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
Clinical Trials Center 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: June 19, 2014
Last verified: June 2014

June 25, 2008
June 19, 2014
November 2008
April 2013   (final data collection date for primary outcome measure)
Changes from baseline to 18 months in depressive symptoms (HADS-D) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Changes from baseline to year 1 in depressive symptoms (HADS-D) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00705965 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Effects of a Psychotherapy Intervention in Depressed Patients With Coronary Artery Disease
A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Coronary Artery Disease
  • Behavioral: Psychotherapy
    Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
    Other Name: Stepwise manualized psychotherapy
  • Behavioral: Information session
    One information session about living with heart disease.
    Other Name: Information session
  • Other: Usual cardiological care
    Usual cardiological care
    Other Name: Usual cardiological care
  • Experimental: 1
    Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
    Interventions:
    • Behavioral: Psychotherapy
    • Other: Usual cardiological care
  • Active Comparator: 2
    Usual cardiological care including one information session.
    Interventions:
    • Behavioral: Information session
    • Other: Usual cardiological care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
570
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00705965
ZKSK-371
Yes
Christoph Herrmann-Lingen, University of Göttingen
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
  • Clinical Trials Center 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
University of Göttingen
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP