Clinical trial NCT00705965: Effects of a Psychotherapy Intervention in Depressed Patients With Coronary Artery Disease
Official title: A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Coronary Artery Disease
Keywords: Coronary artery disease
depression
psychotherapy
randomized controlled trial
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: University of Cologne
name: Johannes Gutenberg University Mainz
name: Humboldt-Universität zu Berlin
name: University Hospital Freiburg
name: Kerckhoff Rehabilitation Center Bad Nauheim
name: Heidelberg University
name: Hannover Medical School
name: Technical University of Munich
name: Technische Universität Dresden
name: Nuremberg General Hospital
name: The Clinical Trials Centre Cologne
name: German Research Foundation
name: Medical University of Graz
First posted: 2008-06-27
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes from baseline to 18 months in depressive symptoms (HADS-D)
timeFrame: 18 months
Secondary outcomes:
measure: Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D)
timeFrame: 18 months
measure: Health-related quality of life (SF36, EuroQuol-5D)
timeFrame: 18 months
measure: cardiovascular risk profile
timeFrame: 18 months
measure: neuroendocrine and immunological activation
timeFrame: 18 months
measure: coagulation
timeFrame: 18 months
measure: heart rate variability
timeFrame: 18 months
measure: cardiac events
timeFrame: 18 months
measure: health care utilisation and costs
timeFrame: 18 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Berlin University Medical Center, Campus Benjamin Franklin, Dept. of Psychosomatics and Psychotherapy
city: Cologne
country: Germany
facility: University of Cologne, Dept. Psychosomatics and Psychotherapy
city: Dresden
country: Germany
facility: Technical University of Dresden, Dept. of Psychotherapy and Psychosomatics
city: Freiburg
country: Germany
facility: University Hospital of Freiburg, Dept. of Psychosomatic Medicine and Psychotherapy
city: Goettingen
country: Germany
facility: University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy
city: Hannover
country: Germany
facility: Hannover Medical School, Dept. of Psychosomatics and Psychotherapy
city: Heidelberg
country: Germany
facility: University of Heidelberg, Dept. of General Internal and Psychosomatic Medicine
city: Mainz
country: Germany
facility: University Hospital of Mainz, Dept. of Psychosomatic Medicine and Psychotherapy
city: Muenchen
country: Germany
facility: Technical University of Munich, Institute and Dept. of Psychosomatic Medicine, Psychotherapy and Medical Psychology
city: Nuremberg
country: Germany
facility: Nuremberg General Hospital, Department of Psychosomatic Medicine and Psychotherapy
Study officials:
affiliation: University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy
name: Christoph Herrmann-Lingen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cologne, Dept. of Psychosomatics and Psychotherapy
name: Christian Albus, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.