Depression
Conditions
Keywords
Cognitive-behavioral treatment, Well-being therapy, Depression, Demoralization, 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.
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
Interventions
BEHAVIORALCBT 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.
Sponsors
Compagnia di San Paolo
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up. | 30-month follow-up post-treatment | 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. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of interest/motivation | 1 | 2 |
| Overall Study | Logistical problems | 1 | 0 |
Baseline characteristics
| Characteristic | CBT/WBT | Total | Clinical Management |
|---|---|---|---|
| Age, Continuous | 57.64 years STANDARD_DEVIATION 9.99 | 58.83 years STANDARD_DEVIATION 10.49 | 60.02 years STANDARD_DEVIATION 10.94 |
| Clinical Interview for Depression (CID) | 38.18 scores on a scale STANDARD_DEVIATION 8.48 | 37.19 scores on a scale STANDARD_DEVIATION 8.54 | 36.2 scores on a scale STANDARD_DEVIATION 8.57 |
| Demoralization (DCPR) | 47 Participants | 91 Participants | 44 Participants |
| Depression (DSM) | 35 Participants | 62 Participants | 27 Participants |
| Education High school | 19 Participants | 44 Participants | 25 Participants |
| Education Middle school | 16 Participants | 34 Participants | 18 Participants |
| Education Post-graduate education | 2 Participants | 3 Participants | 1 Participants |
| Education Primary school | 5 Participants | 10 Participants | 5 Participants |
| Education University | 8 Participants | 9 Participants | 1 Participants |
| GRACE index Probability of Death In-hospital (%) | 3.51 percent probability STANDARD_DEVIATION 8.58 | 4.03 percent probability STANDARD_DEVIATION 8.22 | 4.56 percent probability STANDARD_DEVIATION 7.9 |
| GRACE index Probability of Death Post-discharge to 6 Months (% | 6.60 percent probability STANDARD_DEVIATION 11.6 | 7.64 percent probability STANDARD_DEVIATION 11.09 | 8.69 percent probability STANDARD_DEVIATION 10.57 |
| Marital Status Divorced | 2 Participants | 3 Participants | 1 Participants |
| Marital Status Married | 33 Participants | 69 Participants | 36 Participants |
| Marital Status Separated | 5 Participants | 9 Participants | 4 Participants |
| Marital Status Single | 4 Participants | 11 Participants | 7 Participants |
| Marital Status Widow/Widower | 6 Participants | 8 Participants | 2 Participants |
| Occupation Employed | 34 Participants | 58 Participants | 24 Participants |
| Occupation Homemaker | 2 Participants | 5 Participants | 3 Participants |
| Occupation Retired | 13 Participants | 32 Participants | 19 Participants |
| Occupation Unemployed | 1 Participants | 5 Participants | 4 Participants |
| Psychological Well-Being scales Autonomy | 62.20 scores on a scale STANDARD_DEVIATION 9.18 | 62 scores on a scale STANDARD_DEVIATION 9.17 | 61.80 scores on a scale STANDARD_DEVIATION 9.25 |
| Psychological Well-Being scales Environmental mastery | 55.28 scores on a scale STANDARD_DEVIATION 11.52 | 55.30 scores on a scale STANDARD_DEVIATION 11.04 | 55.32 scores on a scale STANDARD_DEVIATION 10.65 |
| Psychological Well-Being scales Personal growth | 60.48 scores on a scale STANDARD_DEVIATION 9.88 | 58.33 scores on a scale STANDARD_DEVIATION 10.37 | 56.18 scores on a scale STANDARD_DEVIATION 10.5 |
| Psychological Well-Being scales Positive relations with others | 61.26 scores on a scale STANDARD_DEVIATION 13.26 | 60.73 scores on a scale STANDARD_DEVIATION 11.99 | 60.2 scores on a scale STANDARD_DEVIATION 10.68 |
