Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care

Stress, Psychological Clinical Trial

— PRIMA  

Official title:

Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care (PRIMA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022760
• Other study ID #: ISM 03-2015
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: May 2020

Study information

• Verified date: June 2020
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: May 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adjustment Disorders
• Burnout, Professional
• Disease
• Mental Disorders
• Psychotic Disorders
• Stress, Psychological

Intervention

Behavioral:
• Work-related measures
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.

External Links

•   Related Info