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

This study has been completed.
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Esperanza Escortell, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier:
NCT01484223
First received: November 30, 2011
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Quality of Life
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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

Further study details as provided by Gerencia de Atención Primaria, Madrid:

Primary Outcome Measures:
  • Perceived quality of life [ Time Frame: Change from baseline in quality of life at 12 months after the intervention ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Questionnarie on Global Clinical Impression [ Time Frame: Change from baseline in patient and doctor´s perception at 12 months afer the intervention ] [ Designated as safety issue: No ]
    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.

  • Number of examinations [ Time Frame: Number of examinations from baseline until 12 months after the intervention ] [ Designated as safety issue: No ]
    Number of requested and programmed doctor´s examinations during the period of study (itemized between infirmary and medicine)

  • Prescribed medicine [ Time Frame: Prescribed medicine from baseline until 12 months after the intervention ] [ Designated as safety issue: No ]
    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

  • Temporary labor disability (TLD) [ Time Frame: Days on TLD from baseline until 12 months after the intervention ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: October 2009
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Primary Health Care
  • Somatization symptoms
  • Nursing intervention
  • Cognitive behavioral therapy
  • Quality of life
No Intervention: No intervention
Control group: conventional intervention or non_support

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484223

Locations
Spain
Gerencia Atención Primaria, Madrid.
Madrid, Spain
Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
Instituto de Salud Carlos III
Fondo de Investigacion Sanitaria
Investigators
Principal Investigator: Alberto López García-Franco, MD Gerencia Atención Primaria. Madrid
  More Information

No publications provided by Gerencia de Atención Primaria, Madrid

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Esperanza Escortell, Epidemiologist, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier: NCT01484223     History of Changes
Other Study ID Numbers: FIS PI08/90707
Study First Received: November 30, 2011
Last Updated: October 10, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Gerencia de Atención Primaria, Madrid:
Primary Health Care
Somatization symptoms
Cognitive Behavioral Therapy
Nursing intervention

ClinicalTrials.gov processed this record on July 23, 2014