Abstract

BackgroundDepression is a frequently observed and disabling condition in primary care, mainly treated by Primary Care Physicians with antidepressant drugs. Psychological interventions are recommended as first-line treatment by the most authoritative international guidelines but few evidences are available on their efficacy and effectiveness for mild depression.Methods/DesignThis multi-center randomized controlled trial was conducted in 9 Italian centres with the aim to compare the efficacy of Inter-Personal Counseling, a brief structured psychological intervention, to that of Selective Serotonin Reuptake Inhibitors. Patients with depressive symptoms referred by Primary Care Physicians to psychiatric consultation-liaison services were eligible for the study if they met the DSM-IV criteria for major depression, had a score ≥13 on the 21-item Hamilton Depression Rating Scale, and were at their first or second depressive episode. The primary outcome was remission of depressive symptoms at 2-months, defined as a HDRS score ≤ 7. Secondary outcome measures were improvement in global functioning and recurrence of depressive symptoms at 12-months. Patients who did not respond to Inter-Personal Counseling or Selective Serotonin Reuptake Inhibitors at 2-months received augmentation with the other treatment.DiscussionThis trial addresses some of the shortcomings of existing trials targeting major depression in primary care by evaluating the comparative efficacy of a brief psychological intervention that could be easily disseminated, by including a sample of patients with mild/moderate depression and by using different outcome measures.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12608000479303

Highlights

  • Depression is a frequently observed and disabling condition in primary care, mainly treated by Primary Care Physicians with antidepressant drugs

  • This trial addresses some of the shortcomings of existing trials targeting major depression in primary care by evaluating the comparative efficacy of a brief psychological intervention that could be disseminated, by including a sample of patients with mild/moderate depression and by using different outcome measures

  • Psychological interventions are often preferred by primary care patients [17,18] and are recommended as first-line treatment by the most authoritative international guidelines [19,20].The APA guidelines [19] stated that antidepressants or an effective psychotherapy alone may be considered as the first-line treatment for patients with mild to moderate major depression

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Summary

Introduction

Depression is a frequently observed and disabling condition in primary care, mainly treated by Primary Care Physicians with antidepressant drugs. Psychological interventions are recommended as first-line treatment by the most authoritative international guidelines but few evidences are available on their efficacy and effectiveness for mild depression. Many patients with depression seek help in primary care and an increasing proportion has been treated in this setting, especially since the availability of safe and easy to use antidepressants (ADs) [9]. Some problems remain in the management of depression in primary care, including the insufficient duration of antidepressant treatment and the limited use of non-pharmacological options [10,11,12]. Several reasons account for this limited use: the small number of trained therapists in primary care [13,14], the physician’s positive opinion and attitude on drug treatment [15,16], the few evidence on the comparative efficacy and effectiveness of brief psychotherapies vs antidepressants

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