Effectiveness of Cognitive Behavioral Intervention in Patients With Symptoms Somatization in Primary Care

Gerencia de Atención Primaria, Madrid

Status

Completed

Conditions

Quality of Life

Treatments

Behavioral: Cognitive Behavioral Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01484223

FIS PI08/90707

Details and patient eligibility

About

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.

Full 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.

Enrollment

242 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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