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Participative ergonomics for mental health disorders, a randomised controlled trial and cost-effectiveness evalution.


- candidate number1794
- NTR NumberNTR473
- ISRCTNISRCTN92307123
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR28-okt-2005
- Secondary IDsN/A 
- Public TitleParticipative ergonomics for mental health disorders, a randomised controlled trial and cost-effectiveness evalution.
- Scientific TitleParticipatory ergonomics for mental health disorders, a randomised controlled trial and cost-effectiveness evalution.
- ACRONYMN/A
- hypothesisIs participatory ergonomics for workers with common mental disorders more (cost-)effective on return-to-work than usual clinical medical care?
- Healt Condition(s) or Problem(s) studiedMental illness
- Inclusion criteria1. Sicklisted due to distress problems on surmenage niveau (completely of partially); 2. Between 18 and 65 years of age.
- Exclusion criteria1. Duration of sick leave no longer than 3 months; 2. Juridical confict at work; 3. No ability to complete questionnaires written in the Dutch language.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 15-sep-2005
- planned closingdate15-sep-2009
- Target number of participants144
- InterventionsWork(place) adaptations. Based on active participation and strong commitment of both the worker and the employer. It will be applied by a occupational therapist.
- Primary outcomeSickleave duration until full return-to-work.
- Secondary outcomePsychological complaints, functional status, coping and direct and indirect costs.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Han J.R. Anema
- CONTACT for SCIENTIFIC QUERIESDr. Han J.R. Anema
- Sponsor/Initiator TNO Quality of Life (Work and Employment), VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
STECR - Dutch Platform for Return to work
- PublicationsN/A
- Brief summaryBACKGROUND Mental disorders are the main cause of occupational disability in the Netherlands and other countries. For workers sicklisted due to low back pain (LBP) recently a protocol ‘participatory ergonomics’ (PE) was developed and evaluated in the Netherlands. PE accelerated return-to-work with 30 days and was evaluated positively by workers and occupational health care professionals. However, a similar protocol for workers with mental disorders is to date not available and its (cost-)effectiveness has not yet been established. OBJECTIVES -To develop a protocol PE for workers with mental disorders based on the PE-protocol for LBP -To evaluate the cost-effectiveness and applicability of the PE-protocol for workers sicklisted due to mental disorders STUDY POPULATION Workers with mental disorders, visiting their OP will be selected based on the following criteria: sickleave duration shorter than 3 months and distress complaints. INTERVENTIONS - A project group consisting of experts in the field of mental disorders will develop a protocol for workplace adaptations based on methods used in participatory ergonomics. -Work(place) adaptations, will be applied by a trained occupational nurse. A group of stakeholders (sick listed worker, the worker's supervisor, and potential other stakeholders) in the RTW-process will be formed and guided by the occupational nurse. The protocol is directed to achieve consensus among stakeholders regarding feasible work(place) adaptations to facilitate RTW. STUDY DESIGN RCT. Patients will be randomised to PE or usual clinical care (n=2 x 72). A process analysis will be included. OUTCOME MEASURES Outcome measures are: sick leave duration, psychological complaints, functional status (social/at work), coping and direct and indirect costs. Measurements will take place at baseline, 12, 26 and 52 weeks after inclusion.
- Main changes (audit trail)
- RECORD28-okt-2005 - 8-aug-2007


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