Mental Disorders Clinical Trial
Official title:
Effects of Workplace Intervention in Inpatient Occupational Rehabilitation on Return to Work for Persons With Somatic and/or Common Mental Health Problems. A Randomised Controlled Trial
NCT number | NCT02541890 |
Other study ID # | 2014/2279 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | March 2018 |
Verified date | August 2021 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim is to study the effect of a work place intervention during a multicomponent return-to-work rehabilitation program on return-to-work. The intervention is compared with inpatient rehabilitation only, and participants will be recruited from the diagnostic groups dominating the sick-leave statistics, namely musculoskeletal disorders, common mental disorders (e.g. stress, depression and anxiety), and unspecific disorders including chronic fatigue.
Status | Completed |
Enrollment | 175 |
Est. completion date | March 2018 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Resident of Central Norway - Sick-listed due to common mental disorders, musculoskeletal pain/problems, unspecific disorders and/or fatigue - Sick-listed more than 50 % - Sick-listed longer than 8 weeks - Has employer and is willing to participate in a work place intervention during the rehabilitation program Exclusion Criteria: - is self-employed - has, or is currently examined for, a serious somatic or psychiatric disorder - suffers from substance abuse - has trouble with participating in a group - is in a rehabilitation process that will interfere with the occupational rehabilitation program - function level is to weak to participate in the rehabilitation program |
Country | Name | City | State |
---|---|---|---|
Norway | Nowegian University of Science and Technology, Department of public health | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | Trondheim University Hospital |
Norway,
Klevanger NE, Fimland MS, Rise MB. Aligning stakeholders' understandings of the return-to-work process: a qualitative study on workplace meetings in inpatient multimodal occupational rehabilitation. Int J Qual Stud Health Well-being. 2021 Dec;16(1):194692 — View Citation
Rise MB, Skagseth M, Klevanger NE, Aasdahl L, Borchgrevink P, Jensen C, Tenggren H, Halsteinli V, Jacobsen TN, Løland SB, Johnsen R, Fimland MS. Design of a study evaluating the effects, health economics, and stakeholder perspectives of a multi-component occupational rehabilitation program with an added workplace intervention - a study protocol. BMC Public Health. 2018 Feb 5;18(1):219. doi: 10.1186/s12889-018-5130-5. — View Citation
Skagseth M, Fimland MS, Rise MB, Johnsen R, Borchgrevink PC, Aasdahl L. Effectiveness of adding a workplace intervention to an inpatient multimodal occupational rehabilitation program: A randomized clinical trial. Scand J Work Environ Health. 2020 Jul 1;4 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of days on sick-leave | Register data from the national health and welfare services | 12 months | |
Primary | Time until sustainable return to work | Register data from the national health and welfare services | 12 months | |
Secondary | Use of health services. Questionnaire. "How much of this health/social service have you used during the last 4 months?" | 160 participants. "How much of this health/social service have you used during the last 4 months?" Somatic and mental health specialized care (in-patient and outpatient), general practitioner, psychologist, group therapy, physiotherapist, chiropractor, occupational rehabilitation, welfare services, complementary practitioner, emergency unit, ambulatory services, occupational health services, other treatment. | 12 months | |
Secondary | Pain. Questionnaire | Brief pain inventory (BPI). 160 participants | 12 months | |
Secondary | Health related quality of life. Questionnaire | The 15D health-related quality of life instrument. 160 participants | 12 months | |
Secondary | Psychological flexibility and acceptance. Questionnaire | Acceptance and action questionnaire and work acceptance and action questionnaire (AAQ2). 160 participants | 5 months | |
Secondary | Return to work self efficacy. Questionnaire. | Return to work self-efficacy-19 (RTWSE-19). 160 participants. | 5 months | |
Secondary | Fear and avoidance beliefs about work. Questionnaire | Fear Avoidance Belief Questionnaire (FABQ). 160 participants | 5 months | |
Secondary | Expectations about sick leave and return to work. Questionnaire | 160 participants. "How long do you anticipate to be sick-listed (partly/fully)?" 3 questions. | 5 months | |
Secondary | Work ability. Single question | 160 participants. "How will you rate your work ability?" (scale from 0 (no ability) to 10 (my best ability)). | 5 months | |
Secondary | Well-being at work. Single question | 160 participants. "How happy are you at work?" (not at all, not so good, good. very good) | 5 months | |
Secondary | Readiness for return to work. Questionnaire | 160 participants. Readiness for return to work (RRTW) questionnaire. | 5 months |
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