DepressionTREATED-ACSNCT00998400

Treatment of Depression in Acute Coronary Syndrome (ACS) Patients

A study testing CBT in combination with WBT and life style modification in people with Depression, run by University of Bologna at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Depression
What is being tested?: CBT in combination with WBT and life style modification
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 2 sitesItaly
Study dates: Sep 2010to Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

Maggiore Hospital
Bologna, 40100
Molinette Hospital
Torino, 10100

Other trials in Italy

About this study

Official title: Cognitive-behavioral Treatment of Depression in Patients With Acute Coronary Syndrome

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.

Read the 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

Conditions: Depression
Being tested: CBT in combination with WBT and life style modification
Keywords: Cognitive-behavioral treatment, Well-being therapy, Depression, Demoralization, Acute coronary syndrome
Medical subject headings: Depression, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBT in combination with WBT and life style modificationBehavioural
Also called Cognitive-behavioural therapies
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.

Study groups in NCT00998400
Study group	Role	What they receive
Clinical Management	No intervention	Control group
CBT + WBT	Experimental	Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification Receives: Behavioral: CBT in combination with WBT and life style modification

What is being measured

The primary outcome is the main question the study is designed to answer.

Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Clinical Interview for Depression, Compared to Clinical Management
Paykel's 20-item change version of the Clinical Interview for Depression (CID) allows a comprehensive assessment of affective symptomatology and contains 20 items rated on 7-point scales with specification of each anchor point based on severity, frequency and/or quality of symptoms. It adds a dimensional description of mental suffering to traditional psychiatric nosography (DSM). The total score is obtained by adding each of 20 items and it may range from 20 to 140. The higher the score, the worse the psychological condition.
Measured: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Anxiety" Subscale), Compared to Clinical Management
Anxious symptoms subscale of Kellner's Symptom Questionnaire (SQ). SQ is a 92-item self-report questionnaire, which yields 4 main scales including 23 items each: "depression", "anxiety", "hostility-irritability" and "somatization". This instrument helps the identification of self-perceived subclinical psychological distress. Answers are dichotomous (YES/NO or TRUE/FALSE) and rated with 0 or 1, therefore each scale score may range from 0 to 23. The higher the total score, the higher the psychological distress.
Measured: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Autonomy" Dimension), Compared to Clinical Management
Autonomy dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being.
Measured: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Depression" Subscale), Compared to Clinical Management
Depressive symptoms subscale of Kellner's Symptom Questionnaire (SQ). SQ is a 92-item self-report questionnaire, which yields 4 main scales including 23 items each: "depression", "anxiety", "hostility-irritability" and "somatization". This instrument helps the identification of self-perceived subclinical psychological distress. Answers are dichotomous (YES/NO or TRUE/FALSE) and rated with 0 or 1, therefore each scale score may range from 0 to 23. The higher the total score, the higher the psychological distress.
Measured: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Somatization" Subscale), Compared to Clinical Management
Somatic symptoms subscale of Kellner's Symptom Questionnaire (SQ). SQ is a 92-item self-report questionnaire, which yields 4 main scales including 23 items each: "depression", "anxiety", "hostility-irritability" and "somatization". This instrument helps the identification of self-perceived subclinical psychological distress. Answers are dichotomous (YES/NO or TRUE/FALSE) and rated with 0 or 1, therefore each scale score may range from 0 to 23. The higher the total score, the higher the psychological distress.
Measured: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
Depression and Well-being Improvements After Cognitive-Behavioral Therapy and Well-Being Therapy as Assessed by Changes in Symptom Questionnaire ("Hostility" Subscale), Compared to Clinical Management
Hostility symptoms subscale of Kellner's Symptom Questionnaire (SQ). SQ is a 92-item self-report questionnaire, which yields 4 main scales including 23 items each: "depression", "anxiety", "hostility-irritability" and "somatization". This instrument helps the identification of self-perceived subclinical psychological distress. Answers are dichotomous (YES/NO or TRUE/FALSE) and rated with 0 or 1, therefore each scale score may range from 0 to 23. The higher the total score, the higher the psychological distress.
Measured: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Environmental Mastery" Dimension), Compared to Clinical Management
Environmental mastery dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being.
Measured: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Personal Growth" Dimension), Compared to Clinical Management
Personal growth dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being.
Measured: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Positive Relations" Dimension), Compared to Clinical Management
Positive relations dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being.
Measured: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Purpose in Life" Dimension), Compared to Clinical Management
Purpose in life dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being.
Measured: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
Depression and Well-being Improvements After Cognitive-behavioral Therapy and Well-Being Therapy Assessed by Changes in Psychological Well-Being Scales ("Self-acceptance" Dimension), Compared to Clinical Management
Self-acceptance dimension of the Psychological Well-Being scales (PWB). PWB, an 84-item questionnaire with a multidimensional structure, has been used to evaluate the six psychological well-being dimensions conceptualized by Carol Ryff (autonomy, environmental mastery, personal growth, positive relationships, purpose in life, self-acceptance), which include 14 items each. Every item is defined in terms of high or low agreement on a 6-point Likert scale (ranging from 1 to 6); therefore each scale score may range from 14 to 84, with higher scores corresponding to greater psychological well-being.
Measured: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up

