title: Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The trial was registered with ClinicalTrials.gov, number NCT01484223 [http://ClinicalTrials.gov].
authors.affiliation: Centro de Salud Dr Mendiguchia, Leganés, Madrid, Spain. alopez.gapm09@salud.madrid.org
authors.forename: Alberto
authors.initials: A
authors.lastname: López-García-Franco
authors.forename: Ma Isabel
authors.initials: MI
authors.lastname: del-Cura-González
authors.forename: Luis
authors.initials: L
authors.lastname: Caballero-Martinez
authors.forename: Teresa
authors.initials: T
authors.lastname: Sanz-Cuesta
authors.forename: Marta Isabel
authors.initials: MI
authors.lastname: Díaz-García
authors.forename: Ma Teresa
authors.initials: MT
authors.lastname: Rodriguez-Monje
authors.forename: Marcela
authors.initials: M
authors.lastname: Chahua
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Muñoz-Sanchez
authors.forename: Dolores
authors.initials: D
authors.lastname: Serrano-González
authors.forename: Teresa
authors.initials: T
authors.lastname: Rollán-Llanderas
authors.forename: Esther
authors.initials: E
authors.lastname: Nieto-Blanco
authors.forename: Liliana
authors.initials: L
authors.lastname: Losada-Cucco
authors.forename: Fernando
authors.initials: F
authors.lastname: Caballero-Martínez
authors.forename: Nuria
authors.initials: N
authors.lastname: Sanz-García
authors.forename: Belén
authors.initials: B
authors.lastname: Pose-García
authors.forename: Montserrat
authors.initials: M
authors.lastname: Jurado-Sueiro
authors.forename: Manuela Luque
authors.initials: ML
authors.lastname: Rey
authors.forename: Francisca García
authors.initials: FG
authors.lastname: de Blas González
authors.forename: Ma Angeles Miguel
authors.initials: MA
authors.lastname: Abanto
authors.forename: Teresa Sanz
authors.initials: TS
authors.lastname: Bayona
authors.forename: Rafaela
authors.initials: R
authors.lastname: Ayllón-Camargo
authors.forename: Inmaculada Santamaría
authors.initials: IS
authors.lastname: Lopez
authors.forename: María Luisa Santiago
authors.initials: ML
authors.lastname: Hernando
authors.forename: Rosario
authors.initials: R
authors.lastname: Beltran-Alvarez
authors.forename: Ana Isabel
authors.initials: AI
authors.lastname: Aguilar-Gutierrez
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Mota-Rodriguez
authors.forename: Rafaél
authors.initials: R
authors.lastname: Cosculluela-Pueyo
authors.forename: Teresa
authors.initials: T
authors.lastname: López-Martín-Aragón
authors.forename: Rosa
authors.initials: R
authors.lastname: Bonilla-Sanchez
authors.forename: Ma Carmen
authors.initials: MC
authors.lastname: Aritieda-González-Granda
authors.forename: Raquel
authors.initials: R
authors.lastname: Razola-Rincón
authors.forename: Ma Angeles
authors.initials: MA
authors.lastname: Sanchez-de-la-Ventana
authors.forename: Concepción
authors.initials: C
authors.lastname: Martinez-Guinea
authors.forename: Luis
authors.initials: L
authors.lastname: Huerta-Galindo
authors.forename: Ana Belén
authors.initials: AB
authors.lastname: Barrio-Ovalle
authors.forename: Susana
authors.initials: S
authors.lastname: Miguel-Martín
authors.forename: Paz
authors.initials: P
authors.lastname: Portero-Fraile
authors.forename: Higinio
authors.initials: H
authors.lastname: Pensado-Freire
authors.forename: Ma Luisa
authors.initials: ML
authors.lastname: Herrera-Garcia
authors.forename: Amaya
authors.initials: A
authors.lastname: Azcoaga-Lorenzo
authors.forename: Inés
authors.initials: I
authors.lastname: Gómez-García
authors.forename: Nuria
authors.initials: N
authors.lastname: Llamas-Sandino
authors.forename: Isabel
authors.initials: I
authors.lastname: López-Borja
authors.forename: Hortensia
authors.initials: H
authors.lastname: Maldonado-Castro
authors.forename: Patricia
authors.initials: P
authors.lastname: Lumbreras-Villarán
authors.forename: Carlos
authors.initials: C
authors.lastname: Ascanio-Durán
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care / Q000379:methods*; D011615:Psychotherapy, Group / Q000379:methods*; D011788:Quality of Life; D012017:Referral and Consultation / Q000706:statistics & numerical data; D018582:Sick Leave / Q000706:statistics & numerical data; D013001:Somatoform Disorders / Q000628:therapy*; D013030:Spain; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult