Validation of the Spanish Version of the Clinically Useful Depression Outcome Scale (CUDOS) Scale (CUDOS)

December 5, 2011 updated by: AstraZeneca

Psychometric Validation of the Spanish Version of the CUDOS Scale (Clinically Useful Depression Outcome Scale) in Major Depressive Disorder

The Clinically Useful Depression Outcome Scale (CUDOS) is a brief, self-administered instrument that not only evaluates depressive symptoms but also both functioning and quality of life. The assessment of patients´ perspective may provide valuable information that could be lost if relaying only on clinician evaluation. The purpose of this study is to achieve a psychometric validation into Spanish of the CUDOS scale in patients with major depression disorder in a primary care setting.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

330

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
      • A Coruña, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Cadiz, Spain
        • Research Site
      • Cordoba, Spain
        • Research Site
      • El Vendrell, Spain
        • Research Site
      • Granada, Spain
        • Research Site
      • Huelva, Spain
        • Research Site
      • Lugo, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Majadahonda, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
      • Nigran, Spain
        • Research Site
      • Palma Mallorca, Spain
        • Research Site
      • Salamanca, Spain
        • Research Site
      • Terrasa, Spain
        • Research Site
      • Tudela, Spain
        • Research Site
      • Vigo, Spain
        • Research Site

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  • Major depression disorder diagnosis according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria in the last 3 months
  • Major depression disorder diagnosis according to Prime-MD criteria in the last 3 months

Exclusion Criteria:

  • Be unable to understand and comply with the study requirements as judged by the investigator
  • Participation in another trial prior to enrolment into this study

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

Cohorts and Interventions

Group / Cohort
Major Depressive Disorder Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically Useful Depression Outcome Scale
Time Frame: up to 12 weeks after a diagnoses of a major depressive disorder
To analyze feasibility and reliability (internal consistency - Cronbach´s alpha) of the Spanish version of the scale
up to 12 weeks after a diagnoses of a major depressive disorder

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Depression Rating Scale
Time Frame: up to 12 weeks after a diagnoses of a major depressive disorder
To analyze convergent validity of the Spanish version of the CUDOS scale
up to 12 weeks after a diagnoses of a major depressive disorder
SF 36
Time Frame: up to 12 weeks after a diagnoses of a major depressive disorder
To analyze correlation in quality of life -item 18 of the CUDOS scale
up to 12 weeks after a diagnoses of a major depressive disorder
Patient Global Impression Scale
Time Frame: up to 12 weeks after a diagnoses of a major depressive disorder
To analyze criterion validity of the Spanish version of the CUDOS scale
up to 12 weeks after a diagnoses of a major depressive disorder
Social Occupational Functioning Scale
Time Frame: up to 12 weeks after a diagnoses of a major depressive disorder
To analyze correlation in functioning -item 17 of the CUDOS scale
up to 12 weeks after a diagnoses of a major depressive disorder
Clinically Global Impression Scale
Time Frame: up to 12 weeks after a diagnoses of a major depressive disorder
To analyze criterion validity of the Spanish version of the CUDOS scale
up to 12 weeks after a diagnoses of a major depressive disorder

Collaborators and Investigators

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

Sponsor

AstraZeneca

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

June 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

May 16, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (Estimate)

May 25, 2011

Study Record Updates

Last Update Posted (Estimate)

December 6, 2011

Last Update Submitted That Met QC Criteria

December 5, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NES-XXX-2011/1

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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