Trial Outcomes & Findings for Treatment of Depression in Acute Coronary Syndrome (ACS) Patients (NCT NCT00998400)
NCT ID: NCT00998400
Last Updated: 2020-02-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
Results posted on
2020-02-11
Participant Flow
Participant milestones
| Measure |
CBT/WBT
Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification
CBT in combination with WBT and life style modification: CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems. The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
CBT/WBT
Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification
CBT in combination with WBT and life style modification: CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems. The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others.
|
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.
|
|---|---|---|
|
Overall Study
Lack of interest/motivation
|
1
|
2
|
|
Overall Study
Logistical problems
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CBT/WBT
n=50 Participants
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
n=50 Participants
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
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.64 years
STANDARD_DEVIATION 9.99 • n=50 Participants
|
60.02 years
STANDARD_DEVIATION 10.94 • n=50 Participants
|
58.83 years
STANDARD_DEVIATION 10.49 • n=100 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=50 Participants
|
12 Participants
n=50 Participants
|
31 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=50 Participants
|
38 Participants
n=50 Participants
|
69 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Italy
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
100 participants
n=100 Participants
|
|
Marital Status
Single
|
4 Participants
n=50 Participants
|
7 Participants
n=50 Participants
|
11 Participants
n=100 Participants
|
|
Marital Status
Married
|
33 Participants
n=50 Participants
|
36 Participants
n=50 Participants
|
69 Participants
n=100 Participants
|
|
Marital Status
Separated
|
5 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
9 Participants
n=100 Participants
|
|
Marital Status
Divorced
|
2 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=100 Participants
|
|
Marital Status
Widow/Widower
|
6 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
8 Participants
n=100 Participants
|
|
Occupation
Employed
|
34 Participants
n=50 Participants
|
24 Participants
n=50 Participants
|
58 Participants
n=100 Participants
|
|
Occupation
Unemployed
|
1 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
5 Participants
n=100 Participants
|
|
Occupation
Retired
|
13 Participants
n=50 Participants
|
19 Participants
n=50 Participants
|
32 Participants
n=100 Participants
|
|
Occupation
Homemaker
|
2 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
5 Participants
n=100 Participants
|
|
Education
Primary school
|
5 Participants
n=50 Participants
|
5 Participants
n=50 Participants
|
10 Participants
n=100 Participants
|
|
Education
Middle school
|
16 Participants
n=50 Participants
|
18 Participants
n=50 Participants
|
34 Participants
n=100 Participants
|
|
Education
High school
|
19 Participants
n=50 Participants
|
25 Participants
n=50 Participants
|
44 Participants
n=100 Participants
|
|
Education
University
|
8 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
9 Participants
n=100 Participants
|
|
Education
Post-graduate education
|
2 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=100 Participants
|
|
Type of ACS
STEMI acute myocardial infarction
|
33 Participants
n=50 Participants
|
33 Participants
n=50 Participants
|
66 Participants
n=100 Participants
|
|
Type of ACS
NSTEMI acute myocardial infarction
|
14 Participants
n=50 Participants
|
13 Participants
n=50 Participants
|
27 Participants
n=100 Participants
|
|
Type of ACS
Unstable angina
|
3 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
7 Participants
n=100 Participants
|
|
GRACE index
Probability of Death In-hospital (%)
|
3.51 percent probability
STANDARD_DEVIATION 8.58 • n=50 Participants
|
4.56 percent probability
STANDARD_DEVIATION 7.90 • n=50 Participants
|
4.03 percent probability
STANDARD_DEVIATION 8.22 • n=100 Participants
|
|
GRACE index
Probability of Death Post-discharge to 6 Months (%
|
6.60 percent probability
STANDARD_DEVIATION 11.60 • n=50 Participants
|
8.69 percent probability
STANDARD_DEVIATION 10.57 • n=50 Participants
|
7.64 percent probability
STANDARD_DEVIATION 11.09 • n=100 Participants
|
|
Symptom Questionnaire
Anxiety
|
8.60 scores on a scale
STANDARD_DEVIATION 4.73 • n=50 Participants
|
7.24 scores on a scale
STANDARD_DEVIATION 4.67 • n=50 Participants
|
7.92 scores on a scale
STANDARD_DEVIATION 4.73 • n=100 Participants
|
|
Symptom Questionnaire
Depression
|
7.92 scores on a scale
STANDARD_DEVIATION 4.77 • n=50 Participants
|
6.90 scores on a scale
STANDARD_DEVIATION 4.87 • n=50 Participants
|
7.41 scores on a scale
STANDARD_DEVIATION 4.82 • n=100 Participants
|
|
Symptom Questionnaire
Somatization
|
9.82 scores on a scale
STANDARD_DEVIATION 5.65 • n=50 Participants
|
7.82 scores on a scale
STANDARD_DEVIATION 5.12 • n=50 Participants
|
8.82 scores on a scale
STANDARD_DEVIATION 5.46 • n=100 Participants
|
|
Symptom Questionnaire
Hostility
|
4.70 scores on a scale
STANDARD_DEVIATION 4 • n=50 Participants
|
5.34 scores on a scale
STANDARD_DEVIATION 4.36 • n=50 Participants
|
5.02 scores on a scale
STANDARD_DEVIATION 4.17 • n=100 Participants
|
|
Psychological Well-Being scales
Autonomy
|
62.20 scores on a scale
STANDARD_DEVIATION 9.18 • n=50 Participants
|
61.80 scores on a scale
STANDARD_DEVIATION 9.25 • n=50 Participants
|
62 scores on a scale
STANDARD_DEVIATION 9.17 • n=100 Participants
|
|
Psychological Well-Being scales
Environmental mastery
|
55.28 scores on a scale
STANDARD_DEVIATION 11.52 • n=50 Participants
|
55.32 scores on a scale
STANDARD_DEVIATION 10.65 • n=50 Participants
|
55.30 scores on a scale
STANDARD_DEVIATION 11.04 • n=100 Participants
|
|
Psychological Well-Being scales
Personal growth
|
60.48 scores on a scale
STANDARD_DEVIATION 9.88 • n=50 Participants
|
56.18 scores on a scale
STANDARD_DEVIATION 10.50 • n=50 Participants
|
58.33 scores on a scale
STANDARD_DEVIATION 10.37 • n=100 Participants
|
|
Psychological Well-Being scales
Positive relations with others
|
61.26 scores on a scale
STANDARD_DEVIATION 13.26 • n=50 Participants
|
60.2 scores on a scale
STANDARD_DEVIATION 10.68 • n=50 Participants
|
60.73 scores on a scale
STANDARD_DEVIATION 11.99 • n=100 Participants
|
|
Psychological Well-Being scales
Purpose in life
|
56.8 scores on a scale
STANDARD_DEVIATION 11.51 • n=50 Participants
|
56.22 scores on a scale
STANDARD_DEVIATION 11.59 • n=50 Participants
|
56.51 scores on a scale
STANDARD_DEVIATION 11.5 • n=100 Participants
|
|
Psychological Well-Being scales
Self-acceptance
|
54.48 scores on a scale
STANDARD_DEVIATION 11.63 • n=50 Participants
|
55.8 scores on a scale
STANDARD_DEVIATION 13.68 • n=50 Participants
|
55.14 scores on a scale
STANDARD_DEVIATION 12.65 • n=100 Participants
|
|
Depression (DSM)
|
35 Participants
n=50 Participants
|
27 Participants
n=50 Participants
|
62 Participants
n=100 Participants
|
|
Demoralization (DCPR)
|
47 Participants
n=50 Participants
|
44 Participants
n=50 Participants
|
91 Participants
n=100 Participants
|
|
Clinical Interview for Depression (CID)
|
38.18 scores on a scale
STANDARD_DEVIATION 8.48 • n=50 Participants
|
36.2 scores on a scale
STANDARD_DEVIATION 8.57 • n=50 Participants
|
37.19 scores on a scale
STANDARD_DEVIATION 8.54 • n=100 Participants
|
PRIMARY outcome
Timeframe: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-upPaykel'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.
Outcome measures
| Measure |
CBT/WBT
n=50 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
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
|
30.03 score on a scale
Standard Deviation 7.05
|
|
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
|
36.20 score on a scale
Standard Deviation 8.57
|
|
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
|
32.30 score on a scale
Standard Deviation 7.26
|
|
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
|
31.89 score on a scale
Standard Deviation 7.11
|
|
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
|
30.59 score on a scale
Standard Deviation 7.28
|
|
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
|
30.30 score on a scale
Standard Deviation 6.82
|
PRIMARY outcome
Timeframe: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-upAnxious 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.
Outcome measures
| Measure |
CBT/WBT
n=50 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
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
|
6.33 score on a scale
Standard Deviation 5.09
|
|
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
|
7.24 score on a scale
Standard Deviation 4.67
|
|
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
|
6.39 score on a scale
Standard Deviation 4.41
|
|
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
|
6.13 score on a scale
Standard Deviation 4.21
|
|
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
|
7.10 score on a scale
Standard Deviation 5.14
|
|
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
|
5.69 score on a scale
Standard Deviation 4.07
|
PRIMARY outcome
Timeframe: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-upAutonomy 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.
Outcome measures
| Measure |
CBT/WBT
n=50 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
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
|
61.80 score on a scale
Standard Deviation 9.25
|
|
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
|
62.82 score on a scale
Standard Deviation 8.77
|
|
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
|
63.20 score on a scale
Standard Deviation 8.51
|
|
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
|
63.21 score on a scale
Standard Deviation 9.00
|
|
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
|
64.57 score on a scale
Standard Deviation 9.34
|
|
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
|
63.71 score on a scale
Standard Deviation 9.26
|
PRIMARY outcome
Timeframe: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-upDepressive 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.
Outcome measures
| Measure |
CBT/WBT
n=50 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
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
|
6.80 score on a scale
Standard Deviation 5.45
|
|
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
|
6.90 score on a scale
Standard Deviation 4.87
|
|
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
|
5.94 score on a scale
Standard Deviation 4.22
|
|
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
|
5.83 score on a scale
Standard Deviation 4.75
|
|
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
|
6.22 score on a scale
Standard Deviation 5.09
|
|
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
|
5.83 score on a scale
Standard Deviation 4.18
|
PRIMARY outcome
Timeframe: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-upSomatic 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.
Outcome measures
| Measure |
CBT/WBT
n=50 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
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
|
7.82 score on a scale
Standard Deviation 5.12
|
|
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
|
8.24 score on a scale
Standard Deviation 4.90
|
|
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
|
7.87 score on a scale
Standard Deviation 4.58
|
|
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
|
8.15 score on a scale
Standard Deviation 5.64
|
|
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
|
7.90 score on a scale
Standard Deviation 5.38
|
|
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 5.00
|
7.61 score on a scale
Standard Deviation 4.72
|
PRIMARY outcome
Timeframe: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-upHostility 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.
Outcome measures
| Measure |
CBT/WBT
n=50 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
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
|
6.01 score on a scale
Standard Deviation 4.73
|
|
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 4.00
|
5.34 score on a scale
Standard Deviation 4.36
|
|
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
|
4.12 score on a scale
Standard Deviation 3.78
|
|
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
|
4.71 score on a scale
Standard Deviation 3.92
|
|
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
|
5.17 score on a scale
Standard Deviation 4.14
|
|
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
|
4.56 score on a scale
Standard Deviation 4.11
|
PRIMARY outcome
Timeframe: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-upEnvironmental 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.
Outcome measures
| Measure |
CBT/WBT
n=50 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
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
|
55.32 score on a scale
Standard Deviation 10.65
|
|
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
|
56.69 score on a scale
Standard Deviation 8.81
|
|
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
|
57.81 score on a scale
Standard Deviation 10.15
|
|
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
|
57.51 score on a scale
Standard Deviation 8.78
|
|
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
|
58.03 score on a scale
Standard Deviation 11.19
|
|
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
|
58.81 score on a scale
Standard Deviation 8.10
|
PRIMARY outcome
Timeframe: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-upPersonal 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.
Outcome measures
| Measure |
CBT/WBT
n=50 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
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
|
56.18 score on a scale
Standard Deviation 10.50
|
|
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
|
56.54 score on a scale
Standard Deviation 8.70
|
|
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
|
56.67 score on a scale
Standard Deviation 9.65
|
|
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
|
57.10 score on a scale
Standard Deviation 8.90
|
|
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
|
57.64 score on a scale
Standard Deviation 10.24
|
|
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
|
57.00 score on a scale
Standard Deviation 8.85
|
PRIMARY outcome
Timeframe: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-upPositive 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.
Outcome measures
| Measure |
CBT/WBT
n=50 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
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
|
59.93 score on a scale
Standard Deviation 12.13
|
|
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
|
60.20 score on a scale
Standard Deviation 10.68
|
|
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 13.50
|
59.90 score on a scale
Standard Deviation 10.93
|
|
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
|
58.78 score on a scale
Standard Deviation 10.82
|
|
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
|
58.95 score on a scale
Standard Deviation 11.54
|
|
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 11.60
|
60.56 score on a scale
Standard Deviation 10.78
|
PRIMARY outcome
Timeframe: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-upPurpose 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.
Outcome measures
| Measure |
CBT/WBT
n=50 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
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
|
56.22 score on a scale
Standard Deviation 11.59
|
|
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
|
54.97 score on a scale
Standard Deviation 9.41
|
|
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
|
55.47 score on a scale
Standard Deviation 10.32
|
|
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
|
55.96 score on a scale
Standard Deviation 10.12
|
|
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
|
55.63 score on a scale
Standard Deviation 10.82
|
|
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 9.70
|
57.76 score on a scale
Standard Deviation 8.16
|
PRIMARY outcome
Timeframe: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-upSelf-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.
Outcome measures
| Measure |
CBT/WBT
n=50 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
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
|
59.69 score on a scale
Standard Deviation 13.38
|
|
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
|
55.80 score on a scale
Standard Deviation 13.68
|
|
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
|
56.03 score on a scale
Standard Deviation 11.52
|
|
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
|
57.86 score on a scale
Standard Deviation 12.84
|
|
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
|
58.32 score on a scale
Standard Deviation 12.39
|
|
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 13.90
|
59.94 score on a scale
Standard Deviation 10.52
|
SECONDARY outcome
Timeframe: 30-month follow-up post-treatmentFrequencies 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.
Outcome measures
| Measure |
CBT/WBT
n=50 Participants
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
n=50 Participants
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.
|
|---|---|---|
|
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
|
1 Participants
|
|
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
|
5 Participants
|
|
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
|
44 Participants
|
Adverse Events
CBT/WBT
Serious events: 9 serious events
Other events: 0 other events
Deaths: 1 deaths
Clinical Management
Serious events: 6 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CBT/WBT
n=50 participants at risk
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
n=50 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Non-fatal cardiac events
|
16.0%
8/50 • From pre-treatment (baseline) to 30-month follow-up after the end of the interventions (both CBT/WBT and CM)
Re-hospitalizations due to cardiac complications, acute myocardial infarction, unstable angina, angioplasty and cardiac surgery occured after the first episode of ACS
|
10.0%
5/50 • From pre-treatment (baseline) to 30-month follow-up after the end of the interventions (both CBT/WBT and CM)
Re-hospitalizations due to cardiac complications, acute myocardial infarction, unstable angina, angioplasty and cardiac surgery occured after the first episode of ACS
|
|
Cardiac disorders
Cardiac death
|
2.0%
1/50 • From pre-treatment (baseline) to 30-month follow-up after the end of the interventions (both CBT/WBT and CM)
Re-hospitalizations due to cardiac complications, acute myocardial infarction, unstable angina, angioplasty and cardiac surgery occured after the first episode of ACS
|
2.0%
1/50 • From pre-treatment (baseline) to 30-month follow-up after the end of the interventions (both CBT/WBT and CM)
Re-hospitalizations due to cardiac complications, acute myocardial infarction, unstable angina, angioplasty and cardiac surgery occured after the first episode of ACS
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place