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

BMC Psychiatry

Study Protocol

Petra JM Elders¹  Harm WJ van Marwijk¹  Judith E Bosmans²  Susan EM van Dijk²  Maurits W van Tulder²  Marcel C Adriaanse²  Alide D Pols³ 

[1] Department of General Practice and the EMGO institute for Health and Care research, VU University Medical Centre, Amsterdam, The Netherlands;Department of Health Sciences and the EMGO institute for Health and Care research, Faculty of Earth and Life Sciences, VU University Amsterdam, De Boelelaan 1085, 1081, Amsterdam, HV, The Netherlands;Department of Health Sciences and the EMGO institute for Health and Care research, Faculty of Earth and Life Sciences, VU University Amsterdam, De Boelelaan 1085, 1081, Amsterdam, HV, The Netherlands;Department of General Practice and the EMGO institute for Health and Care research, VU University Medical Centre, Amsterdam, The Netherlands;

关键词: Subthreshold depression;    Depression prevention;    Cost-effectiveness;    Type 2 diabetes mellitus;    Coronary heart disease;    Stepped-care;    Primary care;    Nurse led treatment;   

DOI  :  10.1186/1471-244X-13-128

 received in 2013-04-10, accepted in 2013-04-24,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundCo-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/designAn 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.DiscussionThe 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.Trial registrationDutch Trial Register NTR3715

【 授权许可】

CC BY   
© van Dijk et al.; licensee BioMed Central Ltd. 2013