Participatory ergonomics for mental health disorders, a randomised controlled trial and cost-effectiveness evaluation
| ISRCTN | ISRCTN92307123 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92307123 |
| Protocol serial number | NTR473 |
| Sponsor | TNO Quality of Life (Work & Employment) (Netherlands) |
| Funder | Expert Reintegration Studies Centre (STECR) (Netherlands) |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 23/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Han J.R. Anema
Scientific
Scientific
VU University Medical Center
Department of Public and Occupational Health and EMGO-Institute
Body@Work TNO
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 4446495/(0)6 13186986 |
|---|---|
| h.anema@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open label active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Is participatory ergonomics for workers with common mental disorders more (cost-)effective on return-to-work than usual clinical medical care? |
| Ethics approval(s) | Added as of 23/08/2007: The Medical Ethics Committee of the VU University Medical Center (Amsterdam, The Netherlands) has approved the study protocol. |
| Health condition(s) or problem(s) studied | Mental disorders |
| Intervention | 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 (PE). 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 return-to-work (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. Patients will be randomised to PE or usual clinical care (n = 2 x 72). A process analysis will be included. |
| Intervention type | Other |
| Primary outcome measure(s) |
Sickleave duration until full return-to-work |
| Key secondary outcome measure(s) |
1. Psychological complaints |
| Completion date | 15/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 160 |
| Key inclusion criteria | 1. Sicklisted due to distress problems due to overwork (completely or partially) 2. Between 18 and 65 years of age |
| Key exclusion criteria | 1. Duration of sick leave longer than 3 months 2. Juridical conflict at work 3. No ability to complete questionnaires written in the Dutch language |
| Date of first enrolment | 15/09/2005 |
| Date of final enrolment | 15/09/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2010 | Yes | No | |
| Results article | results | 01/09/2010 | Yes | No | |
| Protocol article | protocol | 14/01/2008 | Yes | No |
