Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Cognitive-behavioral Treatment of Depression in Patients With Acute Coronary Syndrome
Brief Summary: Emotional states of depression in association with ischemic heart diseases, such as myocardial infarction or unstable angina, are risk factors for subsequent cardiac events and mortality. However, the only psychological intervention trial attempting to reduce cardiac risk in depressed ACS patients showed that changes in depression did not translate into improved survival. Such intervention did not address issues such as lifestyle modification and improvement in psychological well-being, which were found to affect individual vulnerability to medical disease. Our research group has developed a well-being enhancing psychotherapeutic strategy, well-being therapy (WBT), which has been validated in a number of clinical trials. The aim of this project is to evaluate the efficacy of cognitive behavioral treatment (CBT) together with lifestyle modification and WBT in reducing cardiac risk in depressed and/or demoralized ACS patients compared to a standard clinical procedure of patients' management, the clinical management (CM). The same protocol will be carried out in two centres (Bologna and Torino). 100 patients after a first episode of myocardial infarction or unstable angina, meeting DSM-IV criteria for depressive disorders and DCPR criteria for demoralization will be randomized to one of two treatment groups: 1) CBT supplemented by lifestyle modification and WBT; 2) CM. In both groups, treatment will consist of twelve, 45-minute sessions once a week. A two-year follow-up will be performed. It is expected that psychological treatment may significantly decrease cardiac morbidity and mortality at follow-up compared to clinical management. The findings may entail considerable preventive implications and possible large reductions in health costs.


Options:
A: Arm Label: real-time, face-to-face, video-conferenced CBT (vcCBT); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Online cognitive behavioral therapy | Arm Label: self-administered internet-based CBT (iCBT); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Online cognitive behavioral therapy | Intervention Type: BEHAVIORAL; Name: Online cognitive behavioral therapy; Assigned to Arm(s): real-time, face-to-face, video-conferenced CBT (vcCBT), self-administered internet-based CBT (iCBT)
B: Arm Label: Cohort 1; Type: N/A; Interventions: N/A | Arm Label: Cohort 2; Type: N/A; Interventions: N/A | Arm Label: Cohort 3; Type: N/A; Interventions: N/A | Arm Label: Cohort 4; Type: N/A; Interventions: N/A | Arm Label: Cohort 5; Type: N/A; Interventions: N/A
C: Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Psycho edcuactional support; Type: EXPERIMENTAL; Interventions: Behavioral: Psychoeducational support | Intervention Type: BEHAVIORAL; Name: Psychoeducational support; Assigned to Arm(s): Psycho edcuactional support
D: Arm Label: Clinical Management; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: CBT + WBT; Type: EXPERIMENTAL; Interventions: Behavioral: CBT in combination with WBT and life style modification | Intervention Type: BEHAVIORAL; Name: CBT in combination with WBT and life style modification; Assigned to Arm(s): CBT + WBT

Answer: D