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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00705965 on ClinicalTrials.gov