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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01568970
Enrollment
214
Registered
2012-04-02
Start date
2012-01-31
Completion date
2018-09-30
Last updated
2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Symptom Disorders

Keywords

rehabilitation, return to work, sick leave

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.

Interventions

BEHAVIORALReturn-to-work Rehabilitation + Follow up

3 1/2 weeks of Return-to-work rehabilitation followed by 6 months of Return-to-work follow-up

BEHAVIORALReturn-to-work rehabilitation

3 1/2 weeks of Return-to-work rehabilitation followed by standard follow-up

Sponsors

Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Return to work1 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

MeasureTime frameDescription
quality of life5 years after the end of the rehabilitation stayQuality of life is assessed by 15D, SF8 and function subscale in SF-36
Functional status5 year after the end of the rehabilitation stayFunctional 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)
level of symptoms (somatic and psychological)5 year after the end of the rehabilitation stay,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)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026