Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)

This study has been completed.
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
Emory University
Yale University
Washington University Early Recognition Center
University of Pennsylvania
Information provided by (Responsible Party):
Karina Davidson, Columbia University
ClinicalTrials.gov Identifier:
NCT01032018
First received: December 11, 2009
Last updated: July 21, 2014
Last verified: July 2014
Results First Received: July 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor)
Conditions: Acute Coronary Syndrome
Depression
Interventions: Behavioral: Problem Solving Therapy
Drug: Sertraline, citalopram, or bupropion
Other: Standard care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from sites connected with 5 field centers from March 18, 2010, to January 9, 2012. To be eligible, participants had to demonstrate elevated depressive symptoms on the BDI 2 to 6 months after hospitalization for an ACS.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
724 patients were medically eligible for participation in the study, of which 150 consented to randomization and were enrolled.

Reporting Groups
  Description
Referred Care The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
Stepped Care The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.

Participant Flow:   Overall Study
    Referred Care     Stepped Care  
STARTED     77     73  
COMPLETED     71     67  
NOT COMPLETED     6     6  
Lost to Follow-up                 6                 5  
Death                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Referred Care The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
Stepped Care The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
Total Total of all reporting groups

Baseline Measures
    Referred Care     Stepped Care     Total  
Number of Participants  
[units: participants]
  77     73     150  
Age  
[units: years]
Mean ± Standard Deviation
  60.0  ± 11.1     59.2  ± 9.7     59.6  ± 10.4  
Gender  
[units: participants]
     
Female     33     30     63  
Male     44     43     87  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     13     16     29  
Not Hispanic or Latino     64     56     120  
Unknown or Not Reported     0     1     1  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     1     0     1  
Black or African American     27     23     50  
White     42     42     84  
More than one race     0     0     0  
Unknown or Not Reported     7     7     14  
Beck Depression Inventory Score, continuous [1]
[units: Scores on a scale]
Mean ± Standard Deviation
  20.6  ± 7.8     21.0  ± 7.6     20.8  ± 7.7  
Beck Depression Inventory Score, categorical  
[units: participants]
     
BDI score < 16     27     21     48  
BDI score >= 16     50     52     102  
Type of presenting acute coronary syndrome [2]
[units: participants]
     
Unstable angina     35     35     70  
Non-ST segment elevated MI     19     18     37  
ST-segment elevated MI     21     19     40  
Bundle branch block/uncertain type of MI     2     1     3  
[1] The Beck Depression Inventory (BDI) is a 21-item multiple choice, self-report instrument that is used to assess the severity of symptoms of depression. The score ranges from 0 (no symptoms) to 63 (worst symptoms).
[2] MI = Myocardial Infarction



  Outcome Measures
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1.  Primary:   Depressive Symptom Reduction   [ Time Frame: Change from depression at baseline to depression at 6-months ]

2.  Primary:   Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)   [ Time Frame: 6 months after randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Karina W Davidson, PhD
Organization: Columbia University Medical Center
phone: 212-342-4493
e-mail: kd2124@cumc.columbia.edu


Publications of Results:

Responsible Party: Karina Davidson, Columbia University
ClinicalTrials.gov Identifier: NCT01032018     History of Changes
Other Study ID Numbers: AAAE1932, RC2HL101663
Study First Received: December 11, 2009
Results First Received: July 30, 2013
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board