Treatment of Depression in Acute Coronary Syndrome (ACS) Patients (TREATED-ACS)
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|ClinicalTrials.gov Identifier: NCT00998400|
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: CBT in combination with WBT and life style modification||Not Applicable|
The same protocol will be carried out in the two participating centres (Maggiore Hospital in Bologna and San Giovanni Battista Hospital in Torino).
Participants will be patients recovering from a first episode of acute myocardial infarction or unstable angina. Myocardial infarction will be documented by cardiac symptoms (presence of acute chest, epigastric, neck, jaw, or arm pain or discomfort or pressure without apparent non- cardiac source) and signs (acute congestive heart failure or cardiogenic shock in the absence of non-CHD causes) associated with ECG findings (characteristic evolutionary ST-T changes or new Q waves) and/or cardiac biomarkers (blood measures of myocardial necrosis, specifically CK, CK-MB, CK-MBm, or troponin, cTn). Instable angina will be documented by cardiac symptoms (chest pain lasting less than 20 minutes) with likely ECG findings (ST-segment depression and abnormal T-wave) in absence of myocardial necrosis biomarkers.
Medically eligible patients involved in the study have to meet, when screened 30 days after their index event, the inclusion criteria
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive-behavioral Treatment of Depression in Patients With Acute Coronary Syndrome|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||April 2019|
|Actual Study Completion Date :||April 2019|
No Intervention: Clinical Management
Experimental: CBT + WBT
Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification
Behavioral: CBT in combination with WBT and life style modification
CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems. The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others. CM will consist of reviewing the patients' clinical status, and providing the patient with support and advice if necessary.
Other Name: Cognitive-behavioural therapies
- Depression and well-being improvements after Cognitive-behavioral Therapy and Well-Being Therapy assessed by changes in Clinical Interview for Depression, Symptom Questionnaire and Psychological Well-Being, compared to Clinical Management [ Time Frame: Within two years after the treatment ]
- Reduction of cardiovascular hospitalizations, revascularization, recurrent nonfatal myocardial infarction or cardiac mortality after CBT and WBT compared with CM [ Time Frame: Within two years after the treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998400
|Bologna, Italy, 40100|
|San Giovanni Battista Hospital|
|Torino, Italy, 10100|
|Principal Investigator:||Chiara Rafanelli, MD, Ph.D||Department of Psychology, University of Bologna|