NCT00705965

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 570 (actual)
• Sponsor: University of Göttingen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Psychotherapy	Stepwise, manualized individual and group psychotherapy in addition to usual cardiological care.
BEHAVIORAL	Information session	One information session about living with heart disease.
OTHER	Usual cardiological care	Usual cardiological care

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2008-06-27
• Last updated: 2016-08-30

Locations

10 sites across 1 country: Germany