• Mood Disorders Clinical Trials
• Interventional Techniques & Devices

Results from the Bypassing the Blues trial (NCT00091962) indicate that depression screening shortly after coronary artery bypass graft (CABG) surgery, telephone follow-up using evidence-based depression treatment protocols, and patient education that is supervised by primary care physicians (ie, collaborative care) can improve health-related quality of life (HRQoL), physical functioning, and mood symptoms and thereby speed patient recovery following CABG surgery.

Post-CABG depression is common (20% to 25% incidence) and has been associated with delayed recovery, increased hospital readmissions, cardiovascular events, and death. The Bypassing the Blues trial was designed to test the effectiveness of a telephone-delivered collaborative care strategy for treating post-CABG depression versus doctors' usual care. Post-CABG patients who expressed mood symptoms that were indicative of depression (Patient Health Questionnaire [PHQ-2] positive screen) preceding discharge, followed by a PHQ-9 score ≥10 at 2 weeks posthospitalization, were randomly assigned to an 8-month course of collaborative care (n=150) or their physicians' “usual care” (n=152). Results were also compared with a group of 151 randomly sampled nondepressed post-CABG patients (PHQ-2 negative and PHQ-9 <5).

The intervention consisted of telephone contact at regular intervals, during which the nurses provided basic psycho education, assessed treatment preferences (eg, self-management workbook, antidepressant pharmacotherapy, referral to a mental health specialist), monitored treatment response, and suggested changes to patients and their primary care physicans (PCP) following a discussion with a study psychiatrist and PCP. The study investigators did not prescribe or dispense any antidepressant medications, and patients who were interested in pharmacotherapy were required to obtain this treatment from their PCP and at cost. No pharmaceutical or industry support was involved in this trial.

The primary outcome measure was mental HRQoL, as measured by the Short Form-36 Mental Component Summary (SF-36 MCS) at 8 months. Secondary outcome measures included assessment of mood symptoms (Hamilton Rating Scale for Depression [HRS-D]), physical HRQoL (SF-36 PCS), and functional status (Duke Activity Status Index [DASI]); and rehospitalization rate.

The 302 depressed subjects were well matched by baseline randomization status; however, depressed subjects were slightly younger than those in the nondepressed comparison group (mean age 64 vs 66 years; p=0.03). Approximately 25% of depressed patients were already using an antidepressant medication at baseline.

Depressed subjects who were randomized to collaborative care experienced a significant improvement in HRQoL compared with subjects in the usual care group beginning at 2 month follow-up that was equivalent to a small to moderate effect size (ES) of 0.30 (95% CI, 0.17 to 0.52; p=0.01) and a number needed to treat (NNT) of 4.9 (3.2 to 10.4; p<0.001) to achieve a 50% or greater decline from baseline HRS-D score. The improvement in mood symptoms appeared to be more prominent in men (ES, 0.53; 95% CI, 0.23 to 0.84; p<0.001). Patients who received collaborative care also had improved scores on the HRS-D for mood symptoms (ES, 0.30; 95% CI, 0.08 to 0.53; p=0.009), the SF-36 PCS (ES, 0.26; 95% CI, 0.03 to 0.48; p=0.03) for physical status, and DASI (ES, 0.32; 95% CI, 0.09 to 0.54; p=0.006) for physical functioning. The mean HRQoL and physical functioning of patients who received intervention did not reach those of the nondepressed comparison group for any of the measures.

Overall, while there was no difference in the incidence of rehospitalization between study arms by randomization status, there was a trend toward fewer rehospitalizations for cardiovascular causes among depressed men who were randomized to their intervention (13%) versus men who were randomized to usual care (25%; p=0.07). However, the study was underpowered to detect a difference in cardiovascular events of mortality (1% overall mortality by 8-month follow-up). Cost data are not yet available.

The study results were presented by Bruce L. Rollman, MD, University of Pittsburgh, Pittsburgh, PA, the primary investigator of the study.

• © 2009 MD Conference Express