Complex Symptom Disorders Clinical Trial
Official title:
Multidisciplinary Return-to-work Rehabilitation and Return-to-work Follow-up, a Randomized Study of Patients With Complex Symptom Disorders
| NCT number | NCT01568970 |
| Other study ID # | 2010/2404 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2012 |
| Est. completion date | September 2018 |
| Verified date | December 2018 |
| Source | Norwegian University of Science and Technology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 214 |
| Est. completion date | September 2018 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 59 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Hysnes Helsefort, St Olavs Hospital | Trondheim |
| Lead Sponsor | Collaborator |
|---|---|
| Norwegian University of Science and Technology |
Norway,
Hara KW, Bjørngaard JH, Brage S, Borchgrevink PC, Halsteinli V, Stiles TC, Johnsen R, Woodhouse A. Randomized Controlled Trial of Adding Telephone Follow-Up to an Occupational Rehabilitation Program to Increase Work Participation. J Occup Rehabil. 2018 Ju — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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, |