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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Quality of Life

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Intervention group: Structured nursing intervention | Behavioral: Cognitive Behavioral Therapy<br>* Four Cognitive behavioral group sessions. Each session will last two hours a week<br>* Other names: Quality of life;|
| No Intervention: No intervention<br>Control group: conventional intervention or non_support | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline in quality of life at 12 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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 | Prescribed medicine from baseline until 12 months after the intervention | 
| Temporary labor disability (TLD) |  | Days on TLD from baseline until 12 months after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Health Care, Somatization symptoms, Cognitive Behavioral Therapy, Nursing intervention