Effects of a Psychotherapy Intervention in Depressed Patients With Coronary Artery Disease

Depression Clinical Trial

— SPIRR-CAD  

Official title:

A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705965
• Other study ID #: ZKSK-371
• Status: Completed
• Phase: N/A
• First received: June 25, 2008
• Last updated: August 26, 2016
• Start date: November 2008
• Est. completion date: April 2013

Study information

• Verified date: August 2016
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Depression
• Myocardial Ischemia

Intervention

Behavioral:
• Psychotherapy
Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
• Information session
One information session about living with heart disease.

Other:
• Usual cardiological care
Usual cardiological care

Locations

Country	Name	City	State
Germany	Berlin University Medical Center, Campus Benjamin Franklin, Dept. of Psychosomatics and Psychotherapy	Berlin
Germany	University of Cologne, Dept. Psychosomatics and Psychotherapy	Cologne
Germany	Technical University of Dresden, Dept. of Psychotherapy and Psychosomatics	Dresden
Germany	University Hospital of Freiburg, Dept. of Psychosomatic Medicine and Psychotherapy	Freiburg
Germany	University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy	Goettingen
Germany	Hannover Medical School, Dept. of Psychosomatics and Psychotherapy	Hannover
Germany	University of Heidelberg, Dept. of General Internal and Psychosomatic Medicine	Heidelberg
Germany	University Hospital of Mainz, Dept. of Psychosomatic Medicine and Psychotherapy	Mainz
Germany	Technical University of Munich, Institute and Dept. of Psychosomatic Medicine, Psychotherapy and Medical Psychology	Muenchen
Germany	Nuremberg General Hospital, Department of Psychosomatic Medicine and Psychotherapy	Nuremberg

Sponsors (14)

Lead Sponsor	Collaborator
University of Göttingen	German Research Foundation, Hannover Medical School, Heidelberg University, Humboldt-Universität zu Berlin, Johannes Gutenberg University Mainz, Kerckhoff Rehabilitation Center Bad Nauheim, Medical University of Graz, Nuremberg General Hospital, Technische Universität Dresden, Technische Universität München, The Clinical Trials Centre Cologne, University Hospital Freiburg, University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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 Interven — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline to 18 months in depressive symptoms (HADS-D)		18 months	No
Secondary	Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D)		18 months	No
Secondary	Health-related quality of life (SF36, EuroQuol-5D)		18 months	No
Secondary	cardiovascular risk profile		18 months	No
Secondary	neuroendocrine and immunological activation		18 months	No
Secondary	coagulation		18 months	No
Secondary	heart rate variability		18 months	No
Secondary	cardiac events		18 months	Yes
Secondary	health care utilisation and costs		18 months	No