Effects of a Psychotherapy Intervention in Depressed Patients With Coronary Artery Disease

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Depression
• Interventions: Behavioral: Information session; Behavioral: Psychotherapy; Other: Usual cardiological care

• Registration Number: NCT00705965
• Lead Sponsor: University of Göttingen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-25
• Study First Submitted QC: 2008-06-26
• Study First Posted: 2008-06-27
• Study Start: 2008-11
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

• Patients with coronary artery disease
• German speaking men and women
• Recent coronary angiogram (<= 3 months old)
• Depression score (HADS-D) >= 8
• Written informed consent

Exclusion Criteria

• Severe heart failure
• Other acutely life- threatening conditions
• Severe chronic inflammatory disease
• Current suicidal tendency
• Severe depressive episode
• Other severe mental illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Usual cardiological care	Usual cardiological care including one information session.
2	Information session	Usual cardiological care including one information session.
1	Psychotherapy	Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
1	Usual cardiological care	Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.

Primary Outcome Measures

Name	Time	Method
Changes from baseline to 18 months in depressive symptoms (HADS-D)	18 months

Secondary Outcome Measures

Name	Time	Method
coagulation	18 months
heart rate variability	18 months
cardiac events	18 months
Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D)	18 months
Health-related quality of life (SF36, EuroQuol-5D)	18 months
cardiovascular risk profile	18 months
neuroendocrine and immunological activation	18 months
health care utilisation and costs	18 months

Trial Locations

Locations (10)

Berlin University Medical Center, Campus Benjamin Franklin, Dept. of Psychosomatics and Psychotherapy; 🇩🇪 Berlin, Germany

Technical University of Dresden, Dept. of Psychotherapy and Psychosomatics; 🇩🇪 Dresden, Germany

University of Cologne, Dept. Psychosomatics and Psychotherapy; 🇩🇪 Cologne, Germany

Nuremberg General Hospital, Department of Psychosomatic Medicine and Psychotherapy; 🇩🇪 Nuremberg, Germany

University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy; 🇩🇪 Goettingen, Germany

Hannover Medical School, Dept. of Psychosomatics and Psychotherapy; 🇩🇪 Hannover, Germany

University of Heidelberg, Dept. of General Internal and Psychosomatic Medicine; 🇩🇪 Heidelberg, Germany

University Hospital of Freiburg, Dept. of Psychosomatic Medicine and Psychotherapy; 🇩🇪 Freiburg, 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; 🇩🇪 Muenchen, Germany