WELL.ME - Wellbeing therapy based on real-time personalized mobile architecture, vs. cognitive therapy, to reduce psychological distress and promote healthy lifestyle in cardiovascular disease patients: study protocol for a randomized controlled trial.

BACKGROUND: There is compelling evidence that psychological factors may have the same or even greater impact on the possibility of adverse events on cardiac diseases (CD) than other traditional clinical risk factors. Anxiety and depression are predictors of short- and long-term adverse outcomes, increased risk for higher rates of in-hospital complications, re-infarction, malignant arrhythmias, and mortality in CD patients. Despite researchers finding that cognitive behavior therapy (CBT) reduced depressive and anxiety symptoms, the fact that such results are maintained only in the short term and the lack of maintenance of the long-term affects the absence of changes in lifestyles, preventing the possibility of a wide generalization of results. Recently wellbeing therapy (WBT) has been proposed as a useful approach to improve healthy lifestyle behaviors and reduce psychological distress. METHODS/DESIGN: The present randomized controlled study will test WBT, in comparison with CBT, as far as the reduction of symptoms of depression, anxiety and psychological distress, and the improvement of lifestyle behaviors and quality of life in cardiac patients are concerned. Moreover, innovations in communication technologies allow patients to be constantly followed in real life. Therefore WBT based on personalized mobile technology will allow the testing of its effectiveness in comparison with usual WBT. DISCUSSION: The present study is a large outpatient study on the treatment of co-morbid depression, anxiety, and psychological distress in cardiac patients. The most important issues of this study are its randomized design, the focus on promotion of health-related behaviors, and the use of innovative technologies supporting patients' wellbeing in real life and in a continuous way. First results are expected in 2012. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01543815.