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

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ClinicalTrials.gov Identifier: NCT00705965
Recruitment Status : Completed
First Posted : June 27, 2008
Last Update Posted : August 30, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Depression Coronary Artery Disease Behavioral: Psychotherapy Behavioral: Information session Other: Usual cardiological care

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)
Study Start Date : November 2008
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Active Comparator: 2
Usual cardiological care including one information session.
Behavioral: Information session
One information session about living with heart disease.
Other: Usual cardiological care
Usual cardiological care

Outcome Measures

Primary Outcome Measures :
  1. Changes from baseline to 18 months in depressive symptoms (HADS-D) [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D) [ Time Frame: 18 months ]
  2. Health-related quality of life (SF36, EuroQuol-5D) [ Time Frame: 18 months ]
  3. cardiovascular risk profile [ Time Frame: 18 months ]
  4. neuroendocrine and immunological activation [ Time Frame: 18 months ]
  5. coagulation [ Time Frame: 18 months ]
  6. heart rate variability [ Time Frame: 18 months ]
  7. cardiac events [ Time Frame: 18 months ]
  8. health care utilisation and costs [ Time Frame: 18 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705965

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
The Clinical Trials Centre Cologne
German Research Foundation
Medical University of Graz
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

Study Data/Documents: treatment manual and supplemental content  This link exits the ClinicalTrials.gov site

Responsible Party: Christoph Herrmann-Lingen, Professor Dr., University of Göttingen
ClinicalTrials.gov Identifier: NCT00705965     History of Changes
Other Study ID Numbers: ZKSK-371
First Posted: June 27, 2008    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016

Keywords provided by Christoph Herrmann-Lingen, University of Göttingen:
Coronary artery disease
randomized controlled trial

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