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| Name | Class |
|---|---|
| Compagnia di San Paolo | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Management | No Intervention | Control group | |
| CBT + WBT | Experimental | Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT in combination with WBT and life style modification | Behavioral | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chiara Rafanelli, MD, Ph.D | Department of Psychology, University of Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maggiore Hospital | Bologna | 40100 | Italy | |||
| Molinette Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34910821 | Derived | Tully PJ, Ang SY, Lee EJ, Bendig E, Bauereiss N, Bengel J, Baumeister H. Psychological and pharmacological interventions for depression in patients with coronary artery disease. Cochrane Database Syst Rev. 2021 Dec 15;12(12):CD008012. doi: 10.1002/14651858.CD008012.pub4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CBT/WBT | Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification 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. |
| FG001 | Clinical Management | Clinical management - CM (control group) Clinical management entails the same amount of time and attention from a professional figure than the experimental group, but specific interventions were proscribed. Such form of active control consisted of empathic listening, reviewing patients' clinical status, distress and worries, and encouragement of treatment adherence. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CBT/WBT | Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification (expertimental group) 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up |
|
From pre-treatment (baseline) to 30-month follow-up after the end of the interventions (both CBT/WBT and CM)
Re-hospitalizations due to cardiac complications, acute myocardial infarction, unstable angina, angioplasty and cardiac surgery occured after the first episode of ACS
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBT/WBT | Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification (experimental group) 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-fatal cardiac events | Cardiac disorders | Systematic Assessment | Re-hospitalizations due to cardiac complications, acute myocardial infarction, unstable angina, angioplasty and cardiac surgery after the first episode of ACS |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Chiara Rafanelli | University of Bologna | 0039 051 2091847 | chiara.rafanelli@unibo.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2009 | Dec 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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|
|
| 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 |
| 30-month follow-up post-treatment |
| Torino |
| 10100 |
| Italy |
| BG001 | Clinical Management | Clinical management - CM (control group) Clinical management entails the same amount of time and attention from a professional figure than the experimental group, but specific interventions were proscribed. Such form of active control consisted of empathic listening, reviewing patients' clinical status, distress and worries, and encouragement of treatment adherence. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital Status | Count of Participants | Participants |
|
| Occupation | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Type of ACS | Count of Participants | Participants |
|
| GRACE index | The Global Registry of Acute Coronary Events (GRACE) risk index is calculated during hospital admission and provides an estimate of the probability of cardiac mortality both during hospitalization and within 6 months from hospital discharge in patients with acute coronary syndrome (ACS). In order to calculate the GRACE risk index, the following data are needed: age, heart rate, systolic blood pressure, creatinine level, Killip class, cardiac arrest at admission, ST-segment deviation and elevated enzymes/markers. | Mean | Standard Deviation | percent probability |
|
| Symptom Questionnaire | Kellner's Symptom Questionnaire (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. | Mean | Standard Deviation | scores on a scale |
|
| Psychological Well-Being scales | The Psychological Well-Being scales (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. | Mean | Standard Deviation | scores on a scale |
|
| Depression (DSM) | The presence of clinical depression (Major/minor depression or dysthymia) was assessed by means of the Structured Clinical Interview for DSM-IV-TR Axis I Disorders.(SCID-I), a semistuctured interview designed to be administered by a clinician or trained mental health professional in order to formulate psychiatric diagnoses based on the Diagnostic and Statistical Manual of Mental Disorders (DSM). | Count of Participants | Participants |
|
| Demoralization (DCPR) | Demoralization was assessed by means of the Semi-Structured Interview based on the Diagnostic Criteria for Psychosomatic Research (DCPR), which is an observer-rated measure including skip questions if the main criteria are not satisfied. | Count of Participants | Participants |
|
| Clinical Interview for Depression (CID) | 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. | Mean | Standard Deviation | scores on a scale |
|
| OG001 | Clinical Management | Clinical management - CM (control group) Clinical management entails the same amount of time and attention from a professional figure than the experimental group, but specific interventions were proscribed. Such form of active control consisted of empathic listening, reviewing patients' clinical status, distress and worries, and encouragement of treatment adherence. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up |
|
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| Secondary | 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. | Posted | Count of Participants | Participants | 30-month follow-up post-treatment |
|
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up |
|
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up |
|
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|
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up |
|
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up |
|
|
|
|
| 1 |
| 50 |
| 9 |
| 50 |
| 0 |
| 50 |
| EG001 | Clinical Management | Clinical management - CM (control group) Clinical management entails the same amount of time and attention from a professional figure than the experimental group, but specific interventions were proscribed. Such form of active control consisted of empathic listening, reviewing patients' clinical status, distress and worries, and encouragement of treatment adherence. | 1 | 50 | 6 | 50 | 0 | 50 |
|
| Cardiac death | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| ANXIETY (SQ) 3-month follow-up |
|
| ANXIETY (SQ) 6-month follow-up |
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| ANXIETY (SQ) 12-month follow-up |
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| ANXIETY (SQ) 30-month follow-up |
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| AUTONOMY (PWB) 3-month follow-up |
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| AUTONOMY (PWB) 6-month follow-up |
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| AUTONOMY (PWB) 12-month follow-up |
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| AUTONOMY (PWB) 30-month follow-up |
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| No events |
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| DEPRESSION (SQ) 3-month follow-up |
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| DEPRESSION (SQ) 6-month follow-up |
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| DEPRESSION (SQ) 12-month follow-up |
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| DEPRESSION (SQ) 30-month follow-up |
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| SOMATIZATION (SQ) 3-month follow-up |
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| SOMATIZATION (SQ) 6-month follow-up |
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| SOMATIZATION (SQ) 12-month follow-up |
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| SOMATIZATION (SQ) 30-month follow-up |
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| HOSTILITY (SQ) 3-month follow-up |
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| HOSTILITY (SQ) 6-month follow-up |
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| HOSTILITY (SQ) 12-month follow-up |
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| HOSTILITY (SQ) 30-month follow-up |
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| ENVIRONMENTAL MASTERY (PWB) 3-month follow-up |
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| ENVIRONMENTAL MASTERY (PWB) 6-month follow-up |
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| ENVIRONMENTAL MASTERY (PWB) 12-month follow-up |
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| ENVIRONMENTAL MASTERY (PWB) 30-month follow-up |
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| PERSONAL GROWTH (PWB) 3-month follow-up |
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| PERSONAL GROWTH (PWB) 6-month follow-up |
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| PERSONAL GROWTH (PWB) 12-month follow-up |
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| PERSONAL GROWTH (PWB) 30-month follow-up |
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| POSITIVE RELATIONS (PWB) 3-month follow-up |
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| POSITIVE RELATIONS (PWB) 6-month follow-up |
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| POSITIVE RELATIONS (PWB) 12-month follow-up |
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| POSITIVE RELATIONS (PWB) 30-month follow-up |
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| PURPOSE IN LIFE (PWB) 3-month follow-up |
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| PURPOSE IN LIFE (PWB) 6-month follow-up |
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| PURPOSE IN LIFE (PWB) 12-month follow-up |
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| PURPOSE IN LIFE (PWB) 30-month follow-up |
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| SELF-ACCEPTANCE (PWB) 3-month follow-up |
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| SELF-ACCEPTANCE (PWB) 6-month follow-up |
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| SELF-ACCEPTANCE (PWB) 12-month follow-up |
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| SELF-ACCEPTANCE (PWB) 30-month follow-up |
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