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Effects of Workplace Intervention in Occupational Rehabilitation on Return to Work

Primary Purpose

Mental Disorders, Musculoskeletal Diseases, Fatigue Syndrome, Chronic

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Work place intervention
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorders focused on measuring Rehabilitation, Return to Work

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Work place intervention

Rehabilitation program only

Arm Description

Work place intervention in addition to rehabilitation program.

Rehabilitation program without intervention at the work place.

Outcomes

Primary Outcome Measures

Number of days on sick-leave
Register data from the national health and welfare services
Time until sustainable return to work
Register data from the national health and welfare services

Secondary Outcome Measures

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.
Pain. Questionnaire
Brief pain inventory (BPI). 160 participants
Health related quality of life. Questionnaire
The 15D health-related quality of life instrument. 160 participants
Psychological flexibility and acceptance. Questionnaire
Acceptance and action questionnaire and work acceptance and action questionnaire (AAQ2). 160 participants
Return to work self efficacy. Questionnaire.
Return to work self-efficacy-19 (RTWSE-19). 160 participants.
Fear and avoidance beliefs about work. Questionnaire
Fear Avoidance Belief Questionnaire (FABQ). 160 participants
Expectations about sick leave and return to work. Questionnaire
160 participants. "How long do you anticipate to be sick-listed (partly/fully)?" 3 questions.
Work ability. Single question
160 participants. "How will you rate your work ability?" (scale from 0 (no ability) to 10 (my best ability)).
Well-being at work. Single question
160 participants. "How happy are you at work?" (not at all, not so good, good. very good)
Readiness for return to work. Questionnaire
160 participants. Readiness for return to work (RRTW) questionnaire.

Full Information

First Posted
August 18, 2015
Last Updated
August 7, 2021
Sponsor
Norwegian University of Science and Technology
Collaborators
Trondheim University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02541890
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Trondheim University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Musculoskeletal Diseases, Fatigue Syndrome, Chronic
Keywords
Rehabilitation, Return to Work

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Work place intervention
Arm Type
Experimental
Arm Description
Work place intervention in addition to rehabilitation program.
Arm Title
Rehabilitation program only
Arm Type
No Intervention
Arm Description
Rehabilitation program without intervention at the work place.
Intervention Type
Behavioral
Intervention Name(s)
Work place intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of days on sick-leave
Description
Register data from the national health and welfare services
Time Frame
12 months
Title
Time until sustainable return to work
Description
Register data from the national health and welfare services
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Use of health services. Questionnaire. "How much of this health/social service have you used during the last 4 months?"
Description
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.
Time Frame
12 months
Title
Pain. Questionnaire
Description
Brief pain inventory (BPI). 160 participants
Time Frame
12 months
Title
Health related quality of life. Questionnaire
Description
The 15D health-related quality of life instrument. 160 participants
Time Frame
12 months
Title
Psychological flexibility and acceptance. Questionnaire
Description
Acceptance and action questionnaire and work acceptance and action questionnaire (AAQ2). 160 participants
Time Frame
5 months
Title
Return to work self efficacy. Questionnaire.
Description
Return to work self-efficacy-19 (RTWSE-19). 160 participants.
Time Frame
5 months
Title
Fear and avoidance beliefs about work. Questionnaire
Description
Fear Avoidance Belief Questionnaire (FABQ). 160 participants
Time Frame
5 months
Title
Expectations about sick leave and return to work. Questionnaire
Description
160 participants. "How long do you anticipate to be sick-listed (partly/fully)?" 3 questions.
Time Frame
5 months
Title
Work ability. Single question
Description
160 participants. "How will you rate your work ability?" (scale from 0 (no ability) to 10 (my best ability)).
Time Frame
5 months
Title
Well-being at work. Single question
Description
160 participants. "How happy are you at work?" (not at all, not so good, good. very good)
Time Frame
5 months
Title
Readiness for return to work. Questionnaire
Description
160 participants. Readiness for return to work (RRTW) questionnaire.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius S Fimland, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nowegian University of Science and Technology, Department of public health
City
Trondheim
ZIP/Postal Code
7491
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
29402253
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.
Results Reference
background
PubMed Identifier
31834410
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.
Results Reference
result
PubMed Identifier
34278973
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.
Results Reference
result

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Effects of Workplace Intervention in Occupational Rehabilitation on Return to Work

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