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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depression Coronary Artery Disease | Behavioral: Psychotherapy Behavioral: Information session Other: Usual cardiological care | Not Applicable |
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 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
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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 |
- Changes from baseline to 18 months in depressive symptoms (HADS-D) [ Time Frame: 18 months ]
- Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D) [ Time Frame: 18 months ]
- Health-related quality of life (SF36, EuroQuol-5D) [ Time Frame: 18 months ]
- cardiovascular risk profile [ Time Frame: 18 months ]
- neuroendocrine and immunological activation [ Time Frame: 18 months ]
- coagulation [ Time Frame: 18 months ]
- heart rate variability [ Time Frame: 18 months ]
- cardiac events [ Time Frame: 18 months ]
- health care utilisation and costs [ Time Frame: 18 months ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
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.

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
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 |
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 |
Study Data/Documents: treatment manual and supplemental content

Publications of Results:
Other Publications:
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 |
First Posted: | June 27, 2008 Key Record Dates |
Last Update Posted: | August 30, 2016 |
Last Verified: | August 2016 |
Coronary artery disease depression psychotherapy randomized controlled trial |
Coronary Artery Disease Myocardial Ischemia Coronary Disease Depression Behavioral Symptoms |
Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |