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

Study Overview
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Brief Summary
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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.

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

Conditions
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Unipolar Depression

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Major Depressive Disorder Patients<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Useful Depression Outcome Scale | 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 | 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 | 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 | 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 | 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 | To analyze criterion validity of the Spanish version of the CUDOS scale | up to 12 weeks after a diagnoses of a major depressive disorder | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychometric validation, major depressive disorder, patient-reported outcome