| Psychological Well-Being scales Purpose in life | 56.8 scores on a scale STANDARD_DEVIATION 11.51 | 56.51 scores on a scale STANDARD_DEVIATION 11.5 | 56.22 scores on a scale STANDARD_DEVIATION 11.59 |
| Psychological Well-Being scales Self-acceptance | 54.48 scores on a scale STANDARD_DEVIATION 11.63 | 55.14 scores on a scale STANDARD_DEVIATION 12.65 | 55.8 scores on a scale STANDARD_DEVIATION 13.68 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Italy | 50 participants | 100 participants | 50 participants |
| Sex: Female, Male Female | 19 Participants | 31 Participants | 12 Participants |
| Sex: Female, Male Male | 31 Participants | 69 Participants | 38 Participants |
| Symptom Questionnaire Anxiety | 8.60 scores on a scale STANDARD_DEVIATION 4.73 | 7.92 scores on a scale STANDARD_DEVIATION 4.73 | 7.24 scores on a scale STANDARD_DEVIATION 4.67 |
| Symptom Questionnaire Depression | 7.92 scores on a scale STANDARD_DEVIATION 4.77 | 7.41 scores on a scale STANDARD_DEVIATION 4.82 | 6.90 scores on a scale STANDARD_DEVIATION 4.87 |
| Symptom Questionnaire Hostility | 4.70 scores on a scale STANDARD_DEVIATION 4 | 5.02 scores on a scale STANDARD_DEVIATION 4.17 | 5.34 scores on a scale STANDARD_DEVIATION 4.36 |
| Symptom Questionnaire Somatization | 9.82 scores on a scale STANDARD_DEVIATION 5.65 | 8.82 scores on a scale STANDARD_DEVIATION 5.46 | 7.82 scores on a scale STANDARD_DEVIATION 5.12 |
| Type of ACS NSTEMI acute myocardial infarction | 14 Participants | 27 Participants | 13 Participants |
| Type of ACS STEMI acute myocardial infarction | 33 Participants | 66 Participants | 33 Participants |
| Type of ACS Unstable angina | 3 Participants | 7 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 50 | 1 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 9 / 50 | 6 / 50 |
Outcome results
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.
Time frame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT/WBT | 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 | 38.18 score on a scale | Standard Deviation 8.48 |
| CBT/WBT | 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 | Post-treatment | 29.39 score on a scale | Standard Deviation 6.55 |
| CBT/WBT | 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 | 3-month follow-up | 30.48 score on a scale | Standard Deviation 5.81 |
| CBT/WBT | 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 | 6-month follow-up | 29.89 score on a scale | Standard Deviation 5.88 |
| CBT/WBT | 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 | 12-month follow-up | 29.70 score on a scale | Standard Deviation 6.51 |
| CBT/WBT | 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 | 30-month follow-up | 30.64 score on a scale | Standard Deviation 7.02 |
| Clinical Management | 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 | 12-month follow-up | 30.03 score on a scale | Standard Deviation 7.05 |
| Clinical Management | 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 | 36.20 score on a scale | Standard Deviation 8.57 |
| Clinical Management | 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 | 6-month follow-up | 30.59 score on a scale | Standard Deviation 7.28 |
| Clinical Management | 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 | Post-treatment | 32.30 score on a scale | Standard Deviation 7.26 |
| Clinical Management | 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 | 30-month follow-up | 30.30 score on a scale | Standard Deviation 6.82 |
| Clinical Management | 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 | 3-month follow-up | 31.89 score on a scale | Standard Deviation 7.11 |
p-value: 0.03Repeated Measures ANOVA
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.
