BMC Public Health Study protocol The effectiveness of adding cognitive behavioural therapy aimed at changing lifestyle to managed diabetes care for patients with type 2 diabetes: design of a randomised controlled trial Laura MC Welschen*1,2, Patricia van Oppen1,2,3, Jacqueline M Dekker1, Lex M Bouter1, Wim AB Stalman1,2 and Giel Nijpels1,2 BioMed Central Open Access Address: 1EMGO Institute, VU University Medical Center, Amsterdam, the Netherlands, 2Department of General Practice, VU University Medical Center, Amsterdam, the Netherlands and 3Department of Psychiatry, VU University Medical Center, Amsterdam, The Netherlands Email: Laura MC Welschen* - l.welschen@vumc.nl; Patricia van Oppen - pvanoppen@ggzba.nl; Jacqueline M Dekker - jm.dekker@vumc.nl; Lex M Bouter - lm.bouter@dienst.vu.nl; Wim AB Stalman - w.stalman@vumc.nl; Giel Nijpels - g.nijpels@vumc.nl * Corresponding author Published: 8 May 2007 BMC Public Health 2007, 7:74 doi:10.1186/1471-2458-7-74 This article is available from: http://www.biomedcentral.com/1471-2458/7/74 Received: 15 June 2006 Accepted: 8 May 2007 © 2007 Welschen et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Background: In patients with type 2 diabetes, the risk for cardiovascular disease is substantial. To achieve a more favourable risk profile, lifestyle changes on diet, physical activity and smoking status are needed. This will involve changes in behaviour, which is difficult to achieve. Cognitive behavioural therapies focussing on self-management have been shown to be effective. We have developed an intervention combining techniques of Motivational Interviewing (MI) and Problem Solving Treatment (PST). The aim of our study is to investigate if adding a combined behavioural intervention to managed care, is effective in achieving changes in lifestyle and cardiovascular risk profile. Methods: Patients with type 2 diabetes will be selected from general practices (n = 13), who are participating in a managed diabetes care system. Patients will be randomised into an intervention group receiving cognitive behaviour therapy (CBT) in addition to managed care, and a control group that will receive managed care only. The CBT consists of three to six individual sessions of 30 minutes to increase the patient's motivation, by using principles of MI, and ability to change their lifestyle, by using PST. The first session will start with a risk assessment of diabetes complications that will be used to focus the intervention. The primary outcome measure is the difference between intervention and control group in change in cardiovascular risk score. For this purpose blood pressure, HbA1c, total and HDL-cholesterol and smoking status will be assessed. Secondary outcome measures are quality of life, patient satisfaction, physical activity, eating behaviour, smoking status, depression and determinants of behaviour change. Differences between changes in the two groups will be analysed according to the intention-to-treat principle, with 95% confidence intervals. The power calculation is based on the risk for cardiovascular disease and we calculated that 97 patients should be included in every group. Discussion: Cognitive behavioural therapy may improve self-management and thus strengthen managed diabetes care. This should result in changes in lifestyle and cardiovascular risk profile. In addition, we also expect an improvement of quality of life and patient satisfaction. Trial registration: Current Controlled Trials ISRCTN12666286 Page 1 of 10 (page number not for citation purposes)