Please select the outcome measures that correspond 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: Change in depressive symptoms as a result of intervention effects (Baseline, 3, 6 and 12 months); Change in intervention effects on depressive symptoms moderated by perceived stigma (Baseline, 3, 6, and 12 months); Change in intervention effects on depressive symptoms moderated by sex (Baseline, 3, 6, and 12 months)
B: Death (4 months); Death (8 months); Death (12 months); Death (16 months); Death (20 months); Death (24 months); Death (3 years); Death (4 years); Stroke/Systemic embolism (SE) (4 months); Stroke/Systemic embolism (SE) (8 months); Stroke/Systemic embolism (SE) (12 months); Stroke/Systemic embolism (SE) (16 months); Stroke/Systemic embolism (SE) (20 months); Stroke/Systemic embolism (SE) (24 months); Stroke/Systemic embolism (SE) (3 years); Stroke/Systemic embolism (SE) (4 years); Major bleeding (4 months); Major bleeding (8 months); Major bleeding (12 months); Major bleeding (16 months); Major bleeding (20 months); Major bleeding (24 months); Major bleeding (3 years); Major bleeding (4 years)
C: Perceived control measure by Control Attitude Scale (3 months)
D: Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Clinical Interview for Depression, Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Anxiety" Subscale), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Autonomy" Dimension), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Depression" Subscale), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Somatization" Subscale), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Hostility" Subscale), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Environmental Mastery" Dimension), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Personal Growth" Dimension), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Positive Relations" Dimension), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Purpose in Life" Dimension), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up); Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Self-acceptance" Dimension), Compared to Clinical Management (Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up)

Answer: D