Multidisciplinary Return-to-work Rehabilitation and Return-to-work Follow-up, a Randomized Study of Patients With Complex Symptom Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- Return to work
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Return to work follow-up
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.
Intervention: Return-to-work Rehabilitation + Follow up (Behavioral)
Standard follow-up
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.
Intervention: Return-to-work rehabilitation (Behavioral)
Outcomes
Primary Outcomes
Return to work
Time Frame: 1 year after the end of the stay at the rehabilitation center.
Differences in cumulative days of sick leave, as reported by the government database "FD-Trygd".
Secondary Outcomes
- quality of life(5 years after the end of the rehabilitation stay)
- Functional status(5 year after the end of the rehabilitation stay)
- level of symptoms (somatic and psychological)(5 year after the end of the rehabilitation stay,)