Treatment of Depression in Acute Coronary Syndrome (ACS) Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Cognitive-behavioral Treatment of Depression in Patients With Acute Coronary Syndrome

Conditions
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Depression

Intervention / Treatment
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* Behavioral: CBT in combination with WBT and life style modification


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Clinical Management<br>Control group | |
| Experimental: CBT + WBT<br>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<br>* 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.<br>* Other names: Cognitive-behavioural therapies;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Paykel's 20-item change version of the Clinical Interview for Depression (CID) allows a comprehensive assessment of affective symptomatology and contains 20 items rated on 7-point scales with specification of each anchor point based on severity, frequency and/or quality of symptoms. It adds a dimensional description of mental suffering to traditional psychiatric nosography (DSM). The total score is obtained by adding each of 20 items and it may range from 20 to 140. The higher the score, the worse the psychological condition. | 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 | Anxious symptoms subscale of Kellner's Symptom Questionnaire (SQ). SQ is a 92-item self-report questionnaire, which yields 4 main scales including 23 items each: depression, anxiety, hostility-irritability and somatization. This instrument helps the identification of self-perceived subclinical psychological distress. Answers are dichotomous (YES/NO or TRUE/FALSE) and rated with 0 or 1, therefore each scale score may range from 0 to 23. The higher the total score, the higher the psychological distress. | 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 | Autonomy dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being. | 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 | Depressive symptoms subscale of Kellner's Symptom Questionnaire (SQ). SQ is a 92-item self-report questionnaire, which yields 4 main scales including 23 items each: depression, anxiety, hostility-irritability and somatization. This instrument helps the identification of self-perceived subclinical psychological distress. Answers are dichotomous (YES/NO or TRUE/FALSE) and rated with 0 or 1, therefore each scale score may range from 0 to 23. The higher the total score, the higher the psychological distress. | 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 | Somatic symptoms subscale of Kellner's Symptom Questionnaire (SQ). SQ is a 92-item self-report questionnaire, which yields 4 main scales including 23 items each: depression, anxiety, hostility-irritability and somatization. This instrument helps the identification of self-perceived subclinical psychological distress. Answers are dichotomous (YES/NO or TRUE/FALSE) and rated with 0 or 1, therefore each scale score may range from 0 to 23. The higher the total score, the higher the psychological distress. | 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 | Hostility symptoms subscale of Kellner's Symptom Questionnaire (SQ). SQ is a 92-item self-report questionnaire, which yields 4 main scales including 23 items each: depression, anxiety, hostility-irritability and somatization. This instrument helps the identification of self-perceived subclinical psychological distress. Answers are dichotomous (YES/NO or TRUE/FALSE) and rated with 0 or 1, therefore each scale score may range from 0 to 23. The higher the total score, the higher the psychological distress. | 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 | Environmental mastery dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being. | 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 | Personal growth dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being. | 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 | Positive relations dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being. | 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 | Purpose in life dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being. | 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 | Self-acceptance dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being. | Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up. | Frequencies of negative cardiac outcomes, such as re-hospitalizations due to cardiac complications, acute myocardial infarction, unstable angina, angioplasty, cardiac surgery, and cardiac mortality occuring after the first episode of ACS. | 30-month follow-up post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive-behavioral treatment, Well-being therapy, Depression, Demoralization, Acute coronary syndrome