Nội dung được dịch bởi AI, chỉ mang tính chất tham khảo
Đánh giá hiệu quả của việc chăm sóc tâm lý nâng cao cho bệnh nhân có triệu chứng trầm cảm tham gia phục hồi tim mạch so với điều trị thông thường (CADENCE): giao thức nghiên cứu cho một thử nghiệm ngẫu nhiên có kiểm soát theo nhóm
Tóm tắt
Khoảng 17% người đủ điều kiện tham gia các chương trình phục hồi tim mạch ở Vương quốc Anh sau hội chứng mạch vành cấp tính báo cáo có triệu chứng trầm cảm vừa phải hoặc nặng. Trong khi việc tối đa hóa sức khỏe tâm lý là một mục tiêu cốt lõi của phục hồi tim mạch, sự chăm sóc tâm lý có thể bị phân mảnh và không đồng nhất. Nghiên cứu này kiểm tra tính khả thi và sự chấp nhận của việc tích hợp chăm sóc tâm lý nâng cao, bao gồm hai chiến lược quản lý đã được chứng minh hiệu quả trong các bối cảnh khác (hỗ trợ điều phối chăm sóc sức khỏe tâm thần do y tá dẫn dắt và kích hoạt hành vi), trong quy trình chăm sóc phục hồi tim mạch. Nghiên cứu này xác định những bất định liên quan đến một đánh giá quy mô lớn bằng cách tiến hành một thử nghiệm pilot bên ngoài với một nghiên cứu định tính lồng ghép. Chúng tôi nhằm mục tiêu tuyển dụng và phân ngẫu nhiên tám đội phục hồi tim mạch toàn diện (cụm) vào các nhóm can thiệp (tích hợp chăm sóc tâm lý nâng cao vào các chương trình phục hồi tim mạch thông thường) hoặc đối chứng (chỉ các chương trình phục hồi tim mạch thông thường). Tối đa 64 bệnh nhân (tám bệnh nhân mỗi đội) được xác định có triệu chứng trầm cảm khi đánh giá ban đầu bởi đội phục hồi tim mạch sẽ được tuyển dụng, và các tiêu chí nghiên cứu sẽ được áp dụng tại thời điểm cơ bản (trước khi bắt đầu phục hồi) và vào 5 tháng và 8 tháng sau thời điểm cơ bản. Các kết quả bao gồm triệu chứng trầm cảm, tỷ lệ tử vong và bệnh tật tim mạch, lo âu, chất lượng cuộc sống liên quan đến sức khỏe và mức độ sử dụng tài nguyên dịch vụ. Dữ liệu thí nghiệm về việc tuyển dụng đội ngũ tim mạch và bệnh nhân, cũng như việc giữ chân và dòng chảy của bệnh nhân qua quá trình điều trị sẽ được sử dụng để đánh giá tính khả thi và sự chấp nhận của can thiệp. Các phỏng vấn định tính sẽ được tiến hành để khám phá quan điểm và trải nghiệm của những người tham gia thử nghiệm và các y tá phục hồi tim mạch về các phương pháp thử nghiệm và can thiệp, cũng như xác định lý do mà bệnh nhân từ chối tham gia vào thử nghiệm. Dữ liệu kết quả sẽ cung cấp thông tin cho tính toán kích thước mẫu cho một thử nghiệm xác định. Thử nghiệm pilot và nghiên cứu định tính sẽ thông tin cho việc thiết kế một thử nghiệm ngẫu nhiên có kiểm soát theo cụm với quy mô đầy đủ để đánh giá hiệu quả và chi phí- hiệu quả của việc cung cấp chăm sóc tâm lý nâng cao trong các chương trình phục hồi tim mạch.
Từ khóa
#chăm sóc tâm lý #phục hồi tim mạch #trầm cảm #nghiên cứu ngẫu nhiên #thử nghiệm lâm sàngTài liệu tham khảo
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.
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.
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.
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.
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.
Rugulies R. Depression as a predictor for coronary heart disease. a review and meta-analysis. Am J Prev Med. 2002;23(1):51–61.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
NICE commissioning guides. Cardiac rehabilitation services. London 2013 01 November 2013.
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.
NACR. National Audit of Cardiac Rehabilitation: 2012. London, UK: British Heart Foundation; 2012.
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.
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.
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.).
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.).
Bird A. We need to talk: the case for psychological therapy on the NHS. UK: Mental Health Foundation; 2006.
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.
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.
Layard R. The case for psychological treatment centres. Br Med J. 2006;332(7548):1030–2.
London School of Economics. The Depression Report. A new deal for depression and anxiety disorders. London: London School for Economics; 2006.
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.
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.
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.
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.
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.
Richards D, Farrand P, Chellingsworth M. National Curriculum for the Education of Psychological Wellbeing Practitioners (PWPS). Lancashire: British Association for Behavioural & Cognitive Psychotherapies; 2011.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
NACR. The National Audit of Cardiac Rehabilitation: annual statistical report 2014. London: British Heart Foundation; 2014.
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.
Lewis G. Assessing psychiatric disorder with a human interviewer or a computer. J Epidemiol Community Health. 1994;48(2):207–10.
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.
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.
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.
Beck AT, Steer RA, Brown GK. Beck Depression Inventory – second edition: manual. 2nd ed. San Antonio: The Psychological Corporation; 1996.
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.
Beck AT, Steer RA. Manual for the Beck Anxiety Inventory. San Antonio: The Psychological Corporation; 1990.
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.
The EuroQol Group. EQ-5D user guide. Rotterdam: The EuroQol Group; 1996.
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.
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.
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.
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.
Beecham J, Knapp M. Costing psychiatric interventions. Measuring mental health needs. London: Gaskell; 1992. p. p. viii, 328 p.
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.
Campbell MK, Piaggio G, Elbourne DR, Altman DG, Group C. Consort 2010 statement: extension to cluster randomised trials. Br Med J. 2012;345, e5661.
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.
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.
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.
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.
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.