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Comparison of Depression Identification After Acute Coronary Syndrome: Quality of Life and Cost Outcomes (CODIACSQoL)

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ClinicalTrials.gov Identifier: NCT01993017
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : December 18, 2019
Last Update Posted : November 11, 2021
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
HealthPartners Institute
Kaiser Foundation Research Institute
Information provided by (Responsible Party):
Ian Kronish, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Screening
Conditions Acute Coronary Syndrome
Depressive Symptoms
Interventions Other: Cognitive Behavioral Therapy (CBT)
Drug: Antidepressant Medication
Other: Standard Care
Other: Depressive symptom screener
Other: No intervention
Enrollment 1501
Recruitment Details

Recruitment period: November 1, 2013 to March 31, 2017

Recruitment sites: HealthPartners (Minneapolis, Minnesota), Duke University Health System (Durham, North Carolina), Kaiser Permanente Northwest (Portland, Oregon), and New York-Presbyterian/Columbia University Irving Medical Center (New York, New York)

Pre-assignment Details 1 participant withdrew consent soon after randomization, and this participant's data was excluded from the study.
Arm/Group Title AHA Depression Screen, Notify & Treat Depression Screen & Notify No Depression Screen
Hide Arm/Group Description Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either brief, type of cognitive behavioral therapy (CBT) called problem-solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.

Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.

Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.

Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8

Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.

No intervention

Period Title: Overall Study
Started 499 501 500
Completed 393 411 421
Not Completed 106 90 79
Reason Not Completed
Death             23             26             18
Could not be contacted             43             42             38
Dropped out             19             6             11
Other reasons             17             11             7
Ineligible after randomization             4             5             5
Arm/Group Title AHA Depression Screen, Notify & Treat Depression Screen & Notify No Depression Screen Total
Hide Arm/Group Description Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either a type of brief, cognitive behavioral therapy (CBT) called problem solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.

Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.

Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.

Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8

Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.

No intervention

Total of all reporting groups
Overall Number of Baseline Participants 499 501 500 1500
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 499 participants 501 participants 500 participants 1500 participants
66.2  (11.3) 65.8  (11.7) 65.8  (11.7) 65.9  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 499 participants 501 participants 500 participants 1500 participants
Female
142
  28.5%
137
  27.3%
145
  29.0%
424
  28.3%
Male
357
  71.5%
364
  72.7%
355
  71.0%
1076
  71.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 499 participants 501 participants 500 participants 1500 participants
Hispanic or Latino
82
  16.4%
88
  17.6%
74
  14.8%
244
  16.3%
Not Hispanic or Latino
406
  81.4%
402
  80.2%
410
  82.0%
1218
  81.2%
Unknown or Not Reported
11
   2.2%
11
   2.2%
16
   3.2%
38
   2.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 499 participants 501 participants 500 participants 1500 participants
353
  70.7%
368
  73.5%
359
  71.8%
1080
  72.0%
Black Number Analyzed 499 participants 501 participants 500 participants 1500 participants
47
   9.4%
37
   7.4%
46
   9.2%
130
   8.7%
Other Number Analyzed 499 participants 501 participants 500 participants 1500 participants
92
  18.4%
82
  16.4%
85
  17.0%
259
  17.3%
Refused or unknown Number Analyzed 499 participants 501 participants 500 participants 1500 participants
7
   1.4%
14
   2.8%
10
   2.0%
31
   2.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 499 participants 501 participants 500 participants 1500 participants
499 501 500 1500
PHQ-8 Score >= 10   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 494 participants 501 participants 0 participants 995 participants
38
   7.7%
33
   6.6%
71
   7.1%
[1]
Measure Analysis Population Description: PHQ-8 data were not collected at Baseline in the "No Depression Screen" Arm/Group).
1.Primary Outcome
Title Quality-Adjusted Life Years (QALYs)
Hide Description Change in QALYs from baseline through 18 months. QALYs are a generic measure of disease burden, including both the quality and the quantity of life lived. One QALY equates to one year in perfect health. To measure change in QALYs, utility scores [an overall assessment of well-being on a scale from 0 (death) to 1 (perfect health)], were estimated using the Short Form-6 dimension, with scores derived from responses to the 12-Item Short-Form Health Survey, version 2, at baseline and 6, 12, and 18 months. QALYs for the period from baseline to 18 months were then calculated as the area under the curve by linearly interpolating the utility scores at the 4 assessments. Change in QALYs was then obtained by subtracting the baseline QALY from the observed QALY for an 18-month period, where baseline QALY was calculated under the assumption that the baseline utility score remained constant during the 18-month period.
Time Frame Baseline, 6, 12 and 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AHA Depression Screen, Notify & Treat Depression Screen & Notify No Depression Screen
Hide Arm/Group Description:
Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either brief, type of cognitive behavioral therapy (CBT) called problem-solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.

Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.

Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.

Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8

Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.

