Treatment of Depression in Acute Coronary Syndrome (ACS) Patients (TREATED-ACS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Bologna.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Compagnia San Paolo
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT00998400
First received: October 19, 2009
Last updated: March 1, 2011
Last verified: September 2010
  Purpose

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


Condition Intervention
Depression
Behavioral: CBT in combination with WBT and life style modification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive-behavioral Treatment of Depression in Patients With Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • Depression and well-being improvements after Cognitive-behavioral Therapy and Well-Being Therapy assessed by changes in Clinical Interview for Depression, Symptom Questionnaire and Psychological Well-Being, compared to Clinical Management [ Time Frame: Within two years after the treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction of cardiovascular hospitalizations, revascularization, recurrent nonfatal myocardial infarction or cardiac mortality after CBT and WBT compared with CM [ Time Frame: Within two years after the treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Clinical Management
Control group
Experimental: CBT + WBT
Patients treated with Cognitive-Behavioral Therapy in combination with Well-Being Therapy and lifestyle modification
Behavioral: CBT in combination with WBT and life style modification
CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems. The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others. CM will consist of reviewing the patients' clinical status, and providing the patient with support and advice if necessary.
Other Name: Cognitive-behavioural therapies

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998400

Contacts
Contact: Chiara Rafanelli, MD, Ph.D +39-051-2091847 chiara.rafanelli@unibo.it

Locations
Italy
Maggiore Hospital Recruiting
Bologna, Italy, 40100
Contact: Giuseppe Di Pasquale, MD    +39-051-6478202    giuseppe.dipasquale@ausl.bo.it   
Principal Investigator: Chiara Rafanelli, MD, Ph.D         
San Giovanni Battista Hospital Recruiting
Torino, Italy, 10100
Contact: Fiorenzo Gaita, MD    +39-011-633-5571    fiorenzo.gaita@unito.it   
Principal Investigator: Giovanni Abbate Daga, MD         
Sponsors and Collaborators
University of Bologna
Compagnia San Paolo
Investigators
Principal Investigator: Chiara Rafanelli, MD, Ph.D Department of Psychology, University of Bologna
  More Information

No publications provided

Responsible Party: Chiara Rafanelli, Department of Psychology, University of Bologna
ClinicalTrials.gov Identifier: NCT00998400     History of Changes
Other Study ID Numbers: 2008.1263
Study First Received: October 19, 2009
Last Updated: March 1, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bologna:
Cognitive-behavioral treatment
Well-being therapy
Depression
Demoralization
Acute coronary syndrome

Additional relevant MeSH terms:
Depression
Depressive Disorder
Acute Coronary Syndrome
Behavioral Symptoms
Mood Disorders
Mental Disorders
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014