Time frame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT/WBT | 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 | ANXIETY (SQ) Post-treatment | 7.04 score on a scale | Standard Deviation 5.23 |
| CBT/WBT | 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 | ANXIETY (SQ) Pre-treatment | 8.60 score on a scale | Standard Deviation 4.73 |
| CBT/WBT | 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 | ANXIETY (SQ) 12-month follow-up | 6.62 score on a scale | Standard Deviation 4.51 |
| CBT/WBT | 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 | ANXIETY (SQ) 3-month follow-up | 6.60 score on a scale | Standard Deviation 4.87 |
| CBT/WBT | 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 | ANXIETY (SQ) 30-month follow-up | 6.00 score on a scale | Standard Deviation 4.35 |
| CBT/WBT | 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 | ANXIETY (SQ) 6-month follow-up | 6.67 score on a scale | Standard Deviation 4.19 |
| Clinical Management | 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 | ANXIETY (SQ) 30-month follow-up | 5.69 score on a scale | Standard Deviation 4.07 |
| Clinical Management | 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 | ANXIETY (SQ) Pre-treatment | 7.24 score on a scale | Standard Deviation 4.67 |
| Clinical Management | 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 | ANXIETY (SQ) Post-treatment | 6.39 score on a scale | Standard Deviation 4.41 |
| Clinical Management | 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 | ANXIETY (SQ) 3-month follow-up | 6.13 score on a scale | Standard Deviation 4.21 |
| Clinical Management | 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 | ANXIETY (SQ) 6-month follow-up | 7.10 score on a scale | Standard Deviation 5.14 |
| Clinical Management | 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 | ANXIETY (SQ) 12-month follow-up | 6.33 score on a scale | Standard Deviation 5.09 |
p-value: >0.05Repeated Measures ANOVA
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.
Time frame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT/WBT | 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 | DEPRESSION (SQ) Pre-treatment | 7.92 score on a scale | Standard Deviation 4.77 |
| CBT/WBT | 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 | DEPRESSION (SQ) Post-treatment | 7.21 score on a scale | Standard Deviation 5.42 |
| CBT/WBT | 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 | DEPRESSION (SQ) 3-month follow-up | 6.38 score on a scale | Standard Deviation 5.03 |
| CBT/WBT | 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 | DEPRESSION (SQ) 6-month follow-up | 7.06 score on a scale | Standard Deviation 5.22 |
| CBT/WBT | 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 | DEPRESSION (SQ) 12-month follow-up | 6.91 score on a scale | Standard Deviation 5.08 |
| CBT/WBT | 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 | DEPRESSION (SQ) 30-month follow-up | 5.99 score on a scale | Standard Deviation 4.64 |
| Clinical Management | 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 | DEPRESSION (SQ) 12-month follow-up | 6.22 score on a scale | Standard Deviation 5.09 |
| Clinical Management | 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 | DEPRESSION (SQ) Pre-treatment | 6.90 score on a scale | Standard Deviation 4.87 |
| Clinical Management | 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 | DEPRESSION (SQ) 6-month follow-up | 6.80 score on a scale | Standard Deviation 5.45 |
| Clinical Management | 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 | DEPRESSION (SQ) Post-treatment | 5.94 score on a scale | Standard Deviation 4.22 |
| Clinical Management | 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 | DEPRESSION (SQ) 30-month follow-up | 5.83 score on a scale | Standard Deviation 4.18 |
| Clinical Management | 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 | DEPRESSION (SQ) 3-month follow-up | 5.83 score on a scale | Standard Deviation 4.75 |
p-value: >0.05Repeated Measures ANOVA
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.
Time frame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT/WBT | 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 (SQ) 6-month follow-up | 4.41 score on a scale | Standard Deviation 3.71 |
| CBT/WBT | 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 (SQ) Post-treatment | 5.19 score on a scale | Standard Deviation 4.96 |
| CBT/WBT | 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 (SQ) 12-month follow-up | 5.32 score on a scale | Standard Deviation 4.71 |
| CBT/WBT | 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 (SQ) Pre-treatment | 4.70 score on a scale | Standard Deviation 4 |
| CBT/WBT | 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 (SQ) 30-month follow-up | 3.81 score on a scale | Standard Deviation 3.37 |
| CBT/WBT | 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 (SQ) 3-month follow-up | 5.18 score on a scale | Standard Deviation 4.46 |
| Clinical Management | 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 (SQ) 30-month follow-up | 4.56 score on a scale | Standard Deviation 4.11 |
| Clinical Management | 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 (SQ) Pre-treatment | 5.34 score on a scale | Standard Deviation 4.36 |
| Clinical Management | 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 (SQ) Post-treatment | 4.12 score on a scale | Standard Deviation 3.78 |
| Clinical Management | 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 (SQ) 6-month follow-up | 6.01 score on a scale | Standard Deviation 4.73 |
| Clinical Management | 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 (SQ) 12-month follow-up | 5.17 score on a scale | Standard Deviation 4.14 |
| Clinical Management | 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 (SQ) 3-month follow-up | 4.71 score on a scale | Standard Deviation 3.92 |
p-value: 0.013Repeated Measures ANOVA
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.
Time frame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT/WBT | 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 | SOMATIZATION (SQ) Pre-treatment | 9.82 score on a scale | Standard Deviation 5.65 |
| CBT/WBT | 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 | SOMATIZATION (SQ) Post-treatment | 8.80 score on a scale | Standard Deviation 5.73 |
| CBT/WBT | 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 | SOMATIZATION (SQ) 3-month follow-up | 8.67 score on a scale | Standard Deviation 5.42 |
| CBT/WBT | 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 | SOMATIZATION (SQ) 6-month follow-up | 8.96 score on a scale | Standard Deviation 5.02 |
| CBT/WBT | 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 | SOMATIZATION (SQ) 12-month follow-up | 9.49 score on a scale | Standard Deviation 5.19 |
| CBT/WBT | 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 | SOMATIZATION (SQ) 30-month follow-up | 8.17 score on a scale | Standard Deviation 5 |
| Clinical Management | 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 | SOMATIZATION (SQ) 12-month follow-up | 7.90 score on a scale | Standard Deviation 5.38 |
| Clinical Management | 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 | SOMATIZATION (SQ) Pre-treatment | 7.82 score on a scale | Standard Deviation 5.12 |
| Clinical Management | 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 | SOMATIZATION (SQ) 6-month follow-up | 8.15 score on a scale | Standard Deviation 5.64 |
| Clinical Management | 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 | SOMATIZATION (SQ) Post-treatment | 8.24 score on a scale | Standard Deviation 4.9 |
| Clinical Management | 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 | SOMATIZATION (SQ) 30-month follow-up | 7.61 score on a scale | Standard Deviation 4.72 |
| Clinical Management | 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 | SOMATIZATION (SQ) 3-month follow-up | 7.87 score on a scale | Standard Deviation 4.58 |
p-value: >0.05Repeated Measures ANOVA
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.
Time frame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT/WBT | 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 (PWB) Pre-treatment | 62.20 score on a scale | Standard Deviation 9.18 |
| CBT/WBT | 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 (PWB) Post-treatment | 64.58 score on a scale | Standard Deviation 9.42 |
| CBT/WBT | 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 (PWB) 3-month follow-up | 64.54 score on a scale | Standard Deviation 9.24 |
| CBT/WBT | 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 (PWB) 6-month follow-up | 64.40 score on a scale | Standard Deviation 9.12 |
| CBT/WBT | 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 (PWB) 12-month follow-up | 65.50 score on a scale | Standard Deviation 8.53 |
| CBT/WBT | 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 (PWB) 30-month follow-up | 64.93 score on a scale | Standard Deviation 9.67 |
| Clinical Management | 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 (PWB) 12-month follow-up | 64.57 score on a scale | Standard Deviation 9.34 |
| Clinical Management | 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 (PWB) Pre-treatment | 61.80 score on a scale | Standard Deviation 9.25 |
| Clinical Management | 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 (PWB) 6-month follow-up | 63.21 score on a scale | Standard Deviation 9 |
| Clinical Management | 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 (PWB) Post-treatment | 62.82 score on a scale | Standard Deviation 8.77 |
| Clinical Management | 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 (PWB) 30-month follow-up | 63.71 score on a scale | Standard Deviation 9.26 |
| Clinical Management | 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 (PWB) 3-month follow-up | 63.20 score on a scale | Standard Deviation 8.51 |
p-value: >0.05Repeated Measures ANOVA
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.
