Effect Evaluation of a Workplace Intervention Targeting Subjective Health Complaints

Study Overview
=================
Brief Summary
-----------------
Mental disorders is one of the most frequent causes of long-term sick leave and disability pensions in Norway, and there is a need for a comprehensive, coordinated response from health and social sectors at the country level to address the burden of mental disorders. The aim of this project is to investigate if a workplace intervention with the aim to increase coping of common mental health complaints and social support can reduce sick leave and improve health.

Detailed Description
-----------------
The atWork intervention was established in 2007 as a new stepped-care approach to musculoskeletal complaints. The intervention consisted of workplace information meetings about musculoskeletal complaint to all employees and peer support. The atWork intervention targeting musculoskeletal complaints reduced sick leave and improved health in a randomized controlled trial. The atWork intervention has now been further developed with the aim to increase effect on sick leave and health. The intervention is now extended to include information about mental health complaints, in addition to a management course. The major societal costs and the negative consequences common mental health complaints induce underline the importance of testing if atWork is an effective way of reducing these consequences.

Official Title
-----------------
Effect Evaluation of a Workplace Intervention Targeting Subjective Health Complaints on Sick Leave, Coping, Health, Job Satisfaction and Social Support

Conditions
-----------------
Mental Disorders, Back Pain, Anxiety, Depression

Intervention / Treatment
-----------------
* Behavioral: The new atWork intervention
* Behavioral: The original atWork intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Norwegian primary education unit. Participants must be employed in one of the Norwegian primary education units participating in the study. Participants must have sufficient Norwegian reading and writing skills. Exclusion Criteria: The organization has received the atWork intervention at an earlier time. Participants are not employed in one of the participating organizations. Participants do not have sufficient Norwegian reading and writing skills.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The new atWork intervention<br>The intervention group will receive the new atWork intervention, which include a management course and workplace courses for all employees targeting mental health complaints and musculoskeletal complaints. | Behavioral: The new atWork intervention<br>* atWork is a cognitive intervention, and uses a nondirective delivery approach. It does not prescribe any change in lifestyle, but aims at establishing an understanding of common complaints and what to do when pain and health complaints occur. All information is based on the non-injury model, where pain and complaints are not signs of injury caused by wrongdoing or inappropriate behavior. The consistent take home message from all parts of the intervention is that keeping up usual activities, including going to work, is beneficial for health and recovery. This group will receive one management course, two workplace courses for all employees targeting mild mental disorders and nonspecific musculoskeletal complaints, and one reflection and review meeting.<br>|
| Active Comparator: The original atWork intervention<br>The control group will receive the original atWork intervention, targeting musculoskeletal complaint, and peer support. | Behavioral: The original atWork intervention<br>* This group will receive three workplace courses for all employees targeting nonspecific musculoskeletal complaints, and peer support. Peer support involves selecting a peer advisor at the workplace. A peer advisor is a fellow worker without former medical training who as part of the atWork intervention receive more in-depth medical knowledge and training about nonspecific musculoskeletal complaints. The peer advisors role is to give social support and to use their local knowledge of the work place to facilitate staying at work for colleagues with health complaints.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sick leave, unit level | Sick leave at unit level will be collected through registry data from the Norwegian Labour and Welfare administration (NAV). Thus, we will collect data from all employees in participating units (approximately 100 units), not only the employees responding to questionnaires. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coping Expectancies; Theoretically Originated Measure of the Cognitive Activation Theory of Stress, TOMCATS | All employees will be asked to complete questionnaires, one before the intervention and at 12 months follow-up. | 1 year | 
| Health; self-rated health, Subjective Health Complaints Inventory, SHC, Hopkins Symptom Checklist, HSCL-10 |  | 1 year | 
| Job Satisfaction; Global Job Satisfaction, GJO, Demand-Control-Support-Questionnaire, short Swedish version |  | 1 year | 
| Social Support; Non directive and Directive Support Survey, NDSS-16. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coping, Sick leave, Mental Health, Social Support, Subjective Health Complaints