Clinical trial NCT01484223: Effectiveness of Cognitive Behavioral Intervention in Patients With Symptoms Somatization in Primary Care
Official title: Efectiveness of a Cognitive Behavioral Intervention in Patients With Symptoms Somatization, as Measure Quality of Life, Front the Clinical Practice Usual Action in Primary Health Care. A Controlled Clinical Trial With Parallel Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: Primary Health Care
Somatization symptoms
Cognitive Behavioral Therapy
Nursing intervention
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Salud Carlos III
name: Fondo de Investigacion Sanitaria
First posted: 2011-12-02
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Attending patients with 2 or more medically unexplained somatic symptoms during the last 6 months.
* 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:

* Diagnostics on serious mental disorder.
* 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.

Primary outcomes:
measure: Perceived quality of life
timeFrame: Change from baseline in quality of life at 12 months after the intervention
Secondary outcomes:
measure: Questionnarie on Global Clinical Impression
timeFrame: Change from baseline in patient and doctor´s perception at 12 months afer the intervention
measure: Number of examinations
timeFrame: Number of examinations from baseline until 12 months after the intervention
measure: Prescribed medicine
timeFrame: Prescribed medicine from baseline until 12 months after the intervention
measure: Temporary labor disability (TLD)
timeFrame: Days on TLD from baseline until 12 months after the intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gerencia Atención Primaria, Madrid.
Study officials:
affiliation: Gerencia Atención Primaria. Madrid
name: Alberto López García-Franco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.