- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00998400
Treatment of Depression in Acute Coronary Syndrome (ACS) Patients (TREATED-ACS)
Cognitive-behavioral Treatment of Depression in Patients With Acute Coronary Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bologna, Italy, 40100
- Maggiore Hospital
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Torino, Italy, 10100
- Molinette Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Clinical Management
Control group
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EXPERIMENTAL: CBT + WBT
Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle 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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Clinical Interview for Depression, Compared to Clinical Management
Time Frame: 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.
|
Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
|
Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Anxiety" Subscale), Compared to Clinical Management
Time Frame: 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.
|
Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
|
Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Autonomy" Dimension), Compared to Clinical Management
Time Frame: 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.
|
Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
|
Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Depression" Subscale), Compared to Clinical Management
Time Frame: 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.
|
Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
|
Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Somatization" Subscale), Compared to Clinical Management
Time Frame: 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.
|
Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
|
Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Hostility" Subscale), Compared to Clinical Management
Time Frame: 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.
|
Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
|
Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Environmental Mastery" Dimension), Compared to Clinical Management
Time Frame: 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.
|
Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
|
Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Personal Growth" Dimension), Compared to Clinical Management
Time Frame: 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.
|
Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
|
Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Positive Relations" Dimension), Compared to Clinical Management
Time Frame: 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.
|
Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
|
Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Purpose in Life" Dimension), Compared to Clinical Management
Time Frame: 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.
|
Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
|
Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Self-acceptance" Dimension), Compared to Clinical Management
Time Frame: 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.
|
Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up.
Time Frame: 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.
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30-month follow-up post-treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chiara Rafanelli, MD, Ph.D, Department of Psychology, University of Bologna
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008.1263
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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