- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01039168
Return to Work After a Workplace-oriented Intervention for Patients on Sick Leave Due to Burnout (ADA model)
March 13, 2024 updated by: Region Skane
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lund, Sweden, 22185
- Occupational and Environmental Medicine, Lund University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- employment
- sick leave at lest half time 2-6 months due to work related burnout
- previously healthy
Exclusion Criteria:
- other somatic or psychiatric disease explaining the symptoms
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Workplace dialogue
Clinical examination and dialogue with supervisor to find solutions to reduce job-person mismatch and facilitate return to work
|
|
|
Sham Comparator: Care as usual
No intervention besides of the care as usual being available for the patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Return to work from sick leave
Time Frame: Up to 1,5 years post intervention completion
|
Up to 1,5 years post intervention completion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self-rated health measures (only in the intervention group)
Time Frame: Up to 1,5 years post intervention completion
|
Up to 1,5 years post intervention completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Björn Karlson, PhD, Occupational and Environmental Medicine, Lund University Hospital and Lund University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2003
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
December 22, 2009
First Submitted That Met QC Criteria
December 22, 2009
First Posted (Estimated)
December 24, 2009
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 13, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAS 2003-0765
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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