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Open Access Study protocol

Within-trial economic evaluation of diabetes-specific cognitive behaviour therapy in patients with type 2 diabetes and subthreshold depression

Nadja Chernyak12*, Bernd Kulzer3, Norbert Hermanns3, Andreas Schmitt3, Annika Gahr3, Thomas Haak3, Johannes Kruse4, Christian Ohmann5, Marsel Scheer2, Guido Giani2 and Andrea Icks12

Author Affiliations

1 Department of Public Health, Center of Health and Society, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany

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

3 Diabetes Center Mergentheim, Bad Mergentheim, Germany

4 Clinic for Psychosomatic and Psychotherapy, Universitäty Clinics Gießen/Marburg, Marburg, Germany

5 Coordination Center for Clinical Trials, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany

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BMC Public Health 2010, 10:625  doi:10.1186/1471-2458-10-625

Published: 19 October 2010

Abstract

Background

Despite the high prevalence of subthreshold depression in patients with type 2 diabetes, evidence on cost-effectiveness of different therapy options for these patients is currently lacking.

Methods/Design

Within-trial economic evaluation of the diabetes-specific cognitive behaviour therapy for subthreshold depression. Patients with diabetes and subthreshold depression are randomly assigned to either 2 weeks of diabetes-specific cognitive behaviour group therapy (n = 104) or to standard diabetes education programme only (n = 104). Patients are followed for 12 months. During this period data on total health sector costs, patient costs and societal productivity costs are collected in addition to clinical data. Health related quality of life (the SF-36 and the EQ-5D) is measured at baseline, immediately after the intervention, at 6 and at 12 months after the intervention. Quality adjusted life years (QALYs), and cumulative costs will be estimated for each arm of the trial. Cost-effectiveness of the diabetes-specific cognitive behaviour group therapy will be analysed from the perspective of the German statutory health insurance and from the societal perspective. To this end, incremental cost-effectiveness ratio (ICER) in terms of cost per QALY gained will be calculated.

Discussion

Some methodological issues of the described economic evaluation are discussed.

Trial registration

The trial has been registered at the Clinical Trials Register (NCT01009138).