Comparison of Depression Interventions After Acute Coronary Syndrome - Clinical Trial for Acute Coronary Syndrome | NCT01032018

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Problem Solving Therapy

Sertraline, citalopram, or bupropion

Standard care

About this trial

This is an interventional other trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome, Depression, Satisfaction with care

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Yale University
Emory University
Washington University
Columbia University Medical Center
Trustees of the University of Pennsylvania, Penn Cardiac Center at Mercer Bucks

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Referred Care

Stepped Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)

Secondary Outcome Measures

Full Information

NCT ID

NCT01032018

First Posted

December 11, 2009

Last Updated

August 15, 2017

Sponsor

Columbia University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), University of North Carolina, Chapel Hill, Emory University, Yale University, Washington University School of Medicine, University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT01032018

Brief Title

Comparison of Depression Interventions After Acute Coronary Syndrome

Acronym

CODIACS

Official Title

Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), University of North Carolina, Chapel Hill, Emory University, Yale University, Washington University School of Medicine, University of Pennsylvania

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Depression

Keywords

Acute coronary syndrome, Depression, Satisfaction with care

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Referred Care

Arm Type

Active Comparator

Arm 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.

Arm Title

Stepped Care

Arm Type

Experimental

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Problem Solving Therapy

Intervention Description

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

Drug

Intervention Name(s)

Sertraline, citalopram, or bupropion

Intervention Description

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

Other

Intervention Name(s)

Standard care

Intervention Description

Participants will receive standard of care from the current physicians

Primary Outcome Measure Information:

Title

Depressive Symptom Reduction

Description

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.

Time Frame

Change from depression at baseline to depression at 6-months

Title

Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)

Time Frame

6 months after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karina W Davidson, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

J Thomas Bigger, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert Carney, PhD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kenneth Freedland, PhD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Washington University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63130

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

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

City

Yardley

State/Province

Pennsylvania

ZIP/Postal Code

19067

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23471421

Citation

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.

Results Reference

result

Links:

URL

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

Description

Related Info

URL

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

Description

Baseline design paper

Comparison of Depression Interventions After Acute Coronary Syndrome (CODIACS)

Acute Coronary Syndrome, Depression

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial