Abstract
BackgroundThere 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/designThe 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.DiscussionThe 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 registrationClinicalTrials.gov Identifier: NCT01543815.
Highlights
Hypotheses Starting from current literature, we hypothesize that wellbeing therapy (WBT) and WBT version based on a personalized mobile technology approach will allow for a reduction of symptoms of depression, anxiety, and psychological distress in cardiac patients
E cognitive behavior therapy (CBT)-Anxiety addresses negative patterns and distortions in the way we look at the world and at ourselves
The Psychological General Wellbeing Index (PGWBI) Planned statistical analyses is an index to measure the level of subjective psycho- The demographic and clinical characteristics of the two logical wellbeing that has been validated by decades of study groups will be compared at baseline to verify their clinical practice
Summary
The present study is a large outpatient study on the treatment of co-morbid depression, anxiety, and psychological distress in cardiac patients. T Keywords: Anxiety, Depression, Psychological distress, Cognitive behavior therapy, Wellbeing therapy, Mobile RE technology, Cardiac disease. D Affective disorders including clinical depression and anxiety are common in patients with congestive heart failure. Psychological interventions for anxiety and depression Major behavioral and drug trials conducted in the last 15 years have focused on the best treatment of depression in cardiac patients [21]. WBT aims at enblems may contribute to anxiety or depression, while so- hancing psychological wellbeing on the basis of Ryff’s cial support and active relationships may positively [25] six dimensions: autonomy, personal growth, envirinfluence the psychological health of patients with heart onmental mastery, purpose in life, positive relations, and self-acceptance. After showed that a sequential combination of CBT and WBT this interview, patients satisfying inclusion criteria are yield significant and persistent benefits in cyclothymic further informed about the design of the study and disorder [29]
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