Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
HealthPartners Institute
Kaiser Foundation Research Institute
Information provided by (Responsible Party):
Karina Davidson, Columbia University Identifier:
First received: November 19, 2013
Last updated: July 26, 2016
Last verified: July 2016
The purpose of this study is to examine, in a randomized controlled trial, the benefits and costs of the American Heart Association's (AHA) advisory for depression screen and treatment of post-acute coronary syndrome patients.

Condition Intervention
Acute Coronary Syndrome
Depressive Symptoms
Other: Cognitive Behavioral Therapy (CBT)
Drug: Antidepressant Medication
Other: Standard Care
Other: Depressive symptom screener
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Quality Adjusted Life Years [ Time Frame: Baseline, 6, 12 and 18 months ]
    Change in QALYs from baseline through 18 months post-randomization will serve as the primary outcome for this trial

  • Cost of health care utilization [ Time Frame: 18 months after enrollment ]

Secondary Outcome Measures:
  • Depression-free days [ Time Frame: Baseline, 6, 12, and 18 months ]

Estimated Enrollment: 1500
Study Start Date: November 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AHA Depression Screen & Treat
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 meet with a study care specialist to discuss treatment options. Treatment will be delivered according to participant preference, and will be "stepped algorithm". Stepped care includes, a) participant preference for either brief, cognitive behavior therapy (CBT), delivered centrally, 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.
Other: Cognitive Behavioral Therapy (CBT)

The main intervention is the impact of screening on quality of life and health care costs. CBT is provided only if depressive symptoms are detected and participant prefers this type of treatment.

CBT will be centrally administered by a trained CBT treatment specialist. The treatment specialist will work with local team members throughout a participant's involvement in the study, and will closely follow each participant until he or she has reached a requisite level of improvement .

Drug: Antidepressant Medication

The main intervention is the impact of screening on quality of life and health care costs. Antidepressant Medication is provided only if depressive symptoms are detected and patient prefers this type of treatment.

Antidepressants should be started at the lowest dose, but should be adjusted upward to be within the therapeutic range within 1 week, with further adjustment higher in the therapeutic range possible at 3-4 weeks. Dosage of the first medication selected will be in the therapeutic range by 3 weeks of the initial step, as tolerated.

Other Names:
  • Sertraline
  • Bupropion
Other: Depressive symptom screener
8-item Patient Health Questionnaire, PHQ-8
Other Name: PHQ-8
Active Comparator: Depression Screen & Notify Arm Type :
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. Depending upon the provider's own evaluation of the participant, the participant may defer depression treatment, initiate treatment or may be referred to a mental health specialist.
Other: Standard Care
Participants will receive standard of care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.
Other: Depressive symptom screener
8-item Patient Health Questionnaire, PHQ-8
Other Name: PHQ-8
Placebo Comparator: No Depression Screen
Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.
Other: No intervention

Detailed Description:

Patients with an acute coronary syndrome (ACS) and comorbid depression have a 2-fold higher risk for recurrent ACS and mortality, worse quality of life, and higher costs of care than nondepressed ACS patients. The strength of these observational findings prompted the American Heart Association (AHA) to advise that routine depression screening for ACS patients and referral for depression diagnosis and treatment as indicated occur. Unfortunately, there are no randomized controlled trials (RCT) to inform this potentially expensive screening recommendation. Additionally, screening guidelines/advisories in the absence of RCT evidence have recently been extensively criticized (and withdrawn). This poses a serious dilemma for clinicians, health care systems, and for health care policy leaders. A RCT is urgently needed to provide evidence for these different constituents about the costs and benefits of the AHA depression screen and treat algorithm.

Two critical gaps in knowledge must be filled to determine if public health would be improved by the AHA strategy for depression screening in post-ACS patients: 1) Does this strategy improve quality-adjusted life years for patients with a recent ACS 2) Is the cost of providing depression screening and any type of depression treatment within the acceptable and typical amounts reimbursed for health care services? Our specific aim is to determine the quality-adjusted life year benefits and health care costs of following the AHA's advisory for depression screening and then referral for further diagnosis and treatment in post-ACS patients, if depression is found. To accomplish this aim, we will randomize patients from three different, geographically diverse health maintenance organizations to three different groups: 1) to the AHA depression screen and treat if depression is found algorithm (intervention group) or: 2) to receive no depression screening (strong control group) or: 3) to be screened and a primary care provider notified (minimally enhanced control group). Health-related quality of life, depressive symptoms, and costs will be obtained from all patients, so that the benefits and the costs of these three different depression screening strategies can be compared.


Ages Eligible for Study:   21 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • English-speaking
  • With a documented acute coronary syndrome (ACS) within the past 2-6 months
  • Over the age of 21 years
  • Has access to a phone or computer

Exclusion Criteria:

Medical Exclusions:

  • Terminal illness (life expectancy <1 year as determined by physician/medical record) defined as, but not limited to:
  • NYHA class IV, ACC class D CHF requiring inotropes or mechanical assist devices or critical aortic stenosis without plan for correction
  • End-stage COPD/emphysema
  • Advanced cirrhosis with encephalopathy, varices, severe ascites
  • Severe rheumatologic diseases requiring frequent hospitalizations, and multiple cytotoxic agents and/or disease modifying drugs
  • Metastatic pancreatic, esophageal, colorectal or stomach cancer
  • Metastatic sarcoma, ovarian, melanoma or renal cell cancer
  • Metastatic breast cancer with multiple recurrences despite treatment
  • Advanced CNS malignancies
  • Recurrent hematologic malignancies with multiple recurrences despite treatment
  • Persistent AIDS, untreated or treated

Psychiatric Exclusions:

  • Dementia
  • History of bipolar disorder
  • History of psychosis
  • History of major depression
  • History of suicide attempt or self-inflicted injurys
  • Current alcohol or substance abuse
  • Currently receiving depression treatment
  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 identifier: NCT01993017

United States, Minnesota
Health Partners institute for Researcha and Education Recruiting
Bloomington, Minnesota, United States, 55440
Contact: Karen Margolis, MD, MPH    952-967-7301   
Principal Investigator: Karen Margolis, MD,MPH         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Karina W Davidson, PhD    212-342-4486   
Contact: Ian Kronish, MD    212-342-11335   
Principal Investigator: Nathalie Moise, MD         
United States, North Carolina
Duke University Active, not recruiting
Henderson, North Carolina, United States, 27536
United States, Oregon
Kaiser Foundation Research Institute Recruiting
Portland, Oregon, United States, 97227
Contact: Greg Clarke, PhD    503-335-6673   
Principal Investigator: Greg Clarke, PhD         
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
HealthPartners Institute
Kaiser Foundation Research Institute
Principal Investigator: Karina W Davidson, PhD Columbia University
  More Information

Responsible Party: Karina Davidson, Professor of Behavioral Medicine, Columbia University Identifier: NCT01993017     History of Changes
Other Study ID Numbers: AAAK9253
1R01HL114924 ( US NIH Grant/Contract Award Number )
Study First Received: November 19, 2013
Last Updated: July 26, 2016

Keywords provided by Columbia University:
Acute Coronary Syndrome
Depressive Symptoms

Additional relevant MeSH terms:
Acute Coronary Syndrome
Heart Diseases
Pathologic Processes
Behavioral Symptoms
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Antidepressive Agents
Psychotropic Drugs processed this record on April 26, 2017