Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/21/2016 |
| Start Date: | August 2003 |
| End Date: | December 2009 |
Treatment of Depression Following Bypass Surgery
The purpose of this study is to treat depression in patients who have undergone coronary
artery bypass graft (CABG).
artery bypass graft (CABG).
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.
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.
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
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