title: Cost-effectiveness of a stepped-care intervention to prevent major depression in patients with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression: design of a cluster-randomized controlled trial.
abstract: BACKGROUND
  Co-morbid major depression is a significant problem among patients with type 2 diabetes mellitus and/or coronary heart disease and this negatively impacts quality of life. Subthreshold depression is the most important risk factor for the development of major depression. Given the highly significant association between depression and adverse health outcomes and the limited capacity for depression treatment in primary care, there is an urgent need for interventions that successfully prevent the transition from subthreshold depression into a major depressive disorder. Nurse led stepped-care is a promising way to accomplish this. The aim of this study is to evaluate the cost-effectiveness of a nurse-led indicated stepped-care program to prevent major depression among patients with type 2 diabetes mellitus and/or coronary heart disease in primary care who also have subthreshold depressive symptoms.
  
  
  METHODS
  An economic evaluation will be conducted alongside a cluster-randomized controlled trial in approximately thirty general practices in the Netherlands. Randomization takes place at the level of participating practice nurses. We aim to include 236 participants who will either receive a nurse-led indicated stepped-care program for depressive symptoms or care as usual. The stepped-care program consists of four sequential but flexible treatment steps: 1) watchful waiting, 2) guided self-help treatment, 3) problem solving treatment and 4) referral to the general practitioner. The primary clinical outcome measure is the cumulative incidence of major depressive disorder as measured with the Mini International Neuropsychiatric Interview. Secondary outcomes include severity of depressive symptoms, quality of life, anxiety and physical outcomes. Costs will be measured from a societal perspective and include health care utilization, medication and lost productivity costs. Measurements will be performed at baseline and 3, 6, 9 and 12 months.
  
  
  CONCLUSIONS
  The intervention being investigated is expected to prevent new cases of depression among people with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression, with subsequent beneficial effects on quality of life, clinical outcomes and health care costs. When proven cost-effective, the program provides a viable treatment option in the Dutch primary care system.
  
  
  BACKGROUND
  Dutch Trial Register NTR3715.
authors: Department of Health Sciences and the EMGO institute for Health and Care research, Faculty of Earth and Life Sciences, VU University Amsterdam, Amsterdam, The Netherlands. s.e.m.van.dijk@vu.nl
authors: Susan E M
authors: SE
authors: van Dijk
authors: Alide D
authors: AD
authors: Pols
authors: Marcel C
authors: MC
authors: Adriaanse
authors: Judith E
authors: JE
authors: Bosmans
authors: Petra J M
authors: PJ
authors: Elders
authors: Harm W J
authors: HW
authors: van Marwijk
authors: Maurits W
authors: MW
authors: van Tulder
mesh_terms: D000368:Aged; D002985:Clinical Protocols; D003327:Coronary Disease / Q000150:complications* / Q000191:economics / Q000523:psychology; D003362:Cost-Benefit Analysis; D003863:Depression / Q000150:complications / Q000191:economics / Q000628:therapy*; D003865:Major Depressive Disorder / Q000191:economics / Q000209:etiology / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000191:economics / Q000523:psychology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012107:Research Design
references: Br J Psychiatry. 2004 Jun;184:526-33
references: 15172947
references: BMJ. 2000 Apr 29;320(7243):1197-200
references: 10784550
references: Contemp Clin Trials. 2010 Jul;31(4):312-22
references: 20350619
references: Arch Gen Psychiatry. 2004 Oct;61(10):1042-9
references: 15466678
references: JAMA. 2012 Mar 14;307(10):1033-4
references: 22416097
references: Gen Hosp Psychiatry. 1996 Jan;18(1):61-5
references: 8666215
references: Psychother Psychosom. 2007;76(6):354-60
references: 17917471
references: Diabet Med. 2010 Nov;27(11):1295-301
references: 20950389
references: Gen Hosp Psychiatry. 2009 Sep-Oct;31(5):451-9
references: 19703639
references: Diabetes Care. 2002 Mar;25(3):464-70
references: 11874931
references: PLoS Med. 2006 Nov;3(11):e442
references: 17132052
references: Pharmacoeconomics. 2007;25(1):25-37
references: 17192116
references: Br J Psychiatry. 2006 Apr;188:330-6
references: 16582059
references: Med Care. 2003 Nov;41(11):1284-92
references: 14583691
references: Arch Gen Psychiatry. 1981 Apr;38(4):381-9
references: 6260053
references: Br J Psychiatry. 1997 Feb;170:113-9
references: 9093498
references: Am J Epidemiol. 1997 Sep 15;146(6):510-9
references: 9290512
references: Eval Program Plann. 1983;6(3-4):395-400
references: 10267266
references: J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57
references: 9881538
references: Eur Addict Res. 2005;11(4):157-62
references: 16110221
references: Diabetes Metab Res Rev. 2010 Feb;26(2):75-89
references: 20186998
references: Psychol Med. 1997 Mar;27(2):363-70
references: 9089829
references: Arch Intern Med. 2005 Nov 28;165(21):2508-13
references: 16314548
references: Am J Geriatr Psychiatry. 2011 Mar;19(3):230-9
references: 21425519
references: Biol Psychiatry. 2003 Aug 1;54(3):227-40
references: 12893099
references: Arch Gen Psychiatry. 2005 Dec;62(12):1313-20
references: 16330719
references: J Health Soc Behav. 1978 Mar;19(1):2-21
references: 649936
references: J Gen Intern Med. 2006 Jan;21(1):30-8
references: 16423120
references: Diabetes Care. 2006 Feb;29(2):265-70
references: 16443871
references: Am J Psychiatry. 2008 Oct;165(10):1272-80
references: 18765483
references: Health Policy. 1996 Jul;37(1):53-72
references: 10158943
references: Diabetes Care. 2001 Jun;24(6):1069-78
references: 11375373
references: Soc Psychiatry Psychiatr Epidemiol. 2012 Feb;47(2):203-13
references: 21197531
references: J Gen Intern Med. 2002 Oct;17(10):741-8
references: 12390549
references: JAMA. 2003 Jul 9;290(2):215-21
references: 12851276
references: Annu Rev Clin Psychol. 2010;6:181-212
references: 20192789
references: Diabetes Care. 2008 Jun;31(6):1155-9
references: 18332158
references: J Clin Epidemiol. 1996 Dec;49(12):1407-17
references: 8970491
references: Am J Geriatr Psychiatry. 2008 Jun;16(6):444-53
references: 18515688
references: Diabetes Care. 2004 Sep;27(9):2154-60
references: 15333477
references: Tijdschr Psychiatr. 2007;49(6):393-7
references: 17614093
references: N Engl J Med. 2010 Dec 30;363(27):2611-20
references: 21190455
references: Health Econ. 2004 May;13(5):405-15
references: 15127421
references: Gen Hosp Psychiatry. 2005 Sep-Oct;27(5):344-51
references: 16168795
references: BMC Fam Pract. 2010 Dec 13;11:98
references: 21144018
references: Arch Gen Psychiatry. 2007 Jan;64(1):65-72
references: 17199056
references: Arch Gen Psychiatry. 2009 Mar;66(3):297-304
references: 19255379
references: J Am Coll Cardiol. 2009 Jan 13;53(2):176-83
references: 19130986
references: Ann Fam Med. 2010 Jul-Aug;8(4):348-53
references: 20644190
references: BMC Health Serv Res. 2012 Feb 23;12:46
references: 22361361
references: Ann Fam Med. 2009 Sep-Oct;7(5):414-21
references: 19752469