Acute Coronary SyndromeCODIACSQoLNCT01993017
Comparison of Depression Identification After Acute Coronary Syndrome: Quality of Life and Cost Outcomes
A study testing Cognitive Behavioral Therapy (CBT), Antidepressant Medication and Depressive symptom screener in people with Acute Coronary Syndrome and Depressive Symptoms, run by Columbia University at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Depressive Symptoms
- What is being tested?
- Cognitive Behavioral Therapy (CBT), Antidepressant Medication and Depressive symptom screener
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,501 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2013to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With a documented acute coronary syndrome (ACS) within the past 2-12 months
- Over the age of 21 years
- Has access to a phone
Who cannot join
- 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
Show all 22Show fewer
- 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:
- History of major depression
- Currently receiving depression treatment
- Dementia
- History of bipolar disorder
- History of psychosis
- History of suicide attempt or self-inflicted injuries
- Current alcohol or substance abuse
- Other Exclusions:
- Non-English and non-Spanish speaking
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Health Partners institute for Research and Education
Bloomington, Minnesota, 55440
Duke University
Henderson, North Carolina, 27536
Columbia University Irving Medical Center
New York, New York, 10032
Kaiser Foundation Research Institute
Portland, Oregon, 97227
About this study
Official title: Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes
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.
Read the 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 four different, geographically diverse health care systems to three different groups: 1) to the AHA depression screen and treat if depression is found algorithm (screen and treat intervention group) or: 2) to be screened and a primary care provider notified (screen and notify intervention group) or: 3) to receive no depression screening (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.
- Conditions
- Acute Coronary Syndrome, Depressive Symptoms
- Being tested
- Cognitive Behavioral Therapy (CBT), Antidepressant Medication, Standard Care, Depressive symptom screener, No intervention
- Keywords
- Acute Coronary Syndrome, Depressive Symptoms
- Medical subject headings
- Acute Coronary Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Other
Also called Problem Solving Therapy (PST)
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 telephone-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 .
Antidepressant MedicationDrug
Also called Sertraline, Bupropion
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.
Standard CareOther
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 screenerOther
Also called PHQ-8
8-item Patient Health Questionnaire, PHQ-8
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| AHA Depression Screen & Treat | Experimental | 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, cognitive behavioral therapy (CBT), 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. Receives: Other: Cognitive Behavioral Therapy (CBT); Drug: Antidepressant Medication; Other: Depressive symptom screener |
| Depression Screen & Notify Arm Type : | Active comparator | 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. Receives: Other: Standard Care; Other: Depressive symptom screener |
| No Depression Screen | Placebo comparator | Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality-Adjusted Life Years (QALYs)
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.
Measured: Baseline, 6, 12 and 18 months
Secondary outcomes (2)
Depression-free Days
Depression-free days from baseline through 18 months post-randomization
Measured: Baseline through 18 months
Cost of Health Care Utilization
Total cost of health care utilization from baseline through 18 months post-randomization
Measured: Baseline through 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completion31 Jul 2018
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Duke University, HealthPartners Institute, Kaiser Foundation Research Institute
- Responsible party
- Principal investigator, Ian Kronish, Columbia University
- Investigators
- Ian M Kronish, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993017
- Sponsor's protocol ID
- AAAK9253
- Other IDs
- 1R01HL114924
- Acronym
- CODIACSQoL
- Status last verified
- Apr 2023
- First submitted
- 19 Nov 2013
- Last updated
- 14 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: A deidentified data set and study materials will be provided upon request by other researchers.
Publications
Moise N, Davidson KW, Cheung YKK, Clarke GN, Dolor RJ, Duer-Hefele J, Ladapo JA, Margolis KL, St Onge T, Parsons F, Retuerto J, Schmit KM, Thanataveerat A, Kronish IM. Rationale, design, and baseline data for a multicenter randomized clinical trial comparing depression screening strategies after acute coronary syndrome: The comparison of depression identification after acute Coronary Syndromes-Quality of Life and Cost Outcomes (CODIACS-QOL) trial. Contemp Clin Trials. 2019 Sep;84:105826. doi: 10.1016/j.cct.2019.105826. Epub 2019 Aug 13.
PubMed 31419605Kronish IM, Moise N, Cheung YK, Clarke GN, Dolor RJ, Duer-Hefele J, Margolis KL, St Onge T, Parsons F, Retuerto J, Thanataveerat A, Davidson KW. Effect of Depression Screening After Acute Coronary Syndromes on Quality of Life: The CODIACS-QoL Randomized Clinical Trial. JAMA Intern Med. 2020 Jan 1;180(1):45-53. doi: 10.1001/jamainternmed.2019.4518.
