Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease - a Randomised Controlled Trial (SPIRR-CAD)
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.


Options:
A: Inclusion Criteria:

* Men or women aged 21 years or older
* New York Heart Association (NYHA) Class I-IV HF of at least 3-months duration
* Left ventricular Ejection Fraction (EF) \< 40% by left ventricular angiography, nuclear wall motion study, or echocardiography, within 6 months of study enrollment
* Undergoing treatment with a stable medication regimen.

Exclusion Criteria:

* Myocardial Infarction (MI), Percutaneous Transluminal Coronary Angioplasty(PTCA), Coronary Artery Bypass Graft (CABG) within 3 months of enrollment
* HF due to correctable cause or condition such as uncorrected primary valvular disease
* Alcohol or drug abuse within 12 months
* Illness such as malignancies that are associated with a life-expectancy of \< 12 months
* Current pregnancy
* Inability to provide informed consent
B: 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.
C: Inclusion Criteria:

* New York Heart Association Class I, II, or III Heart Failure (Clinically diagnosed at least 3 months ago)
* Meets the DSM-IV criteria for a current major depressive episode, or for current minor depression with a past history of at least one major depressive episode.
* PHQ-9 score of 10 or greater plus 2 or 3 on question 1 or 2 over the last 2 weeks including today

Exclusion Criteria:

* Less than 30 years old
* Current ETOH / drug abuse
* Bipolar disorder, schizophrenia, or other psychotic disorder
* Communication barrier
* Dementia
* Currently in competing research protocol
* High risk for suicide
* Insurmountable logistical barriers to laboratory assessment visits
* Major mobility-limiting physical disability
* Poor 1 year prognosis not r/t heart failure
* Hospitalized for heart failure or acute coronary syndrome in last month
* Initiated antidepressant therapy in the past 4 weeks
* Current non-study psychotherapy for depression or other psychiatric problem
D: Inclusion Criteria:

* Coronary Artery Bypass Graft (CABG) surgery (alone or combined with valvular or carotid surgery) within past 12 months
* Meets DSM-IV criteria for major or minor depressive episode

Exclusion Criteria:

* Severe cognitive impairment
* Severe psychiatric comorbidity (e.g., alcoholism or schizophrenia)
* Severely debilitating or life-threatening illness other than coronary disease

Answer: B