BurnoutNCT01959750
Psychological Intervention on Burnout in ICU Caregivers
A study testing problem-based sessions in people with Burnout and Anxiety, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
ICU caregivers face up to a demanding job with a high level of technical skills, a stressful environment, and a heavy work load. They run a high risk of developing burnout that can impact on their welfare, performance, and patient care. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Anxiety, Depression
- What is being tested?
- problem-based sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2009to Sep 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all ICU caregivers rrom the University Hospital of Geneva
Who cannot join
- refusals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Intervention on Burnout in ICU Caregivers: a Randomised Controlled Study
ICU caregivers face up to a demanding job with a high level of technical skills, a stressful environment, and a heavy work load. They run a high risk of developing burnout that can impact on their welfare, performance, and patient care. Burnout favours absenteeism and staff quitting their jobs, whereas the shortage of ICU caregivers already started. No randomised controlled intervention aimed at reducing such distresses had been run until now.
This study allowed finding a new method of psychological support applicable in the special environment of ICU. Our findings suggest that psychologists specifically assigned to treat ICU caregivers might be beneficial on their burnout.
- Conditions
- Burnout, Anxiety, Depression
- Being tested
- problem-based sessions
- Medical subject headings
- Burnout, Psychological, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
problem-based sessionsBehavioural
weekly sessions for small groups of caregivers, led by two psychologists acting as moderators and using a systemic approach, as suggested in other peer-support groups using a problem-based method
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: problem-based sessions |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the changes in the levels of anxiety, depression, and burnout in nurses and nursing auxiliaries.
Anxiety (HA) and depression (HD) were identified by the validated French version of the Hospital Anxiety and Depression Scale (HADS), which is composed of 14 items, self-rated using a 4-point Likert scale (0 to 3). The sub-scale scores of anxiety and depression range respectively from 0 to 7 (no distress), 8 to 10 (borderline), 11 to 15 (significant) and 16 to 21 (severe distress).
Burnout was evaluated using the Maslach Burnout Inventory (MBI) in its Fontaine French version; it is composed of 22 questions on a 7-point Likert scale (0 to 6). This tool measures the 3 dimensions of burnout independently: emotional exhaustion, depersonalisation, and personal accomplishment. Scores of ≥ 27, ≥ 10, or ≤33 respectively for the 3 dimensions, can be a sign of burnout. A severe burnout can also be defined as the cumulated score of MBI of > -9.
Measured: At the beginning , at the end and 6 months after the end of the intervention.
Secondary outcomes (1)
Composite measurement of the changes of ICU activity and absenteeism before, during, just after and six months after the intervention.
ICU activities and absenteeism were analysed during 4 three-month time periods, i.e. 3 months before [Before] (January to March 2009), 3 months during [During] (randomly picked out as September and November 2009, and January 2010), 3 months following the end of the intervention [After] (April to June 2010) and from 7 to 10 months after intervention [At 6 months] (November, December 2010 and January 2011). Absenteeism was defined as the number of caregivers absent at least once per time period, independently of the duration of the absence.
Measured: 4 three-months time periods (cf. Description).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Bara RICOU, University Hospital, Geneva
- Investigators
- Bara Ricou, Professor, Study director, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959750
- Sponsor's protocol ID
- CER 08-220 (NAC08-069)
- Status last verified
- Oct 2013
- First submitted
- 23 Sep 2013
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Intervention on Burnout in ICU Caregivers: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT01959750
- Acronym / sponsor ID
- CER 08-220 (NAC08-069)
- Conditions
- Burnout, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Oct 2013 (estimated)
- 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.
ICU caregivers face up to a demanding job with a high level of technical skills, a stressful environment, and a heavy work load. They run a high risk of developing burnout that can impact on their welfare, performance, and patient care. Burnout favours absenteeism and staff quitting their jobs, whereas the shortage of ICU caregivers already started. No randomised controlled intervention aimed at reducing such distresses had been run until now.
This study allowed finding a new method of psychological support applicable in the special environment of ICU. Our findings suggest that psychologists specifically assigned to treat ICU caregivers might be beneficial on their burnout.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: problem-based sessions |
| Control Group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all ICU caregivers rrom the University Hospital of Geneva
Key exclusion criteria (1 listed)
- refusals
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 |
|---|---|---|
| problem-based sessionsweekly sessions for small groups of caregivers, led by two psychologists acting as moderators and using a systemic approach, as suggested in other peer-support groups using a problem-based method | Behavioural | Intervention Group |
Primary outcome
Measurement of the changes in the levels of anxiety, depression, and burnout in nurses and nursing auxiliaries.
Time frame: At the beginning , at the end and 6 months after the end of the intervention.
Anxiety (HA) and depression (HD) were identified by the validated French version of the Hospital Anxiety and Depression Scale (HADS), which is composed of 14 items, self-rated using a 4-point Likert scale (0 to 3). The sub-scale scores of anxiety and depression range respectively from 0 to 7 (no distress), 8 to 10 (borderline), 11 to 15 (significant) and 16 to 21 (severe distress). Burnout was evaluated using the Maslach Burnout Inventory (MBI) in its Fontaine French version; it is composed of 22 questions on a 7-point Likert scale (0 to 6). This tool measures the 3 dimensions of burnout independently: emotional exhaustion, depersonalisation, and personal accomplishment. Scores of ≥ 27, ≥ 10, or ≤33 respectively for the 3 dimensions, can be a sign of burnout. A severe burnout can also be defined as the cumulated score of MBI of > -9.
1 secondary outcome
Composite measurement of the changes of ICU activity and absenteeism before, during, just after and six months after the intervention.
Time frame: 4 three-months time periods (cf. Description).
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 10 Oct 2013.
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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.
Bara Ricou, Professor study director
University Hospitals of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing problem-based sessions in people with Burnout and Anxiety, run by University Hospital, Geneva at 1 site in Switzerland.
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 10 Oct 2013. 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 Switzerland. 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?
Measurement of the changes in the levels of anxiety, depression, and burnout in nurses and nursing auxiliaries. (time frame: At the beginning , at the end and 6 months after the end of the intervention.). 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 10 Oct 2013.