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

A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Coronary Artery Disease
• Intervention / Treatment: Behavioral: Psychotherapy; Other: Usual cardiological care; Behavioral: Information session

• Study Type: Interventional
• Enrollment (Actual): 570
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, D-12200
    • Berlin University Medical Center, Campus Benjamin Franklin, Dept. of Psychosomatics and Psychotherapy
  • Cologne, Germany, D-50931
    • University of Cologne, Dept. Psychosomatics and Psychotherapy
  • Dresden, Germany, D-01307
    • Technical University of Dresden, Dept. of Psychotherapy and Psychosomatics
  • Freiburg, Germany, D-79104
    • University Hospital of Freiburg, Dept. of Psychosomatic Medicine and Psychotherapy
  • Goettingen, Germany, D-37075
    • University of Goettingen, Dept. of Psychosomatic Medicine and Psychotherapy
  • Hannover, Germany, D-30625
    • Hannover Medical School, Dept. of Psychosomatics and Psychotherapy
  • Heidelberg, Germany, D-69120
    • University of Heidelberg, Dept. of General Internal and Psychosomatic Medicine
  • Mainz, Germany, D-55131
    • University Hospital of Mainz, Dept. of Psychosomatic Medicine and Psychotherapy
  • Muenchen, Germany, D- 81675
    • Technical University of Munich, Institute and Dept. of Psychosomatic Medicine, Psychotherapy and Medical Psychology
  • Nuremberg, Germany, D-90419
    • Nuremberg General Hospital, Department of Psychosomatic Medicine and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.	Behavioral: Psychotherapy; Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.; Other Names: Stepwise manualized psychotherapy; Other: Usual cardiological care; Usual cardiological care
Active Comparator: 2; Usual cardiological care including one information session.	Other: Usual cardiological care; Usual cardiological care; Behavioral: Information session; One information session about living with heart disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline to 18 months in depressive symptoms (HADS-D)	18 months

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: June 25, 2008
• First Submitted That Met QC Criteria: June 26, 2008
• First Posted (Estimate): June 27, 2008

Study Record Updates

• Last Update Posted (Estimate): August 30, 2016
• Last Update Submitted That Met QC Criteria: August 26, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: randomized controlled trial; Coronary artery disease; depression; psychotherapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Depression; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: ZKSK-371

Plan for Individual participant data (IPD)

Study Data/Documents

1. treatment manual and supplemental content