Evaluation of Return to Work Rehabilitation

Evaluation of Inpatient-return- To-work, Multicomponent, Rehabilitation Programs for Persons Temporary Out of Work With Musculoskeletal-, Unspecific-, and/or Common Mental Health Disorders; Randomized Controlled Trial

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. Aim of this study is to investigate whether a group based rehabilitation program for musculoskeletal, mental or unspecific complaints can facilitate return-to-work (RTW), thereby testing two multicomponent return-to-work RTW rehabilitation programs.

Study Overview

• Status: Active, not recruiting
• Conditions: Occupational Health; Sick Leave
• Intervention / Treatment: Behavioral: long rehabilitation program; Behavioral: short rehabilitation program; Behavioral: Acceptance and commitment therapy (ACT)

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Rissa, Norway
    • Hysnes Rehabilitation Centre
  • Trondheim, Norway
    • St. Olavs University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• living in the counties of Trøndelag
• on sick leave 2-12 months
• current sick leave status of 50% - 100%
• ICPC-2 (International Classification of Primary Care, Second edition) diagnosis within the L (musculoskeletal), P (psychiatric) or A (unspecific disorders) categories

Exclusion Criteria:

• alcohol or drug abuse
• serious somatic or psychological disorders
• a specific disorder requiring specialized treatment
• pregnancy
• currently participating in another treatment program
• insufficient Norwegian speaking or writing skills to participate in group session and fill out questionnaires
• scheduled for surgery within the next 6 months
• serious problems with functioning in a group setting

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: long rehabilitation; a 3.5-week, in-patient rehabilitation program, organized as a 7-hour workday with weekends off, simulating a close to normal summer work-week in Norway, and mainly group-based with maximum 8 participants per group. Focus on mental training (aimed at increasing motivation and self-efficacy), physical training and work-related problem solving.	Behavioral: long rehabilitation program
Experimental: short rehabilitation; 4+4 full days of rehabilitation at Hysnes Rehabilitation Center, separated by 2 weeks living at home. Group-based with 8 participants per group, focus on mental training (aimed at increasing motivation and self-efficacy), physical training and work-related problem solving. A workplace visit will be included in addition to the 4 + 4 rehabilitation days, if considered relevant.	Behavioral: short rehabilitation program
Active Comparator: Acceptance and commitment therapy; 6 dynamic processes (committed action, self-as-context, presence in the moment, values, defusion and acceptance) are targeted both in group-sessions and individual meetings. Only the psychological part of the experimental interventions is applied, in an outpatient setting.	Behavioral: Acceptance and commitment therapy (ACT)
No Intervention: Untouched; this group will be followed in registers at group level and not be aware of their participation in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time until full sustainable return-to-work (RTW)	return-to-work i.e. for at least 4 weeks without relapse	1 year
Total number of sickness absence days	after enrollment in the study (i.e. after pre-screening)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sickness absence days		3 years
sickness absence days		5 years
Health related quality of life		1 year
Subjective health complaints	Pain, depression, anxiety, and other subjective complaints	1 year
Physical activity		1 year
physical, social and emotional functional status		1 year
Psychological and social factors at work		1 year
readiness for return to work		1 year
fear avoidance beliefs		1 year
psychological flexibility and acceptance		1 year
share of workers at work		1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health economics from the societal perspective	Cost-effectiveness, cost-utility and cost-benefit methods.	1 year

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Study Director: Roar Johnsen, phd prof, Norwegian University of Science and Technology

Publications and helpful links

General Publications

• Fimland MS, Vasseljen O, Gismervik S, Rise MB, Halsteinli V, Jacobsen HB, Borchgrevink PC, Tenggren H, Johnsen R. Occupational rehabilitation programs for musculoskeletal pain and common mental health disorders: study protocol of a randomized controlled trial. BMC Public Health. 2014 Apr 16;14:368. doi: 10.1186/1471-2458-14-368.
• Aasdahl L, Pape K, Vasseljen O, Johnsen R, Gismervik S, Halsteinli V, Fleten N, Nielsen CV, Fimland MS. Effect of Inpatient Multicomponent Occupational Rehabilitation Versus Less Comprehensive Outpatient Rehabilitation on Sickness Absence in Persons with Musculoskeletal- or Mental Health Disorders: A Randomized Clinical Trial. J Occup Rehabil. 2018 Mar;28(1):170-179. doi: 10.1007/s10926-017-9708-z.
• Nordstoga AL, Mork PJ, Steiro Fimland M. Improved cardiorespiratory fitness after occupational rehabilitation in merged diagnostic groups. Ann Occup Environ Med. 2018 Feb 28;30:16. doi: 10.1186/s40557-018-0227-y. eCollection 2018.
• Aasdahl L, Pape K, Vasseljen O, Johnsen R, Fimland MS. Improved Expectations About Length of Sick Leave During Occupational Rehabilitation Is Associated with Increased Work Participation. J Occup Rehabil. 2019 Sep;29(3):475-482. doi: 10.1007/s10926-018-9808-4.
• Aasdahl L, Pape K, Vasseljen O, Johnsen R, Gismervik S, Jensen C, Fimland MS. Effects of Inpatient Multicomponent Occupational Rehabilitation versus Less Comprehensive Outpatient Rehabilitation on Somatic and Mental Health: Secondary Outcomes of a Randomized Clinical Trial. J Occup Rehabil. 2017 Sep;27(3):456-466. doi: 10.1007/s10926-016-9679-5.
• Skagseth M, Fimland MS, Ivar Lund Nilsen T, Aasdahl L. Physical activity after inpatient occupational rehabilitation: Secondary outcomes of two randomized controlled trials. Scand J Med Sci Sports. 2020 Feb;30(2):339-348. doi: 10.1111/sms.13577. Epub 2019 Oct 30.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (Estimate): August 21, 2013

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: rehabilitation; absenteeism; return to work
• Other Study ID Numbers: 2012/1241-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No