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

NCT00705965 | Completed DMC

• 1 other identifier: ZKSK-371
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 10

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

Keywords

Coronary artery disease; depression; psychotherapy; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

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

  18 months

Secondary Outcomes (8)

• Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D)

  18 months

• Health-related quality of life (SF36, EuroQuol-5D)

  18 months

• cardiovascular risk profile

  18 months

• neuroendocrine and immunological activation

  18 months

• coagulation

  18 months

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Psychotherapy; Other: Usual cardiological care

2

ACTIVE COMPARATOR

Usual cardiological care including one information session.

Behavioral: Information session; Other: Usual cardiological care

Interventions

Psychotherapy BEHAVIORAL

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

Also known as: Stepwise manualized psychotherapy

1

Information session BEHAVIORAL

One information session about living with heart disease.

2

Usual cardiological care OTHER

Usual cardiological care

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with coronary artery disease
• German speaking men and women
• Recent coronary angiogram (\<= 3 months old)
• Depression score (HADS-D) \>= 8
• Written informed consent

You may not qualify if:

• Severe heart failure
• Other acutely life- threatening conditions
• Severe chronic inflammatory disease
• Current suicidal tendency
• Severe depressive episode
• Other severe mental illness.

Sponsors & Collaborators

• University of Göttingen: lead
• University of Cologne: collaborator
• Johannes Gutenberg University Mainz: collaborator
• Humboldt-Universität zu Berlin: collaborator
• University Hospital Freiburg: collaborator
• Kerckhoff Rehabilitation Center Bad Nauheim: collaborator
• Heidelberg University: collaborator
• Hannover Medical School: collaborator
• Technical University of Munich: collaborator
• Technische Universität Dresden: collaborator
• Nuremberg General Hospital: collaborator
• The Clinical Trials Centre Cologne: collaborator
• German Research Foundation: collaborator
• Medical University of Graz: collaborator

Study Sites (10)

Berlin University Medical Center, Campus Benjamin Franklin, Dept. of Psychosomatics and Psychotherapy

Berlin, D-12200, Germany

Location

University of Cologne, Dept. Psychosomatics and Psychotherapy

Cologne, D-50931, Germany

Location

Technical University of Dresden, Dept. of Psychotherapy and Psychosomatics

Dresden, D-01307, Germany

Location

University Hospital of Freiburg, Dept. of Psychosomatic Medicine and Psychotherapy

Freiburg im Breisgau, D-79104, Germany

Location

University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy

Göttingen, D-37075, Germany

Location

Hannover Medical School, Dept. of Psychosomatics and Psychotherapy

Hanover, D-30625, Germany

Location

University of Heidelberg, Dept. of General Internal and Psychosomatic Medicine

Heidelberg, D-69120, Germany

Location

University Hospital of Mainz, Dept. of Psychosomatic Medicine and Psychotherapy

Mainz, D-55131, Germany

Location

Technical University of Munich, Institute and Dept. of Psychosomatic Medicine, Psychotherapy and Medical Psychology

München, D- 81675, Germany

Location

Nuremberg General Hospital, Department of Psychosomatic Medicine and Psychotherapy

Nuremberg, D-90419, Germany

Location

Related Publications (7)

• 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.

  PMID: 21911098 BACKGROUND

• 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.

  PMID: 27187851 RESULT

• 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.

  PMID: 31376874 DERIVED

• 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.

  PMID: 30717711 DERIVED

• 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.

  PMID: 29602324 DERIVED

• 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.

  PMID: 29332628 DERIVED

• 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.

  PMID: 29078170 DERIVED

MeSH Terms

Conditions

Depression; Coronary Artery Disease

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 27, 2008
• Study Start: November 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

DE (10)