Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)

Columbia University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Coronary Syndrome; Depression

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01032018

RC2HL101663 (U.S. NIH Grant/Contract)

AAAE1932

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 2 patient groups

Referred Care

Active Comparator group

Description:

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.

Treatment:

Other: Standard care

Stepped Care

Experimental group

Description:

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.

Treatment:

Drug: Sertraline, citalopram, or bupropion

Behavioral: Problem Solving Therapy