Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care (PRIMA)
Primary Purpose
Stress, Psychological, Burnout, Professional, Adjustment Disorders
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Work-related measures
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Psychological focused on measuring Exhaustion Disorder
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of International Classification of Diseases (ICD)10 F43
- Has an employment
- Good command in spoken and written Swedish
Exclusion Criteria:
- Participants must not have been on long term sick-leave (>60 days) during the last three years, regardless of causative diagnosis.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Work-related measures
Treatment as usual
Arm Description
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
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03022760
First Posted
November 1, 2016
Last Updated
June 10, 2020
Sponsor
Vastra Gotaland Region
Collaborators
Göteborg University
1. Study Identification
Unique Protocol Identification Number
NCT03022760
Brief Title
Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care
Acronym
PRIMA
Official Title
Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care (PRIMA)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
Collaborators
Göteborg University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Burnout, Professional, Adjustment Disorders
Keywords
Exhaustion Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Work-related measures
Arm Type
Active Comparator
Arm Description
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
Arm Title
Treatment as usual
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Work-related measures
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
Three measurement time points. First measurement will occur 6 months from baseline.
Title
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.
Time Frame
Second measurement time point will occur at 12 months from baseline.
Title
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.
Time Frame
Third measurement time point will occur at 18 months from baseline.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of International Classification of Diseases (ICD)10 F43
Has an employment
Good command in spoken and written Swedish
Exclusion Criteria:
Participants must not have been on long term sick-leave (>60 days) during the last three years, regardless of causative diagnosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Björk
Organizational Affiliation
the Institute of Stress Medicine
Official's Role
Study Director
Facility Information:
City
Gothenburg
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
29976181
Citation
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.
Results Reference
derived
Learn more about this trial
Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care
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