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| Name | Class |
|---|---|
| University of Cologne | OTHER |
| Johannes Gutenberg University Mainz | OTHER |
| Humboldt-Universität zu Berlin | OTHER |
| University Hospital Freiburg |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care. |
|
| 2 | Active Comparator | Usual cardiological care including one information session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychotherapy | Behavioral | Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline to 18 months in depressive symptoms (HADS-D) | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin University Medical Center, Campus Benjamin Franklin, Dept. of Psychosomatics and Psychotherapy | Berlin | D-12200 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21911098 | Background | 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. | |
| 27187851 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| treatment manual and supplemental content | View IPD |
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| OTHER |
| Kerckhoff Rehabilitation Center Bad Nauheim | UNKNOWN |
| Heidelberg University | OTHER |
| Hannover Medical School | OTHER |
| Technical University of Munich | OTHER |
| Technische Universität Dresden | OTHER |
| Nuremberg General Hospital | UNKNOWN |
| The Clinical Trials Centre Cologne | OTHER |
| German Research Foundation | OTHER |
| Medical University of Graz | OTHER |
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| Information session | Behavioral | One information session about living with heart disease. |
|
| Usual cardiological care | Other | Usual cardiological care |
|
| cardiovascular risk profile |
| 18 months |
| neuroendocrine and immunological activation | 18 months |
| coagulation | 18 months |
| heart rate variability | 18 months |
| cardiac events | 18 months |
| health care utilisation and costs | 18 months |
| University of Cologne, Dept. Psychosomatics and Psychotherapy |
| Cologne |
| D-50931 |
| Germany |
| Technical University of Dresden, Dept. of Psychotherapy and Psychosomatics | Dresden | D-01307 | Germany |
| University Hospital of Freiburg, Dept. of Psychosomatic Medicine and Psychotherapy | Freiburg im Breisgau | D-79104 | Germany |
| University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy | Göttingen | D-37075 | Germany |
| Hannover Medical School, Dept. of Psychosomatics and Psychotherapy | Hanover | D-30625 | Germany |
| University of Heidelberg, Dept. of General Internal and Psychosomatic Medicine | Heidelberg | D-69120 | Germany |
| University Hospital of Mainz, Dept. of Psychosomatic Medicine and Psychotherapy | Mainz | D-55131 | Germany |
| Technical University of Munich, Institute and Dept. of Psychosomatic Medicine, Psychotherapy and Medical Psychology | München | D- 81675 | Germany |
| Nuremberg General Hospital, Department of Psychosomatic Medicine and Psychotherapy | Nuremberg | D-90419 | Germany |
| Result |
| 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. |
| 31376874 | Derived | 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. |
| 30717711 | 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. |
| 29602324 | 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. |
| 29332628 | 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. |
| 29078170 | 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. |
| ID | Term |
|---|---|
| D003863 | Depression |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
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