Clinical trial NCT00091962: Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery
Official title: Treatment of Depression Following Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Depression
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2004-09-23
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Generic Mental Health-Related Quality of Life
timeFrame: Measured 8 months post-CABG
Secondary outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: 8 months post CABG
measure: Generic Physical Health-Related Quality of Life
timeFrame: 8 months post CABG
measure: Disease-Specific Health-Related Quality of Life
timeFrame: 8 months post CABG
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Bruce L. Rollman
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.