NCT03022760

Brief Summary

The aim of this project is to develop a model for return to work (RTW) for patients sick listed due to stress related mental disorders, which takes into account each patient's specific situation; includes the workplace, and is well adapted to the Swedish primary care setting. In late 2016, general practitioners (GPs) and rehabilitation coordinators at both public and private primary care centers will be offered a one-day training about work and workability for patients with stress related mental disorders. Also, the participants will be trained in a specific method that includes the patient's employer early in the rehabilitation process The project has a quasi-experimental and longitudinal design. The intervention will be conducted on 15 different primary care centers, which will be matched with a comparison group. Return to work for 500 patients will be analyzed using registry data, 6, 12 and 18 months after sick-listing. The hypothesis is that patients who are sick-listed at primary care centers that completely or partially implemented the specific method on average will return earlier to work than patients sick-listed at primary care centers that did not implement the method. Alongside studying if the intervention has an effect on the patients' RTW over time, the investigators aim to investigate the mechanisms explaining the effects and the individual and organizational level (primary care units) circumstances necessary for these mechanisms to be triggered. To gain deeper knowledge about mechanisms and context, the investigators will conduct interviews with the treatment staff and collect registry data about the primary care units.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

2.1 years

First QC Date

November 1, 2016

Last Update Submit

June 10, 2020

Conditions

Keywords

Exhaustion Disorder

Outcome Measures

Primary Outcomes (3)

  • Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.

    Three measurement time points. First measurement will occur 6 months from baseline.

  • Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.

    Second measurement time point will occur at 12 months from baseline.

  • Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.

    Third measurement time point will occur at 18 months from baseline.

Study Arms (2)

Work-related measures

ACTIVE COMPARATOR

* One-day training for GP:s and rehabilitation coordinators * A treatment protocol which includes contact with the patient's employer * Clinical support from the Institute of Stress Medicine

Behavioral: Work-related measures

Treatment as usual

NO INTERVENTION

Interventions

After mapping the patient's psychosocial work situation using tools provided at the one-day training, the patient's employer will be contacted and involved in the rehabilitation planning.

Work-related measures

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of International Classification of Diseases (ICD)10 F43
  • Has an employment
  • Good command in spoken and written Swedish

You may not qualify if:

  • Participants must not have been on long term sick-leave (\>60 days) during the last three years, regardless of causative diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Gothenburg, Sweden

Location

Related Publications (2)

  • Beno A, Bertilsson M, Holmgren K, Glise K, Pousette A, Segerfelt K, Bjork L. Does employer involvement in primary health care enhance return to work for patients with stress-related mental disorders? a cluster randomized controlled trial. BMC Prim Care. 2023 Sep 20;24(1):195. doi: 10.1186/s12875-023-02151-0.

  • Bjork L, Glise K, Pousette A, Bertilsson M, Holmgren K. Involving the employer to enhance return to work among patients with stress-related mental disorders - study protocol of a cluster randomized controlled trial in Swedish primary health care. BMC Public Health. 2018 Jul 6;18(1):838. doi: 10.1186/s12889-018-5714-0.

MeSH Terms

Conditions

Stress, PsychologicalBurnout, ProfessionalAdjustment Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorOccupational StressOccupational DiseasesBurnout, PsychologicalTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Lisa Björk

    the Institute of Stress Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2016

First Posted

January 16, 2017

Study Start

December 1, 2016

Primary Completion

January 1, 2019

Study Completion

May 1, 2020

Last Updated

June 12, 2020

Record last verified: 2020-06

Locations