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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
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

Tracking Information
First Submitted Date  ICMJE June 25, 2008
First Posted Date  ICMJE June 27, 2008
Last Update Posted Date August 30, 2016
Study Start Date  ICMJE November 2008
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
Changes from baseline to 18 months in depressive symptoms (HADS-D) [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2008)
Changes from baseline to year 1 in depressive symptoms (HADS-D) [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT00705965 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2008)
  • Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D) [ Time Frame: 1 year ]
  • Health-related quality of life (SF36, EuroQuol-5D) [ Time Frame: 1 year ]
  • cardiovascular risk profile [ Time Frame: 1 year ]
  • neuroendocrine and immunological activation [ Time Frame: 1 year ]
  • coagulation [ Time Frame: 1 year ]
  • heart rate variability [ Time Frame: 1 year ]
  • cardiac events [ Time Frame: 1 year ]
  • health care utilisation and costs [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Psychotherapy Intervention in Depressed Patients With Coronary Artery Disease
Official Title  ICMJE A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Coronary Artery Disease
Intervention  ICMJE
  • 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: Usual cardiological care
    Usual cardiological care
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2013)
570
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2008)
569
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00705965
Other Study ID Numbers  ICMJE ZKSK-371
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christoph Herrmann-Lingen, University of Göttingen
Study Sponsor  ICMJE University of Göttingen
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account University of Göttingen
Verification Date August 2016

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