Clinical trial NCT00998400: Treatment of Depression in Acute Coronary Syndrome (ACS) Patients
Official title: Cognitive-behavioral Treatment of Depression in Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Cognitive-behavioral treatment
Well-being therapy
Depression
Demoralization
Acute coronary syndrome
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: Compagnia di San Paolo
First posted: 2009-10-20
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Emotional states of depression in association with ischemic heart diseases, such as myocardial infarction or unstable angina, are risk factors for subsequent cardiac events and mortality. However, the only psychological intervention trial attempting to reduce cardiac risk in depressed ACS patients showed that changes in depression did not translate into improved survival. Such intervention did not address issues such as lifestyle modification and improvement in psychological well-being, which were found to affect individual vulnerability to medical disease. Our research group has developed a well-being enhancing psychotherapeutic strategy, well-being therapy (WBT), which has been validated in a number of clinical trials. The aim of this project is to evaluate the efficacy of cognitive behavioral treatment (CBT) together with lifestyle modification and WBT in reducing cardiac risk in depressed and/or demoralized ACS patients compared to a standard clinical procedure of patients' management, the clinical management (CM). The same protocol will be carried out in two centres (Bologna and Torino). 100 patients after a first episode of myocardial infarction or unstable angina, meeting DSM-IV criteria for depressive disorders and DCPR criteria for demoralization will be randomized to one of two treatment groups: 1) CBT supplemented by lifestyle modification and WBT; 2) CM. In both groups, treatment will consist of twelve, 45-minute sessions once a week. A two-year follow-up will be performed. It is expected that psychological treatment may significantly decrease cardiac morbidity and mortality at follow-up compared to clinical management. The findings may entail considerable preventive implications and possible large reductions in health costs.

Detailed description: The same protocol will be carried out in the two participating centres (Maggiore Hospital in Bologna and San Giovanni Battista Hospital in Torino).

Participants will be patients recovering from a first episode of acute myocardial infarction or unstable angina. Myocardial infarction will be documented by cardiac symptoms (presence of acute chest, epigastric, neck, jaw, or arm pain or discomfort or pressure without apparent non- cardiac source) and signs (acute congestive heart failure or cardiogenic shock in the absence of non-CHD causes) associated with ECG findings (characteristic evolutionary ST-T changes or new Q waves) and/or cardiac biomarkers (blood measures of myocardial necrosis, specifically CK, CK-MB, CK-MBm, or troponin, cTn). Instable angina will be documented by cardiac symptoms (chest pain lasting less than 20 minutes) with likely ECG findings (ST-segment depression and abnormal T-wave) in absence of myocardial necrosis biomarkers.

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

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
measure: 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
timeFrame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
measure: 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
timeFrame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
measure: 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
timeFrame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
measure: 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
timeFrame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
measure: 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
timeFrame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
measure: 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
timeFrame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
measure: 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
timeFrame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
measure: 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
timeFrame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
measure: 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
timeFrame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
measure: 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
timeFrame: Pre-Treatment, Immediately Post-Treatment, 3-, 6-, 12-, 30-month follow-up
Secondary outcomes:
measure: Number of Participants With Hospitalizations for Cardiac Problems, Revascularization, Recurrent Nonfatal Myocardial Infarction or Cardiac Mortality at 30-month Follow-up.
timeFrame: 30-month follow-up post-treatment
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Maggiore Hospital
city: Torino
country: Italy
facility: Molinette Hospital
Study officials:
affiliation: Department of Psychology, University of Bologna
name: Chiara Rafanelli, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.