Mental DisordersatWorkNCT02396797
Effect Evaluation of a Workplace Intervention Targeting Subjective Health Complaints
A study testing The new atWork intervention and The original atWork intervention in people with Mental Disorders and Back Pain, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Mental Disorders, Back Pain, Anxiety
- What is being tested?
- The new atWork intervention and The original atWork intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,011 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Disorders, Back Pain, Anxiety, Depression
- Being tested
- The new atWork intervention, The original atWork intervention
- Keywords
- Sick leave, Mental Health, Coping, Social Support, Subjective Health Complaints
- Medical subject headings
- Mental Disorders, Back Pain, Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The new atWork interventionBehavioural
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.
The original atWork interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The new atWork intervention | Experimental | 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. Receives: Behavioral: The new atWork intervention |
| The original atWork intervention | Active comparator | The control group will receive the original atWork intervention, targeting musculoskeletal complaint, and peer support. Receives: Behavioral: The original atWork intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 1 year
Health; self-rated health, Subjective Health Complaints Inventory, SHC, Hopkins Symptom Checklist, HSCL-10
Measured: 1 year
Job Satisfaction; Global Job Satisfaction, GJO, Demand-Control-Support-Questionnaire, short Swedish version
Measured: 1 year
Social Support; Non directive and Directive Support Survey, NDSS-16.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital of Vestfold
- Responsible party
- Sponsor
- Investigators
- Torill H Tveito, PhD, Principal investigator, Uni Research Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396797
- Sponsor's protocol ID
- 9747
- Acronym
- atWork
- Status last verified
- May 2018
- First submitted
- 25 Feb 2015
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 29785466Johnsen 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.
PubMed 28820017Johnsen 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.
PubMed 27542921
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Evaluation of a Workplace Intervention Targeting Subjective Health Complaints on Sick Leave, Coping, Health, Job Satisfaction and Social Support
- ClinicalTrials.gov ID
- NCT02396797
- Acronym / sponsor ID
- atWork / 9747
- Conditions
- Mental Disorders, Back Pain, Anxiety, Depression
- Keywords
- Sick leave, Mental Health, Coping, Social Support, Subjective Health Complaints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,011 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- The Hospital of Vestfold
- Study start
- Jan 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The new atWork intervention | Experimental | Behavioral: The new atWork interventionThe 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. |
| The original atWork intervention | Active comparator | Behavioral: The original atWork interventionThe control group will receive the original atWork intervention, targeting musculoskeletal complaint, and peer support. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The new atWork interventionatWork 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. | Behavioural | The new atWork intervention |
| The original atWork interventionThis 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. | Behavioural | The original atWork intervention |
Primary outcome
Sick leave, unit level
Time frame: 1 year
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.
4 secondary outcomes
Coping Expectancies; Theoretically Originated Measure of the Cognitive Activation Theory of Stress, TOMCATS
Time frame: 1 year
Health; self-rated health, Subjective Health Complaints Inventory, SHC, Hopkins Symptom Checklist, HSCL-10
Time frame: 1 year
Job Satisfaction; Global Job Satisfaction, GJO, Demand-Control-Support-Questionnaire, short Swedish version
Time frame: 1 year
Social Support; Non directive and Directive Support Survey, NDSS-16.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Derived from this study: PubMed 29785466Johnsen 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.
- Derived from this study: PubMed 28820017Johnsen 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.
- Derived from this study: PubMed 27542921Johnsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torill H Tveito, PhD principal investigator
Uni Research Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The new atWork intervention and The original atWork intervention in people with Mental Disorders and Back Pain, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sick leave, unit level (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02396797, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.