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Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery

Primary Purpose

Cardiovascular Diseases, Coronary Disease, Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychoeducation; Treatment recommendations
Pharmacotherapy
Usual Care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Recently underwent CABG (combined or redo procedure) at one of 8 Pittsburgh area study hospitals A PHQ score greater than 10 OR if nondepressed control, a PHQ score less than 5 at both 2 days post CABG to the date of discharge following CABG and when reassessed 2 weeks after hospital discharge Folstein Mini-Mental State Examination (MMSE) score greater than or equal to 24 Able to be evaluated and treated for depression as an outpatient post CABG Has a household telephone Exclusion Criteria: Presently in treatment with a mental health specialist Actively suicidal History of psychotic illness History of bipolar illness according to subject self-report and past medical history Current alcohol dependence or other substance abuse as evidenced by chart review and the CAGE questionnaire Organic mood syndromes, including those secondary to medical illness or drugs Presence of non-cardiovascular conditions that are likely to be fatal within 1 year Unstable medical condition as indicated by history, physical, and/or laboratory findings Previous enrollment in the study cohort Non-English speaking, illiterate, or possessing any other communication barrier If nondepressed control, current or previous diagnosis or treatment of depression

Sites / Locations

  • University of Pittsburgh School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Depressed Intervention

Depressed Usual Care

Non-Depressed Control Group

Arm Description

Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs' direction; referral to mental health specialist

"Usual care" for depression; feedback of the depression finding by the study team

Non-depressed control group

Outcomes

Primary Outcome Measures

Generic Mental Health-Related Quality of Life
The 36-item Medical Outcomes Study Form (v.2) Mental Component Scale (SF-36 MCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better. Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User's Manual. 2nd ed. Boston, MA: New England Medical Center; 1994.

Secondary Outcome Measures

Hamilton Rating Scale for Depression
The 17-item Depression Interview and Structured Hamilton (DISH) version of the Hamilton Rating Scale for Depression Standard provides an accurate DSM-IV diagnosis of a cardiac patient's mood disorder and a reliable HRS-D score. Range 0-52. Higher scores are worse. Psychosom Med. 2002;64(6):897-905
Generic Physical Health-Related Quality of Life
The 36-item Medical Outcomes Study Form (v.2) Physical Component Scale (SF-36 PCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better. Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User's Manual. 2nd ed. Boston, MA: New England Medical Center; 1994.
Disease-Specific Health-Related Quality of Life
The 12-item Duke Activity Status Index (DASI). Scores range from 0-58.2, and higher scores the better the functional capacity (Am J Cardiol. 1989;64(10):651-654).

