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

University of Göttingen

Status: Completed

Conditions: Coronary Artery Disease; Depression

Treatments: Behavioral: Information session; Other: Usual cardiological care; Behavioral: Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00705965

ZKSK-371

Details and patient eligibility

About

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.

Enrollment: 570 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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570 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Other: Usual cardiological care

Behavioral: Psychotherapy

2

Active Comparator group

Description:

Usual cardiological care including one information session.

Treatment:

Other: Usual cardiological care

Behavioral: Information session