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

Primary Purpose

Depression, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Psychotherapy
Information session
Usual cardiological care
Sponsored by
University of Göttingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Coronary artery disease, depression, psychotherapy, randomized controlled trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.

Usual cardiological care including one information session.

Outcomes

Primary Outcome Measures

Changes from baseline to 18 months in depressive symptoms (HADS-D)

Secondary Outcome Measures

Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D)
Health-related quality of life (SF36, EuroQuol-5D)
cardiovascular risk profile
neuroendocrine and immunological activation
coagulation
heart rate variability
cardiac events
health care utilisation and costs

Full Information

First Posted
June 25, 2008
Last Updated
August 26, 2016
Sponsor
University of Göttingen
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, Technical University of Munich, Technische Universität Dresden, Nuremberg General Hospital, The Clinical Trials Centre Cologne, German Research Foundation, Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT00705965
Brief Title
Effects of a Psychotherapy Intervention in Depressed Patients With Coronary Artery Disease
Acronym
SPIRR-CAD
Official Title
A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Göttingen
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, Technical University of Munich, Technische Universität Dresden, Nuremberg General Hospital, The Clinical Trials Centre Cologne, German Research Foundation, Medical University of Graz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Coronary Artery Disease
Keywords
Coronary artery disease, depression, psychotherapy, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
570 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Usual cardiological care including one information session.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Other Intervention Name(s)
Stepwise manualized psychotherapy
Intervention Description
Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
Intervention Type
Behavioral
Intervention Name(s)
Information session
Intervention Description
One information session about living with heart disease.
Intervention Type
Other
Intervention Name(s)
Usual cardiological care
Intervention Description
Usual cardiological care
Primary Outcome Measure Information:
Title
Changes from baseline to 18 months in depressive symptoms (HADS-D)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D)
Time Frame
18 months
Title
Health-related quality of life (SF36, EuroQuol-5D)
Time Frame
18 months
Title
cardiovascular risk profile
Time Frame
18 months
Title
neuroendocrine and immunological activation
Time Frame
18 months
Title
coagulation
Time Frame
18 months
Title
heart rate variability
Time Frame
18 months
Title
cardiac events
Time Frame
18 months
Title
health care utilisation and costs
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Herrmann-Lingen, MD
Organizational Affiliation
University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Albus, MD
Organizational Affiliation
University of Cologne, Dept. of Psychosomatics and Psychotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Berlin University Medical Center, Campus Benjamin Franklin, Dept. of Psychosomatics and Psychotherapy
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
University of Cologne, Dept. Psychosomatics and Psychotherapy
City
Cologne
ZIP/Postal Code
D-50931
Country
Germany
Facility Name
Technical University of Dresden, Dept. of Psychotherapy and Psychosomatics
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
University Hospital of Freiburg, Dept. of Psychosomatic Medicine and Psychotherapy
City
Freiburg
ZIP/Postal Code
D-79104
Country
Germany
Facility Name
University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy
City
Goettingen
ZIP/Postal Code
D-37075
Country
Germany
Facility Name
Hannover Medical School, Dept. of Psychosomatics and Psychotherapy
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
University of Heidelberg, Dept. of General Internal and Psychosomatic Medicine
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
University Hospital of Mainz, Dept. of Psychosomatic Medicine and Psychotherapy
City
Mainz
ZIP/Postal Code
D-55131
Country
Germany
Facility Name
Technical University of Munich, Institute and Dept. of Psychosomatic Medicine, Psychotherapy and Medical Psychology
City
Muenchen
ZIP/Postal Code
D- 81675
Country
Germany
Facility Name
Nuremberg General Hospital, Department of Psychosomatic Medicine and Psychotherapy
City
Nuremberg
ZIP/Postal Code
D-90419
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21911098
Citation
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.
Results Reference
background
PubMed Identifier
27187851
Citation
Herrmann-Lingen C, Beutel ME, Bosbach A, Deter HC, Fritzsche K, Hellmich M, Jordan J, Junger J, Ladwig KH, Michal M, Petrowski K, Pieske B, Ronel J, Sollner W, Stohr 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.
Results Reference
result
PubMed Identifier
31376874
Citation
Fangauf SV, Meyer T, Albus C, Binder L, Deter HC, Ladwig KH, Michal M, Ronel J, Rothenberger A, Sollner W, Wachter R, Weber CS, Herrmann-Lingen C; SPIRR-CAD group. Longitudinal relationship between B-type natriuretic peptide and anxiety in coronary heart disease patients with depression. J Psychosom Res. 2019 Aug;123:109728. doi: 10.1016/j.jpsychores.2019.05.006. Epub 2019 May 21.
Results Reference
derived
PubMed Identifier
30717711
Citation
Vitinius F, Escherich S, Deter HC, Hellmich M, Junger J, Petrowski K, Ladwig KH, Lambertus F, Michal M, Weber C, de Zwaan M, Herrmann-Lingen C, Ronel J, Albus C. Somatic and sociodemographic predictors of depression outcome among depressed patients with coronary artery disease - a secondary analysis of the SPIRR-CAD study. BMC Psychiatry. 2019 Feb 4;19(1):57. doi: 10.1186/s12888-019-2026-6.
Results Reference
derived
PubMed Identifier
29602324
Citation
Sollner W, Muller MM, Albus C, Behnisch R, Beutel ME, de Zwaan M, Fritzsche K, Habermeier A, Hellmich M, Jordan J, Junger J, Ladwig KH, Michal M, Petrowski K, Ronel J, Stein B, Weber C, Weber R, Herrmann-Lingen C. The relationship between attachment orientations and the course of depression in coronary artery disease patients: A secondary analysis of the SPIRR-CAD trial. J Psychosom Res. 2018 May;108:39-46. doi: 10.1016/j.jpsychores.2018.02.014. Epub 2018 Feb 24.
Results Reference
derived
PubMed Identifier
29332628
Citation
Orth-Gomer K, Deter HC, Grun AS, Herrmann-Lingen C, Albus C, Bosbach A, Ladwig KH, Ronel J, Sollner W, de Zwaan M, Petrowski K, Weber C; SPIRR-CAD Study Group. Socioeconomic factors in coronary artery disease - Results from the SPIRR-CAD study. J Psychosom Res. 2018 Feb;105:125-131. doi: 10.1016/j.jpsychores.2017.12.005. Epub 2017 Dec 5.
Results Reference
derived
PubMed Identifier
29078170
Citation
Lambertus F, Herrmann-Lingen C, Fritzsche K, Hamacher S, Hellmich M, Junger J, Ladwig KH, Michal M, Ronel J, Schultz JH, Vitinius F, Weber C, Albus C. Prevalence of mental disorders among depressed coronary patients with and without Type D personality. Results of the multi-center SPIRR-CAD trial. Gen Hosp Psychiatry. 2018 Jan-Feb;50:69-75. doi: 10.1016/j.genhosppsych.2017.10.001. Epub 2017 Oct 7.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
treatment manual and supplemental content
Available IPD/Information URL
http://links.lww.com/PSYMED/A275

Learn more about this trial

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

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