No intervention

Overall Number of Participants Analyzed 499 501 500
Mean (Standard Deviation)
Unit of Measure: quality-adjusted life years (QALYs)
-0.06  (0.20) -0.06  (0.20) -0.06  (0.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AHA Depression Screen, Notify & Treat, Depression Screen & Notify, No Depression Screen
Comments We determined that a sample size per group of 500, assuming 5% loss to follow-up, would yield 80% power for a 2-sided t test at the 5% level. These calculations were based on an assumed SD for QALYs of 0.17, expected prevalence of screening-detected depression of 20%, and assumed net improvement in QALYs of 0.155 over 18 months for individuals with depression who received treatment for depression in the Screen, Notify, and Treat group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments A 2-step gatekeeping test procedure was used. An omnibus F test using ANOVA comparing the 3 groups was first performed. Pairwise comparisons using a 2-sided t test at 5% nominal significance were planned only if the omnibus F test had a P value <.05.
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Depression-free Days
Hide Description Depression-free days from baseline through 18 months post-randomization
Time Frame Baseline through 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AHA Depression Screen, Notify & Treat Depression Screen & Notify No Depression Screen
Hide Arm/Group Description:
Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either brief, type of cognitive behavioral therapy (CBT) called problem-solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.

Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.

Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.

Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8

Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.

No intervention

Overall Number of Participants Analyzed 499 501 500
Mean (Standard Deviation)
Unit of Measure: cumulative depression-free days
343.1  (179.0) 351.3  (175.0) 339.0  (176.6)
3.Secondary Outcome
Title Cost of Health Care Utilization
Hide Description Total cost of health care utilization from baseline through 18 months post-randomization
Time Frame Baseline through 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AHA Depression Screen, Notify & Treat Depression Screen & Notify No Depression Screen
Hide Arm/Group Description:
Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either a type of brief, cognitive behavioral therapy (CBT) called problem solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.

Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.

Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.

Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8

Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.

No intervention

Overall Number of Participants Analyzed 499 501 500
Mean (Standard Error)
Unit of Measure: US dollars
6745  (358) 6204  (332) 7440  (501)
Time Frame 18 months
Adverse Event Reporting Description

Serious Adverse Events and mortality were assessed in all participants.

Other Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.

 
Arm/Group Title AHA Depression Screen, Notify & Treat Depression Screen & Notify No Depression Screen
Hide Arm/Group Description Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to "stepped care". Stepped care includes, a) participant preference for either brief, type of cognitive behavioral therapy (CBT) called problem-solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with "stepping up" of care if sufficient progress is not being realized.

Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.

Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.

Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8

Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.

No intervention

All-Cause Mortality
AHA Depression Screen, Notify & Treat Depression Screen & Notify No Depression Screen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/499 (4.61%)   26/501 (5.19%)   18/500 (3.60%) 
Hide Serious Adverse Events
AHA Depression Screen, Notify & Treat Depression Screen & Notify No Depression Screen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/499 (0.00%)   0/501 (0.00%)   0/500 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AHA Depression Screen, Notify & Treat Depression Screen & Notify No Depression Screen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   386/450 (85.78%)   398/455 (87.47%)   399/458 (87.12%) 
Blood and lymphatic system disorders       
Any bleeding at 6 mo  [1]  61/450 (13.56%)  51/455 (11.21%)  72/457 (15.75%) 
Any bleeding at 12 mo   51/423 (12.06%)  50/429 (11.66%)  50/427 (11.71%) 
Any bleeding at 18 mo   40/394 (10.15%)  45/410 (10.98%)  40/419 (9.55%) 
Gastrointestinal disorders       
Gastrointestinal upset at 6 mo  [2]  128/450 (28.44%)  116/454 (25.55%)  112/457 (24.51%) 
Gastrointestinal upset at 12 mo   95/423 (22.46%)  95/431 (22.04%)  107/427 (25.06%) 
Gastrointestinal upset at 18 mo   98/394 (24.87%)  99/410 (24.15%)  100/418 (23.92%) 
Psychiatric disorders       
Increased appetite at 6 mo  [3]  83/450 (18.44%)  84/455 (18.46%)  91/457 (19.91%) 
Decreased appetite at 6 mo  [4]  72/450 (16.00%)  74/455 (16.26%)  76/457 (16.63%) 
Drowsiness at 6 mo  [5]  218/450 (48.44%)  212/455 (46.59%)  217/458 (47.38%) 
Increased appetite at 12 mo   71/423 (16.78%)  77/431 (17.87%)  76/427 (17.80%) 
Decreased appetite at 12 mo   63/423 (14.89%)  65/431 (15.08%)  76/427 (17.80%) 
Drowsiness at 12 mo   179/423 (42.32%)  187/431 (43.39%)  198/427 (46.37%) 
Increased appetite at 18 mo   76/394 (19.29%)  62/410 (15.12%)  60/418 (14.35%) 
Decreased appetite at 18 mo   53/394 (13.45%)  45/410 (10.98%)  62/419 (14.80%) 
Drowsiness at 18 mo   152/394 (38.58%)  177/410 (43.17%)  171/419 (40.81%) 
Indicates events were collected by systematic assessment
[1]
Self-report of any bleeding
[2]
Self-report of gastrointestinal upset
[3]
Self-report of increased appetite
[4]
Self-report of decreased appetite
[5]
Self-report of drowsiness
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ian Kronish, MD, MPH, Principal Investigator
Organization: Center for Behavioral Cardiovascular Health
Phone: 212-342-1335
EMail: ik2293@columbia.edu
Layout table for additonal information
Responsible Party: Ian Kronish, Columbia University
ClinicalTrials.gov Identifier: NCT01993017    
Other Study ID Numbers: AAAK9253
1R01HL114924 ( U.S. NIH Grant/Contract )
First Submitted: November 19, 2013
First Posted: November 25, 2013
Results First Submitted: October 24, 2019
Results First Posted: December 18, 2019
Last Update Posted: November 11, 2021