Bipolar DisorderNCT03162380
Occupational Stress and Bipolar Disorder
An observational study of Bipolar Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Date collection
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2017to 30 Jun 2018
- Phase
- Observational
- 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
Study population: Patients with Bipolar disorder
Who may be able to join
- 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.
Who cannot join
- Deprived of liberty subject (by judicial or administrative decision)
- Protected by law (guardianship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Occupational Stress and Well-being in French Patients Suffering From Bipolar Disorder
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.
Read more
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.
Read the detailed description
Socio-demographic, psychiatric and occupational data of 200 bipolar patients will be collected over a period of 6 months.
- Conditions
- Bipolar Disorder
- Being tested
- Date collection
- Keywords
- Bipolar Disorder, occupational stress
- Medical subject headings
- Bipolar Disorder, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Date collectionOther
Date collection
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (4)
Presenteism during the last month using the Stanford Presenteeism Scale
Presenteism during the last month assessed at the patient visit will be collected
Measured: 1 day
Support of colleagues and superiors using the Karasek questionnaire.
Support of colleagues and superiors assessed at the patient visit will be collected
Measured: 1 day
Impact of work on the private sphere using the SWING scale (survey work-home interaction-Nijmegen)
Impact of work on the private sphere assessed at the patient visit will be collected
Measured: 1 day
Balance effort - reward in using the Siegrist questionaire
Balance effort - reward assessed at the patient visit will be collected
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start22 May 2017
- Primary completion31 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emile OLIE, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162380
- Sponsor's protocol ID
- RECHMPL17_0138
- Status last verified
- Sep 2018
- First submitted
- 19 May 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Occupational Stress and Well-being in French Patients Suffering From Bipolar Disorder
- ClinicalTrials.gov ID
- NCT03162380
- Acronym / sponsor ID
- RECHMPL17_0138
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, occupational stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Socio-demographic, psychiatric and occupational data of 200 bipolar patients will be collected over a period of 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Bipolar disorder
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Deprived of liberty subject (by judicial or administrative decision)
- Protected by law (guardianship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Date collectionDate collection | Other | – |
Primary outcome
Level of occupational stress using a Likert scale
Time frame: 1 day
level of occupational stress assessed at the patient visit will be collected, from 0 (none) to 10 (maximum possible occupational stress).
4 secondary outcomes
Presenteism during the last month using the Stanford Presenteeism Scale
Time frame: 1 day
Support of colleagues and superiors using the Karasek questionnaire.
Time frame: 1 day
Impact of work on the private sphere using the SWING scale (survey work-home interaction-Nijmegen)
Time frame: 1 day
Balance effort - reward in using the Siegrist questionaire
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emile OLIE, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by University Hospital, Montpellier 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 2 inclusion and 2 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 11 Oct 2018. 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?
Level of occupational stress using a Likert scale (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2018.