NCT02905071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2017

Completed
Last Updated

December 22, 2025

Status Verified

November 1, 2018

Enrollment Period

4.1 years

First QC Date

September 14, 2016

Last Update Submit

December 15, 2025

Conditions

Keywords

mental healthwell-being at workscreeningpsychosocial riskpsychometricsquestionnairejob stress

Outcome Measures

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.

    At baseline (T1)

Secondary Outcomes (4)

  • Serenat scale

    one week after baseline (T2)

  • Hospital Anxiety and Depression Scale (HADS)

    At baseline (T1)

  • State-Trait Anxiety inventory (STAI-Y)

    At baseline (T1)

  • The Beck depression inventory (BDI-21)

    At baseline (T1)

Study Arms (4)

Study 1 Group 1 G1 (n =50)

EXPERIMENTAL

filling of Serenat at baseline (T1)

Other: filling of Serenat at baseline (T1)

Study 1 Group 2 G2 (n=50)

EXPERIMENTAL

Serenat at baseline T1 and 3 others questionnaires

Other: Serenat at baseline T1 and 3 others questionnaires

Study 1 Group 3 G3 (n =50)

EXPERIMENTAL

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

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

Study 2 Ancillary study (n=50)

EXPERIMENTAL

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

Other: Serenat at baseline T1 and 3 others questionnaires

Interventions

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)
Study 1 Group 1 G1 (n =50)

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)
Study 1 Group 3 G3 (n =50)

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
Study 1 Group 2 G2 (n=50)Study 2 Ancillary study (n=50)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU,Hôpital Fontan 2

Lille, France

Location

Related Publications (4)

  • 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.

    PMID: 15300374BACKGROUND
  • 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.

    PMID: 17173201BACKGROUND
  • 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.

    PMID: 17407618BACKGROUND
  • 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.

MeSH Terms

Conditions

Adjustment DisordersPsychological Well-BeingOccupational Stress

Interventions

BaseLine dental cement4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental DisordersPersonal SatisfactionBehaviorOccupational DiseasesStress, PsychologicalBehavioral Symptoms

Study Officials

  • Dominique SERVANT, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 19, 2016

Study Start

November 1, 2013

Primary Completion

November 26, 2017

Study Completion

November 26, 2017

Last Updated

December 22, 2025

Record last verified: 2018-11

Locations