Effects of Workplace Intervention in Occupational Rehabilitation on Return to Work

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • 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

      • Trondheim, Norway, 7491
        • Nowegian University of Science and Technology, Department of public health

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

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Work place intervention
Work place intervention in addition to rehabilitation program.
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.
No Intervention: Rehabilitation program only
Rehabilitation program without intervention at the work place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days on sick-leave
Time Frame: 12 months
Register data from the national health and welfare services
12 months
Time until sustainable return to work
Time Frame: 12 months
Register data from the national health and welfare services
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of health services. Questionnaire. "How much of this health/social service have you used during the last 4 months?"
Time Frame: 12 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.
12 months
Pain. Questionnaire
Time Frame: 12 months
Brief pain inventory (BPI). 160 participants
12 months
Health related quality of life. Questionnaire
Time Frame: 12 months
The 15D health-related quality of life instrument. 160 participants
12 months
Psychological flexibility and acceptance. Questionnaire
Time Frame: 5 months
Acceptance and action questionnaire and work acceptance and action questionnaire (AAQ2). 160 participants
5 months
Return to work self efficacy. Questionnaire.
Time Frame: 5 months
Return to work self-efficacy-19 (RTWSE-19). 160 participants.
5 months
Fear and avoidance beliefs about work. Questionnaire
Time Frame: 5 months
Fear Avoidance Belief Questionnaire (FABQ). 160 participants
5 months
Expectations about sick leave and return to work. Questionnaire
Time Frame: 5 months
160 participants. "How long do you anticipate to be sick-listed (partly/fully)?" 3 questions.
5 months
Work ability. Single question
Time Frame: 5 months
160 participants. "How will you rate your work ability?" (scale from 0 (no ability) to 10 (my best ability)).
5 months
Well-being at work. Single question
Time Frame: 5 months
160 participants. "How happy are you at work?" (not at all, not so good, good. very good)
5 months
Readiness for return to work. Questionnaire
Time Frame: 5 months
160 participants. Readiness for return to work (RRTW) questionnaire.
5 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Marius S Fimland, PhD, Norwegian University of Science and Technology

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.

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)

April 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

September 2, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 7, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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 Work place intervention

3
Subscribe