Study protocol

Cost-effectiveness analysis of cognitive behaviour therapy for treatment of minor or mild-major depression in elderly patients with type 2 diabetes: study protocol for the economic evaluation alongside the MIND-DIA randomized controlled trial (MIND-DIA CEA)

Nadja Chernyak¹ , Frank Petrak² , Kristin Plack³ , Martin Hautzinger⁴ , Matthias J Müller⁵ , Guido Giani¹ and Andrea Icks¹

¹  Institute of Biometrics and Epidemiology, German Diabetes Research Centre, Düsseldorf, Germany

²  Department of Psychosomatic Medicine and Psychotherapy, LWL-Clinic Dortmund/Ruhr-University of Bochum, Dortmund, Germany

³  Department of Clinical Psychology and Psychotherapy, Johannes Gutenberg University, Mainz, Germany

⁴  Department of Psychology, Clinical Psychology and Psychotherapy, Eberhard Karls University, Tübingen, Germany

⁵  Clinic for Psychiatry and Psychotherapy, Giessen, and Clinic for Psychiatry and Psychotherapy, Marburg-Süd, Germany

author email corresponding author email

BMC Geriatrics 2009, 9:25doi:10.1186/1471-2318-9-25

Published:	1 July 2009

Abstract

Background

Depression and elevated depression symptoms are more prevalent in patients with type 2 diabetes than in those without diabetes and are associated with adverse health outcomes and increased total healthcare utilization. This suggests that more effective depression treatment might not only improve health outcome, but also reduce costs. However, there is a lack of evidence on (cost-) effectiveness of treatment options for minor and mild-major depression in patients with type 2 diabetes. In this paper we describe the design and methods of the economic evaluation, which will be conducted alongside the MIND-DIA trial (Cognitive behaviour therapy in elderly type 2 diabetes patients with minor or mild-major depression). The objective of the economic evaluation (MIND-DIA CEA) is to examine incremental cost-effectiveness of a diabetes specific cognitive behaviour group therapy (CBT) as compared to intensified treatment as usual (TAU) and to a guided self-help group intervention (SH).

Methods/Design

Patients will be followed for 15 months. During this period data on health sector costs, patient costs and societal productivity/time costs will be collected in addition to clinical data. Person-years free of moderate/severe major depression, quality adjusted life years (QALYs), and cumulative costs will be estimated for each arm of the trial (CBT, TAU and SH). To determine cost-effectiveness of the CBT, differences in costs and effects between the CBT group and TAU/SH group will be calculated.

Discussion

CBT is a potentially effective treatment option to improve quality of life and to avoid the onset of a moderate/severe major depression in elderly patients with type 2 diabetes and minor or mild-major depression. This hypothesis will be evaluated in the MIND-DIA trial. Based on these results the associated economic evaluation will provide additional evidence on the cost-effectiveness of CBT in this target population. Methodological strengths and weaknesses of the planned economic evaluation are discussed.

Trial registration

The MIND-DIA study has been registered at the Current Controlled Trials Register (ISRCTN58007098).