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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00705965
Acronym
SPIRR-CAD
Enrollment
570
Registered
2008-06-27
Start date
2008-11-30
Completion date
2013-04-30
Last updated
2016-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Coronary Artery Disease

Keywords

Coronary artery disease, depression, psychotherapy, randomized controlled trial

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.

Interventions

BEHAVIORALPsychotherapy

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

One information session about living with heart disease.

OTHERUsual cardiological care

Usual cardiological care

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Health-related quality of life (SF36, EuroQuol-5D)18 months
cardiovascular risk profile18 months
neuroendocrine and immunological activation18 months
Remission of depressive disorder (SCID) and the Type D pattern (DS-14), reduced severity of depressive symptoms (HAM-D)18 months
heart rate variability18 months
cardiac events18 months
health care utilisation and costs18 months
coagulation18 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026