Comparison of Depression Interventions After Acute Coronary Syndrome

Phase 1

Completed

Conditions: Acute Coronary Syndrome
Depression

Interventions: Other: Standard care
Behavioral: Problem Solving Therapy
Drug: Sertraline, citalopram, or bupropion

Registration Number: NCT01032018

Lead Sponsor: Columbia University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 150

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Referred Care	Standard 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.
Stepped Care	Problem Solving Therapy	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.
Stepped Care	Sertraline, citalopram, or bupropion	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.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (5): Columbia University Medical Center
🇺🇸
New York, New York, United States
Yale University
🇺🇸
New Haven, Connecticut, United States
Trustees of the University of Pennsylvania, Penn Cardiac Center at Mercer Bucks
🇺🇸
Yardley, Pennsylvania, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Washington University
🇺🇸
Saint Louis, Missouri, United States