- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02396797
Effect Evaluation of a Workplace Intervention Targeting Subjective Health Complaints (atWork)
May 9, 2018 updated by: NORCE Norwegian Research Centre AS
Effect Evaluation of a Workplace Intervention Targeting Subjective Health Complaints on Sick Leave, Coping, Health, Job Satisfaction and Social Support
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1011
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bergen, Norway
- Torill Helene Tveito
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 67 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The new atWork intervention
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.
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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.
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Active Comparator: The original atWork intervention
The control group will receive the original atWork intervention, targeting musculoskeletal complaint, and peer support.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sick leave, unit level
Time Frame: 1 year
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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.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coping Expectancies; Theoretically Originated Measure of the Cognitive Activation Theory of Stress, TOMCATS
Time Frame: 1 year
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All employees will be asked to complete questionnaires, one before the intervention and at 12 months follow-up.
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1 year
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Health; self-rated health, Subjective Health Complaints Inventory, SHC, Hopkins Symptom Checklist, HSCL-10
Time Frame: 1 year
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1 year
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Job Satisfaction; Global Job Satisfaction, GJO, Demand-Control-Support-Questionnaire, short Swedish version
Time Frame: 1 year
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1 year
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Social Support; Non directive and Directive Support Survey, NDSS-16.
Time Frame: 1 year
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Torill H Tveito, PhD, Uni Research Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Johnsen TL, Eriksen HR, Baste V, Indahl A, Odeen M, Tveito TH. Effect of Reassuring Information About Musculoskeletal and Mental Health Complaints at the Workplace: A Cluster Randomized Trial of the atWork Intervention. J Occup Rehabil. 2019 Jun;29(2):274-285. doi: 10.1007/s10926-018-9786-6.
- Johnsen TL, Eriksen HR, Indahl A, Tveito TH. Directive and nondirective social support in the workplace - is this social support distinction important for subjective health complaints, job satisfaction, and perception of job demands and job control? Scand J Public Health. 2018 May;46(3):358-367. doi: 10.1177/1403494817726617. Epub 2017 Aug 18.
- Johnsen TL, Indahl A, Baste V, Eriksen HR, Tveito TH. Protocol for the atWork trial: a randomised controlled trial of a workplace intervention targeting subjective health complaints. BMC Public Health. 2016 Aug 19;16(1):844. doi: 10.1186/s12889-016-3515-x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 1, 2018
Study Registration Dates
First Submitted
February 25, 2015
First Submitted That Met QC Criteria
March 17, 2015
First Posted (Estimate)
March 24, 2015
Study Record Updates
Last Update Posted (Actual)
May 15, 2018
Last Update Submitted That Met QC Criteria
May 9, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9747
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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