Cost-Effectiveness and Cost-Utility Analysis of the Treatment of Emotional Disorders in Primary Care: PsicAP Clinical Trial. Description of the Sub-study Design.

Paloma Ruiz-Rodríguez,Antonio Cano-Vindel,Luciana Sofía Moretti,Cristina M Wood,Roger Muñoz-Navarro,Leonardo A Medrano

doi:10.3389/fpsyg.2018.00281

Abstract

Introduction: In the primary care (PC) setting in Spain, the prevalence of emotional disorders (EDs) such as anxiety, depression and somatoform disorder is high. In PC patients, these disorders are not always managed in accordance with the recommendations provided by clinical practice guidelines, resulting in major direct and indirect economic costs and suboptimal treatment outcomes. The aim is to analyze and compare the cost-effectiveness and cost-utility of group-based psychological therapy versus treatment as usual (TAU).Methods: Multicenter, randomized controlled trial involving 300 patients recruited from PC centers in Madrid, Spain, with symptoms or possible diagnosis of anxiety, mood (mild or moderate), or somatoform disorders. Patients will be randomized to one of two groups: an experimental group, which will receive group-based transdiagnostic cognitive-behavioral therapy (TD-CBT); and a control group, which will receive TAU (mainly pharmacological interventions) prescribed by their general practitioner (GP). Clinical assessment will be performed with the Patient Health Questionnaire (PHQ). Direct and indirect costs will be calculated and relevant socio-demographic variables will be registered. The Spanish version of the EuroQol 5D-5L will be administered. Patients will be assessed at baseline, immediately after treatment finalization, and at 6 and 12 months post-treatment.Discussion: To our knowledge, this is the first study to compare TD-CBT to TAU in the PC setting in Spain. This is the first comparative economic evaluation of these two treatment approaches in PC. The strength of the study is that it is a multicenter, randomized, controlled trial of psychotherapy and TAU for EDs in PC.Trial registration: Protocol code: ISCRCTN58437086; 20/05/2013. EUDRACT: 2013-001955-11. Protocol Version: 6, 11/01/2014.

Highlights

In the primary care (PC) setting in Spain, the prevalence of emotional disorders (EDs) such as anxiety, depression and somatoform disorder is high
To our knowledge, this is the first study to compare TD-cognitive behavioral treatment (CBT) to treatment as usual (TAU) in the PC setting in Spain
In Spain, the entry point to the health care system is the PC center, and the general practitioner (GP) is the first point of contact with the health care system for most patients in Spain with an ED

Summary

Introduction

In the primary care (PC) setting in Spain, the prevalence of emotional disorders (EDs) such as anxiety, depression and somatoform disorder is high. Emotional disorders (EDs)—especially anxiety, mood, and somatoform disorders—are the most prevalent types of mental disorders in Spain (Haro et al, 2006). According to clinical practice guidelines, medical therapy is not the treatment of choice; rather, for most EDs, the initial treatment recommendation is psychological therapy. Given this tendency in the Spanish system to prescribe medications, it is not surprising that anxiolytic use in Spain is much higher than in other countries. According to a recent report (OECD, 2015), the median DDD of anxiolytics per 1000 inhabitants in Spain was 52.3 doses—double the median rate (22.3 DDD) reported by the OECD

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