Effectiveness of Cognitive Behavioral Intervention in Patients With Symptoms Somatization in Primary Care
NCT ID: NCT01484223
Last Updated: 2012-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
242 participants
INTERVENTIONAL
2009-10-31
2012-08-31
Brief Summary
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Detailed Description
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Method:
Design:cluster randomized trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service. unit of randomization are centres.Analysis unit: patients between 18 and 65 years old.
Intervention: The cognitive behavioral grupal Terapy in the internention group and the usual intervention in the control group.
Sample size adjusted for design effect=242 (121 in each arm). Main response variable: preceived quality of life (SF-12).
Data Analysis:comparison of the proportion of patients that improve in 4 or more points in the area of Mental Healthcare from the SF-12 in both groups,at 6 months and 1 year after patient inclusion.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Experimental Group
Intervention group: Structured nursing intervention
Cognitive Behavioral Therapy
Four Cognitive behavioral group sessions. Each session will last two hours a week
No intervention
Control group: conventional intervention or non\_support
No interventions assigned to this group
Interventions
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Cognitive Behavioral Therapy
Four Cognitive behavioral group sessions. Each session will last two hours a week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having came to medical examination on primary care at least 10 times during the last year.
* be able to follow the trial´s demands, not have plans for moving another place and understand the Spanish language.
* Patients who consent to take part.
Exclusion Criteria
* Suicidal intentions at the moment of getting involved in the study.
* Diagnostics on addiction to toxic substances.
* Diagnostics on well-known body illness responsible for the symptoms.
* Previous psychotherapy during the previous year.
18 Years
65 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Fondo de Investigacion Sanitaria
OTHER
Gerencia de Atención Primaria, Madrid
OTHER_GOV
Responsible Party
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Esperanza Escortell
Epidemiologist
Principal Investigators
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Alberto López García-Franco, MD
Role: PRINCIPAL_INVESTIGATOR
Gerencia Atención Primaria. Madrid
Locations
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Gerencia Atención Primaria, Madrid.
Madrid, Madrid, Spain
Countries
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References
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Lopez-Garcia-Franco A, del-Cura-Gonzalez MI, Caballero-Martinez L, Sanz-Cuesta T, Diaz-Garcia MI, Rodriguez-Monje MT, Chahua M, Munoz-Sanchez I, Serrano-Gonzalez D, Rollan-Llanderas T, Nieto-Blanco E, Losada-Cucco L, Caballero-Martinez F, Sanz-Garcia N, Pose-Garcia B, Jurado-Sueiro M, Rey ML, de Blas Gonzalez FG, Abanto MA, Bayona TS, Ayllon-Camargo R, Lopez IS, Hernando ML, Beltran-Alvarez R, Aguilar-Gutierrez AI, Mota-Rodriguez JL, Cosculluela-Pueyo R, Lopez-Martin-Aragon T, Bonilla-Sanchez R, Aritieda-Gonzalez-Granda MC, Razola-Rincon R, Sanchez-de-la-Ventana MA, Martinez-Guinea C, Huerta-Galindo L, Barrio-Ovalle AB, Miguel-Martin S, Portero-Fraile P, Pensado-Freire H, Herrera-Garcia ML, Azcoaga-Lorenzo A, Gomez-Garcia I, Llamas-Sandino N, Lopez-Borja I, Maldonado-Castro H, Lumbreras-Villaran P, Ascanio-Duran C. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial. BMC Fam Pract. 2012 May 2;13:35. doi: 10.1186/1471-2296-13-35.
Other Identifiers
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FIS PI08/90707
Identifier Type: -
Identifier Source: org_study_id