Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)

Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Acute Coronary Syndrome
• Intervention / Treatment: Other: Standard care; Behavioral: Problem Solving Therapy; Drug: Sertraline, citalopram, or bupropion

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Pennsylvania
    • Yardley, Pennsylvania, United States, 19067
      • Trustees of the University of Pennsylvania, Penn Cardiac Center at Mercer Bucks

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Standard care; Participants will receive standard of care from the current physicians
Experimental: 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.	Behavioral: Problem 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).; Drug: Sertraline, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from depression at baseline to depression at 6-months
Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)		6 months after randomization

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: University of Pennsylvania; Washington University School of Medicine; National Heart, Lung, and Blood Institute (NHLBI); Yale University; Emory University; University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Karina W Davidson, PhD, Columbia University; Principal Investigator: J Thomas Bigger, MD, Columbia University; Principal Investigator: Robert Carney, PhD, Washington University School of Medicine; Principal Investigator: Kenneth Freedland, PhD, Washington University School of Medicine

Publications and helpful links

General Publications

• Davidson KW, Bigger JT, Burg MM, Carney RM, Chaplin WF, Czajkowski S, Dornelas E, Duer-Hefele J, Frasure-Smith N, Freedland KE, Haas DC, Jaffe AS, Ladapo JA, Lesperance F, Medina V, Newman JD, Osorio GA, Parsons F, Schwartz JE, Shaffer JA, Shapiro PA, Sheps DS, Vaccarino V, Whang W, Ye S. Centralized, stepped, patient preference-based treatment for patients with post-acute coronary syndrome depression: CODIACS vanguard randomized controlled trial. JAMA Intern Med. 2013 Jun 10;173(11):997-1004. doi: 10.1001/jamainternmed.2013.915.
• Davidson KW. Centralized, patient preference-based treatment for patients with acute coronary syndrome depression: Codiacs vanguard rct. 27th Conference of the European Health Psychology Society.

Helpful Links

• Related Info
• Baseline design paper

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: December 11, 2009
• First Submitted That Met QC Criteria: December 13, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Actual): September 13, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Acute coronary syndrome; Satisfaction with care
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Mood Disorders; Disease; Depression; Depressive Disorder; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Sertraline; Citalopram; Bupropion
• Other Study ID Numbers: AAAE1932; RC2HL101663 (U.S. NIH Grant/Contract)