Quality of Life Clinical Trial
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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