Skip to main content
OpenTrials
Completed

NCT Number: NCT01568970

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Complex Symptom Disorders

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hysnes Helsefort, St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Return-to-work Rehabilitation + Follow up

Behavioral

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

Other names: Acceptance commitment therapy

Return-to-work rehabilitation

Behavioral

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

Other names: Acceptance commitment therapy

Primary outcomes

  1. Return to work

    Time frame: 1 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 outcomes

  1. quality of life

    Time frame: 5 years after the end of the rehabilitation stay

    Quality of life is assessed by 15D, SF8 and function subscale in SF-36

  2. Functional status

    Time frame: 5 year after the end of the rehabilitation stay

    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)

  3. level of symptoms (somatic and psychological)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2018
First posted
Apr 2, 2012
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.