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

Alberto López-García-Franco, Ma Isabel del-Cura-González, Luis Caballero-Martinez, Teresa Sanz-Cuesta, Marta Isabel Díaz-García, Ma Teresa Rodriguez-Monje, Marcela Chahua, Inmaculada Muñoz-Sanchez, Dolores Serrano-González, Teresa Rollán-Llanderas, Esther Nieto-Blanco, Liliana Losada-Cucco, Fernando Caballero-Martínez, Nuria Sanz-García, Belén Pose-García, Montserrat Jurado-Sueiro, Manuela Luque Rey, Francisca García de Blas González, Ma Angeles Miguel Abanto, Teresa Sanz BayonaRafaela Ayllón-Camargo, Inmaculada Santamaría Lopez, María Luisa Santiago Hernando, Rosario Beltran-Alvarez, Ana Isabel Aguilar-Gutierrez, Jose Luis Mota-Rodriguez, Rafaél Cosculluela-Pueyo, Teresa López-Martín-Aragón, Rosa Bonilla-Sanchez, Ma Carmen Aritieda-González-Granda, Raquel Razola-Rincón, Ma Angeles Sanchez-de-la-Ventana, Concepción Martinez-Guinea, Luis Huerta-Galindo, Ana Belén Barrio-Ovalle, Susana Miguel-Martín, Paz Portero-Fraile, Higinio Pensado-Freire, Ma Luisa Herrera-Garcia, Amaya Azcoaga-Lorenzo, Inés Gómez-García, Nuria Llamas-Sandino, Isabel López-Borja, Hortensia Maldonado-Castro, Patricia Lumbreras-Villarán, Carlos Ascanio-Durán

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

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].

Original languageEnglish
Pages (from-to)35
JournalBMC Family Practice
Volume13
DOIs
Publication statusPublished - 2 May 2012

Keywords

  • Adolescent
  • Adult
  • Aged
  • Cognitive Therapy/methods
  • Female
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Primary Health Care/methods
  • Psychotherapy, Group/methods
  • Quality of Life
  • Referral and Consultation/statistics & numerical data
  • Sick Leave/statistics & numerical data
  • Somatoform Disorders/therapy
  • Spain
  • Surveys and Questionnaires
  • Treatment Outcome
  • Young Adult

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