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

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ClinicalTrials.gov Identifier: NCT02414711
Recruitment Status : Completed
First Posted : April 13, 2015
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Other: HSCL25 scale Other: PSE9 questionary Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1128 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Validation of the French Translation of the Scale HSCL25 in the Diagnosis of Depression in Primary Care
Study Start Date : June 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No depressed

If the result of the HSCL25 scale is inferior than 1.75, then the patient is considered as no depressed.

50 of these patients have to have a psychological interview with the PSE9 questionary to validate the result of the HSCL25 scale.

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)

Other: 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

Depressed

If the result of the HSCL25 scale is superior or equal to 1.75, then the patient is considered as depressed.

50 of these patients have to have a psychological interview with the PSE9 questionary to validate the result of the HSCL25 scale.

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)

Other: 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




Primary Outcome Measures :
  1. To validate the French translation of the HSCL25 scale [ Time Frame: 1 month ]
    The score between HSCL25 scale and PSE9 questionary will be compared

  2. To assess the HSCL25 scale diagnosis efficacy of depression in primary care ambulatory practice [ Time Frame: 1 month ]
    The score between HSCL25 scale and PSE9 questionary will be compared



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414711


Locations
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France
Cabinet médical en zone urbaine
Brest, France, 29200
Cabinet médical en zone rurale - Pôle Santé Universitaire
Lanmeur, France, 29620
Cabinet médical en zone semi-rurale
Plounéour Trez, France, 29890
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Patrice NABBE, GP GP department

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02414711     History of Changes
Other Study ID Numbers: HSCL25 Validation
First Posted: April 13, 2015    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Keywords provided by University Hospital, Brest:
Depression
Primary care
General Practitioners
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders