Human CharacteristicsNCT02325115
Validation of the French Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
An observational study of Human Characteristics and Attitude to Health, run by Hôpital le Vinatier.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Characteristics, Attitude to Health
- How many people
- 515 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- -
About this study
Official title: Validation of the French Warwick-Edinburgh Mental Well-being Scale (WEMWBS) in Both Non-clinical and Clinical Populations
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.
Read the detailed 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.
- Conditions
- Human Characteristics, Attitude to Health
- Keywords
- well-being, mental health, schizophrenia, quality of life
- Medical subject headings
- Psychological Well-Being, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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), |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Measured: Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human CharacteristicsStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche Biomedicale des Armees, Fondation de France, Université d'Auvergne, Australian Catholic University
- Responsible party
- Principal investigator, Nicolas FRANCK, Pr, Hôpital le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325115
- Sponsor's protocol ID
- 2010-A00212-37
- Status last verified
- Dec 2014
- First submitted
- 17 Dec 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Warwick-Edinburgh Mental Well-being Scale (WEMWBS) in Both Non-clinical and Clinical Populations
- ClinicalTrials.gov ID
- NCT02325115
- Acronym / sponsor ID
- 2010-A00212-37
- Conditions
- Human Characteristics, Attitude to Health
- Keywords
- well-being, mental health, schizophrenia, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Collaborators
- Institut de Recherche Biomedicale des Armees, Fondation de France, Université d'Auvergne, Australian Catholic University
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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), |
Who may qualify
- Ages
- 18 to 65 years
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
Time frame: Baseline and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Characteristics and Attitude to Health, run by Hôpital le Vinatier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) (time frame: Baseline and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2014.