Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Depressive Symptom Reduction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Referred Care
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.
干预措施: Standard care (Other)
Stepped Care
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.
干预措施: Problem Solving Therapy (Behavioral)
Stepped Care
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.
干预措施: Sertraline, citalopram, or bupropion (Drug)
结局指标
主要结局
Depressive Symptom Reduction
时间窗: 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)
时间窗: 6 months after randomization
次要结局
未报告次要终点
研究者
Karina Davidson
Professor of Behavioral Medicine
Columbia University