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| ID | Type | Description | Link |
|---|---|---|---|
| GCO 02-0247 | Other Identifier | Grant ID | |
| N01HC25197-0-0-0 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The specific aim of the "Coronary Patients Evaluation Study" (COPES) Project 2 is, within a Phase-I RCT, to examine patient satisfaction, treatment safety, and symptom reduction associated with treatment for symptoms of distress and/or depressed mood among post acute coronary syndrome (ACS) patients, as compared to usual cardiology care. For the purposes of this study, "symptoms of distress and/or depressed mood" is defined by a score on the Beck Depression Inventory (BDI) >10. The specific treatment approach utilized follows the, "Improving Mood-Promoting Access to Collaborative Treatment" (IMPACT) Clinical Trial, and involves up to 6-months of a patient preference, stepped-care protocol. Within this protocol, patients choose between brief, problem focused psychotherapy and anti-depressant medication. Treatment progress is reviewed at 2-month intervals, providing opportunities to 'step-up' treatment if patients are not demonstrating sufficient symptom reduction.
Objectives: To examine patient satisfaction, treatment safety, and symptom reduction associated with treatment for symptoms of distress and/or depressed mood among post acute coronary syndrome (ACS) patients, as compared to usual cardiology care.
Research Design: The Study utilizes a Phase-I RCT design to achieve this Aim.
Methodology: Patients with confirmed ACS are screened for symptoms of distress and/or depressed mood within 7 days of the index ACS event, using the Beck Depression Inventory (BDI). Those meeting inclusion criterion on the BDI (score>10) and consenting to study are followed for 3-months, at which time they are re-assessed. Those continuing to show BDI score >10 and consenting, are randomized to the intervention condition (INT) or to usual cardiologic care (UCC). INT is defined by up to 6-months of a patient preference, stepped care treatment whereby patients chose between brief, problem-focused psychotherapy (PST) and antidepressant medication (MED). Patients are re-evaluated at 2- and 4-months after randomization. Those not showing sufficient improvement in symptoms receive augmented therapy. Those who initially choose PST can receive more frequent sessions and/or the addition of MED; those who initially choose MED can receive a change of agent, an increase in dosage, an additional medication, and/or PST.
Hypotheses to be tested are:
This is a multi-site study involving Mt. Sinai, and Yale and Columbia University Schools of Medicine. A total of 500 people will be screened into the initial 'observational period', which occurs at the time of new ACS diagnosis. From among these, it is anticipated that 200 people will evidence persistent BDI > 10 at 3-month follow-up and agree to be enrolled in the Phase 1 RCT.
The clinical relevance of the Study concerns demonstration of the acceptability and satisfaction with the treatment approach by post-ACS patients, as preliminary to a Phase-III RCT that would test the effect of such an intervention on event-free survival after ACS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Condition (INT) | Experimental | Enhanced depression care: Participants assigned to INT condition will be given an information brochure describing the intervention. This description will include an overview of the two elements of treatment (Problem Solving Therapy (PST), pharmacotherapy), the choice that the participant has for which element of treatment they will receive, and the stepped care aspect of treatment. |
|
| Usual Cardiologic Care Condition (UCC) | Other | Referred depression care: Participants assigned to the usual cardiologic care condition (UCC) condition will be scheduled for their next follow-up visit and thanked for their time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced depression care | Behavioral | Initial patient preference for problem-solving therapy and/or pharmacotherapy, then a stepped-care approach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. | Number of participants who rated their depression care as excellent or very good as a percentage. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Depressive Symptoms | Depressive symptoms were measured using the Beck Depression Inventory (BDI), which 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). | 6 months |
| Number of Participants Experiencing Major Adverse Cardiovascular Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karina Davidson, Ph.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States | ||
| Mount Sinai School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24835038 | Derived | Ye S, Shaffer JA, Rieckmann N, Schwartz JE, Kronish IM, Ladapo JA, Whang W, Burg MM, Davidson KW. Long-term outcomes of enhanced depression treatment in patients with acute coronary syndromes. Am J Med. 2014 Oct;127(10):1012-6. doi: 10.1016/j.amjmed.2014.05.004. Epub 2014 May 14. | |
| 20386003 | Derived | Davidson KW, Rieckmann N, Clemow L, Schwartz JE, Shimbo D, Medina V, Albanese G, Kronish I, Hegel M, Burg MM. Enhanced depression care for patients with acute coronary syndrome and persistent depressive symptoms: coronary psychosocial evaluation studies randomized controlled trial. Arch Intern Med. 2010 Apr 12;170(7):600-8. doi: 10.1001/archinternmed.2010.29. |
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Participants were recruited at 5 hospital sites (Mount Sinai Hospital and New York Presbyterian Hospital, New York, New York; and New Haven Hospital, Hospital of St Raphael, and Veterans Affairs Connecticut Healthcare System-West Haven, New Haven, Connecticut) from January 1, 2005, through February 29, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Depression Care | The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms. |
| FG001 | Referred Depression Care | The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Depression Care | The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms. |
| 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 |
| 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 | Percentage of Patients That Self-reported as Satisfied With Care for Depressive Symptoms. | Number of participants who rated their depression care as excellent or very good as a percentage. | Posted | Number | percentage of participants | 6 months |
|
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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 | Enhanced Depression Care | The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACS (intervention) | Cardiac disorders | Systematic Assessment | Acute coronary syndrome (intervention) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | 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 |
|---|---|
| D006331 | Heart Diseases |
| D003863 | Depression |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D017202 | Myocardial Ischemia |
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| Referred depression care | Behavioral | Physician notified of depression symptoms, usual care followed. |
|
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The table represents the number of participants experiencing major adverse cardiovascular events |
| 6 months |
| All-cause Mortality | All- cause mortality | 18 months |
| New York |
| New York |
| 10029 |
| United States |
| Columbia University | New York | New York | 10032 | United States |
| BG001 | Referred Depression Care | The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
|
| Type of presenting acute coronary syndrome | MI = Myocardial Infarction | Number | participants |
|
| Beck Depression Inventory Score, categorical | 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). | Number | participants |
|
| Diagnosis of major depressive episode | Number | participants |
|
| GRACE ACS Risk and Mortality Score | The GRACE Risk and Mortality score is one tool used to help clinicians assess the future risk of death or myocardial infarction (MI), as a guide to treatment options, in a patient with an acute coronary syndrome (ACS). Range of values: 2 to 372. Patients are categorized as low risk (score <= 108), medium risk (score between 109 - 140), and high risk (>140 score). | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Referred Depression Care |
The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode. |
|
|
| Secondary | Level of Depressive Symptoms | Depressive symptoms were measured using the Beck Depression Inventory (BDI), which 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). | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months |
|
|
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| Secondary | Number of Participants Experiencing Major Adverse Cardiovascular Events | The table represents the number of participants experiencing major adverse cardiovascular events | Posted | Number | participants | 6 months |
|
|
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| Secondary | All-cause Mortality | All- cause mortality | Posted | Number | participants | 18 months |
|
|
|
| 22 |
| 80 |
| 60 |
| 80 |
| EG001 | Referred Depression Care | The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode. | 22 | 77 | 74 | 77 |
|
| ACS (non-intervention) | Cardiac disorders | Systematic Assessment | Acute coronary syndrome (non-intervention) |
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| Cath (diagnostic/non-intervention) | Cardiac disorders | Systematic Assessment | Catheterization (diagnostic/non-intervention) |
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| Chest pain | Cardiac disorders | Systematic Assessment |
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| Chest pain (non-cardiac) | General disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Hypotension/Postural Hypotension | Cardiac disorders | Systematic Assessment |
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| Intervention (scheduled/non-urgent) | Cardiac disorders | Systematic Assessment |
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| Life-threatening arrythmia | Cardiac disorders | Systematic Assessment |
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| Non-CV | General disorders | Systematic Assessment | Non-Cardiovascular |
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| Other (cardiac) | Cardiac disorders | Systematic Assessment |
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| Other (non-cardiac) | General disorders | Systematic Assessment |
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| Other (psych) | Psychiatric disorders | Systematic Assessment |
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| Self-report only; no additional info | General disorders | Systematic Assessment |
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| Shortness of breath, fatigue, CHF | General disorders | Systematic Assessment |
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| Stroke | Vascular disorders | Systematic Assessment |
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| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Chest pain (non-cardiac) | General disorders | Systematic Assessment |
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| Hypotension/Postural Hypotension | Cardiac disorders | Systematic Assessment |
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| Intervention (scheduled/non-urgent) | Cardiac disorders | Systematic Assessment |
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| Non-CV | General disorders | Systematic Assessment | Non-Cardiovascular |
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| Other (cardiac) | Cardiac disorders | Systematic Assessment |
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| Other (non-cardiac) | General disorders | Systematic Assessment |
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| Other (psych) | Psychiatric disorders | Systematic Assessment |
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| Self-report only; no additional info | General disorders | Systematic Assessment |
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| Shortness of breath, fatigue, CHF | General disorders | Systematic Assessment |
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| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
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| Worsening Depressioin | Psychiatric disorders | Systematic Assessment |
|
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| D014652 |
| Vascular Diseases |