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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1011

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Norway
      • Bergen, Norway
        • Torill Helene Tveito

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: The new atWork intervention
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.
Active Comparator: The original atWork intervention
The control group will receive the original atWork intervention, targeting musculoskeletal complaint, and peer support.
Behavioral: The original atWork intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coping Expectancies; Theoretically Originated Measure of the Cognitive Activation Theory of Stress, TOMCATS
Time Frame: 1 year
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
Time Frame: 1 year
1 year
Job Satisfaction; Global Job Satisfaction, GJO, Demand-Control-Support-Questionnaire, short Swedish version
Time Frame: 1 year
1 year
Social Support; Non directive and Directive Support Survey, NDSS-16.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NORCE Norwegian Research Centre AS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Hospital of Vestfold

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Mental Disorders

Clinical Trials on The new atWork intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings