In patients with coronary artery disease (CAD), depressive symptoms are frequent and highly relevant for quality of life, health behaviour, health care costs, and prognosis. The aim of the current study is to evaluate the effects of a psychotherapy intervention on symptoms of depression in patients with CAD. Therefore, depressed patients diagnosed with CAD will be randomised into a controlled intervention trial, comparing a stepwise psychotherapy intervention with usual cardiological care. The manualized psychotherapy intervention starts with three individual sessions offered on a weekly basis. Afterwards, symptoms of depression will be re-evaluated and, in case of persisting symptoms, patients receive an additional 25 sessions of psychodynamic group psychotherapy over a total period of one year. The psychodynamic approach was chosen in order to specifically take into account personality traits such as negative affectivity and social inhibition, the components of the Type D personality, which may explain why recent cognitive behavioural psychotherapy (CBT) trials produced only small effects in depressed CAD patients. The investigators expect that the intervention will reduce depressive symptoms as well as the prevalence of depressive disorders. It will also improve both behaviourally and physiologically mediated cardiovascular risk indicators, promote better quality of life, and reduce healthcare costs. Subgroup analyses will be performed in order to identify gender-specific treatment effects, effects on immunological stress reactivity, and genetic predictors of treatment success.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
570
Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
One information session about living with heart disease.
Usual cardiological care
Berlin University Medical Center, Campus Benjamin Franklin, Dept. of Psychosomatics and Psychotherapy
Berlin, Germany
University of Cologne, Dept. Psychosomatics and Psychotherapy
Cologne, Germany
Technical University of Dresden, Dept. of Psychotherapy and Psychosomatics
Dresden, Germany
University Hospital of Freiburg, Dept. of Psychosomatic Medicine and Psychotherapy
Freiburg im Breisgau, Germany
University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy
Göttingen, Germany
Hannover Medical School, Dept. of Psychosomatics and Psychotherapy
Hanover, Germany
University of Heidelberg, Dept. of General Internal and Psychosomatic Medicine
Heidelberg, Germany
University Hospital of Mainz, Dept. of Psychosomatic Medicine and Psychotherapy
Mainz, Germany
Technical University of Munich, Institute and Dept. of Psychosomatic Medicine, Psychotherapy and Medical Psychology
München, Germany
Nuremberg General Hospital, Department of Psychosomatic Medicine and Psychotherapy
Nuremberg, Germany
Changes from baseline to 18 months in depressive symptoms (HADS-D)
Time frame: 18 months
Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D)
Time frame: 18 months
Health-related quality of life (SF36, EuroQuol-5D)
Time frame: 18 months
cardiovascular risk profile
Time frame: 18 months
neuroendocrine and immunological activation
Time frame: 18 months
coagulation
Time frame: 18 months
heart rate variability
Time frame: 18 months
cardiac events
Time frame: 18 months
health care utilisation and costs
Time frame: 18 months
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