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CompletedNCT02905071SERENATUpdated Dec 22, 2025

Validation of a Scale of Well-being at Work

An interventional study of filling of Serenat at baseline (T1) and Serenat at baseline T1 and 3 others questionnaires in Adjustment Disorder, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Nov 2013, registered Sep 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
226
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Adjustment Disorder

Keywords

  • mental health
  • well-being at work
  • screening
  • psychosocial risk
  • psychometrics
  • questionnaire
  • job stress
03

In context

Adjustment Disorders

63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.

This study's enrollment of 226 is above the median of 100 across 52 interventional studies indexed under Adjustment Disorders.

Browse Adjustment Disorders studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Browse University Hospital, Lille studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
226 participants (actual)

Study arms

  • Experimental
    Study 1 Group 1 G1 (n =50)

    filling of Serenat at baseline (T1)

    Other: filling of Serenat at baseline (T1)

  • Experimental
    Study 1 Group 2 G2 (n=50)

    Serenat at baseline T1 and 3 others questionnaires

    Other: Serenat at baseline T1 and 3 others questionnaires

  • Experimental
    Study 1 Group 3 G3 (n =50)

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

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

  • Experimental
    Study 2 Ancillary study (n=50)

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

    Other: Serenat at baseline T1 and 3 others questionnaires

Interventions

  • Otherfilling 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.

    Also known as: filling of Serenat at T1 (baseline)

  • OtherSerenat 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.

    Also known as: Serenat and 3 others questionnaires at T1

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

    Patients who consult a psychiatrist in a stress anxiety unit complete the 4 questionnaires.

    Also known as: filling of Serenat at baseline T1 and T2 (one week later)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline (T1)

Secondary outcomes

  1. 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.

    Time frame: one week after baseline (T2)

  2. Hospital Anxiety and Depression Scale (HADS)

    For group 2: The scale allows to detect anxiety and depression using 14 items rated from 0-3.

    Time frame: At baseline (T1)

  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

    Time frame: At baseline (T1)

  4. The Beck depression inventory (BDI-21)

    For Group, Self-assessment questionnaire measuring the severity of depression

    Time frame: At baseline (T1)

07

Study locations

1 site
  • CHRU,Hôpital Fontan 2
    Lille, France
08

References and documents

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. PubMed 15300374 ↗
  • 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. PubMed 17173201 ↗
  • 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. PubMed 17407618 ↗
  • 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. PubMed 31262608 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2013 to primary completion in Nov 2017, 48 months.

Of 25 interventional studies with no phase under Adjustment Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's 48 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2016
First posted
Sep 19, 2016
StartActual
Nov 2013
Primary completionActual
Nov 26, 2017
CompletionActual
Nov 26, 2017
Last update
Dec 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02905071
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Sep 19, 2016
Start date
Nov 2013
Primary completion
Nov 26, 2017
Completion
Nov 26, 2017
Last update
Dec 22, 2025

Study contacts

Dominique SERVANT, MD, PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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