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Effects of a Psychotherapy Intervention in Depressed Patients With Coronary Artery Disease (SPIRR-CAD)

This study has been completed.
Sponsor:
Collaborators:
University of Cologne
Johannes Gutenberg University Mainz
Humboldt-Universität zu Berlin
University Hospital Freiburg
Kerckhoff Rehabilitation Center Bad Nauheim
Heidelberg University
Hannover Medical School
Technische Universität München
Technische Universität Dresden
Nuremberg General Hospital
Clinical Trials Center Cologne
German Research Foundation
Medical University of Graz
Information provided by (Responsible Party):
Christoph Herrmann-Lingen, University of Göttingen
ClinicalTrials.gov Identifier:
NCT00705965
First received: June 25, 2008
Last updated: June 19, 2014
Last verified: June 2014
History of Changes
  Purpose

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.


Condition Intervention
Depression
Coronary Artery Disease
 Behavioral: Psychotherapy
Behavioral: Information session
Other: Usual cardiological care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Göttingen:

Primary Outcome Measures:
  • Changes from baseline to 18 months in depressive symptoms (HADS-D) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Health-related quality of life (SF36, EuroQuol-5D) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • cardiovascular risk profile [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • neuroendocrine and immunological activation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • coagulation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • heart rate variability [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • cardiac events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • health care utilisation and costs [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Enrollment: 570
Study Start Date: November 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
 Behavioral: Psychotherapy
Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
Other Name: Stepwise manualized psychotherapy
Other: Usual cardiological care
Usual cardiological care
Other Name: Usual cardiological care
Active Comparator: 2
Usual cardiological care including one information session.
 Behavioral: Information session
One information session about living with heart disease.
Other Name: Information session
Other: Usual cardiological care
Usual cardiological care
Other Name: Usual cardiological care

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705965

Locations
Germany
Berlin University Medical Center, Campus Benjamin Franklin, Dept. of Psychosomatics and Psychotherapy
Berlin, Germany, D-12200
University of Cologne, Dept. Psychosomatics and Psychotherapy
Cologne, Germany, D-50931
Technical University of Dresden, Dept. of Psychotherapy and Psychosomatics
Dresden, Germany, D-01307
University Hospital of Freiburg, Dept. of Psychosomatic Medicine and Psychotherapy
Freiburg, Germany, D-79104
University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy
Goettingen, Germany, D-37075
Hannover Medical School, Dept. of Psychosomatics and Psychotherapy
Hannover, Germany, D-30625
University of Heidelberg, Dept. of General Internal and Psychosomatic Medicine
Heidelberg, Germany, D-69120
University Hospital of Mainz, Dept. of Psychosomatic Medicine and Psychotherapy
Mainz, Germany, D-55131
Technical University of Munich, Institute and Dept. of Psychosomatic Medicine, Psychotherapy and Medical Psychology
Muenchen, Germany, D- 81675
Nuremberg General Hospital, Department of Psychosomatic Medicine and Psychotherapy
Nuremberg, Germany, D-90419
Sponsors and Collaborators
University of Göttingen
University of Cologne
Johannes Gutenberg University Mainz
Humboldt-Universität zu Berlin
University Hospital Freiburg
Kerckhoff Rehabilitation Center Bad Nauheim
Heidelberg University
Hannover Medical School
Technische Universität München
Technische Universität Dresden
Nuremberg General Hospital
Clinical Trials Center Cologne
German Research Foundation
Medical University of Graz
Investigators
Principal Investigator: Christoph Herrmann-Lingen, MD University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy
Principal Investigator: Christian Albus, MD University of Cologne, Dept. of Psychosomatics and Psychotherapy
  More Information

No publications provided by University of Göttingen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christoph Herrmann-Lingen, Professor Dr., University of Göttingen
ClinicalTrials.gov Identifier: NCT00705965     History of Changes
Other Study ID Numbers: ZKSK-371
Study First Received: June 25, 2008
Last Updated: June 19, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Göttingen:
Coronary artery disease
depression
psychotherapy
randomized controlled trial

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
 Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015