Sick LeaveNCT01926574
Evaluation of Return to Work Rehabilitation
A study testing long rehabilitation program, short rehabilitation program and Acceptance and commitment therapy (ACT) in people with Sick Leave and Occupational Health, run by Norwegian University of Science and Technology at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sick Leave, Occupational Health
- What is being tested?
- long rehabilitation program, short rehabilitation program and Acceptance and commitment therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Jan 2013to 5 Jan 2022
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Hysnes Rehabilitation Centre
Rissa
St. Olavs University Hospital
Trondheim
About this study
Official title: 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.
- Conditions
- Sick Leave, Occupational Health
- Being tested
- long rehabilitation program, short rehabilitation program, Acceptance and commitment therapy (ACT)
- Keywords
- absenteeism, rehabilitation, return to work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long rehabilitation programBehavioural
short rehabilitation programBehavioural
Acceptance and commitment therapy (ACT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| long rehabilitation | Experimental | 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. Receives: Behavioral: long rehabilitation program |
| short rehabilitation | Experimental | 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. Receives: Behavioral: short rehabilitation program |
| Acceptance and commitment therapy | Active comparator | 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. Receives: Behavioral: Acceptance and commitment therapy (ACT) |
| Untouched | No intervention | this group will be followed in registers at group level and not be aware of their participation in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
time until full sustainable return-to-work (RTW)
return-to-work i.e. for at least 4 weeks without relapse
Measured: 1 year
Total number of sickness absence days
after enrollment in the study (i.e. after pre-screening)
Measured: 1 year
Secondary outcomes (11)
Sickness absence days
Measured: 3 years
sickness absence days
Measured: 5 years
Health related quality of life
Measured: 1 year
Subjective health complaints
Pain, depression, anxiety, and other subjective complaints
Measured: 1 year
Physical activity
Measured: 1 year
physical, social and emotional functional status
Measured: 1 year
Psychological and social factors at work
Measured: 1 year
readiness for return to work
Measured: 1 year
fear avoidance beliefs
Measured: 1 year
psychological flexibility and acceptance
Measured: 1 year
share of workers at work
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study start1 Jan 2013
- Primary completion5 Jan 2016
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sick LeaveStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Roar Johnsen, phd prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926574
- Sponsor's protocol ID
- 2012/1241-1
- Status last verified
- Nov 2026
- First submitted
- 19 Aug 2013
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 24735616Aasdahl 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.
PubMed 28401441Nordstoga 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.
PubMed 29507732Aasdahl 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.
PubMed 30151631Aasdahl 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.
PubMed 27815771Skagseth 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.
PubMed 31609021
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01926574
- Acronym / sponsor ID
- 2012/1241-1
- Conditions
- Sick Leave, Occupational Health
- Keywords
- absenteeism, rehabilitation, return to work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 5 Jan 2016 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 21 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| long rehabilitation | Experimental | Behavioral: long rehabilitation programa 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. |
| short rehabilitation | Experimental | Behavioral: short rehabilitation program4+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. |
| Acceptance and commitment therapy | Active comparator | Behavioral: Acceptance and commitment therapy (ACT)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. |
| Untouched | No intervention | –this group will be followed in registers at group level and not be aware of their participation in the study |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- alcohol or drug abuse
- serious somatic or psychological disorders
- a specific disorder requiring specialized treatment
- pregnancy
- currently participating in another treatment program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| long rehabilitation program | Behavioural | long rehabilitation |
| short rehabilitation program | Behavioural | short rehabilitation |
| Acceptance and commitment therapy (ACT) | Behavioural | Acceptance and commitment therapy |
Primary outcome
time until full sustainable return-to-work (RTW)
Time frame: 1 year
return-to-work i.e. for at least 4 weeks without relapse
Total number of sickness absence days
Time frame: 1 year
after enrollment in the study (i.e. after pre-screening)
11 secondary outcomes
Sickness absence days
Time frame: 3 years
sickness absence days
Time frame: 5 years
Health related quality of life
Time frame: 1 year
Subjective health complaints
Time frame: 1 year
Physical activity
Time frame: 1 year
physical, social and emotional functional status
Time frame: 1 year
Psychological and social factors at work
Time frame: 1 year
readiness for return to work
Time frame: 1 year
fear avoidance beliefs
Time frame: 1 year
psychological flexibility and acceptance
Time frame: 1 year
share of workers at work
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 24735616Fimland 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.
- Results publication: PubMed 28401441Aasdahl 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.
- Results publication: PubMed 29507732Nordstoga 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.
- Results publication: PubMed 30151631Aasdahl 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.
- Results publication: PubMed 27815771Aasdahl 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.
- Results publication: PubMed 31609021Skagseth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roar Johnsen, phd prof study director
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing long rehabilitation program, short rehabilitation program and Acceptance and commitment therapy (ACT) in people with Sick Leave and Occupational Health, run by Norwegian University of Science and Technology at 2 sites 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 4 inclusion and 8 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
time until full sustainable return-to-work (RTW) (time frame: 1 year). 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 NCT01926574, which also lists 6 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 3 Nov 2026.