López García Franco, Albertodel Cura González, Mª IsabelCaballero Martinez, LuisSanz Cuesta, TeresaDíaz García, Marta IsabelRodriguez Monje, Mª TeresaChahua, MarcelaMuñoz Sanchez, InmaculadaSerrano González, DoloresRollán Llanderas, TeresaNieto Blanco, EstherLosada Cucco, LilianaCaballero Martínez, FernandoSanz García, NuriaPose García, BelénJurado Sueiro, MontserratRey, Manuela Luquede Blas González, Francisca GarcíaAbanto, Mª Angeles MiguelBayona, Teresa SanzAyllón Camargo, RafaelaLopez, Inmaculada SantamaríaHernando, María Luisa SantiagoBeltran Alvarez, RosarioAguilar Gutierrez, Ana IsabelMota Rodriguez, Jose LuisCosculluela Pueyo, RafaélLópez Martín Aragón, TeresaBonilla Sanchez, RosaAritieda González Granda, Mª CarmenRazola Rincón, RaquelSánchez de la Ventana, María de los ÁngelesMartinez Guinea, ConcepciónHuerta Galindo, LuisBarrio Ovalle, Ana BelénMiguel Martín, SusanaPortero Fraile, PazPensado Freire, HiginioHerrera Garcia, Mª LuisaAzcoaga Lorenzo, AmayaGómez García, InésLlamas Sandino, NuriaLópez Borja, IsabelMaldonado Castro, HortensiaLumbreras Villarán, PatriciaAscanio Durán, Carlos2025-11-212025-11-212012-05-02Lápez-García-Franco A, Del-Cura-González MI, Caballero-Martinez L, Sanz-Cuesta T, Díaz-García MI, Rodriguez-Monje MT, et al. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: Cluster randomized trial. BMC Family Practice. 2012;13.1471-229610.1186/1471-2296-13-35https://hdl.handle.net/20.500.14352/126342Background 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].engAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/journal article1471-2296https://doi.org/10.1186/1471-2296-13-35https://bmcprimcare.biomedcentral.com/articles/10.1186/1471-2296-13-35open access61Ciencias Biomédicas3299 Otras Especialidades Médicas