Evaluation of Return to Work Rehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Sick Leave, Occupational Health

Intervention / Treatment
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* Behavioral: long rehabilitation program
* Behavioral: short rehabilitation program
* Behavioral: Acceptance and commitment therapy (ACT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: long rehabilitation<br>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<br> <br> |
| Experimental: short rehabilitation<br>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<br> <br> |
| Active Comparator: Acceptance and commitment therapy<br>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)<br> <br> |
| No Intervention: Untouched<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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absenteeism, rehabilitation, return to work