Treatment of Depression in Acute Coronary Syndrome (ACS) Patients (TREATED-ACS)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Depression |
Behavioral: CBT in combination with WBT and life style modification |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cognitive-behavioral Treatment of Depression in Patients With Acute Coronary Syndrome |
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Clinical Management
Control group
|
|
|
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
|
Detailed Description:
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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- a current diagnosis of at least one of the following: major or minor depression, dysthymia according to DSM-IV criteria, and demoralization according to DCPR criteria
- Mini-Mental State Examination score higher than 24
- written informed consent provided by the patient to participate
Exclusion Criteria:
- history of bipolar disorder (DSM-IV criteria)
- major depression with psychotic features
- history of substance abuse or dependency during the previous 12 months
- serious suicide risk
- current use of antidepressants
- current treatment with any form of psychotherapy
Contacts and Locations| Contact: Chiara Rafanelli, MD, Ph.D | +39-051-2091847 | chiara.rafanelli@unibo.it |
| Italy | |
| Maggiore Hospital | Recruiting |
| Bologna, Italy, 40100 | |
| Contact: Giuseppe Di Pasquale, MD +39-051-6478202 giuseppe.dipasquale@ausl.bo.it | |
| Principal Investigator: Chiara Rafanelli, MD, Ph.D | |
| San Giovanni Battista Hospital | Recruiting |
| Torino, Italy, 10100 | |
| Contact: Fiorenzo Gaita, MD +39-011-633-5571 fiorenzo.gaita@unito.it | |
| Principal Investigator: Giovanni Abbate Daga, MD | |
| Principal Investigator: | Chiara Rafanelli, MD, Ph.D | Department of Psychology, University of Bologna |
More Information
No publications provided
| Responsible Party: | Chiara Rafanelli, Department of Psychology, University of Bologna |
| ClinicalTrials.gov Identifier: | NCT00998400 History of Changes |
| Other Study ID Numbers: | 2008.1263 |
| Study First Received: | October 19, 2009 |
| Last Updated: | March 1, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Bologna:
|
Cognitive-behavioral treatment Well-being therapy Depression Demoralization Acute coronary syndrome |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Acute Coronary Syndrome Behavioral Symptoms Mood Disorders Mental Disorders Myocardial Ischemia |
Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013