Secondary outcomes (1)

Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up.
Frequencies of negative cardiac outcomes, such as re-hospitalizations due to cardiac complications, acute myocardial infarction, unstable angina, angioplasty, cardiac surgery, and cardiac mortality occuring after the first episode of ACS.
Measured: 30-month follow-up post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Apr 2019

First posted20 Oct 2009 (estimated)
Study startSep 2010
Primary completionApr 2019
Study completionApr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00998400
Sponsor's protocol ID: 2008.1263
Acronym: TREATED-ACS
Status last verified: Jan 2020
First submitted: 19 Oct 2009
Last updated: 11 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tully PJ, Ang SY, Lee EJ, Bendig E, Bauereiss N, Bengel J, Baumeister H. Psychological and pharmacological interventions for depression in patients with coronary artery disease. Cochrane Database Syst Rev. 2021 Dec 15;12(12):CD008012. doi: 10.1002/14651858.CD008012.pub4.
PubMed 34910821

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive-behavioral Treatment of Depression in Patients With Acute Coronary Syndrome
ClinicalTrials.gov ID: NCT00998400
Acronym / sponsor ID: TREATED-ACS / 2008.1263
Conditions: Depression
Keywords: Cognitive-behavioral treatment, Well-being therapy, Depression, Demoralization, Acute coronary syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of BolognaUniversity, hospital or other
Collaborators: Compagnia di San Paolo
Study start: Sep 2010
Primary completion: Apr 2019 (actual)
Study completion: Apr 2019 (actual)
First posted: 20 Oct 2009 (estimated)
Results: Posted 11 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Medically eligible patients involved in the study have to meet, when screened 30 days after their index event, the inclusion criteria

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Clinical Management	No intervention	–Control group
CBT + WBT	Experimental	Behavioral: CBT in combination with WBT and life style modificationPatients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CBT in combination with WBT and life style modificationAlso: Cognitive-behavioural therapiesCBT 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.	Behavioural	CBT + WBT

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 11 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CBT/WBT	50	48
Clinical Management	50	48

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	CBT/WBT n = 50	Clinical Management n = 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)

CBT/WBT vs Clinical Management: p = 0.030, Repeated Measures ANOVA

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	CBT/WBT n = 50	Clinical Management n = 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)

CBT/WBT vs Clinical Management: p >0.05, Repeated Measures ANOVA

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	CBT/WBT n = 50	Clinical Management n = 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)

CBT/WBT vs Clinical Management: p >0.05, Repeated Measures ANOVA

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	CBT/WBT n = 50	Clinical Management n = 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)

CBT/WBT vs Clinical Management: p >0.05, Repeated Measures ANOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From pre-treatment (baseline) to 30-month follow-up after the end of the interventions (both CBT/WBT and CM). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CBT/WBT	9 of 50 (18%)	0 of 50 (0%)	1 of 50
Clinical Management	6 of 50 (12%)	0 of 50 (0%)	1 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34910821Tully PJ, Ang SY, Lee EJ, Bendig E, Bauereiss N, Bengel J, Baumeister H. Psychological and pharmacological interventions for depression in patients with coronary artery disease. Cochrane Database Syst Rev. 2021 Dec 15;12(12):CD008012. doi: 10.1002/14651858.CD008012.pub4.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chiara Rafanelli, MD, Ph.D principal investigator

Department of Psychology, University of Bologna

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CBT in combination with WBT and life style modification in people with Depression, run by University of Bologna at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00998400, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.