract. 2011;61(593):e808–20. doi:10.3399/bjgp11X613151 .PubMedCentral CrossRef PubMed
60.Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the Patient Health Questionnaire-9. Med Care. 2004;42(12):1194–201.CrossRef PubMed
61.NACR. The National Audit of Cardiac Rehabilitation: annual statistical report 2014. London: British Heart Foundation; 2014.
62.McMillan D, Gilbody S, Richards D. Defining successful treatment outcome in depression using the PHQ-9: a comparison of methods. J Affect Disord. 2010;127(1-3):122–9. doi:10.1016/j.jad.2010.04.030 .CrossRef PubMed
63.Lewis G. Assessing psychiatric disorder with a human interviewer or a computer. J Epidemiol Community Health. 1994;48(2):207–10.PubMedCentral CrossRef PubMed
64.Lewis G, Pelosi AJ, Araya R, Dunn G. Measuring psychiatric disorder in the community: a standardized assessment for use by lay interviewers. Psychol Med. 1992;22(2):465–86.CrossRef PubMed
65.King M, Nazareth I, Lampe F, Bower P, Chandler M, Morou M, et al. Conceptual framework and systematic review of the effects of participants’ and professionals’ preferences in randomised controlled trials. Health Technol Assess. 2005;9(35):1–186. iii-iv.
66.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.CrossRef PubMed
67.Beck AT, Steer RA, Brown GK. Beck Depression Inventory – second edition: manual. 2nd ed. San Antonio: The Psychological Corporation; 1996.
68.Beck CA, Joseph L, Belisle P, Pilote L. QOLAMI Investigators. Predictors of quality of life 6 months and 1 year after acute myocardial infarction. Am Heart J. 2001;142(2):271–9. doi:10.1067/mhj.2001.116758 .CrossRef PubMed
69.Beck AT, Steer RA. Manual for the Beck Anxiety Inventory. San Antonio: The Psychological Corporation; 1990.
70.Beck AT, Steer RA, Ball R, Ciervo CA, Kabat M. Use of the Beck Anxiety and Depression Inventories for primary care with medical outpatients. Assessment. 1997;4(3):211–9.CrossRef PubMed
71.The EuroQol Group. EQ-5D user guide. Rotterdam: The EuroQol Group; 1996.
72.Oldridge N, Hofer S, McGee H, Conroy R, Doyle F, Saner H. The HeartQoL: Part II. Validation of a new core health-related quality of life questionnaire for patients with ischemic heart disease. Eur J Prev Cardiol. 2012. doi:10.1177/2047487312450545.
73.Oldridge N, Hofer S, McGee H, Conroy R, Doyle F, Saner H. The HeartQoL: Part I. Development of a new core health-related quality of life questionnaire for patients with ischemic heart disease. Eur J Prev Cardiol. 2012. doi:10.1177/2047487312450544.
74.Manos RC, Kanter JW, Luo W. The behavioral activation for depression scale-short form: development and validation. Behav Ther. 2011;42(4):726–39. doi:10.1016/j.beth.2011.04.004 .CrossRef PubMed
75.Attkisson C, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233–7.CrossRef PubMed
76.Beecham J, Knapp M. Costing psychiatric interventions. Measuring mental health needs. London: Gaskell; 1992. p. p. viii, 328 p.
77.Weijer C, Grimshaw J, Eccles M, McRae A, White A, Brehaut J, et al. The Ottawa Statement on the ethical design and conduct of cluster randomized trials. PLoS Med. 2012;9(11), e1001346. doi:10.1371/journal.pmed.1001346 .PubMedCentral CrossRef PubMed
78.Campbell MK, Piaggio G, Elbourne DR, Altman DG, Group C. Consort 2010 statement: extension to cluster randomised trials. Br Med J. 2012;345, e5661.CrossRef
79.Eldridge S, Kerry S, Torgerson DJ. Bias in identifying and recruiting participants in cluster randomised trials: what can be done? Br Med J. 2009;339:b4006. doi:10.1136/bmj.b4006 .CrossRef
80.Sturges JE, Hanrahan KJ. Comparing telephone and face-to-face qualitative interviewing: a research note. Qual Res. 2004;4(1):107–18. doi:10.1177/1468794104041110 .CrossRef
81.Ritchie J, Spencer L. Qualitative data analysis for applied policy research. In: Bryman A, Burgess RG, editors. Analyzing qualitative data. London: Routledge; 1994. p. 173–94.CrossRef
82.Gibson A, Britten N, Lynch J. Theoretical directions for an emancipatory concept of patient and public involvement. Health. 2012;16(5):531–47. doi:10.1177/1363459312438563 .PubMed
83.Department of Health, Strategic Commissioning Development Unit. Cardiac Rehabilitation Commissioning Pack. London: UK Department of Health 2010. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/Browsable/DH_117506 . - 作者单位：Suzanne H. Richards (1)
Chris Dickens (1)
Rob Anderson (1)
David A. Richards (1)
Rod S. Taylor (1)
Obioha C. Ukoumunne (2)
David Kessler (3)
Katrina Turner (4)
Willem Kuyken (5)
Manish Gandhi (6)
Luke Knight (6)
Andrew Gibson (7)
Antoinette Davey (1)
Fiona Warren (1)
Rachel Winder (1)
Christine Wright (1)
John Campbell (1)
1. University of Exeter Medical School, St Luke’s Campus, Exeter, EX1 2LU, UK
2. NIHR Collaboration for Leadership in Applied Health Research and Care for the South West Peninsula, University of Exeter Medical School, St Luke’s Campus, Exeter, EX1 2LU, UK
3. School of Social and Community Medicine, University of Bristol, Oakfield House, Oakfield Grove, Clifton, Bristol, BS8 2BN, UK
4. School of Social and Community Medicine, University of Bristol, Canynge Hall, Whatley Road, Bristol, BS8 2PS, UK
5. University Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, 0X3 7JX, UK
6. Royal Devon and Exeter NHS Foundation Trust, Barrack Road, Exeter, EX2 5DW, UK
7. Health and Social Sciences, University of the West of England, Frenchay Campus, Coldharbour Lane, Bristol, BS16 1QY, UK - 刊物主题：Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
- 出版者：BioMed Central
- ISSN：1745-6215
文摘
Background Around 17 % of people eligible for UK cardiac rehabilitation programmes following an acute coronary syndrome report moderate or severe depressive symptoms. While maximising psychological health is a core goal of cardiac rehabilitation, psychological care can be fragmented and patchy. This study tests the feasibility and acceptability of embedding enhanced psychological care, composed of two management strategies of proven effectiveness in other settings (nurse-led mental health care coordination and behavioural activation), within the cardiac rehabilitation care pathway.