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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL114924 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Duke University | OTHER |
| HealthPartners Institute | OTHER |
| Kaiser Foundation Research Institute |
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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.
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screening guidelines/advisories in the absence of RCT evidence have recently been extensively criticized (and withdrawn).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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Other | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6, 12 and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depression-free Days | Depression-free days from baseline through 18 months post-randomization | Baseline through 18 months |
| Cost of Health Care Utilization | Total cost of health care utilization from baseline through 18 months post-randomization |
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Inclusion Criteria:
Exclusion Criteria:
Medical Exclusions:
Psychiatric Exclusions:
Other Exclusions:
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| Name | Affiliation | Role |
|---|---|---|
| Ian M Kronish, MD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Partners institute for Research and Education | Bloomington | Minnesota | 55440 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31419605 | Background | 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. | |
| 31633746 |
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A deidentified data set and study materials will be provided upon request by other researchers.
Starting in January 2021
Contact the study PI with data requests
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1 participant withdrew consent soon after randomization, and this participant's data was excluded from the study.
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)
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| ID | Title | Description |
|---|---|---|
| FG000 | AHA Depression Screen, Notify & 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 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2021 | Nov 10, 2021 |
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| OTHER |
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| Antidepressant Medication | Drug | 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. |
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| Standard Care | Other | 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. |
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| Depressive symptom screener | Other | 8-item Patient Health Questionnaire, PHQ-8 |
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| No intervention | Other |
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| Baseline through 18 months |
| Columbia University Irving Medical Center |
| New York |
| New York |
| 10032 |
| United States |
| Duke University | Henderson | North Carolina | 27536 | United States |
| Kaiser Foundation Research Institute | Portland | Oregon | 97227 | United States |
| Result |
| Kronish 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. |
| 33933921 | Result | Ladapo 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. |
| FG001 | Depression Screen & Notify | 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 |
| FG002 | 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. No intervention |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AHA Depression Screen, Notify & 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 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. |
| BG001 | Depression Screen & Notify | 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 |
| BG002 | 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. No intervention |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| PHQ-8 Score >= 10 | PHQ-8 data were not collected at Baseline in the "No Depression Screen" Arm/Group). | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | quality-adjusted life years (QALYs) | Baseline, 6, 12 and 18 months |
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| Secondary | Depression-free Days | Depression-free days from baseline through 18 months post-randomization | Posted | Mean | Standard Deviation | cumulative depression-free days | Baseline through 18 months |
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| Secondary | Cost of Health Care Utilization | Total cost of health care utilization from baseline through 18 months post-randomization | Posted | Mean | Standard Error | US dollars | Baseline through 18 months |
|
18 months
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AHA Depression Screen, Notify & 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 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. | 23 | 499 | 0 | 499 | 386 | 450 |
| EG001 | Depression Screen & Notify | 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 | 26 | 501 | 0 | 501 | 398 | 455 |
| EG002 | 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. No intervention | 18 | 500 | 0 | 500 | 399 | 458 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any bleeding at 6 mo | Blood and lymphatic system disorders | Systematic Assessment | Self-report of any bleeding |
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| Increased appetite at 6 mo | Psychiatric disorders | Systematic Assessment | Self-report of increased appetite |
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| Decreased appetite at 6 mo | Psychiatric disorders | Systematic Assessment | Self-report of decreased appetite |
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| Drowsiness at 6 mo | Psychiatric disorders | Systematic Assessment | Self-report of drowsiness |
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| Gastrointestinal upset at 6 mo | Gastrointestinal disorders | Systematic Assessment | Self-report of gastrointestinal upset |
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| Any bleeding at 12 mo | Blood and lymphatic system disorders | Systematic Assessment |
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| Increased appetite at 12 mo | Psychiatric disorders | Systematic Assessment |
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| Decreased appetite at 12 mo | Psychiatric disorders | Systematic Assessment |
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| Drowsiness at 12 mo | Psychiatric disorders | Systematic Assessment |
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| Gastrointestinal upset at 12 mo | Gastrointestinal disorders | Systematic Assessment |
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| Any bleeding at 18 mo | Blood and lymphatic system disorders | Systematic Assessment |
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| Increased appetite at 18 mo | Psychiatric disorders | Systematic Assessment |
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| Decreased appetite at 18 mo | Psychiatric disorders | Systematic Assessment |
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| Drowsiness at 18 mo | Psychiatric disorders | Systematic Assessment |
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| Gastrointestinal upset at 18 mo | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ian Kronish, MD, MPH, Principal Investigator | Center for Behavioral Cardiovascular Health | 212-342-1335 | ik2293@columbia.edu |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 1, 2019 | Oct 22, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003863 | Depression |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000928 | Antidepressive Agents |
| D020280 | Sertraline |
| D016642 | Bupropion |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Black |
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| Other |
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| Refused or unknown |
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| Superiority |
| OG002 | 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. No intervention |
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| OG002 | 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. No intervention |
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