Comparison of Depression Interventions After Acute Coronary Syndrome

NCT ID: NCT01032018

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-07-31

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.

Conditions

Acute Coronary Syndrome; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Participants will receive standard of care from the current physicians

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.

Group Type: EXPERIMENTAL

Problem Solving Therapy

Intervention Type: BEHAVIORAL

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).

Sertraline, citalopram, or bupropion

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: BEHAVIORAL

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

Intervention Type: DRUG

Standard care

Participants will receive standard of care from the current physicians

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Karina Davidson

Professor of Behavioral Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karina W Davidson, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

J Thomas Bigger, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Robert Carney, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Kenneth Freedland, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Yale University

New Haven, Connecticut, United States

Emory University

Atlanta, Georgia, United States

Washington University

St Louis, Missouri, United States

Columbia University Medical Center

New York, New York, United States

Trustees of the University of Pennsylvania, Penn Cardiac Center at Mercer Bucks

Yardley, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23471421 (View on PubMed)

Related Links

http://www.nhlbi.nih.gov/

Related Info

http://dx.doi.org/10.1016/j.cct.2012.05.005

Baseline design paper

Other Identifiers

RC2HL101663

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAE1932

Identifier Type: -

Identifier Source: org_study_id