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Mental DisordersNCT02541890

Effects of Workplace Intervention in Occupational Rehabilitation on Return to Work

A study testing Work place intervention in people with Mental Disorders and Musculoskeletal Diseases, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Work place intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
1 siteNorway
Study dates
Apr 2015to Mar 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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Nowegian University of Science and Technology, Department of public health

    Trondheim, 7491

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
Work place intervention
Keywords
Rehabilitation, Return to Work
Medical subject headings
Mental Disorders, Musculoskeletal Diseases, Fatigue Syndrome, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Work place interventionBehavioural

    Meeting at the work place including the patient, the employer and the rehabilitation therapist. Aim of meeting is to discuss challenges and possibilities in the patient's return to work process and to make a plan for return to work.

Study groups in NCT02541890
Study groupRoleWhat they receive
Work place interventionExperimentalWork place intervention in addition to rehabilitation program.
Receives: Behavioral: Work place intervention
Rehabilitation program onlyNo interventionRehabilitation program without intervention at the work place.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of days on sick-leave

    Register data from the national health and welfare services

    Measured: 12 months

  2. Time until sustainable return to work

    Register data from the national health and welfare services

    Measured: 12 months

Secondary outcomes (10)

  1. Use of health services. Questionnaire. "How much of this health/social service have you used during the last 4 months?"

    160 participants. "How much of this health/social service have you used during the last 4 months?" Somatic and mental health specialized care (in-patient and outpatient), general practitioner, psychologist, group therapy, physiotherapist, chiropractor, occupational rehabilitation, welfare services, complementary practitioner, emergency unit, ambulatory services, occupational health services, other treatment.

    Measured: 12 months

  2. Pain. Questionnaire

    Brief pain inventory (BPI). 160 participants

    Measured: 12 months

  3. Health related quality of life. Questionnaire

    The 15D health-related quality of life instrument. 160 participants

    Measured: 12 months

  4. Psychological flexibility and acceptance. Questionnaire

    Acceptance and action questionnaire and work acceptance and action questionnaire (AAQ2). 160 participants

    Measured: 5 months

  5. Return to work self efficacy. Questionnaire.

    Return to work self-efficacy-19 (RTWSE-19). 160 participants.

    Measured: 5 months

  6. Fear and avoidance beliefs about work. Questionnaire

    Fear Avoidance Belief Questionnaire (FABQ). 160 participants

    Measured: 5 months

  7. Expectations about sick leave and return to work. Questionnaire

    160 participants. "How long do you anticipate to be sick-listed (partly/fully)?" 3 questions.

    Measured: 5 months

  8. Work ability. Single question

    160 participants. "How will you rate your work ability?" (scale from 0 (no ability) to 10 (my best ability)).

    Measured: 5 months

  9. Well-being at work. Single question

    160 participants. "How happy are you at work?" (not at all, not so good, good. very good)

    Measured: 5 months

  10. Readiness for return to work. Questionnaire

    160 participants. Readiness for return to work (RRTW) questionnaire.

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJul 2017
  4. Study completionMar 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02541890
Sponsor's protocol ID
2014/2279
Status last verified
Aug 2021
First submitted
18 Aug 2015
Last updated
13 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29402253

  • 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.

    PubMed 31834410

  • 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.

    PubMed 34278973

Questions about this trial

What is this clinical trial studying?

A study testing Work place intervention in people with Mental Disorders and Musculoskeletal Diseases, run by Norwegian University of Science and Technology 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 5 inclusion and 6 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 13 Aug 2021. 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?

Number of days on sick-leave (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02541890, 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 13 Aug 2021.

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