NCT02325115

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
515

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
Last Updated

December 24, 2014

Status Verified

December 1, 2014

Enrollment Period

1 month

First QC Date

December 17, 2014

Last Update Submit

December 19, 2014

Conditions

Keywords

well-being, mental health, schizophrenia, quality of life

Outcome Measures

Primary Outcomes (1)

  • Change in The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)

    Baseline and 2 months

Study Arms (3)

students (STUD)

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.

working adults (WORK)

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.

remitted schizophrenia (PRS)

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),

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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).

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-BeingSchizophrenia

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 24, 2014

Study Start

January 1, 2014

Primary Completion

February 1, 2014

Study Completion

October 1, 2014

Last Updated

December 24, 2014

Record last verified: 2014-12