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Validation of a Scale of Well-being at Work (SERENAT)

Primary Purpose

Adjustment Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
filling of Serenat at baseline (T1)
Serenat at baseline T1 and 3 others questionnaires
filling of Serenat, HADS, STAY-Y and BDI at baseline T1
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Adjustment Disorder focused on measuring mental health, well-being at work, screening, psychosocial risk, psychometrics, questionnaire, job stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHRU,Hôpital Fontan 2

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Study 1 Group 1 G1 (n =50)

Study 1 Group 2 G2 (n=50)

Study 1 Group 3 G3 (n =50)

Study 2 Ancillary study (n=50)

Arm Description

filling of Serenat at baseline (T1)

Serenat at baseline T1 and 3 others questionnaires

filling of Serenat at baseline T1 and T2 (one week after baseline).

filling of Serenat, HADS, STAY-Y and BDI at baseline T1

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Hospital Anxiety and Depression Scale (HADS)
For group 2: The scale allows to detect anxiety and depression using 14 items rated from 0-3.
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
The Beck depression inventory (BDI-21)
For Group, Self-assessment questionnaire measuring the severity of depression

Full Information

First Posted
September 14, 2016
Last Updated
November 12, 2018
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT02905071
Brief Title
Validation of a Scale of Well-being at Work
Acronym
SERENAT
Official Title
Study of the Psychometric Properties of the Scale of Well-being at Work: The Serenat Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
November 26, 2017 (Actual)
Study Completion Date
November 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adjustment Disorder
Keywords
mental health, well-being at work, screening, psychosocial risk, psychometrics, questionnaire, job stress

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study 1 Group 1 G1 (n =50)
Arm Type
Experimental
Arm Description
filling of Serenat at baseline (T1)
Arm Title
Study 1 Group 2 G2 (n=50)
Arm Type
Experimental
Arm Description
Serenat at baseline T1 and 3 others questionnaires
Arm Title
Study 1 Group 3 G3 (n =50)
Arm Type
Experimental
Arm Description
filling of Serenat at baseline T1 and T2 (one week after baseline).
Arm Title
Study 2 Ancillary study (n=50)
Arm Type
Experimental
Arm Description
filling of Serenat, HADS, STAY-Y and BDI at baseline T1
Intervention Type
Other
Intervention Name(s)
filling of Serenat at baseline (T1)
Other Intervention Name(s)
filling of Serenat at T1 (baseline)
Intervention Description
Patients who consult occupational doctor complete the serenat questionnaire.The time taken to complete the serenat scale is about 5 minutes.
Intervention Type
Other
Intervention Name(s)
Serenat at baseline T1 and 3 others questionnaires
Other Intervention Name(s)
Serenat and 3 others questionnaires at T1
Intervention Description
Subjects who consult occupational doctor complete the 4 questionnaires.The time taken to complete the 4 questionnaires is about 15 minutes.
Intervention Type
Other
Intervention Name(s)
filling of Serenat, HADS, STAY-Y and BDI at baseline T1
Other Intervention Name(s)
filling of Serenat at baseline T1 and T2 (one week later)
Intervention Description
Patients who consult a psychiatrist in a stress anxiety unit complete the 4 questionnaires.
Primary Outcome Measure Information:
Title
Serenat scale
Description
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.
Time Frame
At baseline (T1)
Secondary Outcome Measure Information:
Title
Serenat scale
Description
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.
Time Frame
one week after baseline (T2)
Title
Hospital Anxiety and Depression Scale (HADS)
Description
For group 2: The scale allows to detect anxiety and depression using 14 items rated from 0-3.
Time Frame
At baseline (T1)
Title
State-Trait Anxiety inventory (STAI-Y)
Description
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
Time Frame
At baseline (T1)
Title
The Beck depression inventory (BDI-21)
Description
For Group, Self-assessment questionnaire measuring the severity of depression
Time Frame
At baseline (T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique SERVANT, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU,Hôpital Fontan 2
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15300374
Citation
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.
Results Reference
background
PubMed Identifier
17173201
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. doi: 10.5271/sjweh.1050.
Results Reference
background
PubMed Identifier
17407618
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. doi: 10.1017/S0033291707000414. Epub 2007 Apr 4.
Results Reference
background
PubMed Identifier
31262608
Citation
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.
Results Reference
derived

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Validation of a Scale of Well-being at Work

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