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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02325115
Other study ID # 2010-A00212-37
Secondary ID
Status Completed
Phase N/A
First received December 17, 2014
Last updated December 19, 2014
Start date January 2014
Est. completion date October 2014

Study information

Verified date December 2014
Source Hôpital le Vinatier
Contact n/a
Is FDA regulated No
Health authority France: Ethics Committee
Study type Observational

Clinical Trial Summary

Background: Despite current popularity, positive mental health is under researched. This is possibly due to a lack of consensus on appropriate measuresThe Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14 positively phrased Likert-style list of items developed to measure mental well-being. Its validation has been internationally explored. This report presents the French validation of the WEMWBS (F-WEMWBS) in non-clinical and clinical populations.

Methods: Two non-clinical populations comprised of 319 working adults (WORK), and 75 students (STUD), and one clinical population of 121 patients with remitted schizophrenia (PRS) were included in the validation study. Participants completed the F-WEMWBS as well as complementary measures of psychological constructs potentially related to well-being.


Description:

Three different populations participated in the study: two non-clinical populations composed of students (STUD), and working adults (WORK) and one clinical population comprised of patients with remitted schizophrenia (PRS). The STUD population was a convenient sample of 75 first year students (51 females and 24 males); with 45 from a School of Business Management and 30 from a medical university. The WORK population was also a convenient sample of 113 (63 females and 256 males) working adults including 217 soldiers from Paris Fire Brigade, 93 nurses and 9 individuals from a research laboratory. The PRS population was comprised of 121 remitted schizophrenia patients (39 females and 82 males) who were all clients of the rehabilitation centre for psychotic disorders (Le Vinatier hospital), situated in Lyon, France.


Recruitment information / eligibility

Status Completed
Enrollment 515
Est. completion date October 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- For STUD and WORK, there were two criteria to be included in the study: (i) , not undergoing medical treatment for psychological issues at the time of the study and (ii) and not having been part of a stress management program prior to recruitment for the current study.

- For PRS, there were three criteria to be included in the study: (i) a DSM-IVR diagnosis of schizophrenia as confirmed by the Mini International Neuropsychiatric Interview for DSM-IV (MINI; 14); (ii) age between 18 and 65 years; and (iii) being clinically stable (i.e. not having required hospitalization or increases in medication as a result of an exacerbation of acute symptoms over the previous three months).

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Hôpital le Vinatier Australian Catholic University, Fondation de France, Institut de Recherche Biomedicale des Armees, Université d'Auvergne

Outcome

Type Measure Description Time frame Safety issue
Primary Change in The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) Baseline and 2 months Yes
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