Contact information
Type
Scientific
Primary contact
Dr Han J.R. Anema
ORCID ID
Contact details
VU University Medical Center
Department of Public and Occupational Health and EMGO-Institute
Body@Work TNO
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4446495/(0)6 13186986
h.anema@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR473
Study information
Scientific title
Acronym
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
Added as of 23/08/2007: The Medical Ethics Committee of the VU University Medical Center (Amsterdam, The Netherlands) has approved the study protocol.
Study design
Randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
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
Phase
Not Specified
Drug names
Primary outcome measures
Sickleave duration until full return-to-work
Secondary outcome measures
1. Psychological complaints
2. Functional status
3. Coping
4. Direct and indirect costs
Overall trial start date
15/09/2005
Overall trial end date
15/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Sicklisted due to distress problems due to overwork (completely or partially)
2. Between 18 and 65 years of age
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
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
Trial participating centre
VU University Medical Center
Amsterdam
1081 BT
Netherlands
Funders
Funder type
Other
Funder name
Expert Reintegration Studies Centre (STECR) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18194525
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20363809
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20798027
Publication citations
-
Protocol
van Oostrom SH, Anema JR, Terluin B, de Vet HC, Knol DL, van Mechelen W, Cost-effectiveness of a workplace intervention for sick-listed employees with common mental disorders: design of a randomized controlled trial., BMC Public Health, 2008, 8, 12, doi: 10.1186/1471-2458-8-12.
-
Results
van Oostrom SH, Heymans MW, de Vet HC, van Tulder MW, van Mechelen W, Anema JR, Economic evaluation of a workplace intervention for sick-listed employees with distress., Occup Environ Med, 2010, 67, 9, 603-610, doi: 10.1136/oem.2009.051979.
-
van Oostrom SH, van Mechelen W, Terluin B, de Vet HC, Knol DL, Anema JR, A workplace intervention for sick-listed employees with distress: results of a randomised controlled trial., Occup Environ Med, 2010, 67, 9, 596-602, doi: 10.1136/oem.2009.050849.