Hygienic-dietary recommendations for major depression treatment: Study protocol of a randomized controlled trial

Multicenter, randomized, controlled, two arm-parallel, clinical trial involving 300 patients over 18 years old with a diagnosis of Major Depression. Major depression will be diagnosed by means of the Mini-International Neuropsychiatric Interview. The Beck Depression Inventory total score at the end of the study will constitute the main efficacy outcome. Quality of Life and Social and Health Care Services Consumption Scales will be also administered. Patients will be assessed at three different occasions: baseline, 6-month follow-up and 12-month follow-up.We expect the patients in the active lifestyle recommendations group to experience a greater improvement in their depressive symptoms and quality of life with lower socio-sanitary costs.ISRCTN73931675Depression is a highly prevalent mental disorder in our society, with 10 to 20% of the population experiencing a major depressive disorder/depressive episode during their lives [1-4]. From the health care system perspective, some studies confirm that 25-35% of patients consuming Primary Care services have a psychiatric condition, with over 80% of these patients presenting depression or anxiety disorders [5]. It is well known that General Practitioners (GPs) only refer approximately 5-10% of the psychiatric patients detected in Primary Care to Mental Health Services [6]. Despite this low referral rate, Mental Health Services in occidental countries are currently congested due to the high prevalence of minor psychiatric problems and this situation is very likely to worsen in the future [7]. Thus, it is of great interest to propose cost-effective alternatives for depression treatment in Primary Care settings which could improve efficacy to standard treatment while tolerability and security levels are sustained.An essential issue regarding this alarming increment of the incidence and prevalence rates of depression is the fact that it seems to be occurring mainly in occidental countries [8,9]. Hence, it is necessary to rapid