TREATED-ACS: Treatment of Depression in Acute Coronary Syndrome (ACS) Patients
Sponsor
University of Bologna (Other)
Overall Status
Completed
CT.gov ID
NCT00998400
Collaborator
Compagnia di San Paolo (Other)
100
2
2
103
50
0.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Design
Study Type:
Interventional
Actual Enrollment
:
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cognitive-behavioral Treatment of Depression in Patients With Acute Coronary Syndrome
Study Start Date
:
Sep 1, 2010
Actual Primary Completion Date
:
Apr 1, 2019
Actual Study Completion Date
:
Apr 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Clinical Management Control group |
|
| Experimental: CBT + WBT Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification |
Behavioral: CBT in combination with WBT and life style modification
CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems. The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others. CM will consist of reviewing the patients' clinical status, and providing the patient with support and advice if necessary.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
a current diagnosis of at least one of the following: major or minor depression, dysthymia according to DSM-IV criteria, and demoralization according to DCPR criteria
-
Mini-Mental State Examination score higher than 24
-
written informed consent provided by the patient to participate
Exclusion Criteria:
-
history of bipolar disorder (DSM-IV criteria)
-
major depression with psychotic features
-
history of substance abuse or dependency during the previous 12 months
-
serious suicide risk
-
current use of antidepressants
-
current treatment with any form of psychotherapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maggiore Hospital | Bologna | Italy | 40100 | |
| 2 | Molinette Hospital | Torino | Italy | 10100 |
Sponsors and Collaborators
- University of Bologna
- Compagnia di San Paolo
Investigators
- Principal Investigator: Chiara Rafanelli, MD, Ph.D, Department of Psychology, University of Bologna
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Chiara Rafanelli,
Professor,
University of Bologna
ClinicalTrials.gov Identifier:
NCT00998400
Other Study ID Numbers:
- 2008.1263
First Posted:
Oct 20, 2009
Last Update Posted:
Feb 11, 2020
Last Verified:
Jan 1, 2020
Keywords provided by Chiara Rafanelli,
Professor,
University of Bologna
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | CBT/WBT | Clinical Management |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 50 | 50 |
| COMPLETED | 48 | 48 |
| NOT COMPLETED | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | CBT/WBT | Clinical Management | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Total of all reporting groups |
| Overall Participants | 50 | 50 | 100 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
57.64
(9.99)
|
60.02
(10.94)
|
58.83
(10.49)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
19
38%
|
12
24%
|
31
31%
|
| Male |
31
62%
|
38
76%
|
69
69%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (participants) [Number] | |||
| Italy |
50
100%
|
50
100%
|
100
100%
|
| Marital Status (Count of Participants) | |||
| Single |
4
8%
|
7
14%
|
11
11%
|
| Married |
33
66%
|
36
72%
|
69
69%
|
| Separated |
5
10%
|
4
8%
|
9
9%
|
| Divorced |
2
4%
|
1
2%
|
3
3%
|
| Widow/Widower |
6
12%
|
2
4%
|
8
8%
|
| Occupation (Count of Participants) | |||
| Employed |
34
68%
|
24
48%
|
58
58%
|
| Unemployed |
1
2%
|
4
8%
|
5
5%
|
| Retired |
13
26%
|
19
38%
|
32
32%
|
| Homemaker |
2
4%
|
3
6%
|
5
5%
|
| Education (Count of Participants) | |||
| Primary school |
5
10%
|
5
10%
|
10
10%
|
| Middle school |
16
32%
|
18
36%
|
34
34%
|
| High school |
19
38%
|
25
50%
|
44
44%
|
| University |
8
16%
|
1
2%
|
9
9%
|
| Post-graduate education |
2
4%
|
1
2%
|
3
3%
|
| Type of ACS (Count of Participants) | |||
| STEMI acute myocardial infarction |
33
66%
|
33
66%
|
66
66%
|
| NSTEMI acute myocardial infarction |
14
28%
|
13
26%
|
27
27%
|
| Unstable angina |
3
6%
|
4
8%
|
7
7%
|
| GRACE index (percent probability) [Mean (Standard Deviation) ] | |||
| Probability of Death In-hospital (%) |
3.51
(8.58)
|
4.56
(7.90)
|
4.03
(8.22)
|
| Probability of Death Post-discharge to 6 Months (% |
6.60
(11.60)
|
8.69
(10.57)
|
7.64
(11.09)
|
| Symptom Questionnaire (scores on a scale) [Mean (Standard Deviation) ] | |||
| Anxiety |
8.60
(4.73)
|
7.24
(4.67)
|
7.92
(4.73)
|
| Depression |
7.92
(4.77)
|
6.90
(4.87)
|
7.41
(4.82)
|
| Somatization |
9.82
(5.65)
|
7.82
(5.12)
|
8.82
(5.46)
|
| Hostility |
4.70
(4)
|
5.34
(4.36)
|
5.02
(4.17)
|
| Psychological Well-Being scales (scores on a scale) [Mean (Standard Deviation) ] | |||
| Autonomy |
62.20
(9.18)
|
61.80
(9.25)
|
62
(9.17)
|
| Environmental mastery |
55.28
(11.52)
|
55.32
(10.65)
|
55.30
(11.04)
|
| Personal growth |
60.48
(9.88)
|
56.18
(10.50)
|
58.33
(10.37)
|
| Positive relations with others |
61.26
(13.26)
|
60.2
(10.68)
|
60.73
(11.99)
|
| Purpose in life |
56.8
(11.51)
|
56.22
(11.59)
|
56.51
(11.5)
|
| Self-acceptance |
54.48
(11.63)
|
55.8
(13.68)
|
55.14
(12.65)
|
| Depression (DSM) (Count of Participants) | |||
| Count of Participants [Participants] |
35
70%
|
27
54%
|
62
62%
|
| Demoralization (DCPR) (Count of Participants) | |||
| Count of Participants [Participants] |
47
94%
|
44
88%
|
91
91%
|
| Clinical Interview for Depression (CID) (scores on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [scores on a scale] |
38.18
(8.48)
|
36.2
(8.57)
|
37.19
(8.54)
|
Outcome Measures
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT/WBT | Clinical Management |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 50 | 50 |
| Pre-treatment |
38.18
(8.48)
|
36.20
(8.57)
|
| Post-treatment |
29.39
(6.55)
|
32.30
(7.26)
|
| 3-month follow-up |
30.48
(5.81)
|
31.89
(7.11)
|
| 6-month follow-up |
29.89
(5.88)
|
30.59
(7.28)
|
| 12-month follow-up |
29.70
(6.51)
|
30.03
(7.05)
|
| 30-month follow-up |
30.64
(7.02)
|
30.30
(6.82)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CBT/WBT, Clinical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.030 |
| Comments | ||
| Method | Repeated Measures ANOVA | |
| Comments | All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure. | |
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT/WBT | Clinical Management |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 50 | 50 |
| ANXIETY (SQ) Pre-treatment |
8.60
(4.73)
|
7.24
(4.67)
|
| ANXIETY (SQ) Post-treatment |
7.04
(5.23)
|
6.39
(4.41)
|
| ANXIETY (SQ) 3-month follow-up |
6.60
(4.87)
|
6.13
(4.21)
|
| ANXIETY (SQ) 6-month follow-up |
6.67
(4.19)
|
7.10
(5.14)
|
| ANXIETY (SQ) 12-month follow-up |
6.62
(4.51)
|
6.33
(5.09)
|
| ANXIETY (SQ) 30-month follow-up |
6.00
(4.35)
|
5.69
(4.07)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CBT/WBT, Clinical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | Repeated Measures ANOVA | |
| Comments | All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure. | |
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT/WBT | Clinical Management |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 50 | 50 |
| AUTONOMY (PWB) Pre-treatment |
62.20
(9.18)
|
61.80
(9.25)
|
| AUTONOMY (PWB) Post-treatment |
64.58
(9.42)
|
62.82
(8.77)
|
| AUTONOMY (PWB) 3-month follow-up |
64.54
(9.24)
|
63.20
(8.51)
|
| AUTONOMY (PWB) 6-month follow-up |
64.40
(9.12)
|
63.21
(9.00)
|
| AUTONOMY (PWB) 12-month follow-up |
65.50
(8.53)
|
64.57
(9.34)
|
| AUTONOMY (PWB) 30-month follow-up |
64.93
(9.67)
|
63.71
(9.26)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CBT/WBT, Clinical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | Repeated Measures ANOVA | |
| Comments | All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure. | |
| Title | Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT/WBT | Clinical Management |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 50 | 50 |
| Non-fatal cardiac events |
8
16%
|
5
10%
|
| Cardiac death |
1
2%
|
1
2%
|
| No events |
41
82%
|
44
88%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CBT/WBT, Clinical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | Kaplan-Meier Survival analysis | |
| Comments | ||
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT/WBT | Clinical Management |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 50 | 50 |
| DEPRESSION (SQ) Pre-treatment |
7.92
(4.77)
|
6.90
(4.87)
|
| DEPRESSION (SQ) Post-treatment |
7.21
(5.42)
|
5.94
(4.22)
|
| DEPRESSION (SQ) 3-month follow-up |
6.38
(5.03)
|
5.83
(4.75)
|
| DEPRESSION (SQ) 6-month follow-up |
7.06
(5.22)
|
6.80
(5.45)
|
| DEPRESSION (SQ) 12-month follow-up |
6.91
(5.08)
|
6.22
(5.09)
|
| DEPRESSION (SQ) 30-month follow-up |
5.99
(4.64)
|
5.83
(4.18)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CBT/WBT, Clinical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | Repeated Measures ANOVA | |
| Comments | All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure. | |
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT/WBT | Clinical Management |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 50 | 50 |
| SOMATIZATION (SQ) Pre-treatment |
9.82
(5.65)
|
7.82
(5.12)
|
| SOMATIZATION (SQ) Post-treatment |
8.80
(5.73)
|
8.24
(4.90)
|
| SOMATIZATION (SQ) 3-month follow-up |
8.67
(5.42)
|
7.87
(4.58)
|
| SOMATIZATION (SQ) 6-month follow-up |
8.96
(5.02)
|
8.15
(5.64)
|
| SOMATIZATION (SQ) 12-month follow-up |
9.49
(5.19)
|
7.90
(5.38)
|
| SOMATIZATION (SQ) 30-month follow-up |
8.17
(5.00)
|
7.61
(4.72)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CBT/WBT, Clinical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | Repeated Measures ANOVA | |
| Comments | All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure. | |
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT/WBT | Clinical Management |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 50 | 50 |
| HOSTILITY (SQ) Pre-treatment |
4.70
(4.00)
|
5.34
(4.36)
|
| HOSTILITY (SQ) Post-treatment |
5.19
(4.96)
|
4.12
(3.78)
|
| HOSTILITY (SQ) 3-month follow-up |
5.18
(4.46)
|
4.71
(3.92)
|
| HOSTILITY (SQ) 6-month follow-up |
4.41
(3.71)
|
6.01
(4.73)
|
| HOSTILITY (SQ) 12-month follow-up |
5.32
(4.71)
|
5.17
(4.14)
|
| HOSTILITY (SQ) 30-month follow-up |
3.81
(3.37)
|
4.56
(4.11)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CBT/WBT, Clinical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.013 |
| Comments | ||
| Method | Repeated Measures ANOVA | |
| Comments | All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure. | |
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT/WBT | Clinical Management |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 50 | 50 |
| ENVIRONMENTAL MASTERY (PWB) Pre-treatment |
55.28
(11.52)
|
55.32
(10.65)
|
| ENVIRONMENTAL MASTERY (PWB) Post-treatment |
57.33
(12.93)
|
56.69
(8.81)
|
| ENVIRONMENTAL MASTERY (PWB) 3-month follow-up |
59.48
(11.32)
|
57.81
(10.15)
|
| ENVIRONMENTAL MASTERY (PWB) 6-month follow-up |
58.02
(11.83)
|
57.51
(8.78)
|
| ENVIRONMENTAL MASTERY (PWB) 12-month follow-up |
58.36
(12.15)
|
58.03
(11.19)
|
| ENVIRONMENTAL MASTERY (PWB) 30-month follow-up |
58.69
(10.97)
|
58.81
(8.10)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CBT/WBT, Clinical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | Repeated Measures ANOVA | |
| Comments | All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure. | |
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT/WBT | Clinical Management |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 50 | 50 |
| PERSONAL GROWTH (PWB) Pre-treatment |
60.48
(9.88)
|
56.18
(10.50)
|
| PERSONAL GROWTH (PWB) Post-treatment |
61.46
(9.92)
|
56.54
(8.70)
|
| PERSONAL GROWTH (PWB) 3-month follow-up |
61.95
(9.91)
|
56.67
(9.65)
|
| PERSONAL GROWTH (PWB) 6-month follow-up |
60.79
(9.58)
|
57.10
(8.90)
|
| PERSONAL GROWTH (PWB) 12-month follow-up |
60.55
(9.54)
|
57.64
(10.24)
|
| PERSONAL GROWTH (PWB) 30-month follow-up |
59.94
(9.34)
|
57.00
(8.85)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CBT/WBT, Clinical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | Repeated Measures ANOVA | |
| Comments | All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure. | |
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT/WBT | Clinical Management |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 50 | 50 |
| POSITIVE RELATIONS (PWB) Pre-treatment |
61.26
(13.26)
|
60.20
(10.68)
|
| POSITIVE RELATIONS (PWB) Post-treatment |
61.82
(13.50)
|
59.90
(10.93)
|
| POSITIVE RELATIONS (PWB) 3-month follow-up |
61.88
(12.86)
|
59.93
(12.13)
|
| POSITIVE RELATIONS (PWB) 6-month follow-up |
60.60
(13.08)
|
58.78
(10.82)
|
| POSITIVE RELATIONS (PWB) 12-month follow-up |
61.27
(12.08)
|
58.95
(11.54)
|
| POSITIVE RELATIONS (PWB) 30-month follow-up |
60.48
(11.60)
|
60.56
(10.78)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CBT/WBT, Clinical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | Repeated Measures ANOVA | |
| Comments | All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure. | |
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT/WBT | Clinical Management |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 50 | 50 |
| PURPOSE IN LIFE (PWB) Pre-treatment |
56.80
(11.51)
|
56.22
(11.59)
|
| PURPOSE IN LIFE (PWB) Post-treatment |
57.31
(11.21)
|
54.97
(9.41)
|
| PURPOSE IN LIFE (PWB) 3-month follow-up |
58.35
(10.09)
|
55.47
(10.32)
|
| PURPOSE IN LIFE (PWB) 6-month follow-up |
57.88
(10.85)
|
55.96
(10.12)
|
| PURPOSE IN LIFE (PWB) 12-month follow-up |
57.42
(9.81)
|
55.63
(10.82)
|
| PURPOSE IN LIFE (PWB) 30-month follow-up |
57.63
(9.70)
|
57.76
(8.16)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CBT/WBT, Clinical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | Repeated Measures ANOVA | |
| Comments | All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure. | |
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | CBT/WBT | Clinical Management |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 50 | 50 |
| SELF-ACCEPTANCE (PWB) Pre-treatment |
54.58
(11.63)
|
55.80
(13.68)
|
| SELF-ACCEPTANCE (PWB) Post-treatment |
55.70
(14.36)
|
56.03
(11.52)
|
| SELF-ACCEPTANCE (PWB) 3-month follow-up |
57.59
(13.51)
|
57.86
(12.84)
|
| SELF-ACCEPTANCE (PWB) 6-month follow-up |
55.83
(14.19)
|
58.32
(12.39)
|
| SELF-ACCEPTANCE (PWB) 12-month follow-up |
56.66
(11.92)
|
59.69
(13.38)
|
| SELF-ACCEPTANCE (PWB) 30-month follow-up |
56.15
(13.90)
|
59.94
(10.52)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CBT/WBT, Clinical Management |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | Repeated Measures ANOVA | |
| Comments | All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure. | |
Adverse Events
| Time Frame | From pre-treatment (baseline) to 30-month follow-up after the end of the interventions (both CBT/WBT and CM) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Re-hospitalizations due to cardiac complications, acute myocardial infarction, unstable angina, angioplasty and cardiac surgery occured after the first episode of ACS | |||
| Arm/Group Title | CBT/WBT | Clinical Management | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
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| CBT/WBT | Clinical Management | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/50 (2%) | 1/50 (2%) | ||
Serious Adverse Events |
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| CBT/WBT | Clinical Management | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/50 (18%) | 6/50 (12%) | ||
| Cardiac disorders | ||||
| Non-fatal cardiac events | 8/50 (16%) | 5/50 (10%) | ||
| Cardiac death | 1/50 (2%) | 1/50 (2%) | ||
Other (Not Including Serious) Adverse Events |
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| CBT/WBT | Clinical Management | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/50 (0%) | 0/50 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Professor Chiara Rafanelli |
|---|---|
| Organization | University of Bologna |
| Phone | 0039 051 2091847 |
| chiara.rafanelli@unibo.it |
Responsible Party:
Chiara Rafanelli,
Professor,
University of Bologna
ClinicalTrials.gov Identifier:
NCT00998400
Other Study ID Numbers:
- 2008.1263
First Posted:
Oct 20, 2009
Last Update Posted:
Feb 11, 2020
Last Verified:
Jan 1, 2020