ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01032018
Recruitment Status : Completed
First Posted : December 15, 2009
Results First Posted : August 12, 2014
Last Update Posted : September 13, 2017
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of North Carolina, Chapel Hill
Emory University
Yale University
Washington University School of Medicine
University of Pennsylvania
Information provided by (Responsible Party):
Karina Davidson, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Other
Conditions Acute Coronary Syndrome
Depression
Interventions Behavioral: Problem Solving Therapy
Drug: Sertraline, citalopram, or bupropion
Other: Standard care
Enrollment 150
Recruitment Details 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 724 patients were medically eligible for participation in the study, of which 150 consented to randomization and were enrolled.
Arm/Group Title Referred Care Stepped Care
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 77 73
Completed 71 67
Not Completed 6 6
Reason Not Completed
Lost to Follow-up             6             5
Death             0             1
Arm/Group Title Referred Care Stepped Care Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 77 73 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 73 participants 150 participants
60.0  (11.1) 59.2  (9.7) 59.6  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 73 participants 150 participants
Female
33
  42.9%
30
  41.1%
63
  42.0%
Male
44
  57.1%
43
  58.9%
87
  58.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 73 participants 150 participants
Hispanic or Latino
13
  16.9%
16
  21.9%
29
  19.3%
Not Hispanic or Latino
64
  83.1%
56
  76.7%
120
  80.0%
Unknown or Not Reported
0
   0.0%
1
   1.4%
1
   0.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 73 participants 150 participants
American Indian or Alaska Native
0
   0.0%
1
   1.4%
1
   0.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   1.3%
0
   0.0%
1
   0.7%
Black or African American
27
  35.1%
23
  31.5%
50
  33.3%
White
42
  54.5%
42
  57.5%
84
  56.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
7
   9.1%
7
   9.6%
14
   9.3%
Beck Depression Inventory Score, continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 77 participants 73 participants 150 participants
20.6  (7.8) 21.0  (7.6) 20.8  (7.7)
[1]
Measure Description: 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).
Beck Depression Inventory Score, categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 73 participants 150 participants
BDI score < 16 27 21 48
BDI score >= 16 50 52 102
Type of presenting acute coronary syndrome   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 73 participants 150 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]
Measure Description: MI = Myocardial Infarction
1.Primary Outcome
Title Depressive Symptom Reduction
Hide Description Symptoms of depression were assessed using the Beck Depression Inventory (BDI). This 21-question, multiple choice self-report instrument includes items pertaining to symptoms of depression, including hopelessness and irritability, physical symptoms such as fatigue, and thoughts such as guilt. Each item has at a set of four possible responses, ranging in intensity for least intense to most intense. The total score is calculated by adding the responses to each item. Higher scores indicate more severe depressive symptoms. The total score on the scale ranges from 0 to 63. Total scores on the scale of less 10 indicate minimal depression; total scores between 10 and 15 indicate mild depression; and total scores greater than 16 indicate a probable clinical diagnosis of depression.
Time Frame Change from depression at baseline to depression at 6-months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Referred Care Stepped Care
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 77 73
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-6.6  (1.0) -10.1  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Referred Care, Stepped Care
Comments The trial was powered to detect a between-group difference in the 6-month change in depression symptoms. Assuming 5% attrition rate, we estimated that a sample of 150 patients would be needed to have 80% power to detect a clinically meaningful differential change in depression scores between groups of 0.46 SD.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of back-transformed means.
Estimated Value -3.5
Confidence Interval 95%
-6.1 to -0.7
Estimation Comments [Not Specified]
2.Primary Outcome
Title Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)
Hide Description [Not Specified]
Time Frame 6 months after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Referred Care Stepped Care
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: dollars
4289.23  (826.56) 4358.02  (883.76)
Time Frame 2, 4, and 6 months after enrollment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Referred Care Stepped Care