PubMed 31633746Ladapo JA, Davidson KW, Moise N, Chen A, Clarke GN, Dolor RJ, Margolis KL, Thanataveerat A, Kronish IM. Economic outcomes of depression screening after acute coronary syndromes: The CODIACS-QoL randomized clinical trial. Gen Hosp Psychiatry. 2021 Jul-Aug;71:47-54. doi: 10.1016/j.genhosppsych.2021.04.001. Epub 2021 Apr 3.
PubMed 33933921
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes
- ClinicalTrials.gov ID
- NCT01993017
- Acronym / sponsor ID
- CODIACSQoL / AAAK9253
- Conditions
- Acute Coronary Syndrome, Depressive Symptoms
- Keywords
- Acute Coronary Syndrome, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,501 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Duke University, HealthPartners Institute, Kaiser Foundation Research Institute
- Study start
- Nov 2013 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 18 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 four different, geographically diverse health care systems to three different groups: 1) to the AHA depression screen and treat if depression is found algorithm (screen and treat intervention group) or: 2) to be screened and a primary care provider notified (screen and notify intervention group) or: 3) to receive no depression screening (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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AHA Depression Screen & Treat | Experimental | Other: Cognitive Behavioral Therapy (CBT), Drug: Antidepressant Medication, Other: Depressive symptom screenerParticipants 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, cognitive behavioral therapy (CBT), 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. |
| Depression Screen & Notify Arm Type : | Active comparator | Other: Standard Care, Other: Depressive symptom screenerParticipants 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. |
| No Depression Screen | Placebo comparator | Other: No interventionParticipants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- With a documented acute coronary syndrome (ACS) within the past 2-12 months
- Over the age of 21 years
- Has access to a phone
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)Also: Problem Solving Therapy (PST)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 telephone-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 . | Other | AHA Depression Screen & Treat |
| Antidepressant MedicationAlso: Sertraline, BupropionThe 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. | Drug | AHA Depression Screen & Treat |
| Standard CareParticipants 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. | Other | Depression Screen & Notify Arm Type : |
| Depressive symptom screenerAlso: PHQ-88-item Patient Health Questionnaire, PHQ-8 | Other | AHA Depression Screen & Treat, Depression Screen & Notify Arm Type : |
| No intervention | Other | No Depression Screen |
Primary outcome
Quality-Adjusted Life Years (QALYs)
Time frame: Baseline, 6, 12 and 18 months
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.
2 secondary outcomes
Depression-free Days
Time frame: Baseline through 18 months
Cost of Health Care Utilization
Time frame: Baseline through 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31419605Moise N, Davidson KW, Cheung YKK, Clarke GN, Dolor RJ, Duer-Hefele J, Ladapo JA, Margolis KL, St Onge T, Parsons F, Retuerto J, Schmit KM, Thanataveerat A, Kronish IM. Rationale, design, and baseline data for a multicenter randomized clinical trial comparing depression screening strategies after acute coronary syndrome: The comparison of depression identification after acute Coronary Syndromes-Quality of Life and Cost Outcomes (CODIACS-QOL) trial. Contemp Clin Trials. 2019 Sep;84:105826. doi: 10.1016/j.cct.2019.105826. Epub 2019 Aug 13.
- Results publication: PubMed 31633746Kronish IM, Moise N, Cheung YK, Clarke GN, Dolor RJ, Duer-Hefele J, Margolis KL, St Onge T, Parsons F, Retuerto J, Thanataveerat A, Davidson KW. Effect of Depression Screening After Acute Coronary Syndromes on Quality of Life: The CODIACS-QoL Randomized Clinical Trial. JAMA Intern Med. 2020 Jan 1;180(1):45-53. doi: 10.1001/jamainternmed.2019.4518.
- Results publication: PubMed 33933921Ladapo JA, Davidson KW, Moise N, Chen A, Clarke GN, Dolor RJ, Margolis KL, Thanataveerat A, Kronish IM. Economic outcomes of depression screening after acute coronary syndromes: The CODIACS-QoL randomized clinical trial. Gen Hosp Psychiatry. 2021 Jul-Aug;71:47-54. doi: 10.1016/j.genhosppsych.2021.04.001. Epub 2021 Apr 3.
- Individual participant dataSharing planned: Yes. A deidentified data set and study materials will be provided upon request by other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian M Kronish, MD, MPH principal investigator
Columbia University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT), Antidepressant Medication and Depressive symptom screener in people with Acute Coronary Syndrome and Depressive Symptoms, run by Columbia University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality-Adjusted Life Years (QALYs) (time frame: Baseline, 6, 12 and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01993017, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.