- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02905071
Validation of a Scale of Well-being at Work (SERENAT)
Study of the Psychometric Properties of the Scale of Well-being at Work: The Serenat Study
Study Overview
Status
Conditions
Detailed Description
This is a cross sectional survey. 200 subjects were selected among people having consulted an occupational doctor to validate the scale in the general population (study 1), and 50 subjects among a psychiatric population for the ancillary study (study 2).
The Serenat Scale is a self-report questionnaire composed of 20 items. All items are scored on a four point Likert scale ranging from 0 (strongly disagree) to 3 (strongly agree) resulting in a range of 0 to 60. The 20 items are related to different domains. 10 items explore psychological balance at work: relaxation (item 1), sleep quality (item 2), concentration (item 3), form (item 4), sense of security (item 5), satisfaction (item 6), quality of relationships and contacts at work (item 7), voltage or aggressiveness (item 8), optimism for the future from a professional point of view (item 9), life balance (item 10). 10 items are related to working conditions and organization of work: comfort of the working environment (item 11), time constraint (item 12), sense of competence (item 13), decision latitude (item 14), interest at work and variety of tasks (item 15), recognition (item 16), professional support (item 17), communication and transfer of information (item 18), human conflict (item 19), satisfactory work schedules (item 20).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lille, France
- CHRU,Hôpital Fontan 2
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- agree to participate, exert a professional activity for at least 3 months at the time of inclusion, consult an occupational doctor or go to consultations related to stress and anxiety, read and be able to respond to the scale,
Exclusion Criteria:
- not be acting on work stoppage, nor pregnant, be capable of consent, not benefit from any legal protection regime and not be deprived of freedom.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study 1 Group 1 G1 (n =50)
filling of Serenat at baseline (T1)
|
Patients who consult occupational doctor complete the serenat questionnaire.The time taken to complete the serenat scale is about 5 minutes.
Other Names:
|
Experimental: Study 1 Group 2 G2 (n=50)
Serenat at baseline T1 and 3 others questionnaires
|
Subjects who consult occupational doctor complete the 4 questionnaires.The time taken to complete the 4 questionnaires is about 15 minutes.
Other Names:
|
Experimental: Study 1 Group 3 G3 (n =50)
filling of Serenat at baseline T1 and T2 (one week after baseline).
|
Patients who consult a psychiatrist in a stress anxiety unit complete the 4 questionnaires.
Other Names:
|
Experimental: Study 2 Ancillary study (n=50)
filling of Serenat, HADS, STAY-Y and BDI at baseline T1
|
Subjects who consult occupational doctor complete the 4 questionnaires.The time taken to complete the 4 questionnaires is about 15 minutes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serenat scale
Time Frame: At baseline (T1)
|
For Group 1, Group 2, Group 3: The Serenat Scale is a self-report questionnaire composed of 20 items.
All items are scored on a four point Likert scale ranging from 0 (strongly disagree) to 3 (strongly agree) resulting in a range of 0 to 60.
The 20 items are related to different domains.
10 items explore psychological balance at work. 10 items are related to working conditions and organization of work.
|
At baseline (T1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serenat scale
Time Frame: one week after baseline (T2)
|
For Group 3: The Serenat Scale is a self-report questionnaire composed of 20 items.
All items are scored on a four point Likert scale ranging from 0 (strongly disagree) to 3 (strongly agree) resulting in a range of 0 to 60.
The 20 items are related to different domains.
10 items explore psychological balance at work. 10 items are related to working conditions and organization of work.
|
one week after baseline (T2)
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: At baseline (T1)
|
For group 2: The scale allows to detect anxiety and depression using 14 items rated from 0-3.
|
At baseline (T1)
|
State-Trait Anxiety inventory (STAI-Y)
Time Frame: At baseline (T1)
|
For Group: Self-administered questionnaire of 20 items side on 4 levels from 'not at all' to one side "many" side 4 (total score of 20-80).
It measures an intensity of more anxiety and is not related to an anxiety disorder
|
At baseline (T1)
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The Beck depression inventory (BDI-21)
Time Frame: At baseline (T1)
|
For Group, Self-assessment questionnaire measuring the severity of depression
|
At baseline (T1)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dominique SERVANT, MD, PhD, University Hospital, Lille
Publications and helpful links
General Publications
- Andrea H, Bultmann U, Beurskens AJ, Swaen GM, van Schayck CP, Kant IJ. Anxiety and depression in the working population using the HAD Scale--psychometrics, prevalence and relationships with psychosocial work characteristics. Soc Psychiatry Psychiatr Epidemiol. 2004 Aug;39(8):637-46. doi: 10.1007/s00127-004-0797-6.
- Stansfeld S, Candy B. Psychosocial work environment and mental health--a meta-analytic review. Scand J Work Environ Health. 2006 Dec;32(6):443-62. doi: 10.5271/sjweh.1050.
- Melchior M, Caspi A, Milne BJ, Danese A, Poulton R, Moffitt TE. Work stress precipitates depression and anxiety in young, working women and men. Psychol Med. 2007 Aug;37(8):1119-29. doi: 10.1017/S0033291707000414. Epub 2007 Apr 4.
- Servant D, Drumez E, Raynal S, Demarty AL, Salembier A, Deschepper MH, Bizet MA, Pisanu-Zimny A, Culem JB, Labreuche J, Duhamel A, Vaiva G. [Elaboration and psychometric properties of a well-being scale at work. The Serenat study among employees in occupational medicine unit]. Rev Epidemiol Sante Publique. 2019 Sep;67(5):303-309. doi: 10.1016/j.respe.2019.05.011. Epub 2019 Jun 28. French.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012_63
- 2013-A00831-44 (Other Identifier: ID-RDB number, ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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