Time frame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT/WBT | 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 (PWB) Post-treatment | 57.33 score on a scale | Standard Deviation 12.93 |
| CBT/WBT | 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 (PWB) 6-month follow-up | 58.02 score on a scale | Standard Deviation 11.83 |
| CBT/WBT | 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 (PWB) Pre-treatment | 55.28 score on a scale | Standard Deviation 11.52 |
| CBT/WBT | 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 (PWB) 12-month follow-up | 58.36 score on a scale | Standard Deviation 12.15 |
| CBT/WBT | 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 (PWB) 30-month follow-up | 58.69 score on a scale | Standard Deviation 10.97 |
| CBT/WBT | 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 (PWB) 3-month follow-up | 59.48 score on a scale | Standard Deviation 11.32 |
| Clinical Management | 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 (PWB) 30-month follow-up | 58.81 score on a scale | Standard Deviation 8.1 |
| Clinical Management | 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 (PWB) 12-month follow-up | 58.03 score on a scale | Standard Deviation 11.19 |
| Clinical Management | 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 (PWB) Post-treatment | 56.69 score on a scale | Standard Deviation 8.81 |
| Clinical Management | 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 (PWB) 3-month follow-up | 57.81 score on a scale | Standard Deviation 10.15 |
| Clinical Management | 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 (PWB) 6-month follow-up | 57.51 score on a scale | Standard Deviation 8.78 |
| Clinical Management | 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 (PWB) Pre-treatment | 55.32 score on a scale | Standard Deviation 10.65 |
p-value: >0.05Repeated Measures ANOVA
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.
Time frame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT/WBT | 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 (PWB) 3-month follow-up | 61.95 score on a scale | Standard Deviation 9.91 |
| CBT/WBT | 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 (PWB) Pre-treatment | 60.48 score on a scale | Standard Deviation 9.88 |
| CBT/WBT | 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 (PWB) Post-treatment | 61.46 score on a scale | Standard Deviation 9.92 |
| CBT/WBT | 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 (PWB) 6-month follow-up | 60.79 score on a scale | Standard Deviation 9.58 |
| CBT/WBT | 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 (PWB) 12-month follow-up | 60.55 score on a scale | Standard Deviation 9.54 |
| CBT/WBT | 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 (PWB) 30-month follow-up | 59.94 score on a scale | Standard Deviation 9.34 |
| Clinical Management | 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 (PWB) 12-month follow-up | 57.64 score on a scale | Standard Deviation 10.24 |
| Clinical Management | 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 (PWB) 6-month follow-up | 57.10 score on a scale | Standard Deviation 8.9 |
| Clinical Management | 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 (PWB) Pre-treatment | 56.18 score on a scale | Standard Deviation 10.5 |
| Clinical Management | 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 (PWB) 30-month follow-up | 57.00 score on a scale | Standard Deviation 8.85 |
| Clinical Management | 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 (PWB) Post-treatment | 56.54 score on a scale | Standard Deviation 8.7 |
| Clinical Management | 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 (PWB) 3-month follow-up | 56.67 score on a scale | Standard Deviation 9.65 |
p-value: >0.05Repeated Measures ANOVA
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.
Time frame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT/WBT | 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 (PWB) Pre-treatment | 61.26 score on a scale | Standard Deviation 13.26 |
| CBT/WBT | 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 (PWB) Post-treatment | 61.82 score on a scale | Standard Deviation 13.5 |
| CBT/WBT | 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 (PWB) 3-month follow-up | 61.88 score on a scale | Standard Deviation 12.86 |
| CBT/WBT | 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 (PWB) 6-month follow-up | 60.60 score on a scale | Standard Deviation 13.08 |
| CBT/WBT | 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 (PWB) 12-month follow-up | 61.27 score on a scale | Standard Deviation 12.08 |
| CBT/WBT | 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 (PWB) 30-month follow-up | 60.48 score on a scale | Standard Deviation 11.6 |
| Clinical Management | 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 (PWB) 12-month follow-up | 58.95 score on a scale | Standard Deviation 11.54 |
| Clinical Management | 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 (PWB) Pre-treatment | 60.20 score on a scale | Standard Deviation 10.68 |
| Clinical Management | 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 (PWB) 6-month follow-up | 58.78 score on a scale | Standard Deviation 10.82 |
| Clinical Management | 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 (PWB) Post-treatment | 59.90 score on a scale | Standard Deviation 10.93 |
| Clinical Management | 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 (PWB) 30-month follow-up | 60.56 score on a scale | Standard Deviation 10.78 |
| Clinical Management | 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 (PWB) 3-month follow-up | 59.93 score on a scale | Standard Deviation 12.13 |
p-value: >0.05Repeated Measures ANOVA
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.
