Validation of the French Translation of the Scale HSCL25 in the Diagnosis of Depression in Primary Care

Depression Clinical Trial

— HSCL25  

Official title:

Validation of the French Translation of the Scale HSCL25 in the Diagnosis of Depression in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414711
• Other study ID #: HSCL25 Validation
• Status: Completed
• Phase: N/A
• First received: March 19, 2015
• Last updated: January 11, 2017
• Start date: June 2015
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Depression has emotional consequences, social and important business. Reaching at least 7.5% of French aged 15 to 85 years. General Practitioners are the first professional consulted in terms of frequency of consultations. Indeed, in primary care, 10 to 25% of patients with depression that General Practitioners are often alone to support and follow. But General Practitioners are faced with diagnostic difficulties facing the diagnosis of depression, because if the patient does not engage itself, no tool is validated in France to help them in their diagnosis. However, standardized questionary exist that allow to overcome this difficulty. Questionary used in other european countries. Among them, the HSCL25 scale was selected by a systematic review of literature and a RAND UCLA type of consensus procedure. This HSCL25 scale is the most efficient for the diagnosis of depression in terms of efficiency tool, reproducibility and ergonomics. However, it remains necessary to confirm its validity in terms of the French translation and in terms of efficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1128
• Est. completion date: October 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (18 and over) consultant in primary care

Exclusion Criteria:

• Child or young person under 18

• Women with a declared pregnancy to prevent puerperal depression whose support is different.

• Adult consultant to obtain a medical certificate

• Psychotic patients and\or requiring immediate care

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• HSCL25 scale
The patient must answer to 25 questions of the HSCL25 scale. In function of the results, the patients was diagnosed depressed (=1.75) or not depressed (<1.75)
• PSE9 questionary
On the 900 patients recruited, 50 patients who was diagnosed depressed or no depressed have to have a psychological interview with the PSE9 questionary to validate the first diagnosis done by the HSCL25 scale

Locations

Country	Name	City	State
France	Cabinet médical en zone urbaine	Brest
France	Cabinet médical en zone rurale - Pôle Santé Universitaire	Lanmeur
France	Cabinet médical en zone semi-rurale	Plounéour Trez

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To validate the French translation of the HSCL25 scale	The score between HSCL25 scale and PSE9 questionary will be compared	1 month	No
Primary	To assess the HSCL25 scale diagnosis efficacy of depression in primary care ambulatory practice	The score between HSCL25 scale and PSE9 questionary will be compared	1 month	No