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

Gerencia de Atención Primaria, Madrid242 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

242

Conditions

Quality of Life

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

Four Cognitive behavioral group sessions. Each session will last two hours a week

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Gerencia Atención Primaria, Madrid.

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline in quality of life at 12 months after the intervention

Secondary Outcomes

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.

Time frame: Change from baseline in patient and doctor´s perception at 12 months afer the intervention

Number of examinations

Number of requested and programmed doctor´s examinations during the period of study (itemized between infirmary and medicine)

Time frame: 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

Time frame: Prescribed medicine from baseline until 12 months after the intervention

Temporary labor disability (TLD)

Time frame: Days on TLD from baseline until 12 months after the intervention

Data from ClinicalTrials.gov

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