Time frame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT/WBT | 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 (PWB) Pre-treatment | 56.80 score on a scale | Standard Deviation 11.51 |
| CBT/WBT | 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 (PWB) Post-treatment | 57.31 score on a scale | Standard Deviation 11.21 |
| CBT/WBT | 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 (PWB) 3-month follow-up | 58.35 score on a scale | Standard Deviation 10.09 |
| CBT/WBT | 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 (PWB) 6-month follow-up | 57.88 score on a scale | Standard Deviation 10.85 |
| CBT/WBT | 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 (PWB) 12-month follow-up | 57.42 score on a scale | Standard Deviation 9.81 |
| CBT/WBT | 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 (PWB) 30-month follow-up | 57.63 score on a scale | Standard Deviation 9.7 |
| Clinical Management | 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 (PWB) 12-month follow-up | 55.63 score on a scale | Standard Deviation 10.82 |
| Clinical Management | 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 (PWB) Pre-treatment | 56.22 score on a scale | Standard Deviation 11.59 |
| Clinical Management | 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 (PWB) 6-month follow-up | 55.96 score on a scale | Standard Deviation 10.12 |
| Clinical Management | 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 (PWB) Post-treatment | 54.97 score on a scale | Standard Deviation 9.41 |
| Clinical Management | 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 (PWB) 30-month follow-up | 57.76 score on a scale | Standard Deviation 8.16 |
| Clinical Management | 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 (PWB) 3-month follow-up | 55.47 score on a scale | Standard Deviation 10.32 |
p-value: >0.05Repeated Measures ANOVA
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.
Time frame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT/WBT | 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 (PWB) Pre-treatment | 54.58 score on a scale | Standard Deviation 11.63 |
| CBT/WBT | 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 (PWB) Post-treatment | 55.70 score on a scale | Standard Deviation 14.36 |
| CBT/WBT | 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 (PWB) 3-month follow-up | 57.59 score on a scale | Standard Deviation 13.51 |
| CBT/WBT | 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 (PWB) 6-month follow-up | 55.83 score on a scale | Standard Deviation 14.19 |
| CBT/WBT | 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 (PWB) 12-month follow-up | 56.66 score on a scale | Standard Deviation 11.92 |
| CBT/WBT | 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 (PWB) 30-month follow-up | 56.15 score on a scale | Standard Deviation 13.9 |
| Clinical Management | 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 (PWB) 12-month follow-up | 59.69 score on a scale | Standard Deviation 13.38 |
| Clinical Management | 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 (PWB) Pre-treatment | 55.80 score on a scale | Standard Deviation 13.68 |
| Clinical Management | 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 (PWB) 6-month follow-up | 58.32 score on a scale | Standard Deviation 12.39 |
| Clinical Management | 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 (PWB) Post-treatment | 56.03 score on a scale | Standard Deviation 11.52 |
| Clinical Management | 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 (PWB) 30-month follow-up | 59.94 score on a scale | Standard Deviation 10.52 |
| Clinical Management | 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 (PWB) 3-month follow-up | 57.86 score on a scale | Standard Deviation 12.84 |
p-value: >0.05Repeated Measures ANOVA
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.
Time frame: 30-month follow-up post-treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CBT/WBT | Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up. | Non-fatal cardiac events | 8 Participants |
| CBT/WBT | Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up. | Cardiac death | 1 Participants |
| CBT/WBT | Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up. | No events | 41 Participants |
| Clinical Management | Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up. | Non-fatal cardiac events | 5 Participants |
| Clinical Management | Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up. | Cardiac death | 1 Participants |
| Clinical Management | Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up. | No events | 44 Participants |
p-value: >0.05Kaplan-Meier Survival analysis