Participatory ergonomics for mental health disorders, a randomised controlled trial and cost-effectiveness evaluation

ISRCTN	ISRCTN92307123
DOI	https://doi.org/10.1186/ISRCTN92307123
Secondary identifying numbers	NTR473

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

Not provided at time of registration

Contact information

Dr Han J.R. Anema
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
Email	h.anema@vumc.nl

Study information

Study design	Randomised open label active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Other
Scientific title
Study hypothesis	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.
Condition	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	Sickleave duration until full return-to-work
Secondary outcome measures	1. Psychological complaints 2. Functional status 3. Coping 4. Direct and indirect costs
Overall study start date	15/09/2005
Overall study end date	15/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	160
Participant inclusion criteria	1. Sicklisted due to distress problems due to overwork (completely or partially) 2. Between 18 and 65 years of age
Participant 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
Recruitment start date	15/09/2005
Recruitment end date	15/09/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Center

Amsterdam
1081 BT
Netherlands

Sponsor information

TNO Quality of Life (Work & Employment) (Netherlands)
Research organisation

P.O. Box 718
Hoofddorp
2130 AS
Netherlands

"ROR"	https://ror.org/01bnjb948

Funders

Funder type

Other

Expert Reintegration Studies Centre (STECR) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	14/01/2008	Yes	No
Results article	results	01/09/2010	Yes	No
Results article	results	01/09/2010	Yes	No