Impact of an educational module in antidepressant-naive patients prescribed antidepressants for depression: Pilot, proof-of-concept, randomized controlled trial

BACKGROUND: Patients are educated about their illness and its treatment at the time of diagnosis. However, little is known about how much of this education is retained and how it influences knowledge about, attitudes toward, and experiences with medication in antidepressant-naive patients with depression. METHODS: Antidepressant-naive outpatients with International Classification of Diseases-10 dysthymia or mild to moderate depression, who were advised antidepressant monotherapy, were randomized to control (n = 22) or intervention (n = 17) groups. Control patients received treatment as usual, and intervention patients received, in addition, a face-to-face, individualized, 10-min education session about the nature of depression, antidepressant treatment, efficacy and adverse effects of the prescribed drug, and plan of management. Knowledge about the illness and its treatment were assessed at baseline (before the educational intervention) and 6 weeks later. At follow-up, experiences with treatment were also evaluated. The study was double-blind. RESULTS: At baseline, patients had poor knowledge about their illness and its treatment (most patients could not even name their diagnosis); however, few held unfavorable attitudes toward their prescribed medicines. At follow-up, there were modest improvements in both sets of outcomes. There were no differences between intervention and control groups in knowledge and attitude outcomes at baseline and end-point. Drug compliance did not differ between groups. However, importantly, intervention patients experienced a significantly larger number of adverse events than controls (mean, 3.5 vs. 1.7, respectively). CONCLUSIONS: For ethical reasons, patients need to be educated about their illness and its treatment. However, such education may be a two-edged sword, with an increased nocebo effect as the most salient consequence. Failure to identify benefits in our study may have been the result of a Type 2 error. This study provides a wealth of information on a large number of issues related to knowledge, attitudes, and experiences of depressed, mostly low-income outpatients in relation to education about depression and its treatment, and future research can build on the findings of this study. We also provide an extensive discussion on directions for further research.