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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Fondo de Investigacion Sanitaria | OTHER |
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The purpose of this study is to evaluate the efectiveness of a behavioral cognitive grupal intervention (BCI) in patients with somatization symptoms which has an effect on the perceived quality of life front conventional intervention.
Aim: to determine whether a cognitive-behavioral group intervention in patients with unexplicated somatic symptoms, that have come to the primary care medical in Madrid, is more effective than normal practice in terms of improving life quality at one year.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Intervention group: Structured nursing intervention |
|
| No intervention | No Intervention | Control group: conventional intervention or non_support |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | Four Cognitive behavioral group sessions. Each session will last two hours a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perceived quality of life | Perceived quality of life: Quality of life measured by SF-12 questionnare on Mental Healthcare Change from baseline in quality of life at 3, 6 and 12 months after the intervention. | Change from baseline in quality of life at 12 months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnarie on Global Clinical Impression | It is used to assess the patient´s(PGI questionnarie) and the doctor´s(CGI questionnarie)perception on the former´s improvement after the interventions have been carried out. It will be undertaken 6 and 12 moths later, so as to assess the effectiveness of the group intervention. | Change from baseline in patient and doctor´s perception at 12 months afer the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto López GarcÃa-Franco, MD | Gerencia Atención Primaria. Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gerencia Atención Primaria, Madrid. | Madrid | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22551252 | Derived | 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. |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D011320 | Primary Health Care |
| D008722 | Methods |
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D003191 | Comprehensive Health Care |
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| Number of examinations | Number of requested and programmed doctor´s examinations during the period of study (itemized between infirmary and medicine) | Number of examinations from baseline until 12 months after the intervention |
| Prescribed medicine | Prescribed medicine during the period of study, with doubtful therapeutic value for their processing, related to the unexplained somatic symptoms. The included medicines are those related to the functional symptomatology | Prescribed medicine from baseline until 12 months after the intervention |
| Temporary labor disability (TLD) | Days on TLD from baseline until 12 months after the intervention |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |