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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01568970
First received: March 8, 2012
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Complex Symptom Disorders
Behavioral: Return-to-work Rehabilitation + Follow up
Behavioral: Return-to-work rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Multidisciplinary Return-to-work Rehabilitation and Return-to-work Follow-up, a Randomized Study of Patients With Complex Symptom Disorders

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Return to work [ Time Frame: 1 year after the end of the stay at the rehabilitation center. ] [ Designated as safety issue: No ]
    Differences in cumulative days of sick leave, as reported by the government database "FD-Trygd".


Secondary Outcome Measures:
  • quality of life [ Time Frame: 5 years after the end of the rehabilitation stay ] [ Designated as safety issue: No ]
    Quality of life is assessed by 15D, SF8 and function subscale in SF-36

  • Functional status [ Time Frame: 5 year after the end of the rehabilitation stay ] [ Designated as safety issue: No ]
    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)

  • level of symptoms (somatic and psychological) [ Time Frame: 5 year after the end of the rehabilitation stay, ] [ Designated as safety issue: No ]

    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)



Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Return-to-work Rehabilitation + Follow up
3 1/2 weeks of Return-to-work rehabilitation followed by 6 months of Return-to-work follow-up
Other Name: Acceptance commitment therapy
Active Comparator: 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.
Behavioral: Return-to-work rehabilitation
3 1/2 weeks of Return-to-work rehabilitation followed by standard follow-up
Other Name: Acceptance commitment therapy

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568970

Locations
Norway
Hysnes Helsefort, St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Petter Borchgrevink Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01568970     History of Changes
Other Study ID Numbers: 2010/2404
Study First Received: March 8, 2012
Last Updated: July 25, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
rehabilitation
return to work
sick leave

Additional relevant MeSH terms:
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014