AzTrials
AzTrials

Adjustment DisorderSERENATNCT02905071

Validation of a Scale of Well-being at Work

A study testing filling of Serenat at baseline (T1), Serenat at baseline T1 and 3 others questionnaires and filling of Serenat, HADS, STAY-Y and BDI at baseline T1 in people with Adjustment Disorder, run by University Hospital, Lille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Adjustment Disorder
What is being tested?
filling of Serenat at baseline (T1), Serenat at baseline T1 and 3 others questionnaires and filling of Serenat, HADS, STAY-Y and BDI at baseline T1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
1 siteFrance
Study dates
Nov 2013to 26 Nov 2017
Phase
Interventional
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHRU,Hôpital Fontan 2

    Lille

Other trials in France

About this study

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

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).

Being tested
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
Keywords
mental health, well-being at work, screening, psychosocial risk, psychometrics, questionnaire, job stress
Medical subject headings
Adjustment Disorders, Psychological Well-Being, Occupational Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • filling of Serenat at baseline (T1)Other

    Also called filling of Serenat at T1 (baseline)

    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 questionnairesOther

    Also called Serenat and 3 others questionnaires at T1

    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 T1Other

    Also called filling of Serenat at baseline T1 and T2 (one week later)

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

Study groups in NCT02905071
Study groupRoleWhat they receive
Study 1 Group 1 G1 (n =50)Experimentalfilling of Serenat at baseline (T1)
Receives: Other: filling of Serenat at baseline (T1)
Study 1 Group 2 G2 (n=50)ExperimentalSerenat at baseline T1 and 3 others questionnaires
Receives: Other: Serenat at baseline T1 and 3 others questionnaires
Study 1 Group 3 G3 (n =50)Experimentalfilling of Serenat at baseline T1 and T2 (one week after baseline).
Receives: Other: filling of Serenat, HADS, STAY-Y and BDI at baseline T1
Study 2 Ancillary study (n=50)Experimentalfilling of Serenat, HADS, STAY-Y and BDI at baseline T1
Receives: Other: Serenat at baseline T1 and 3 others questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At baseline (T1)

Secondary outcomes (4)

  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.

    Measured: 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.

    Measured: 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

    Measured: At baseline (T1)

  4. The Beck depression inventory (BDI-21)

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

    Measured: At baseline (T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2016 (estimated)
  2. Study startNov 2013
  3. Primary completion26 Nov 2017
  4. Study completion26 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02905071
Sponsor's protocol ID
2012_63
Other IDs
2013-A00831-44
Acronym
SERENAT
Status last verified
Nov 2018
First submitted
14 Sep 2016
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing filling of Serenat at baseline (T1), Serenat at baseline T1 and 3 others questionnaires and filling of Serenat, HADS, STAY-Y and BDI at baseline T1 in people with Adjustment Disorder, run by University Hospital, Lille at 1 site in France.

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 1 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Serenat scale (time frame: At baseline (T1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02905071, which also lists 4 linked publications.

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 22 Dec 2025.

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