Please select the arm or intervention descriptions that belong 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: Arm Label: SMT-enhanced Cardiac Rehabilitation; Type: EXPERIMENTAL; Interventions: Behavioral: SMT-enhanced Cardiac Rehabilitation | Arm Label: Standard Cardiac Rehabilitation; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard Cardiac Rehabilitation | Intervention Type: BEHAVIORAL; Name: SMT-enhanced Cardiac Rehabilitation; Assigned to Arm(s): SMT-enhanced Cardiac Rehabilitation | Intervention Type: BEHAVIORAL; Name: Standard Cardiac Rehabilitation; Assigned to Arm(s): Standard Cardiac Rehabilitation
B: Arm Label: Intervention Condition (INT); Type: EXPERIMENTAL; Interventions: Behavioral: Enhanced depression care | Arm Label: Usual Cardiologic Care Condition (UCC); Type: OTHER; Interventions: Behavioral: Referred depression care | Intervention Type: BEHAVIORAL; Name: Enhanced depression care; Assigned to Arm(s): Intervention Condition (INT) | Intervention Type: BEHAVIORAL; Name: Referred depression care; Assigned to Arm(s): Usual Cardiologic Care Condition (UCC)
C: Arm Label: Sertraline/omega-3 supplement; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sertraline/omega-3 | Arm Label: Sertraline/corn oil; Type: PLACEBO_COMPARATOR; Interventions: Drug: Sertraline/Corn Oil | Intervention Type: DRUG; Name: Sertraline/omega-3; Assigned to Arm(s): Sertraline/omega-3 supplement | Intervention Type: DRUG; Name: Sertraline/Corn Oil; Assigned to Arm(s): Sertraline/corn oil
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Psychotherapy, Other: Usual cardiological care | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Information session, Other: Usual cardiological care | Intervention Type: BEHAVIORAL; Name: Psychotherapy; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Information session; Assigned to Arm(s): 2 | Intervention Type: OTHER; Name: Usual cardiological care; Assigned to Arm(s): 1, 2

Answer: D