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. 2018 Mar 6:9:281.
doi: 10.3389/fpsyg.2018.00281. eCollection 2018.

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  1 , Antonio Cano-Vindel  2 , Roger Muñoz-Navarro  3 , Cristina M Wood  2 , Leonardo A Medrano  4 , Luciana Sofía Moretti  4 ; PsicAP Research Group
Affiliations

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 et al. Front Psychol. .

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.

Keywords: QALYs; cost-utility; emotional disorders; primary care; transdiagnostic cognitive-behavioral therapy.

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Figures

FIGURE 1
FIGURE 1
Flowchart of the study.
See this image and copyright information in PMC

References

    1. Autonomous Community of Madrid (2013). Public prices for the provision of services and activities network health centers of the community of Madrid. Off. Gouv. J. 215 8–30.
    1. Cano-Vindel A. (2011). Bases Teóricas y Apoyo Empírico de la Intervención Psicológica Sobre Los Desórdenes Emocionales en Atención Primaria. Una Actualización [Theoretical and empirically supported psychological interventions for emotional disorders in primary care: an update]. Ansiedad Estres 17 157–184.
    1. Cano-Vindel A., Muñoz-Navarro R., Wood C. M., Limonero J. T., Medrano L. A., Ruiz-Rodríguez P., et al. (2016). Transdiagnostic cognitive behavioral therapy versus treatment as usual in adult patients with emotional disorders in the primary care setting (PsicAP Study): protocol for a randomized controlled trial. JMIR Res. Protoc. 5:e246. 10.2196/resprot.6351 - DOI - PMC - PubMed
    1. Cordero-Andrés P., González-Blanch C., Umaran-Alfageme O., Muñoz-Navarro R., Ruíz-Rodríguez P., Medrano L. A., et al. (2017). Tratamiento psicológico de los trastornos emocionales en atención primaria: fundamentos teóricos y empíricos del estudio PsicAP. Ansiedad Estrés 23 91–98. 10.1016/j.anyes.2017.10.004 - DOI
    1. Diez-Quevedo C., Rangil T., Sanchez-Planell L., Kroenke K., Spitzer R. L. (2001). Validation and utility of the patient health questionnaire in diagnosing mental disorders in 1003 general hospital Spanish inpatients. Psychosom. Med. 63 679–686. 10.1097/00006842-200107000-00021 - DOI - PubMed

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