Full Information

First Posted
September 20, 2004
Last Updated
March 14, 2016
Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00091962
Brief Title
Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery
Official Title
Treatment of Depression Following Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to treat depression in patients who have undergone coronary artery bypass graft (CABG).
Detailed Description
BACKGROUND: Cardiovascular disease morbidity and mortality is an important health issue. Depression has emerged as a risk factor for increased morbidity and mortality in patients with coronary heart disease. CABG is a surgical procedure that is specifically directed to improvement in quality of life for patients with severe coronary artery disease, though its impact on mortality is questionable. Patients with depression after CABG are found to not demonstrate sufficient improvement in quality of life, resulting in a significantly higher level of healthcare costs. DESIGN NARRATIVE: In this randomized study, 300 patients who show elevated levels of depressive symptoms at 3 to 5 days following CABG and at 2 weeks after hospital discharge will be recruited. They will be randomized to receive either 1) their physician's "usual care" for depression, or 2) a stepped collaborative care program involving a telephone-based nurse care manager. The nurse care manager will contact patients at regular intervals to assess treatment preferences for depression (e.g., counseling, self-management workbook, pharmacotherapy, or specialty referral), promote adherence with care, and monitor the therapeutic response in concert with patient's primary care physicians and under the supervision of a study clinician. One hundred and fifty nondepressed post-CABG patients will be randomly selected to serve as a control cohort to facilitate comparisons with the depressed patients on various baseline and follow-up measures, and to better understand the benefits derived from depression treatment (total N=450). Blinded telephone assessments will be conducted at 2, 4, 8, and 12 months post CABG and then every 6 months until the last patient completes his/her 8-month assessment (range: 8-44 months follow-up). Intent-to-treat analyses will be used to test the primary hypothesis that the intervention will produce at least a clinically meaningful 0.5 effect size improvement in health related quality of life (HRQoL) at 8 months post CABG, as measured by the SF-36 Mental Component Summary score, compared to patients who receive their primary care physician's "usual care" for depression. The secondary hypotheses are that compared to "usual care" patients, intervention patients will 1) experience higher levels of functional status, and lower levels of depressive symptoms, risk for future cardiovascular events, and health services costs, and 2) report similar levels of HRQoL as nondepressed post-CABG patients. Providing evidence-based, stepped, collaborative care treatment for post-CABG depression may be an ideal method for organized health care delivery systems to improve outcomes. The focus on HRQoL and health services costs will facilitate comparisons of the benefits derived from the intervention to that of other established treatments of cardiovascular risk factors and care for other chronic conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
453 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depressed Intervention
Arm Type
Experimental
Arm Description
Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs' direction; referral to mental health specialist
Arm Title
Depressed Usual Care
Arm Type
Active Comparator
Arm Description
"Usual care" for depression; feedback of the depression finding by the study team
Arm Title
Non-Depressed Control Group
Arm Type
No Intervention
Arm Description
Non-depressed control group
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation; Treatment recommendations
Intervention Description
Counseling program
Intervention Type
Drug
Intervention Name(s)
Pharmacotherapy
Intervention Description
Recommendations to patients' PCP for medication to treat depression
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Physicians' Usual care
Primary Outcome Measure Information:
Title
Generic Mental Health-Related Quality of Life
Description
The 36-item Medical Outcomes Study Form (v.2) Mental Component Scale (SF-36 MCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better. Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User's Manual. 2nd ed. Boston, MA: New England Medical Center; 1994.
Time Frame
Measured 8 months post-CABG
Secondary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression
Description
The 17-item Depression Interview and Structured Hamilton (DISH) version of the Hamilton Rating Scale for Depression Standard provides an accurate DSM-IV diagnosis of a cardiac patient's mood disorder and a reliable HRS-D score. Range 0-52. Higher scores are worse. Psychosom Med. 2002;64(6):897-905
Time Frame
8 months post CABG
Title
Generic Physical Health-Related Quality of Life
Description
The 36-item Medical Outcomes Study Form (v.2) Physical Component Scale (SF-36 PCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better. Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User's Manual. 2nd ed. Boston, MA: New England Medical Center; 1994.
Time Frame
8 months post CABG
Title
Disease-Specific Health-Related Quality of Life
Description
The 12-item Duke Activity Status Index (DASI). Scores range from 0-58.2, and higher scores the better the functional capacity (Am J Cardiol. 1989;64(10):651-654).
Time Frame
8 months post CABG

