Clinical trial NCT02541890: Effects of Workplace Intervention in Occupational Rehabilitation on Return to Work
Official title: Effects of Workplace Intervention in Inpatient Occupational Rehabilitation on Return to Work for Persons With Somatic and/or Common Mental Health Problems. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Musculoskeletal Diseases
Fatigue Syndrome, Chronic
Keywords: Rehabilitation
Return to Work
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Trondheim University Hospital
First posted: 2015-09-04
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim is to study the effect of a work place intervention during a multicomponent return-to-work rehabilitation program on return-to-work. The intervention is compared with inpatient rehabilitation only, and participants will be recruited from the diagnostic groups dominating the sick-leave statistics, namely musculoskeletal disorders, common mental disorders (e.g. stress, depression and anxiety), and unspecific disorders including chronic fatigue.

Detailed description: Long-term sick-listing from work has considerable impact on social function, on the families of the sick-listed persons, the companies they work for, and society as a whole. Hence, the need for documented effective vocational rehabilitation programs is pressing. Vocational rehabilitation services described in the scientific literature have been specific to one single or a specific group of medical conditions (e.g.low back pain). In contrast, most people on sick leave have several health complaints, and many of the factors influencing sick leave are shared regardless of disorder (e.g. social surroundings, workplace environment), calling for rehabilitation programs that can be employed for both musculoskeletal, unspecific and common mental disorders. Research indicates that interventions on the work place might facilitate return to work. The aim of this study is therefore to investigate the effect of a work place intervention during a multicomponent return-to-work rehabilitation program on return-to-work.

Eligibility criteria: Inclusion Criteria:

* Resident of Central Norway
* Sick-listed due to common mental disorders, musculoskeletal pain/problems, unspecific disorders and/or fatigue
* Sick-listed more than 50 %
* Sick-listed longer than 8 weeks
* Has employer and is willing to participate in a work place intervention during the rehabilitation program

Exclusion Criteria:

* is self-employed
* has, or is currently examined for, a serious somatic or psychiatric disorder
* suffers from substance abuse
* has trouble with participating in a group
* is in a rehabilitation process that will interfere with the occupational rehabilitation program
* function level is to weak to participate in the rehabilitation program

Primary outcomes:
measure: Number of days on sick-leave
timeFrame: 12 months
measure: Time until sustainable return to work
timeFrame: 12 months
Secondary outcomes:
measure: Use of health services. Questionnaire. "How much of this health/social service have you used during the last 4 months?"
timeFrame: 12 months
measure: Pain. Questionnaire
timeFrame: 12 months
measure: Health related quality of life. Questionnaire
timeFrame: 12 months
measure: Psychological flexibility and acceptance. Questionnaire
timeFrame: 5 months
measure: Return to work self efficacy. Questionnaire.
timeFrame: 5 months
measure: Fear and avoidance beliefs about work. Questionnaire
timeFrame: 5 months
measure: Expectations about sick leave and return to work. Questionnaire
timeFrame: 5 months
measure: Work ability. Single question
timeFrame: 5 months
measure: Well-being at work. Single question
timeFrame: 5 months
measure: Readiness for return to work. Questionnaire
timeFrame: 5 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Nowegian University of Science and Technology, Department of public health
Study officials:
affiliation: Norwegian University of Science and Technology
name: Marius S Fimland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rise MB, Skagseth M, Klevanger NE, Aasdahl L, Borchgrevink P, Jensen C, Tenggren H, Halsteinli V, Jacobsen TN, Loland SB, Johnsen R, Fimland MS. Design of a study evaluating the effects, health economics, and stakeholder perspectives of a multi-component occupational rehabilitation program with an added workplace intervention - a study protocol. BMC Public Health. 2018 Feb 5;18(1):219. doi: 10.1186/s12889-018-5130-5.
citation: Skagseth M, Fimland MS, Rise MB, Johnsen R, Borchgrevink PC, Aasdahl L. Effectiveness of adding a workplace intervention to an inpatient multimodal occupational rehabilitation program: A randomized clinical trial. Scand J Work Environ Health. 2020 Jul 1;46(4):356-363. doi: 10.5271/sjweh.3873. Epub 2019 Dec 13.
citation: Klevanger NE, Fimland MS, Rise MB. Aligning stakeholders' understandings of the return-to-work process: a qualitative study on workplace meetings in inpatient multimodal occupational rehabilitation. Int J Qual Stud Health Well-being. 2021 Dec;16(1):1946927. doi: 10.1080/17482631.2021.1946927.