Burnout, ProfessionalsNCT02825004
Recognizing and Preventing Burnout
A study testing Psychological Intervention in people with Burnout, Professionals, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
The purpose of this study is to prevent burnout and offer the hospital staff a space for processing the emotional experiences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burnout, Professionals
- What is being tested?
- Psychological Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2016to Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Doctors, physiotherapists, nurses and care workers
- Be a Professional Worker at the Rehabilitation Respiratory Unit
- Age > 18 years old
Who cannot join
- Refusal at the Informed Consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recognizing and Preventing Burnout: A Pilot Randomized Controlled Trial
The purpose of this study is to prevent burnout and offer the hospital staff a space for processing the emotional experiences.
- Conditions
- Burnout, Professionals
- Being tested
- Psychological Intervention
- Keywords
- Burnout, Health Care Workers, Coping Skills, Clinical Trial
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Psychological Intervention | Experimental | All the professionals workers involved in the experimental group will attend three intensive psychological meetings about emotional exhaustion, depersonalisation, low personal accomplishment and how to improve coping skills. Receives: Behavioral: Psychological Intervention |
| Control Group | No intervention | There is not any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in burnout, as assessed by the Maslach Burnout Inventory (MBI) (Maslach C., 1981) between baseline (T0), 6 months (T1) and 12 months (T2)
Measured: At the baseline (T0), 6 months (T1) and 12 months (T2)
Secondary outcomes (2)
Changes in coping strategies as assessed by the Coping Orientation to Problems Experienced (COPE) (Carver et al., 1989) between baseline (T0), 6 months (T1) and 12 months (T2)
Measured: At the baseline (T0), 6 months (T1) and 12 months (T2)
Changes in psychological symptoms as assessed by the Symptom Checklist-90-R (Prunas et al., 2012) between baseline (T0), 6 months (T1) and 12 months (T2)
Measured: At the baseline (T0), 6 months (T1) and 12 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Banfi, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825004
- Sponsor's protocol ID
- FDG_BURN01_HP
- Status last verified
- Jan 2018
- First submitted
- 4 Jul 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Prunas A, Sarno I, Preti E, Madeddu F, Perugini M. Psychometric properties of the Italian version of the SCL-90-R: a study on a large community sample. Eur Psychiatry. 2012 Nov;27(8):591-7. doi: 10.1016/j.eurpsy.2010.12.006. Epub 2011 Feb 21.
PubMed 21334861Kleijweg JH, Verbraak MJ, Van Dijk MK. The clinical utility of the Maslach Burnout Inventory in a clinical population. Psychol Assess. 2013 Jun;25(2):435-41. doi: 10.1037/a0031334. Epub 2013 Jan 28.
PubMed 23356679Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.
PubMed 2926629
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recognizing and Preventing Burnout: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02825004
- Acronym / sponsor ID
- FDG_BURN01_HP
- Conditions
- Burnout, Professionals
- Keywords
- Burnout, Health Care Workers, Coping Skills, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 Jul 2016 (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.
The purpose of this study is to prevent burnout and offer the hospital staff a space for processing the emotional experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological Intervention | Experimental | Behavioral: Psychological InterventionAll the professionals workers involved in the experimental group will attend three intensive psychological meetings about emotional exhaustion, depersonalisation, low personal accomplishment and how to improve coping skills. |
| Control Group | No intervention | –There is not any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Doctors, physiotherapists, nurses and care workers
- Be a Professional Worker at the Rehabilitation Respiratory Unit
- Age > 18 years old
Key exclusion criteria (1 listed)
- Refusal at the Informed Consent
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 |
|---|---|---|
| Psychological Intervention | Behavioural | Psychological Intervention |
Primary outcome
Changes in burnout, as assessed by the Maslach Burnout Inventory (MBI) (Maslach C., 1981) between baseline (T0), 6 months (T1) and 12 months (T2)
Time frame: At the baseline (T0), 6 months (T1) and 12 months (T2)
2 secondary outcomes
Changes in coping strategies as assessed by the Coping Orientation to Problems Experienced (COPE) (Carver et al., 1989) between baseline (T0), 6 months (T1) and 12 months (T2)
Time frame: At the baseline (T0), 6 months (T1) and 12 months (T2)
Changes in psychological symptoms as assessed by the Symptom Checklist-90-R (Prunas et al., 2012) between baseline (T0), 6 months (T1) and 12 months (T2)
Time frame: At the baseline (T0), 6 months (T1) and 12 months (T2)
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 1 Feb 2018.
- Results publication: PubMed 21334861Prunas A, Sarno I, Preti E, Madeddu F, Perugini M. Psychometric properties of the Italian version of the SCL-90-R: a study on a large community sample. Eur Psychiatry. 2012 Nov;27(8):591-7. doi: 10.1016/j.eurpsy.2010.12.006. Epub 2011 Feb 21.
- Results publication: PubMed 23356679Kleijweg JH, Verbraak MJ, Van Dijk MK. The clinical utility of the Maslach Burnout Inventory in a clinical population. Psychol Assess. 2013 Jun;25(2):435-41. doi: 10.1037/a0031334. Epub 2013 Jan 28.
- Results publication: PubMed 2926629Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Intervention in people with Burnout, Professionals, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 3 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 1 Feb 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 Italy. 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?
Changes in burnout, as assessed by the Maslach Burnout Inventory (MBI) (Maslach C., 1981) between baseline (T0), 6 months (T1) and 12 months (T2) (time frame: At the baseline (T0), 6 months (T1) and 12 months (T2)). 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 NCT02825004, which also lists 3 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 1 Feb 2018.