Clinical trial NCT01568970: Multidisciplinary Return-to-work Rehabilitation and Return-to Work Follow-up
Official title: Multidisciplinary Return-to-work Rehabilitation and Return-to-work Follow-up, a Randomized Study of Patients With Complex Symptom Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Symptom Disorders
Keywords: rehabilitation
return to work
sick leave
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Return to work
timeFrame: 1 year after the end of the stay at the rehabilitation center.
Secondary outcomes:
measure: quality of life
timeFrame: 5 years after the end of the rehabilitation stay
measure: Functional status
timeFrame: 5 year after the end of the rehabilitation stay
measure: level of symptoms (somatic and psychological)
timeFrame: 5 year after the end of the rehabilitation stay,
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Hysnes Helsefort, St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Petter Borchgrevink
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hara KW, Bjorngaard 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 Jun;28(2):265-278. doi: 10.1007/s10926-017-9711-4.
citation: Vethe D, Kallestad H, Jacobsen HB, Landro NI, Borchgrevink PC, Stiles TC. The Relationship Between Improvement in Insomnia Severity and Long-Term Outcomes in the Treatment of Chronic Fatigue. Front Psychol. 2018 Sep 21;9:1764. doi: 10.3389/fpsyg.2018.01764. eCollection 2018.