|- candidate number||1794|
|- NTR Number||NTR473|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||28-okt-2005|
|- Secondary IDs||N/A |
|- Public Title||Participative ergonomics for mental health disorders, a randomised controlled trial and cost-effectiveness evalution.
|- Scientific Title||Participatory ergonomics for mental health disorders, a randomised controlled trial and cost-effectiveness evalution.
|- hypothesis||Is 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) studied||Mental illness|
|- Inclusion criteria||1. Sicklisted due to distress problems on surmenage niveau (completely of partially);
2. Between 18 and 65 years of age.|
|- Exclusion criteria||1. 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 received||no|
|- multicenter trial||no|
|- planned startdate ||15-sep-2005|
|- planned closingdate||15-sep-2009|
|- Target number of participants||144|
|- Interventions||Work(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 outcome||Sickleave duration until full return-to-work.|
|- Secondary outcome||Psychological complaints, functional status, coping and direct and indirect costs. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. Han J.R. Anema|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Han J.R. Anema|
|- Sponsor/Initiator ||TNO Quality of Life (Work and Employment), VU University Medical Center|
(Source(s) of Monetary or Material Support)
|STECR - Dutch Platform for Return to work|
|- Brief summary||BACKGROUND
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.
-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
Workers with mental disorders, visiting their OP will be selected based on the following criteria: sickleave duration shorter than 3 months and distress complaints.
- 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.
RCT. Patients will be randomised to PE or usual clinical care (n=2 x 72). A process analysis will be included.
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)|
|- RECORD||28-okt-2005 - 8-aug-2007|