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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
242

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gerencia de Atención Primaria, Madrid

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondo de Investigacion Sanitaria
Instituto de Salud Carlos III

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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