Centralized, stepped, patient preference-based treatment for patients with post-acute coronary syndrome depression: CODIACS vanguard randomized controlled trial

Abstract

Importance: Controversy remains about whether depression can be successfully managed after acute coronary syndrome (ACS) and the costs and benefits of doing so.

Objective: To determine the effects of providing post-ACS depression care on depressive symptoms and health care costs.

Design: Multicenter randomized controlled trial.

Setting: Patients were recruited from 2 private and 5 academic ambulatory centers across the United States.

Participants: A total of 150 patients with elevated depressive symptoms (Beck Depression Inventory [BDI] score ≥10) 2 to 6 months after an ACS, recruited between March 18, 2010, and January 9, 2012.

Interventions: Patients were randomized to 6 months of centralized depression care (patient preference for problem-solving treatment given via telephone or the Internet, pharmacotherapy, both, or neither), stepped every 6 to 8 weeks (active treatment group; n = 73), or to locally determined depression care after physician notification about the patient's depressive symptoms (usual care group; n = 77).

Main outcome measures: Change in depressive symptoms during 6 months and total health care costs.

Results: Depressive symptoms decreased significantly more in the active treatment group than in the usual care group (differential change between groups, -3.5 BDI points; 95% CI, -6.1 to -0.7; P = .01). Although mental health care estimated costs were higher for active treatment than for usual care, overall health care estimated costs were not significantly different (difference adjusting for confounding, -$325; 95% CI, -$2639 to $1989; P = .78).

Conclusions: For patients with post-ACS depression, active treatment had a substantial beneficial effect on depressive symptoms. This kind of depression care is feasible, effective, and may be cost-neutral within 6 months; therefore, it should be tested in a large phase 3 pragmatic trial.

Trial registration: clinicaltrials.gov Identifier: NCT01032018.

Figure 1

CONSORT diagram of the CODIACS Vanguard trial.

Figure 2

Comparison of health care use costs during the 6 months between treatment groups.

Figure 3

Comparison of the CODIACS Vanguard trial with other trials of depression treatments in coronary heart disease and primary care patients. *This trial included participants with elevated depressive symptoms; other trials included only patients with major depressive disorder. It is also important to note that some of these trials had more active control conditions, leading possibly to smaller depression differences between groups. Full-information maximum-likelihood estimates were used to determine intent-to-treat treatment effects; other trials may have used other estimating methods. IPT indicates interpersonal psychotherapy. Note: a larger Hedges’ G indicates a stronger positive effect of the tested intervention. Note: Vertical dashed lines indicate the 95% confidence intervals for the Hedges’ G estimates from the three meta-analyses. Note: Horizontal solid line indicates the 95% confidence interval for each individual study