Effects of a Psychotherapy Intervention in Depressed Patients With Coronary Artery Disease - Full Text View

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

This study is currently recruiting participants.

Verified by University of Göttingen, February 2009

First Received: June 25, 2008 Last Updated: February 12, 2009 History of Changes

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 University of Heidelberg Hannover Medical School Technische Universität München Dresden University of Technology Nuremberg General Hospital Clinical Trials Center Cologne German Research Foundation Medical University of Graz
Information provided by:	University of Göttingen
ClinicalTrials.gov Identifier:	NCT00705965

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 hospitalised for 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

MedlinePlus related topics: Coronary Artery Disease Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)

Further study details as provided by University of Göttingen:

Primary Outcome Measures:

Changes from baseline to year 1 in depressive symptoms (HADS-D) [ Time Frame: 1 year ] [ 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: 1 year ] [ Designated as safety issue: No ]
Health-related quality of life (SF36, EuroQuol-5D) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
cardiovascular risk profile [ Time Frame: 1 year ] [ Designated as safety issue: No ]
neuroendocrine and immunological activation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
coagulation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
heart rate variability [ Time Frame: 1 year ] [ Designated as safety issue: No ]
cardiac events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
health care utilisation and costs [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	569
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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: Usual cardiological care Usual cardiological care
2: Active Comparator 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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hospitalised 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

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

Contacts

Contact: Christoph Herrmann-Lingen, MD

+49 551 39 67 07

cherrma@gwdg.de

Locations

Germany
University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy	Recruiting
Goettingen, Germany, D-37075
Contact: Christoph Herrmann-Lingen, MD +49 551 39 67 07 cherrma@gwdg.de
Principal Investigator: Christoph Herrmann-Lingen, MD
University of Cologne, Dept. Psychosomatics and Psychotherapy	Recruiting
Cologne, Germany, D-50931
Contact: Christian Albus, MD +49 221 4784365 christian.albus@uk-koeln.de
Principal Investigator: Christian Albus, MD
University Hospital of Freiburg, Dept. of Psychosomatic Medicine and Psychotherapy	Recruiting
Freiburg, Germany, D-79104
Contact: Kurt Fritzsche, MD +49 761 2706871 kf@psysom.ukl.uni-freiburg.de
Principal Investigator: Kurt Fritzsche, MD
University Hospital of Mainz, Dept. of Psychosomatic Medicine and Psychotherapy	Recruiting
Mainz, Germany, D-55131
Contact: Manfred E. Beutel, MD +49 6131 172841 beutel@psychosomatik.klinik.uni-mainz.de
Principal Investigator: Manfred E. Beutel, MD
University of Heidelberg, Dept. of General Internal and Psychosomatic Medicine	Not yet recruiting
Heidelberg, Germany, D-69120
Contact: Jana Juenger, MD +49 6221 568657 jana_juenger@med.uni-heidelberg.de
Principal Investigator: Jana Juenger, MD
Nuremberg General Hospital, Department of Psychosomatic Medicine and Psychotherapy	Recruiting
Nuremberg, Germany, D-90419
Contact: Wolfgang Soellner, MD +49-911-398-2839 wolfgang.soellner@klinikum-nuernberg.de
Principal Investigator: Wolfgang Soellner, MD
Technical University of Dresden, Dept. of Psychotherapy and Psychosomatics	Not yet recruiting
Dresden, Germany, D-01307
Contact: Michael Mueck-Weymann, MD +49-351-4582070 michael.mueck@web.de
Principal Investigator: Michael Mueck-Weymann, MD
Hannover Medical School, Dept. of Psychosomatics and Psychotherapy	Recruiting
Hannover, Germany, D-30625
Contact: Christiane Waller, MD +49 511 5322633 Waller.Christiane@MH-Hannover.de
Principal Investigator: Christiane Waller, MD
Berlin University Medical Center, Campus Benjamin Franklin, Dept. of Psychosomatics and Psychotherapy	Recruiting
Berlin, Germany, D-12200
Contact: Hans-Christian Deter, MD +49 3084453996 deter@charite.de
Principal Investigator: Hans-Christian Deter, MD
Technical University of Munich, Institute and Dept. of Psychosomatic Medicine, Psychotherapy and Medical Psychology	Recruiting
Muenchen, Germany, D- 81675
Contact: Karl-Heinz Ladwig, MD +49 89 4149 4399 kh.ladwig@lrz-tu.muenchen.de
Principal Investigator: Karl-Heinz Ladwig, MD

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

University of Heidelberg

Hannover Medical School

Technische Universität München

Dresden University of Technology

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

Responsible Party:	University of Göttingen, Dept. of Psychosomatic Medicine and Psychotherapy ( Prof. Dr. med. Christoph Herrmann-Lingen )
Study ID Numbers:	ZKSK-371
Study First Received:	June 25, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00705965 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Göttingen:

Coronary artery disease
depression
psychotherapy
randomized controlled trial

Study placed in the following topic categories:

Arterial Occlusive Diseases
Depression
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis

Depressive Disorder
Behavioral Symptoms
Coronary Disease
Mental Disorders
Mood Disorders
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Depression
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Depressive Disorder

Behavioral Symptoms
Coronary Disease
Mental Disorders
Mood Disorders
Cardiovascular Diseases
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 06, 2009