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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484223
• Other study ID #: FIS PI08/90707
• Status: Completed
• Phase: N/A
• First received: November 30, 2011
• Last updated: October 10, 2012
• Start date: October 2009
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Quality of Life

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Four Cognitive behavioral group sessions. Each session will last two hours a week

Locations

Country	Name	City	State
Spain	Gerencia Atención Primaria, Madrid.	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid	Fondo de Investigacion Sanitaria, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Temporary labor disability (TLD)		Days on TLD from baseline until 12 months after the intervention	No