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recently underwent CABG (combined or redo procedure) at one of 8 Pittsburgh area study hospitals A PHQ score greater than 10 OR if nondepressed control, a PHQ score less than 5 at both 2 days post CABG to the date of discharge following CABG and when reassessed 2 weeks after hospital discharge Folstein Mini-Mental State Examination (MMSE) score greater than or equal to 24 Able to be evaluated and treated for depression as an outpatient post CABG Has a household telephone Exclusion Criteria: Presently in treatment with a mental health specialist Actively suicidal History of psychotic illness History of bipolar illness according to subject self-report and past medical history Current alcohol dependence or other substance abuse as evidenced by chart review and the CAGE questionnaire Organic mood syndromes, including those secondary to medical illness or drugs Presence of non-cardiovascular conditions that are likely to be fatal within 1 year Unstable medical condition as indicated by history, physical, and/or laboratory findings Previous enrollment in the study cohort Non-English speaking, illiterate, or possessing any other communication barrier If nondepressed control, current or previous diagnosis or treatment of depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce L. Rollman
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Chair
Facility Information:
Facility Name
University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19188529
Citation
Rollman BL, Belnap BH, LeMenager MS, Mazumdar S, Schulberg HC, Reynolds CF 3rd. The Bypassing the Blues treatment protocol: stepped collaborative care for treating post-CABG depression. Psychosom Med. 2009 Feb;71(2):217-30. doi: 10.1097/PSY.0b013e3181970c1c. Epub 2009 Feb 2.
Results Reference
result
PubMed Identifier
20562371
Citation
Morone NE, Weiner DK, Belnap BH, Karp JF, Mazumdar S, Houck PR, He F, Rollman BL. The impact of pain and depression on recovery after coronary artery bypass grafting. Psychosom Med. 2010 Sep;72(7):620-5. doi: 10.1097/PSY.0b013e3181e6df90. Epub 2010 Jun 18.
Results Reference
result
PubMed Identifier
19918088
Citation
Rollman BL, Belnap BH, LeMenager MS, Mazumdar S, Houck PR, Counihan PJ, Kapoor WN, Schulberg HC, Reynolds CF 3rd. Telephone-delivered collaborative care for treating post-CABG depression: a randomized controlled trial. JAMA. 2009 Nov 18;302(19):2095-103. doi: 10.1001/jama.2009.1670. Epub 2009 Nov 16.
Results Reference
result
PubMed Identifier
22286847
Citation
Tindle H, Belnap BH, Houck PR, Mazumdar S, Scheier MF, Matthews KA, He F, Rollman BL. Optimism, response to treatment of depression, and rehospitalization after coronary artery bypass graft surgery. Psychosom Med. 2012 Feb-Mar;74(2):200-7. doi: 10.1097/PSY.0b013e318244903f. Epub 2012 Jan 27.
Results Reference
result
PubMed Identifier
22209126
Citation
Ghesquiere A, Shear MK, Gesi C, Kahler J, Belnap BH, Mazumdar S, He F, Rollman BL. Prevalence and correlates of complicated grief in adults who have undergone a coronary artery bypass graft. J Affect Disord. 2012 Feb;136(3):381-5. doi: 10.1016/j.jad.2011.11.018. Epub 2011 Dec 29.
Results Reference
result
PubMed Identifier
21972329
Citation
Rollman BL, Belnap BH. The Bypassing the Blues trial: collaborative care for post-CABG depression and implications for future research. Cleve Clin J Med. 2011 Aug;78 Suppl 1:S4-12. doi: 10.3949/ccjm.78.s1.01.
Results Reference
result
PubMed Identifier
21946803
Citation
Schulberg HC, Belnap BH, Houck PR, Mazumdar S, Reynolds CF 3rd, Rollman BL. Treating post-CABG depression with telephone-delivered collaborative care: does patient age affect treatment and outcome? Am J Geriatr Psychiatry. 2011 Oct;19(10):871-80. doi: 10.1097/JGP.0b013e31820d9416.
Results Reference
result
PubMed Identifier
24973911
Citation
Donohue JM, Belnap BH, Men A, He F, Roberts MS, Schulberg HC, Reynolds CF 3rd, Rollman BL. Twelve-month cost-effectiveness of telephone-delivered collaborative care for treating depression following CABG surgery: a randomized controlled trial. Gen Hosp Psychiatry. 2014 Sep-Oct;36(5):453-9. doi: 10.1016/j.genhosppsych.2014.05.012. Epub 2014 May 21.
Results Reference
result
PubMed Identifier
24360138
Citation
Meyer T, Belnap BH, Herrmann-Lingen C, He F, Mazumdar S, Rollman BL. Benefits of collaborative care for post-CABG depression are not related to adjustments in antidepressant pharmacotherapy. J Psychosom Res. 2014 Jan;76(1):28-33. doi: 10.1016/j.jpsychores.2013.10.017. Epub 2013 Nov 5.
Results Reference
result
PubMed Identifier
22878857
Citation
Morone NE, Belnap BH, He F, Mazumdar S, Weiner DK, Rollman BL. Pain adversely affects outcomes to a collaborative care intervention for anxiety in primary care. J Gen Intern Med. 2013 Jan;28(1):58-66. doi: 10.1007/s11606-012-2186-2. Epub 2012 Aug 10.
Results Reference
result
PubMed Identifier
25592159
Citation
Herbeck Belnap B, Schulberg HC, He F, Mazumdar S, Reynolds CF 3rd, Rollman BL. Electronic protocol for suicide risk management in research participants. J Psychosom Res. 2015 Apr;78(4):340-5. doi: 10.1016/j.jpsychores.2014.12.012. Epub 2014 Dec 27.
Results Reference
result
PubMed Identifier
31675390
Citation
Waterman LA, Belnap BH, Gebara MA, Huang Y, Abebe KZ, Rollman BL, Karp JF. Bypassing the blues: Insomnia in the depressed post-CABG population. Ann Clin Psychiatry. 2020 Feb;32(1):17-26.
Results Reference
derived
Links:
URL
http://www.bypassingtheblues.pitt.edu
Description
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Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery

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