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

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

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.

Study Overview

• Status: Completed
• Conditions: Burnout, Professional; Stress, Psychological; Adjustment Disorders
• Intervention / Treatment: Behavioral: Work-related measures

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as usual
Active Comparator: Work-related measures; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Göteborg University
• Investigators: Study Director: Lisa Björk, the Institute of Stress Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 16, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Exhaustion Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Occupational Stress; Occupational Diseases; Trauma and Stressor Related Disorders; Burnout, Psychological; Disease; Psychotic Disorders; Burnout, Professional; Stress, Psychological; Mental Disorders; Adjustment Disorders
• Other Study ID Numbers: ISM 03-2015