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| ID | Type | Description | Link |
|---|---|---|---|
| RC2HL101663 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of North Carolina, Chapel Hill | OTHER |
| Emory University | OTHER |
| Yale University |
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Patients will be consented and screened within 2 to 6 months of the index ACS. Patients who have elevated depression (BDI>=15 or BDI>=10 assessed twice over two week period) and who continue to meet all of the trial's eligibility criteria will be consented. Through informed consent, both arms of the trial will be described with equipoise as to these approaches to postACS depression care. Patients who consent to randomization will be enrolled in the treatment trial.
The intervention phase will be 6 months, and hence the final outcome assessments will be performed approximately 9 months after the index ACS. Interim measures of depression will be obtained at 2 and 4 months post-enrollment. Major adverse cardiac events and all-cause mortality will also be ascertained at 6 months post-enrollment. Quality assurance by an independent medical event adjudication committee using prospective guidelines will be employed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Referred Care | Active Comparator | Immediately after the initial post-ACS screening, the participant's physician will be notified in writing if the participant is depressed according to the BDI. Depending upon the physician's own evaluation of the participant, he or she may elect to defer depression treatment, initiate it, or to refer the patient to a mental health specialist. |
|
| Stepped Care | Experimental | Stepped Care participants will be given a description of the choices available in this arm, including choosing antidepressant medication and/or telephone-based, Problem-Solving Therapy (PST). If the patient is randomized to Stepped Care, their physician will be informed that depression treatment is being provided by the trial. Patients will select their preferred treatment approach. Depression symptoms will be monitored to determine whether the patient is improving relative to his/her baseline score. Relapse monitoring and maintenance therapy will continue for the duration of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem Solving Therapy | Behavioral | Problem Solving Therapy (PST) will be administered by a trained provider. The concepts of PST will be taught to the participant in the first session and reinforced across subsequent sessions. Sessions will last between 30 and 60 minutes each and continue weekly for the duration of the study (6 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptom Reduction | 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. | Change from depression at baseline to depression at 6-months |
| Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) | 6 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karina W Davidson, PhD | Columbia University | Principal Investigator |
| J Thomas Bigger, MD | Columbia University | Principal Investigator |
| Robert Carney, PhD | Washington University School of Medicine | Principal Investigator |
| Kenneth Freedland, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23471421 | Result | Davidson KW, Bigger JT, Burg MM, Carney RM, Chaplin WF, Czajkowski S, Dornelas E, Duer-Hefele J, Frasure-Smith N, Freedland KE, Haas DC, Jaffe AS, Ladapo JA, Lesperance F, Medina V, Newman JD, Osorio GA, Parsons F, Schwartz JE, Shaffer JA, Shapiro PA, Sheps DS, Vaccarino V, Whang W, Ye S. Centralized, stepped, patient preference-based treatment for patients with post-acute coronary syndrome depression: CODIACS vanguard randomized controlled trial. JAMA Intern Med. 2013 Jun 10;173(11):997-1004. doi: 10.1001/jamainternmed.2013.915. |
| Label | URL |
|---|---|
| Related Info | View source |
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724 patients were medically eligible for participation in the study, of which 150 consented to randomization and were enrolled.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Referred Care | 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. |
| FG001 | Stepped Care | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Referred Care | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Depressive Symptom Reduction | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Change from depression at baseline to depression at 6-months |
|
2, 4, and 6 months after enrollment
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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 | Referred Care | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal hernia | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karina W Davidson, PhD | Columbia University Medical Center | 212-342-4493 | kd2124@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003863 | Depression |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| D015283 | Citalopram |
| D016642 | Bupropion |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
Not provided
Not provided
| OTHER |
| Washington University School of Medicine | OTHER |
| University of Pennsylvania | OTHER |
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|
| Sertraline, citalopram, or bupropion | Drug | 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. If a patient cannot tolerate a particular treatment (i.e., intolerable side effects even with careful titration and clinical management), a switch to an alternative antidepressant or PST-PC after 2-4 weeks and 'restart' step 1. Sertraline: 25-150qam Citalopram: 10-40qam Bupropion: 100-450qam |
|
| Standard care | Other | Participants will receive standard of care from the current physicians |
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Washington University | St Louis | Missouri | 63130 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Trustees of the University of Pennsylvania, Penn Cardiac Center at Mercer Bucks | Yardley | Pennsylvania | 19067 | United States |
| Baseline design paper | View source |
| BG001 | Stepped Care | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Beck Depression Inventory Score, continuous | 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). | Mean | Standard Deviation | Scores on a scale |
|
| Beck Depression Inventory Score, categorical | Number | participants |
|
| Type of presenting acute coronary syndrome | MI = Myocardial Infarction | Number | participants |
|
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.
| OG001 | Stepped Care | 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. |
|
|
|
| Primary | Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) | Posted | Mean | Standard Error | dollars | 6 months after randomization |
|
|
|
| 8 |
| 77 |
| 63 |
| 77 |
| EG001 | Stepped Care | 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. | 7 | 73 | 59 | 73 |
| GI bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| MRSA Infection | Infections and infestations | Systematic Assessment |
|
| Internal bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Worsened agitation | Psychiatric disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Worsened anxiety/nervousness | Psychiatric disorders | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Blood in stool | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Worsened decreased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Worsened diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
|
| Worsened dizziness | Nervous system disorders | Systematic Assessment |
|
| Worsened drowsiness | Nervous system disorders | Systematic Assessment |
|
| Worsened dry mouth | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Ear bleeding | Ear and labyrinth disorders | Systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| GI problems | Gastrointestinal disorders | Systematic Assessment |
|
| Gum bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Headaches | Nervous system disorders | Systematic Assessment |
|
| Heavy menstrual bleeding | Reproductive system and breast disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Worsened increase in appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Worsened indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| Worsened insomnia | Nervous system disorders | Systematic Assessment |
|
| Irregular menstrual period | Gastrointestinal disorders | Systematic Assessment |
|
| Joint pains | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Leg edema | Cardiac disorders | Systematic Assessment |
|
| Low potassium | Metabolism and nutrition disorders | Systematic Assessment |
|
| Middle ear effusion | Ear and labyrinth disorders | Systematic Assessment |
|
| Mood disturbance | Psychiatric disorders | Systematic Assessment |
|
| Worsened nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nosebleed | Blood and lymphatic system disorders | Systematic Assessment |
|
| Numbness of arms and legs | Nervous system disorders | Systematic Assessment |
|
| Oral bleedin | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pain | Nervous system disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Pruritus | Nervous system disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rectal bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Worsened sexual side effects | Reproductive system and breast disorders | Systematic Assessment |
|
| Strep throat | Infections and infestations | Systematic Assessment |
|
| Worsened sweating | Metabolism and nutrition disorders | Systematic Assessment |
|
| Tingling of fingers and toes | Nervous system disorders | Systematic Assessment |
|
| Worsened tremors | Nervous system disorders | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Upset stomach | Gastrointestinal disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Vaginal bleeding | Reproductive system and breast disorders | Systematic Assessment |
|
| Varicose veins | Vascular disorders | Systematic Assessment |
|
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| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011437 | Propylamines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic 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 |