NCT01484223

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

2.5 years

First QC Date

November 30, 2011

Last Update Submit

October 10, 2012

Conditions

Quality of Life

Keywords

Primary Health CareSomatization symptomsCognitive Behavioral TherapyNursing intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Questionnarie on Global Clinical Impression

    Change from baseline in patient and doctor´s perception at 12 months afer the intervention

  • Number of examinations

    Number of examinations from baseline until 12 months after the intervention

  • Prescribed medicine

    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

Study Arms (2)

Experimental Group

EXPERIMENTAL

Intervention group: Structured nursing intervention

Behavioral: Cognitive Behavioral Therapy

No intervention

NO INTERVENTION

Control group: conventional intervention or non\_support

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

Four Cognitive behavioral group sessions. Each session will last two hours a week

Also known as: Primary Health Care, Somatization symptoms, Nursing intervention, Quality of life
Experimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerencia Atención Primaria, Madrid.

Madrid, Madrid, Spain

Location

Related Publications (1)

  • Lopez-Garcia-Franco A, del-Cura-Gonzalez MI, Caballero-Martinez L, Sanz-Cuesta T, Diaz-Garcia MI, Rodriguez-Monje MT, Chahua M, Munoz-Sanchez I, Serrano-Gonzalez D, Rollan-Llanderas T, Nieto-Blanco E, Losada-Cucco L, Caballero-Martinez F, Sanz-Garcia N, Pose-Garcia B, Jurado-Sueiro M, Rey ML, de Blas Gonzalez FG, Abanto MA, Bayona TS, Ayllon-Camargo R, Lopez IS, Hernando ML, Beltran-Alvarez R, Aguilar-Gutierrez AI, Mota-Rodriguez JL, Cosculluela-Pueyo R, Lopez-Martin-Aragon T, Bonilla-Sanchez R, Aritieda-Gonzalez-Granda MC, Razola-Rincon R, Sanchez-de-la-Ventana MA, Martinez-Guinea C, Huerta-Galindo L, Barrio-Ovalle AB, Miguel-Martin S, Portero-Fraile P, Pensado-Freire H, Herrera-Garcia ML, Azcoaga-Lorenzo A, Gomez-Garcia I, Llamas-Sandino N, Lopez-Borja I, Maldonado-Castro H, Lumbreras-Villaran P, Ascanio-Duran C. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial. BMC Fam Pract. 2012 May 2;13:35. doi: 10.1186/1471-2296-13-35.

    PMID: 22551252DERIVED

MeSH Terms

Interventions

Cognitive Behavioral TherapyPrimary Health CareMethodsQuality of Life

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesComprehensive Health CarePatient Care ManagementHealth Services AdministrationInvestigative TechniquesHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Alberto López García-Franco, MD

    Gerencia Atención Primaria. Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Epidemiologist

Study Record Dates

First Submitted

November 30, 2011

First Posted

December 2, 2011

Study Start

October 1, 2009

Primary Completion

April 1, 2012

Study Completion

August 1, 2012

Last Updated

October 11, 2012

Record last verified: 2012-10

Locations

ES(1)