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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01926574
Other study ID # 2012/1241-1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 2013
Est. completion date January 2022

Study information

Verified date April 2021
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date January 2022
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
long rehabilitation program

short rehabilitation program

Acceptance and commitment therapy (ACT)


Locations

Country Name City State
Norway Hysnes Rehabilitation Centre Rissa
Norway St. Olavs University Hospital Trondheim

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (6)

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/s10926-018-98 — View Citation

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 — View Citation

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 Randomi — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Health economics from the societal perspective Cost-effectiveness, cost-utility and cost-benefit methods. 1 year
Primary time until full sustainable return-to-work (RTW) return-to-work i.e. for at least 4 weeks without relapse 1 year
Primary Total number of sickness absence days after enrollment in the study (i.e. after pre-screening) 1 year
Secondary Sickness absence days 3 years
Secondary sickness absence days 5 years
Secondary Health related quality of life 1 year
Secondary Subjective health complaints Pain, depression, anxiety, and other subjective complaints 1 year
Secondary Physical activity 1 year
Secondary physical, social and emotional functional status 1 year
Secondary Psychological and social factors at work 1 year
Secondary readiness for return to work 1 year
Secondary fear avoidance beliefs 1 year
Secondary psychological flexibility and acceptance 1 year
Secondary share of workers at work 1 year
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