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

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.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.Current Controlled Trials ISRCTN12666286Diabetes mellitus is a major health problem. It was estimated that in 2000 approximately 177 million people worldwide had diabetes, and this number is expected to double by the year 2030 [1]. Cardiovascular disease is the leading cause of death among patients with diabetes. Both cardiovascular disease and diabetes are associated with similar risk factors, namely unhealthy diet, smokin