NCT01039168

Brief 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 group with respect to return to work.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

5.8 years

First QC Date

December 22, 2009

Last Update Submit

March 13, 2024

Conditions

Keywords

BurnoutSick leaveIntervention studyProspective studyWork

Outcome Measures

Primary Outcomes (1)

  • Return to work from sick leave

    Up to 1,5 years post intervention completion

Secondary Outcomes (1)

  • Self-rated health measures (only in the intervention group)

    Up to 1,5 years post intervention completion

Study Arms (2)

Workplace dialogue

ACTIVE COMPARATOR

Clinical examination and dialogue with supervisor to find solutions to reduce job-person mismatch and facilitate return to work

Behavioral: Workplace dialogue

Care as usual

SHAM COMPARATOR

No intervention besides of the care as usual being available for the patient

Other: Care as usual

Interventions

Workplace dialogue
Care as usual

Eligibility Criteria

AgeUp to 63 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • employment
  • sick leave at lest half time 2-6 months due to work related burnout
  • previously healthy

You may not qualify if:

  • other somatic or psychiatric disease explaining the symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Occupational and Environmental Medicine, Lund University Hospital

Lund, 22185, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Burnout, ProfessionalBurnout, Psychological

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Björn Karlson, PhD

    Occupational and Environmental Medicine, Lund University Hospital and Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

November 1, 2003

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations