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Open Access Highly Accessed Study protocol

Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

Alberto López-García-Franco1*, Mª Isabel del-Cura-González23, Luis Caballero-Martinez4, Teresa Sanz-Cuesta2, Marta Isabel Díaz-García5, Mª Teresa Rodriguez-Monje6, Marcela Chahua7, Inmaculada Muñoz-Sanchez8, Dolores Serrano-González6, Teresa Rollán-Llanderas9, Esther Nieto-Blanco10, Liliana Losada-Cucco6, Fernando Caballero-Martínez11, Nuria Sanz-García1, Belén Pose-García1, Montserrat Jurado-Sueiro12, Manuela Luque Rey13, Francisca García de Blas González1, Mª Angeles Miguel Abanto13, Teresa Sanz Bayona13, Rafaela Ayllón-Camargo6, Inmaculada Santamaría Lopez6, María Luisa Santiago Hernando12, Rosario Beltran-Alvarez14, Ana Isabel Aguilar-Gutierrez14, Jose Luis Mota-Rodriguez14, Rafaél Cosculluela-Pueyo14, Teresa López-Martín-Aragón13, Rosa Bonilla-Sanchez15, Mª Carmen Aritieda-González-Granda15, Raquel Razola-Rincón15, Mª Angeles Sanchez-de-la-Ventana16, Concepción Martinez-Guinea16, Luis Huerta-Galindo16, Ana Belén Barrio-Ovalle16, Susana Miguel-Martín16, Paz Portero-Fraile16, Higinio Pensado-Freire17, Mª Luisa Herrera-Garcia18, Amaya Azcoaga-Lorenzo1, Inés Gómez-García19, Nuria Llamas-Sandino19, Isabel López-Borja19, Hortensia Maldonado-Castro19, Patricia Lumbreras-Villarán1 and Carlos Ascanio-Durán1

Author Affiliations

1 Centro de Salud Dr Mendiguchia, Leganés, Madrid, Spain

2 Unidad de Apoyo a la investigación, Gerencia de Atención Primaria, Madrid, Spain

3 Facultad de Ciencias de la Salud, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain

4 Hospital Puerta de Hierro, Majadahonda, Madrid, Spain

5 Facultad de psicología, Universidad de Educación a Distancia, Madrid, Spain

6 Centro de Salud M, Ángeles López Gómez, Leganés, Madrid, Spain

7 Escuela Nacional de Sanidad, Instituto de Salud Carlos III, Madrid, Spain

8 Centro de Salud Huerta de los Frailes, Leganés, Madrid, Spain

9 Centro de Salud Maria Jesús Hereza, Leganés, Madrid, Spain

10 Centro de Salud Argüelles, Madrid, Spain

11 Facultad de ciencias biosanitarias, Universidad Francisco de Vitoria, Pozuelo de Alarcón, Madrid, Spain

12 Centro de Salud Castilla la Nueva, Fuenlabrada, Madrid, Spain

13 Centro de Salud Cuzco, Fuenlabrada, Madrid, Spain

14 Centro de Salud Boadilla, Boadilla del Monte, Madrid, Spain

15 Centro de Salud Pozuelo Estación, Pozuelo de Alarcón, Madrid, Spain

16 Centro de Salud Sierra de Guadarrama, Collado Villalba, Madrid, Spain

17 Centro de Salud Francia, Fuenlabrada, Madrid, Spain

18 Centro de Salud Loranca, Fuenlabrada, Madrid, Spain

19 Centro de Salud Valdezarza, Madrid, Spain

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BMC Family Practice 2012, 13:35  doi:10.1186/1471-2296-13-35

Published: 2 May 2012

Abstract

Background

Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services.

Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month.

Methods/design

This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain). The number of patients required is 242 (121 in each arm), all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions) and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.

Discussion

This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity of the symptoms, improve quality of life, and reduce frequency of medical consultations.

Trial registration

The trial was registered with ClinicalTrials.gov, number NCT01484223 [ http://ClinicalTrials.gov webcite].