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

BMC Family Practice

Study Protocol

Esther Nieto-Blanco¹  Rafaél Cosculluela-Pueyo²  Rosario Beltran-Alvarez²  Jose Luis Mota-Rodriguez²  Ana Isabel Aguilar-Gutierrez²  María Luisa Santiago Hernando³  Montserrat Jurado-Sueiro³  Mª Angeles Miguel Abanto⁴  Teresa López-Martín-Aragón⁴  Manuela Luque Rey⁴  Teresa Sanz Bayona⁴  Carlos Ascanio-Durán⁵  Patricia Lumbreras-Villarán⁵  Amaya Azcoaga-Lorenzo⁵  Belén Pose-García⁵  Nuria Sanz-García⁵  Francisca García de Blas González⁵  Alberto López-García-Franco⁵  Higinio Pensado-Freire⁶  Inmaculada Muñoz-Sanchez⁷  Mª Luisa Herrera-Garcia⁸  Mª Teresa Rodriguez-Monje⁹  Rafaela Ayllón-Camargo⁹  Dolores Serrano-González⁹  Liliana Losada-Cucco⁹  Inmaculada Santamaría Lopez⁹  Teresa Rollán-Llanderas^1,10  Rosa Bonilla-Sanchez^1,11  Mª Carmen Aritieda-González-Granda^1,11  Raquel Razola-Rincón^1,11  Susana Miguel-Martín^1,12  Ana Belén Barrio-Ovalle^1,12  Luis Huerta-Galindo^1,12  Concepción Martinez-Guinea^1,12  Mª Angeles Sanchez-de-la-Ventana^1,12  Paz Portero-Fraile^1,12  Inés Gómez-García^1,13  Nuria Llamas-Sandino^1,13  Isabel López-Borja^1,13  Hortensia Maldonado-Castro^1,13  Marcela Chahua^1,14  Fernando Caballero-Martínez^1,15  Marta Isabel Díaz-García^1,16  Luis Caballero-Martinez^1,17  Teresa Sanz-Cuesta^1,18  Mª Isabel del-Cura-González^1,19 

[1] Centro de Salud Argüelles, Madrid, Spain;Centro de Salud Boadilla, Boadilla del Monte, Madrid, Spain;Centro de Salud Castilla la Nueva, Fuenlabrada, Madrid, Spain;Centro de Salud Cuzco, Fuenlabrada, Madrid, Spain;Centro de Salud Dr Mendiguchia, Leganés, Madrid, Spain;Centro de Salud Francia, Fuenlabrada, Madrid, Spain;Centro de Salud Huerta de los Frailes, Leganés, Madrid, Spain;Centro de Salud Loranca, Fuenlabrada, Madrid, Spain;Centro de Salud M, Ángeles López Gómez, Leganés, Madrid, Spain;Centro de Salud Maria Jesús Hereza, Leganés, Madrid, Spain;Centro de Salud Pozuelo Estación, Pozuelo de Alarcón, Madrid, Spain;Centro de Salud Sierra de Guadarrama, Collado Villalba, Madrid, Spain;Centro de Salud Valdezarza, Madrid, Spain;Escuela Nacional de Sanidad, Instituto de Salud Carlos III, Madrid, Spain;Facultad de ciencias biosanitarias, Universidad Francisco de Vitoria, Pozuelo de Alarcón, Madrid, Spain;Facultad de psicología, Universidad de Educación a Distancia, Madrid, Spain;Hospital Puerta de Hierro, Majadahonda, Madrid, Spain;Unidad de Apoyo a la investigación, Gerencia de Atención Primaria, Madrid, Spain;Unidad de Apoyo a la investigación, Gerencia de Atención Primaria, Madrid, Spain;Facultad de Ciencias de la Salud, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain;

关键词: Primary Care;    Irritable Bowel Syndrome;    Sickness Absence;    Routine Clinical Practice;    Somatic Symptom;   

DOI  :  10.1186/1471-2296-13-35

 received in 2011-12-23, accepted in 2012-05-02,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundMedically 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/designThis 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.DiscussionThis 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 registrationThe trial was registered with ClinicalTrials.gov, number NCT01484223 [http://ClinicalTrials.gov].

【 授权许可】

Unknown   
© Lopez-García-Franco et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.