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Centralized, Stepped, Patient Preference–Based Treatment for Patients With Post–Acute Coronary Syndrome Depression: CODIACS Vanguard Randomized Controlled Trial
Study Questions:
Does treatment for depression improve symptoms and reduce health care costs after acute coronary syndrome (ACS)?
Methods:
This was a multicenter, randomized, controlled trial, which enrolled patients from two private and five academic ambulatory medical centers in the United States between March 18, 2010, and January 9, 2012. Potential participants with ACS (n = 724) were asked to participate in an eligibility interview; 177 patients (24.4%) were found to be eligible, and 150 were enrolled and randomly allocated: 73 to active treatment and 77 to usual care. Two participants in each group were lost to follow-up at 6 months, and four from each group (5.3% total) had missing 6-month depression data. Patients with depressive symptoms (defined as a Beck Depression Inventory [BDI] score ≥10) in the 2-6 months after ACS 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 6-8 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). The primary outcome of interest was change in depressive symptoms during the 6 months and change in total health care costs.
Results:
A total of 150 patients were included. Of the 150 trial participants, 27 of the active treatment and 26 of the usual care participants reported that they were already receiving antidepressants at randomization; at the end of the trial, 37 of the 73 active treatment participants (50.7%) and 28 of the 77 usual care participants (36.4%) were still using antidepressants. Before randomization, six patients (8.2%) and seven patients (9.1%) in the active treatment and usual care groups, respectively, were participating in psychotherapy; at the end of the trial, these numbers had increased to 48 (65.8%) and 14 (18.2%), respectively. Remission of depression (Beck Depression Inventory [BDI] score ≥10 at 6 months) occurred in 24 active treatment participants (47.1%) and 16 usual care participants (27.6%) (p = 0.04; number needed to treat = 5). No significant differences were found between groups in the proportion of participants who achieved a 0.5-standard deviation reduction of depressive symptoms or 30 or more depression-free days. 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% confidence interval [CI], -6.1 to -0.7; p = 0.01). Mental health costs were significantly higher for the active treatment group than for the usual care group (adjusted change, $687; 95% CI, $466-$909; p < 0.001), whereas average hospital costs were lower in the active treatment group (adjusted change, -$1,010; 95% CI, -$3,294 to $1,274; p = 0.39). As a result of this offset, total health care costs in the study intervention group were not higher than in the comparison group (adjusted change, -$325; 95% CI, -$2,639 to $1,989; p = 0.78).
Conclusions:
The investigators concluded that active treatment of depressive symptoms after ACS resulted in substantial benefit in terms of reducing depressive symptoms. The cost of this program was similar to routine post-ACS care demonstrating feasibility of such programs. The investigators recommended further examination in a large-scale trial.
Perspective:
Depressive symptoms after ACS are common, and can affect adherence to effective cardiac therapies while reducing quality of life. Trials such as this one are important to conduct to allow for development of effective management strategies of depression without undue cost.
Keywords: Depression, Acute Coronary Syndrome, Quality of Life, Cardiovascular Diseases, Health Care Costs, Lost to Follow-Up, Confidence Intervals, Patient Preference, Psychotherapy, United States
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