Ruiz-Rodríguez Paloma, Cano-Vindel Antonio, Muñoz-Navarro Roger, Wood Cristina M, Medrano Leonardo A, Moretti Luciana Sofía
Castilla La Nueva Primary Care Center, Health Service of Madrid, Madrid, Spain.
Department of Basic Psychology II (Cognitive Processes), Faculty of Psychology, Complutense University of Madrid, Madrid, Spain.
Front Psychol. 2018 Mar 6;9:281. doi: 10.3389/fpsyg.2018.00281. eCollection 2018.
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). 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. 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. Protocol code: ISCRCTN58437086; 20/05/2013. EUDRACT: 2013-001955-11. Protocol Version: 6, 11/01/2014.
在西班牙的基层医疗（PC）环境中，焦虑、抑郁和躯体形式障碍等情绪障碍（EDs）的患病率很高。在基层医疗患者中，这些障碍并不总是按照临床实践指南的建议进行管理，从而导致重大的直接和间接经济成本以及不理想的治疗效果。目的是分析和比较基于团体的心理治疗与常规治疗（TAU）的成本效益和成本效用。这是一项多中心随机对照试验，从西班牙马德里的基层医疗中心招募了300名有焦虑、情绪（轻度或中度）或躯体形式障碍症状或可能诊断的患者。患者将被随机分为两组：实验组接受基于团体的跨诊断认知行为疗法（TD-CBT）；对照组接受其全科医生（GP）开出的常规治疗（主要是药物干预）。将使用患者健康问卷（PHQ）进行临床评估。将计算直接和间接成本，并记录相关的社会人口统计学变量。将使用欧洲五维度健康量表5D-5L的西班牙语版本。将在基线、治疗结束后立即以及治疗后6个月和12个月对患者进行评估。据我们所知，这是西班牙首次在基层医疗环境中将TD-CBT与常规治疗进行比较的研究。这是对基层医疗中这两种治疗方法的首次比较经济评估。该研究的优势在于它是一项针对基层医疗中情绪障碍的心理治疗和常规治疗的多中心、随机、对照试验。方案代码：ISCRCTN58437086；2013年5月20日。欧盟临床试验注册号：2013-001955-11。方案版本：6，2014年1月11日。
