Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Depression
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Depression; Depressive Disorder
Study type: Interventional

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.
    

Intervention name(s): Psychoeducation; Treatment recommendations; Pharmacotherapy; Usual Care
Intervention type(s): Behavioral; Drug; Other
Intervention description(s): Counseling program; Recommendations to patients' PCP for medication to treat depression; Physicians' Usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment