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

The Clinical Trials Centre 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: August 26, 2016

Last verified: August 2016

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:

MedlinePlus related topics: Coronary Artery Disease

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
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

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
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

The Clinical Trials Centre 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

Publications:

Herrmann-Lingen C, Beutel ME, Bosbach A, Deter HC, Fritzsche K, Hellmich M, Jordan J, Jünger J, Ladwig KH, Michal M, Petrowski K, Pieske B, Ronel J, Söllner W, Stöhr A, Weber C, de Zwaan M, Albus C; SPIRR-CAD Study Group. A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease (SPIRR-CAD): Results of an Observer-Blinded, Multicenter, Randomized Trial in Depressed Patients With Coronary Artery Disease. Psychosom Med. 2016 Jul-Aug;78(6):704-15. doi: 10.1097/PSY.0000000000000332.

Albus C, Beutel ME, Deter HC, Fritzsche K, Hellmich M, Jordan J, Juenger J, Krauth C, Ladwig KH, Michal M, Mueck-Weymann M, Petrowski K, Pieske B, Ronel J, Soellner W, Waller C, Weber C, Herrmann-Lingen C. A stepwise psychotherapy intervention for reducing risk in coronary artery disease (SPIRR-CAD) - rationale and design of a multicenter, randomized trial in depressed patients with CAD. J Psychosom Res. 2011 Oct;71(4):215-22. doi: 10.1016/j.jpsychores.2011.02.013. Epub 2011 Apr 15.

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
Study First Received:	June 25, 2008
Last Updated:	August 26, 2016
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Göttingen:


Coronary artery disease depression psychotherapy randomized controlled trial

Additional relevant MeSH terms:


Depression Coronary Artery Disease Myocardial Ischemia Coronary Disease Behavioral Symptoms	Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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