Multidisciplinary Return-to-work Rehabilitation and Return-to Work Follow-up

Study Overview
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Brief Summary
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The large number of people on long-term sick leave is a major public health concern in Norway. The main causes of disability are musculoskeletal and mental disorders. Long-term sick leave causes a decline in individual life-quality, is associated with increased risk for mental disorders and represents a very large cost for the Norwegian society. The purpose of this study is to determine whether the patients included return to work after rehabilitation at Hysnes Rehabilitation Centre. This includes an investigation of what is considered to be the effect of Return-to-work rehabilitation measured before, during and after the stay at the rehabilitation centre: The study specifically looks at the effect of structured and standardized return-to-work follow up of the patient, including contact with stakeholders (general practitioner, social security office and workplace). In addition there is a need to describe the patients participating in the program. The aetiology of complex symptom disorders is poorly understood and the role of genetics and stress is not translatable to a complex symptom population. This complicates the transition from current biological research to a clinical use regarding these patients. If the investigators can assist in understanding how these patients, who are multiusers of health care and have received sickness benefit for a long time, develop their disorders and symptoms, it will be of great importance to the Norwegian community. Therefore the study consists of multimodal measurements of the patients before, during and after a rehabilitation programme at Hysnes Rehabilitation Centre. These measures include genotype, saliva cortisol, medical-, psychological-, physiological diagnostics and work related factors. Related aims: Investigate if multidisciplinary treatment based on acceptance and commitment therapy, contributes to normalisation of cortisol release with regards to a standardized stress test. See wether individual differences regarding the stress profile can predict return to work in patients with complex symptom disorders. Investigate genetic risk factors in relation to Return to Work rehabilitation and identify treatment moderators in a multidisciplinary rehabilitation program.

Official Title
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Multidisciplinary Return-to-work Rehabilitation and Return-to-work Follow-up, a Randomized Study of Patients With Complex Symptom Disorders

Conditions
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Complex Symptom Disorders

Intervention / Treatment
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* Behavioral: Return-to-work Rehabilitation + Follow up
* Behavioral: Return-to-work rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age between 18-59 years A self defined goal of increasing their work ability and work participation within a period of no more than six months They fill the criteria of a complex symptom disorder, or they are diagnosed with a common mental disorder A satisfactory level of examination and treatment to participate at Hysnes Rehabilitation Centre Sick leave > 8weeks or receiving work ability assessment benefit for any diagnosis, except as stated below. On a level of linguistic, physical and mental function required to participate in the rehabilitation Exclusion criteria: Ongoing alcohol/drug abuse Ongoing psychosis, ongoing manic episode or suicide risk Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Return to work follow-up<br>Regular contact between the patient and his/her caretaker at the rehabilitation center over a 6 month period, including joint communication between patient, caretaker at the rehabilitation center and stake holders such as social security office, general practitioner and workplace. | Behavioral: Return-to-work Rehabilitation + Follow up<br>* 3 1/2 weeks of Return-to-work rehabilitation followed by 6 months of Return-to-work follow-up<br>* Other names: Acceptance commitment therapy;|
| Active Comparator: Standard follow-up<br>Standard follow-up of the patient after ended rehabilitation by the return-to-work stakeholders, ie. the general practitioner, social security office and the employer. Limited contact between the caretaker at the rehabilitation center and the patient and stakeholders. | Behavioral: Return-to-work rehabilitation<br>* 3 1/2 weeks of Return-to-work rehabilitation followed by standard follow-up<br>* Other names: Acceptance commitment therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work | Differences in cumulative days of sick leave, as reported by the government database FD-Trygd. | 1 year after the end of the stay at the rehabilitation center. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | Quality of life is assessed by 15D, SF8 and function subscale in SF-36 | 5 years after the end of the rehabilitation stay | 
| Functional status | Functional status will be measured with elements from the Norwegian Function Assessment Scale (Osteras et al., 2007) and the function subscale of SF-36 (Ware Jr & Sherbourne, 1992) | 5 year after the end of the rehabilitation stay | 
| level of symptoms (somatic and psychological) | The Hospital Anxiety and Depression Scale (HADS) measure changes in anxiety and depression. Changes regarding physical and mental fatigue are registered through the Chalder Fatigue Questionnaire. Changes in participants subjective experience of pain measured by numerical rating scale (NRS) | 5 year after the end of the rehabilitation stay, | 

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