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

Publicated to:Bmc Family Practice. 13 (35): 35- - 2012-05-02 13(35), DOI: 10.1186/1471-2296-13-35

Authors: Lopez-Garcia-Franco, Alberto; Isabel del-Cura-Gonzalez, Ma; Caballero-Martinez, Luis; Sanz-Cuesta, Teresa; Isabel Diaz-Garcia, Marta; Teresa Rodriguez-Monje, Ma; Chahua, Marcela; Munoz-Sanchez, Inmaculada; Serrano-Gonzalez, Dolores; Rollan-Llanderas, Teresa; Nieto-Blanco, Esther; Losada-Cucco, Liliana; Caballero-Martinez, Fernando; Sanz-Garcia, Nuria; Pose-Garcia, Belen; Jurado-Sueiro, Montserrat; Luque Rey, Manuela; de Blas Gonzalez, Francisca Garcia; Miguel Abanto, Ma Angeles; Sanz Bayona, Teresa; Ayllon-Camargo, Rafaela; Santamaria Lopez, Inmaculada; Santiago Hernando, Maria Luisa; Beltran-Alvarez, Rosario; Isabel Aguilar-Gutierrez, Ana; Luis Mota-Rodriguez, Jose; Cosculluela-Pueyo, Rafael; Lopez-Martin-Aragon, Teresa; Bonilla-Sanchez, Rosa; Carmen Aritieda-Gonzalez-Granda, Ma; Razola-Rincon, Raquel; Angeles Sanchez-de-la-Ventana, Ma; Martinez-Guinea, Concepcion; Huerta-Galindo, Luis; Belen Barrio-Ovalle, Ana; Miguel-Martin, Susana; Portero-Fraile, Paz; Pensado-Freire, Higinio; Luisa Herrera-Garcia, Ma; Azcoaga-Lorenzo, Amaya; Gomez-Garcia, Ines; Llamas-Sandino, Nuria; Lopez-Borja, Isabel; Maldonado-Castro, Hortensia; Lumbreras-Villaran, Patricia; Ascanio-Duran, Carlos

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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.

Keywords

AdolescentAdultAgedArticleCognitive therapyControlled clinical trialControlled studyEfficacyFemaleGroup therapyHealthHumanHumansLogistic modelsMaleMedical leaveMethodologyMiddle agedOutcomesPatient referralPrimary health carePrimary-care patientsPsychiatric-consultationPsychotherapy, groupQuality of lifeQuestionnaireQuestionnairesRandomized controlled trialReferral and consultationSick leaveSomatization disorderSomatoform disorderSomatoform disordersSpainStatistical modelStatisticsTherapyTreatment outcomeYoung adult

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Bmc Family Practice due to its progression and the good impact it has achieved in recent years, according to the agency Scopus (SJR), it has become a reference in its field. In the year of publication of the work, 2012, it was in position , thus managing to position itself as a Q1 (Primer Cuartil), in the category Family Practice.

Independientemente del impacto esperado determinado por el canal de difusión, es importante destacar el impacto real observado de la propia aportación.

Según las diferentes agencias de indexación, el número de citas acumuladas por esta publicación hasta la fecha 2025-06-07:

  • WoS: 2
  • Scopus: 2

Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2025-06-07:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 149.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 147 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 2.85.
  • The number of mentions on the social network X (formerly Twitter): 4 (Altmetric).

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.