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

NCT ID: NCT01568970

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2018-09-30

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.

Conditions

Complex Symptom Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Return-to-work Rehabilitation + Follow up

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Return-to-work rehabilitation

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Return-to-work rehabilitation

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Acceptance commitment therapy; Acceptance commitment therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petter Borchgrevink

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

Hysnes Helsefort, St Olavs Hospital

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 28597308 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30298037 (View on PubMed)

Other Identifiers

2010/2404

Identifier Type: -

Identifier Source: org_study_id