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Referred Care Stepped Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Referred Care Stepped Care
Affected / at Risk (%) Affected / at Risk (%)
Total   8/77 (10.39%)   7/73 (9.59%) 
Blood and lymphatic system disorders     
Internal bleeding   0/77 (0.00%)  1/73 (1.37%) 
Gastrointestinal disorders     
GI bleeding   1/77 (1.30%)  2/73 (2.74%) 
General disorders     
Death   0/77 (0.00%)  1/73 (1.37%) 
Infections and infestations     
MRSA Infection   1/77 (1.30%)  0/73 (0.00%) 
Pneumonia   5/77 (6.49%)  3/73 (4.11%) 
Nervous system disorders     
Stroke   0/77 (0.00%)  1/73 (1.37%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion   1/77 (1.30%)  0/73 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Referred Care Stepped Care
Affected / at Risk (%) Affected / at Risk (%)
Total   63/77 (81.82%)   59/73 (80.82%) 
Blood and lymphatic system disorders     
Anemia   0/77 (0.00%)  1/73 (1.37%) 
Gum bleeding   1/77 (1.30%)  2/73 (2.74%) 
Nosebleed   2/77 (2.60%)  7/73 (9.59%) 
Oral bleedin   1/77 (1.30%)  0/73 (0.00%) 
Cardiac disorders     
Leg edema   22/77 (28.57%)  15/73 (20.55%) 
Palpitations   1/77 (1.30%)  0/73 (0.00%) 
Ear and labyrinth disorders     
Ear bleeding   0/77 (0.00%)  1/73 (1.37%) 
Middle ear effusion   0/77 (0.00%)  1/73 (1.37%) 
Gastrointestinal disorders     
Blood in stool   2/77 (2.60%)  1/73 (1.37%) 
Worsened decreased appetite   8/77 (10.39%)  6/73 (8.22%) 
Worsened diarrhea   3/77 (3.90%)  5/73 (6.85%) 
Diverticulitis   1/77 (1.30%)  0/73 (0.00%) 
Dysphagia   1/77 (1.30%)  0/73 (0.00%) 
GI problems   25/77 (32.47%)  30/73 (41.10%) 
Worsened increase in appetite   5/77 (6.49%)  9/73 (12.33%) 
Worsened indigestion   15/77 (19.48%)  14/73 (19.18%) 
Irregular menstrual period   1/77 (1.30%)  0/73 (0.00%) 
Worsened nausea   8/77 (10.39%)  6/73 (8.22%) 
Rectal bleeding   4/77 (5.19%)  5/73 (6.85%) 
Upset stomach   33/77 (42.86%)  35/73 (47.95%) 
Infections and infestations     
Strep throat   0/77 (0.00%)  1/73 (1.37%) 
Upper respiratory infection   1/77 (1.30%)  0/73 (0.00%) 
Urinary tract infection   0/77 (0.00%)  2/73 (2.74%) 
Injury, poisoning and procedural complications     
Abdominal hernia   0/77 (0.00%)  1/73 (1.37%) 
Metabolism and nutrition disorders     
Low potassium   0/77 (0.00%)  1/73 (1.37%) 
Worsened sweating   4/77 (5.19%)  6/73 (8.22%) 
Musculoskeletal and connective tissue disorders     
Arthritis   0/77 (0.00%)  1/73 (1.37%) 
Back pain   2/77 (2.60%)  1/73 (1.37%) 
Fall   2/77 (2.60%)  1/73 (1.37%) 
Hip pain   0/77 (0.00%)  1/73 (1.37%) 
Joint pains   1/77 (1.30%)  1/73 (1.37%) 
Joint stiffness   0/77 (0.00%)  1/73 (1.37%) 
Knee injury   0/77 (0.00%)  1/73 (1.37%) 
Neck pain   0/77 (0.00%)  1/73 (1.37%) 
Nervous system disorders     
Worsened dizziness   0/77 (0.00%)  1/73 (1.37%) 
Worsened drowsiness   7/77 (9.09%)  2/73 (2.74%) 
Dysgeusia   0/77 (0.00%)  1/73 (1.37%) 
Headaches   0/77 (0.00%)  2/73 (2.74%) 
Worsened insomnia   3/77 (3.90%)  4/73 (5.48%) 
Numbness of arms and legs   1/77 (1.30%)  1/73 (1.37%) 
Pain   0/77 (0.00%)  1/73 (1.37%) 
Pruritus   1/77 (1.30%)  0/73 (0.00%) 
Tingling of fingers and toes   1/77 (1.30%)  0/73 (0.00%) 
Worsened tremors   6/77 (7.79%)  3/73 (4.11%) 
Psychiatric disorders     
Worsened agitation   7/77 (9.09%)  4/73 (5.48%) 
Worsened anxiety/nervousness   5/77 (6.49%)  4/73 (5.48%) 
Mood disturbance   1/77 (1.30%)  0/73 (0.00%) 
Renal and urinary disorders     
Hematuria   0/77 (0.00%)  1/73 (1.37%) 
Reproductive system and breast disorders     
Heavy menstrual bleeding   1/77 (1.30%)  0/73 (0.00%) 
Worsened sexual side effects   5/77 (6.49%)  3/73 (4.11%) 
Vaginal bleeding   1/77 (1.30%)  0/73 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough   2/77 (2.60%)  0/73 (0.00%) 
Skin and subcutaneous tissue disorders     
Worsened dry mouth   14/77 (18.18%)  8/73 (10.96%) 
Rash   1/77 (1.30%)  1/73 (1.37%) 
Vascular disorders     
Varicose veins   0/77 (0.00%)  1/73 (1.37%) 
Indicates events were collected by systematic assessment
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
Publications of Results:
Davidson KW. Centralized, patient preference-based treatment for patients with acute coronary syndrome depression: Codiacs vanguard rct. 18th World Congress on Heart Disease.
Davidson KW. Centralized, patient preference-based treatment for patients with acute coronary syndrome depression: Codiacs vanguard rct. 27th Conference of the European Health Psychology Society.
Responsible Party: Karina Davidson, Columbia University
ClinicalTrials.gov Identifier: NCT01032018     History of Changes
Other Study ID Numbers: AAAE1932
RC2HL101663 ( U.S. NIH Grant/Contract )
First Submitted: December 11, 2009
First Posted: December 15, 2009
Results First Submitted: July 30, 2013
Results First Posted: August 12, 2014
Last Update Posted: September 13, 2017