NCT03162380

Brief Summary

Bipolar disorder is a mental disorder characterized by alternance of depressive and manic phases, separated by intercritical phases (euthymia). The majority of patients report occupation and professional difficulties. Sixty percent of bipolar patients are inactive . Indeed, according to the World Health Organisation, bipolar disorder is the second cause of days not worked. Several factors are related to the lower professional functioning observed in bipolar patients: early age of onset, delay of diagnosis and treatment, recurrence of thymic episodes, residual symptoms and cognitive disorders during euthymia, side effects of mood stabilizers. To our knowledge, no study has ever focused on well-being at work in French patients. However, suffering from a psychiatric disorder and the lack of support from colleagues and the hierarchy are risk factors for burnout, a growing health issue. Patients with mental illness are often victims of stigmatization, which may involve the professional field. In addition, thymic recurrences may alter professional functioning of active patients: multiplication of work disruptions, conflicts with peers. Conversely work can be stressful, promoting thyic relapses. It is therefore essential to better understand the occupational stresses of active patients suffering from bipolar disorder in order to promote functional remission beyond clinical remission. The aim of this study is to assess the level of stress and well-being at work in active French bipolar patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

October 11, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

May 19, 2017

Last Update Submit

October 10, 2018

Conditions

Keywords

Bipolar Disorderoccupational stress

Outcome Measures

Primary Outcomes (1)

  • Level of occupational stress using a Likert scale

    level of occupational stress assessed at the patient visit will be collected, from 0 (none) to 10 (maximum possible occupational stress).

    1 day

Secondary Outcomes (4)

  • Presenteism during the last month using the Stanford Presenteeism Scale

    1 day

  • Support of colleagues and superiors using the Karasek questionnaire.

    1 day

  • Impact of work on the private sphere using the SWING scale (survey work-home interaction-Nijmegen)

    1 day

  • Balance effort - reward in using the Siegrist questionaire

    1 day

Interventions

Date collection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Bipolar disorder

You may qualify if:

  • out patients and inpatients in the Department of Emergency Psychiatry and Post Acute Care, CHU Montpellier, France
  • to have completed the self-administered questionnaire on professional activity.

You may not qualify if:

  • Deprived of liberty subject (by judicial or administrative decision)
  • Protected by law (guardianship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Bipolar DisorderOccupational Stress

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Emile OLIE, MD, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2017

First Posted

May 22, 2017

Study Start

May 22, 2017

Primary Completion

May 31, 2018

Study Completion

June 30, 2018

Last Updated

October 11, 2018

Record last verified: 2018-09

Locations