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Evaluation of Return to Work Rehabilitation

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ClinicalTrials.gov Identifier: NCT01926574
Recruitment Status : Active, not recruiting
First Posted : August 21, 2013
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
Long-term sick-listing from work has considerable impact on social function, on the families of the sick-listed persons, the companies they work for, and society as a whole. Hence, the need for documented effective vocational rehabilitation programs is pressing. Vocational rehabilitation services described in the scientific literature have been specific to one single or a specific group of medical conditions (e.g.low back pain). In contrast, most people on sick leave have several health complaints, and many of the factors influencing sick leave are shared regardless of disorder (e.g. social surroundings, workplace environment), calling for rehabilitation programs that can be employed for both musculoskeletal-, unspecific- and common mental disorders. Aim of this study is to investigate whether a group based rehabilitation program for musculoskeletal, mental or unspecific complaints can facilitate return-to-work (RTW), thereby testing two multicomponent return-to-work RTW rehabilitation programs.

Condition or disease Intervention/treatment Phase
Sick Leave Occupational Health Behavioral: long rehabilitation program Behavioral: short rehabilitation program Behavioral: Acceptance and commitment therapy (ACT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Inpatient-return- To-work, Multicomponent, Rehabilitation Programs for Persons Temporary Out of Work With Musculoskeletal-, Unspecific-, and/or Common Mental Health Disorders; Randomized Controlled Trial
Actual Study Start Date : January 2013
Actual Primary Completion Date : June 2015
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: long rehabilitation
a 3.5-week, in-patient rehabilitation program, organized as a 7-hour workday with weekends off, simulating a close to normal summer work-week in Norway, and mainly group-based with maximum 8 participants per group. Focus on mental training (aimed at increasing motivation and self-efficacy), physical training and work-related problem solving.
Behavioral: long rehabilitation program
Experimental: short rehabilitation
4+4 full days of rehabilitation at Hysnes Rehabilitation Center, separated by 2 weeks living at home. Group-based with 8 participants per group, focus on mental training (aimed at increasing motivation and self-efficacy), physical training and work-related problem solving. A workplace visit will be included in addition to the 4 + 4 rehabilitation days, if considered relevant.
Behavioral: short rehabilitation program
Active Comparator: Acceptance and commitment therapy
6 dynamic processes (committed action, self-as-context, presence in the moment, values, defusion and acceptance) are targeted both in group-sessions and individual meetings. Only the psychological part of the experimental interventions is applied, in an outpatient setting.
Behavioral: Acceptance and commitment therapy (ACT)
No Intervention: Untouched
this group will be followed in registers at group level and not be aware of their participation in the study



Primary Outcome Measures :
  1. time until full sustainable return-to-work (RTW) [ Time Frame: 1 year ]
    return-to-work i.e. for at least 4 weeks without relapse

  2. Total number of sickness absence days [ Time Frame: 1 year ]
    after enrollment in the study (i.e. after pre-screening)


Secondary Outcome Measures :
  1. Sickness absence days [ Time Frame: 3 years ]
  2. sickness absence days [ Time Frame: 5 years ]
  3. Health related quality of life [ Time Frame: 1 year ]
  4. Subjective health complaints [ Time Frame: 1 year ]
    Pain, depression, anxiety, and other subjective complaints

  5. Physical activity [ Time Frame: 1 year ]
  6. physical, social and emotional functional status [ Time Frame: 1 year ]
  7. Psychological and social factors at work [ Time Frame: 1 year ]
  8. readiness for return to work [ Time Frame: 1 year ]
  9. fear avoidance beliefs [ Time Frame: 1 year ]
  10. psychological flexibility and acceptance [ Time Frame: 1 year ]
  11. share of workers at work [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Health economics from the societal perspective [ Time Frame: 1 year ]
    Cost-effectiveness, cost-utility and cost-benefit methods.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • living in the counties of Trøndelag
  • on sick leave 2-12 months
  • current sick leave status of 50% - 100%
  • ICPC-2 (International Classification of Primary Care, Second edition) diagnosis within the L (musculoskeletal), P (psychiatric) or A (unspecific disorders) categories

Exclusion Criteria:

  • alcohol or drug abuse
  • serious somatic or psychological disorders
  • a specific disorder requiring specialized treatment
  • pregnancy
  • currently participating in another treatment program
  • insufficient Norwegian speaking or writing skills to participate in group session and fill out questionnaires
  • scheduled for surgery within the next 6 months
  • serious problems with functioning in a group setting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926574


Locations
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Norway
Hysnes Rehabilitation Centre
Rissa, Norway
St. Olavs University Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Study Director: Roar Johnsen, phd prof Norwegian University of Science and Technology

Publications of Results:
Other Publications:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01926574     History of Changes
Other Study ID Numbers: 2012/1241-1
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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