This trial is active, not recruiting.

Condition complex symptom disorders
Treatments return-to-work rehabilitation + follow up, return-to-work rehabilitation
Sponsor Norwegian University of Science and Technology
Start date January 2012
End date June 2014
Trial size 200 participants
Trial identifier NCT01568970, 2010/2404


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
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.
return-to-work rehabilitation + follow up Acceptance commitment therapy
3 1/2 weeks of Return-to-work rehabilitation followed by 6 months of Return-to-work follow-up
(Active Comparator)
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.
return-to-work rehabilitation Acceptance commitment therapy
3 1/2 weeks of Return-to-work rehabilitation followed by standard follow-up

Primary Outcomes

Return to work
time frame: 1 year after the end of the stay at the rehabilitation center.

Secondary Outcomes

quality of life
time frame: 5 years after the end of the rehabilitation stay
Functional status
time frame: 5 year after the end of the rehabilitation stay
level of symptoms (somatic and psychological)
time frame: 5 year after the end of the rehabilitation stay,

Eligibility Criteria

Male or female participants from 18 years up to 59 years old.

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

Additional Information

Official title Multidisciplinary Return-to-work Rehabilitation and Return-to-work Follow-up, a Randomized Study of Patients With Complex Symptom Disorders
Principal investigator Petter Borchgrevink
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Norwegian University of Science and Technology.