NCT02396797

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,011

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

3.3 years

First QC Date

February 25, 2015

Last Update Submit

May 9, 2018

Conditions

Mental DisordersBack PainAnxietyDepression

Keywords

Sick leaveMental HealthCopingSocial SupportSubjective Health Complaints

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Coping Expectancies; Theoretically Originated Measure of the Cognitive Activation Theory of Stress, TOMCATS

    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

Study Arms (2)

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.

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.

Behavioral: The original atWork intervention

Interventions

The new atWork interventionBEHAVIORAL

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 new atWork intervention
The original atWork interventionBEHAVIORAL

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.

The original atWork intervention

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Torill Helene Tveito

Bergen, Norway

Location

Related Publications (3)

  • 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.

    PMID: 29785466DERIVED

  • 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.

    PMID: 28820017DERIVED

  • 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.

    PMID: 27542921DERIVED

MeSH Terms

Conditions

Mental DisordersBack PainAnxiety DisordersDepressionPsychological Well-Being

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Torill H Tveito, PhD

    Uni Research Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 24, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

May 15, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)