Acute Coronary Syndrome, Depression
Conditions
Keywords
Acute coronary syndrome, Depression, Satisfaction with care
Brief summary
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.
Interventions
BEHAVIORALProblem Solving Therapy
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).
DRUGSertraline, citalopram, or bupropion
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
OTHERStandard care
Participants will receive standard of care from the current physicians
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of North Carolina, Chapel Hill
Emory University
Yale University
Washington University School of Medicine
University of Pennsylvania
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized for ACS defined as unstable angina or MI * BDI greater or equal to 10 and \< 15 2-6 months post-ACS on each of 2 occasions, or BDI greater than 15 on one occasion * Age at least 35 years * Fluent in English or Spanish * Able to complete baseline assessment within 2-6 months of index ACS event * Able and willing to provide informed consent
Exclusion criteria
* Presence of non-cardiac condition likely to terminate fatally within 1 year * Inaccessibility for intervention or follow-up (e.g., plans to move from the area) * Cognitive impairment * Need for immediate psychiatric intervention (i.e., requiring hospitalization or psychiatric intervention within 72 hours) * Suicidal ideation * Major psychiatric co-morbidity (current or by history) including active psychosis, bipolar disorder, or overt personality disorder * Active substance abuse or dependency * Chronic renal failure (receiving chronic dialysis treatment, or estimated glomerular filtration rate…\[eGFR\] \< 30 ml/min/1.73 m2) or moderate/severe liver disease (e.g., esophageal varices, portal hypertension, encephalopathy, GI bleeding) * Participation in another clinical trial for the treatment of depression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptom Reduction | Change from depression at baseline to depression at 6-months | 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. |
| Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) | 6 months after randomization | — |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
724 patients were medically eligible for participation in the study, of which 150 consented to randomization and were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 77 |
| 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. | 73 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 6 | 5 |
Baseline characteristics
| Characteristic | Total | Referred Care | Stepped Care |
|---|---|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 10.4 | 60.0 years STANDARD_DEVIATION 11.1 | 59.2 years STANDARD_DEVIATION 9.7 |
| Beck Depression Inventory Score, categorical BDI score < 16 | 48 participants | 27 participants | 21 participants |
| Beck Depression Inventory Score, categorical BDI score >= 16 | 102 participants | 50 participants | 52 participants |
| Beck Depression Inventory Score, continuous | 20.8 Scores on a scale STANDARD_DEVIATION 7.7 | 20.6 Scores on a scale STANDARD_DEVIATION 7.8 | 21.0 Scores on a scale STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 13 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 120 Participants | 64 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants | 27 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) White | 84 Participants | 42 Participants | 42 Participants |
| Sex: Female, Male Female | 63 Participants | 33 Participants | 30 Participants |
| Sex: Female, Male Male | 87 Participants | 44 Participants | 43 Participants |
| Type of presenting acute coronary syndrome Bundle branch block/uncertain type of MI | 3 participants | 2 participants | 1 participants |
| Type of presenting acute coronary syndrome Non-ST segment elevated MI | 37 participants | 19 participants | 18 participants |
| Type of presenting acute coronary syndrome ST-segment elevated MI | 40 participants | 21 participants | 19 participants |
| Type of presenting acute coronary syndrome Unstable angina | 70 participants | 35 participants | 35 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 63 / 77 | 59 / 73 |
| serious Total, serious adverse events | 8 / 77 | 7 / 73 |
Outcome results
Primary
Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)
Time frame: 6 months after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Referred Care | Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) | 4289.23 dollars | Standard Error 826.56 |
| Stepped Care | Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) | 4358.02 dollars | Standard Error 883.76 |
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.
Time frame: Change from depression at baseline to depression at 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Referred Care | Depressive Symptom Reduction | -6.6 Scores on a scale | Standard Deviation 1 |
| Stepped Care | Depressive Symptom Reduction | -10.1 Scores on a scale | Standard Deviation 0.9 |
Comparison: The trial was powered to detect a between-group difference in the 6-month change in depression symptoms. Assuming 5% attrition rate, we estimated that a sample of 150 patients would be needed to have 80% power to detect a clinically meaningful differential change in depression scores between groups of 0.46 SD.p-value: 0.0195% CI: [-6.1, -0.7]Mixed Models Analysis