NCT00091962

Brief Summary

The purpose of this study is to treat depression in patients who have undergone coronary artery bypass graft (CABG).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
453

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Aug 2003

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2004

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

April 14, 2016

Completed
Last Updated

April 14, 2016

Status Verified

March 1, 2016

Enrollment Period

4.8 years

First QC Date

September 20, 2004

Results QC Date

January 25, 2016

Last Update Submit

March 14, 2016

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesDepression

Outcome Measures

Primary Outcomes (1)

  • 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.

    Measured 8 months post-CABG

Secondary Outcomes (3)

  • Hamilton Rating Scale for Depression

    8 months post CABG

  • Generic Physical Health-Related Quality of Life

    8 months post CABG

  • Disease-Specific Health-Related Quality of Life

    8 months post CABG

Study Arms (3)

Depressed Intervention

EXPERIMENTAL

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

Behavioral: Psychoeducation; Treatment recommendationsDrug: Pharmacotherapy

Depressed Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Non-Depressed Control Group

NO INTERVENTION

Non-depressed control group

Interventions

Psychoeducation; Treatment recommendationsBEHAVIORAL

Counseling program

Depressed Intervention
PharmacotherapyDRUG

Recommendations to patients' PCP for medication to treat depression

Depressed Intervention
Usual CareOTHER

Physicians' Usual care

Depressed Usual Care

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (12)

  • 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.

    PMID: 19188529RESULT

  • 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.

    PMID: 20562371RESULT

  • 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.

    PMID: 19918088RESULT

  • 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.

    PMID: 22286847RESULT

  • 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.

    PMID: 22209126RESULT

  • 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.

    PMID: 21972329RESULT

  • 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.

    PMID: 21946803RESULT

  • 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.

    PMID: 24973911RESULT

  • 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.

    PMID: 24360138RESULT

  • 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.

    PMID: 22878857RESULT

  • 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.

    PMID: 25592159RESULT

  • 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.

    PMID: 31675390DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesDepression

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

Selection bias if patients with severe depression were less likely to participate in our screening procedure. Also, the trial recruited just from one U.S. region.

Results Point of Contact

Title
Dr. Bruce L Rollman, Principal Investigator
Organization
University of Pittsburgh School of Medicine
rollmanbl@upmc.edu
(412) 692-2659

Study Officials

  • Bruce L. Rollman

    University of Pittsburgh

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 20, 2004

First Posted

September 23, 2004

Study Start

August 1, 2003

Primary Completion

June 1, 2008

Study Completion

December 1, 2009

Last Updated

April 14, 2016

Results First Posted

April 14, 2016

Record last verified: 2016-03

Locations

US(1)