NCT01484223

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Gerencia de Atención Primaria, Madrid · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Quality of Life

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy	Four Cognitive behavioral group sessions. Each session will last two hours a week

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-04-01
• Completion: 2012-08-01
• First posted: 2011-12-02
• Last updated: 2012-10-11

Locations

1 site across 1 country: Spain