Effects of a Psychotherapy Intervention in Depressed Patients With Coronary Artery Disease
NCT00705965 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 570
Last updated 2016-08-30
Summary
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.
Conditions
Interventions
- BEHAVIORAL
-
Psychotherapy
Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
- BEHAVIORAL
-
Information session
One information session about living with heart disease.
- OTHER
-
Usual cardiological care
Usual cardiological care
Sponsors & Collaborators
-
University of Cologne
collaborator OTHER -
Johannes Gutenberg University Mainz
collaborator OTHER -
Humboldt-Universität zu Berlin
collaborator OTHER -
University Hospital Freiburg
collaborator OTHER -
Kerckhoff Rehabilitation Center Bad Nauheim
collaborator UNKNOWN -
Heidelberg University
collaborator OTHER -
Hannover Medical School
collaborator OTHER -
Technical University of Munich
collaborator OTHER -
Technische Universität Dresden
collaborator OTHER -
Nuremberg General Hospital
collaborator UNKNOWN -
The Clinical Trials Centre Cologne
collaborator OTHER -
German Research Foundation
collaborator OTHER -
Medical University of Graz
collaborator OTHER -
University of Göttingen
lead OTHER
Principal Investigators
-
Christoph Herrmann-Lingen, MD · University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy
-
Christian Albus, MD · University of Cologne, Dept. of Psychosomatics and Psychotherapy
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-11-30
- Primary Completion
- 2013-04-30
- Completion
- 2013-04-30
Countries
- Germany
Study Locations
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