Validation of a Scale of Well-being at Work

Adjustment Disorder Clinical Trial

— SERENAT  

Official title:

Study of the Psychometric Properties of the Scale of Well-being at Work: The Serenat Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905071
• Other study ID #: 2012_63
• Secondary ID: 2013-A00831-44
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: November 26, 2017

Study information

• Verified date: November 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this work is to explore the psychometric properties of scale of well-being at work called "Serenat" in order to validate it. Secondary objectives are to study the influence of socio-demographic characteristics of the subjects on the results of Serenat and to describe the results on subjects monitored among an adult psychiatric population.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: November 26, 2017
• Est. primary completion date: November 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adjustment Disorder
• Adjustment Disorders

Intervention

Other:
• 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.
• 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.
• filling of Serenat, HADS, STAY-Y and BDI at baseline T1
Patients who consult a psychiatrist in a stress anxiety unit complete the 4 questionnaires.

Locations

Country	Name	City	State
France	CHRU,Hôpital Fontan 2	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

References & Publications (3)

Andrea H, Bültmann 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. — View Citation

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. Epub 2007 Apr 4. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serenat scale	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	Serenat scale	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)
Secondary	Hospital Anxiety and Depression Scale (HADS)	For group 2: The scale allows to detect anxiety and depression using 14 items rated from 0-3.	At baseline (T1)
Secondary	State-Trait Anxiety inventory (STAI-Y)	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)
Secondary	The Beck depression inventory (BDI-21)	For Group, Self-assessment questionnaire measuring the severity of depression	At baseline (T1)