Professional BurnoutADA modelNCT01039168
Return to Work After a Workplace-oriented Intervention for Patients on Sick Leave Due to Burnout
A study testing Workplace dialogue and Care as usual in people with Professional Burnout, run by Region Skane at 1 site in Sweden.
Trial summary
The study aims to evaluate the effect on return to work of a workplace intervention with patients being treated for burnout. The intervention intends to reduce job-person mismatch through patient-supervisor communication.The hypothesis is that the intervention group will show a more favourable outcome than a control… Read more about this study
- Who is it for?
- Ages Up to 63 years
- Conditions the study is for
- Professional Burnout
- What is being tested?
- Workplace dialogue and Care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2003to Sep 2009
- 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 Up to 63 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- employment
- sick leave at lest half time 2-6 months due to work related burnout
- previously healthy
Who cannot join
- other somatic or psychiatric disease explaining the symptoms
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Occupational and Environmental Medicine, Lund University Hospital
Lund, 22185
About this study
Official title: Reduction of Person-job Mismatch to Increase Work Capacity, by Education of, and Dialogue Between Involved Parties - Evaluation of an Intervention Program
The study aims to evaluate the effect on return to work of a workplace intervention with patients being treated for burnout. The intervention intends to reduce job-person mismatch through patient-supervisor communication.The hypothesis is that the intervention group will show a more favourable outcome than a control group with respect to return to work.
Read the detailed description
Participants are consecutively recruited in co-operation with regional social insurance offices (RSIOs) in the two southern counties of Sweden. Persons accepting participation are clinically examined and interviewed of the course of events leading up to the burnout and the patient's expectations of changes necessary to facilitate return to work are recorded. The patient´s supervisor is then interviewed at the workplace, responding to the same questions on perceived main causes of the subordinate's sick leave and changes necessary to facilitate return to work. Finally, the core intervention takes place, namely a dialogue being initiated between the patient and the supervisor to find solutions to facilitate return to work. Out of those who do not want to participate, without giving any specific reason for that, a control group is matched by length and degree of sick leave at the time of the intervention.
- Conditions
- Professional Burnout
- Being tested
- Workplace dialogue, Care as usual
- Keywords
- Burnout, Sick leave, Intervention study, Prospective study, Work
- Medical subject headings
- Burnout, Professional, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workplace dialogueBehavioural
Care as usualOther
| Study group | Role | What they receive |
|---|---|---|
| Workplace dialogue | Active comparator | Clinical examination and dialogue with supervisor to find solutions to reduce job-person mismatch and facilitate return to work Receives: Behavioral: Workplace dialogue |
| Care as usual | Sham comparator | No intervention besides of the care as usual being available for the patient Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work from sick leave
Measured: Up to 1,5 years post intervention completion
Secondary outcomes (1)
Self-rated health measures (only in the intervention group)
Measured: Up to 1,5 years post intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startNov 2003
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Professional BurnoutStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research, Lund University, County Councils of Southern Sweden
- Responsible party
- Sponsor
- Investigators
- Björn Karlson, PhD, Principal investigator, Occupational and Environmental Medicine, Lund University Hospital and Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039168
- Sponsor's protocol ID
- FAS 2003-0765
- Acronym
- ADA model
- Status last verified
- Mar 2024
- First submitted
- 22 Dec 2009
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Karlson B, Jonsson P, Palsson B, Abjornsson G, Malmberg B, Larsson B, Osterberg K. Return to work after a workplace-oriented intervention for patients on sick-leave for burnout--a prospective controlled study. BMC Public Health. 2010 Jun 2;10:301. doi: 10.1186/1471-2458-10-301.
PubMed 20515510
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Person-job Mismatch to Increase Work Capacity, by Education of, and Dialogue Between Involved Parties - Evaluation of an Intervention Program
- ClinicalTrials.gov ID
- NCT01039168
- Acronym / sponsor ID
- ADA model / FAS 2003-0765
- Conditions
- Professional Burnout
- Keywords
- Burnout, Sick leave, Intervention study, Prospective study, Work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research, Lund University, County Councils of Southern Sweden
- Study start
- Nov 2003
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 24 Dec 2009 (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 study aims to evaluate the effect on return to work of a workplace intervention with patients being treated for burnout. The intervention intends to reduce job-person mismatch through patient-supervisor communication.The hypothesis is that the intervention group will show a more favourable outcome than a control group with respect to return to work.
Detailed description
Participants are consecutively recruited in co-operation with regional social insurance offices (RSIOs) in the two southern counties of Sweden. Persons accepting participation are clinically examined and interviewed of the course of events leading up to the burnout and the patient's expectations of changes necessary to facilitate return to work are recorded. The patient´s supervisor is then interviewed at the workplace, responding to the same questions on perceived main causes of the subordinate's sick leave and changes necessary to facilitate return to work. Finally, the core intervention takes place, namely a dialogue being initiated between the patient and the supervisor to find solutions to facilitate return to work. Out of those who do not want to participate, without giving any specific reason for that, a control group is matched by length and degree of sick leave at the time of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workplace dialogue | Active comparator | Behavioral: Workplace dialogueClinical examination and dialogue with supervisor to find solutions to reduce job-person mismatch and facilitate return to work |
| Care as usual | Sham comparator | Other: Care as usualNo intervention besides of the care as usual being available for the patient |
Who may qualify
- Ages
- Up to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- employment
- sick leave at lest half time 2-6 months due to work related burnout
- previously healthy
Key exclusion criteria (1 listed)
- other somatic or psychiatric disease explaining the symptoms
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 |
|---|---|---|
| Workplace dialogue | Behavioural | Workplace dialogue |
| Care as usual | Other | Care as usual |
Primary outcome
Return to work from sick leave
Time frame: Up to 1,5 years post intervention completion
1 secondary outcome
Self-rated health measures (only in the intervention group)
Time frame: Up to 1,5 years post intervention completion
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 15 Mar 2024.
- Derived from this study: PubMed 20515510Karlson B, Jonsson P, Palsson B, Abjornsson G, Malmberg B, Larsson B, Osterberg K. Return to work after a workplace-oriented intervention for patients on sick-leave for burnout--a prospective controlled study. BMC Public Health. 2010 Jun 2;10:301. doi: 10.1186/1471-2458-10-301.
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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.
Björn Karlson, PhD principal investigator
Occupational and Environmental Medicine, Lund University Hospital and Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workplace dialogue and Care as usual in people with Professional Burnout, run by Region Skane at 1 site in Sweden.
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 15 Mar 2024. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
Return to work from sick leave (time frame: Up to 1,5 years post intervention completion). 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 NCT01039168, which also lists 1 linked publication.
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 15 Mar 2024.