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

NCT ID: NCT00705965

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 570 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2013-04-30

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.

Conditions

Depression; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: BEHAVIORAL

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

Usual cardiological care

Intervention Type: OTHER

Usual cardiological care

2

Usual cardiological care including one information session.

Group Type: ACTIVE_COMPARATOR

Information session

Intervention Type: BEHAVIORAL

One information session about living with heart disease.

Usual cardiological care

Intervention Type: OTHER

Usual cardiological care

Interventions

Psychotherapy

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

Intervention Type: BEHAVIORAL

Information session

One information session about living with heart disease.

Intervention Type: BEHAVIORAL

Usual cardiological care

Usual cardiological care

Intervention Type: OTHER

Other Intervention Names

Stepwise manualized psychotherapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: collaborator

Humboldt-Universität zu Berlin

OTHER

Sponsor Role: collaborator

University Hospital Freiburg

OTHER

Sponsor Role: collaborator

Kerckhoff Rehabilitation Center Bad Nauheim

UNKNOWN

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: collaborator

Nuremberg General Hospital

UNKNOWN

Sponsor Role: collaborator

The Clinical Trials Centre Cologne

OTHER

Sponsor Role: collaborator

German Research Foundation

OTHER

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: collaborator

University of Göttingen

OTHER

Sponsor Role: lead

Responsible Party

Christoph Herrmann-Lingen

Professor Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph Herrmann-Lingen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy

Christian Albus, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne, Dept. of Psychosomatics and Psychotherapy

Locations

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 im Breisgau, , Germany

University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy

Göttingen, , Germany

Hannover Medical School, Dept. of Psychosomatics and Psychotherapy

Hanover, , 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

München, , Germany

Nuremberg General Hospital, Department of Psychosomatic Medicine and Psychotherapy

Nuremberg, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 21911098 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27187851 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31376874 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30717711 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29602324 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29332628 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29078170 (View on PubMed)

Study Documents

Document Type: treatment manual and supplemental content

View Document

Other Identifiers

ZKSK-371

Identifier Type: -

Identifier Source: org_study_id