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

October 10, 2012 updated by: Esperanza Escortell, Gerencia de Atención Primaria, Madrid

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Gerencia Atención Primaria, Madrid.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Intervention group: Structured nursing intervention
Behavioral: Cognitive Behavioral Therapy
Four Cognitive behavioral group sessions. Each session will last two hours a week
Other Names:
  • Quality of life
  • Primary Health Care
  • Somatization symptoms
  • Nursing intervention
No Intervention: No intervention
Control group: conventional intervention or non_support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived quality of life
Time Frame: Change from baseline in quality of life at 12 months after the intervention
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
Time Frame: Change from baseline in patient and doctor´s perception at 12 months afer the intervention
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
Time Frame: Number of examinations from baseline until 12 months after the intervention
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
Time Frame: Prescribed medicine from baseline until 12 months after the intervention
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)
Time Frame: Days on TLD from baseline until 12 months after the intervention
Days on TLD from baseline until 12 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerencia de Atención Primaria, Madrid

Collaborators

Fondo de Investigacion Sanitaria
Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Alberto López García-Franco, MD, Gerencia Atención Primaria. Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

November 30, 2011

First Submitted That Met QC Criteria

December 1, 2011

First Posted (Estimate)

December 2, 2011

Study Record Updates

Last Update Posted (Estimate)

October 11, 2012

Last Update Submitted That Met QC Criteria

October 10, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FIS PI08/90707

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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